Native mass spectrometry-directed drug discovery: Recent advances in investigating protein function and modulation

✅ 全文

天然质谱导向的药物发现:在蛋白质功能与调控研究中的最新进展

作者 Francesco Fiorentino; Dante Rotili; Antonello Mai 期刊 Drug Discovery Today 发表日期 2023 ISSN 1359-6446 DOI 10.1016/j.drudis.2023.103548 类型 原创研究 (Original Research)

📄 中文摘要 Chinese Abstract

中文
天然质谱(nMS)是一种在气相中保持非共价相互作用的生物物理技术,能够在接近天然状态下研究蛋白质复合物。该技术为蛋白质-配体及蛋白质-蛋白质相互作用(PPIs)、亚基化学计量比以及复合物组成提供了关键见解。在早期药物发现中,nMS日益展现出重要价值,尤其适用于表征传统方法难以分析的动态寡聚体和膜蛋白等挑战性靶标,因为等温滴定量热法(ITC)、表面等离子共振(SPR)、核磁共振(NMR)或X射线晶体学等方法存在蛋白标记、固定化或缺乏酶活性等局限性。

📋 英文结构化总结 English Structured Summary

全文整理

EN

Background:

Native mass spectrometry (nMS) is a biophysical technique that preserves non-covalent interactions in the gas phase, enabling the study of protein complexes in their native state. It provides critical insights into protein–ligand and protein–protein interactions (PPIs), subunit stoichiometry, and complex composition. nMS has become increasingly valuable in early drug discovery, particularly for characterizing challenging targets such as dynamic oligomers and membrane proteins, which are difficult to analyze using traditional methods like ITC, SPR, NMR, or X-ray crystallography due to limitations including protein labeling, immobilization, or lack of enzymatic activity.

Methods:

This is a review article; therefore, no original experimental methodology is presented. The authors discuss recent advances and applications of nMS in drug discovery by synthesizing findings from published studies. The review focuses on three main areas: evaluation of protein–ligand interactions, assessment of PPI modulators, and analysis of proteolysis-targeting chimeras (PROTACs). Techniques highlighted include nano-electrospray ionization (nESI), size exclusion chromatography coupled with nMS (SEC-nMS), ion mobility–mass spectrometry (IM-MS), collision-induced unfolding (CIU), tandem MS (MSⁿ) for ligand identification, and variable-temperature nMS for thermodynamic profiling.

Results:

nMS has been successfully applied to detect and quantify protein–ligand interactions with minimal sample consumption (picomolar quantities) and without labeling or immobilization. It enables direct observation of binding events, calculation of dissociation constants (K_D), and identification of allosteric mechanisms. Studies demonstrate its utility in screening natural product libraries, analyzing membrane protein–ligand interactions (e.g., GPCRs, BAM complex), and evaluating ligand binding directly from cell lysates. nMS also effectively assesses PPI modulators by monitoring compound-induced disruption or stabilization of protein complexes, as shown in systems like LptH, M^pro, KRas–SOScat, and 14-3-3 protein interactions. Furthermore, nMS captures ternary complex formation in PROTAC-mediated degradation pathways, revealing selectivity and cooperativity effects.

Data Summary:

Key quantitative results include: identification of 96 potential binders from a natural product fragment screen against 32 *Plasmodium falciparum* proteins; K_D values in the low micromolar range (e.g., 27 µM for 1,2,3,4,6-penta-O-galloyl-β-D-glucose binding to hCAI; 21 µM for a JNK3 ligand); VC50 measurements correlating with K_D for IDO1 inhibitors; and stoichiometric quantification of ternary complexes (e.g., optimal 1:2:1 E3 ligase:PROTAC:POI ratio for VCB–AT1–Brd4^BD2). nMS also revealed that cardiolipin enhances darobactin A binding to the BAM complex and that Zn²⁺ stabilizes tb1AR–mini-Gs coupling, abolished by EDTA and restored by ZnCl₂.

Conclusions:

nMS is a powerful, complementary tool in early drug discovery that overcomes key limitations of conventional biophysical methods. It allows direct, label-free analysis of native protein complexes, provides stoichiometric and thermodynamic insights, and supports hit validation across diverse target classes—including soluble proteins, membrane proteins, and multi-subunit complexes. Its integration with automation (e.g., chip-based nESI, SEC-nMS) enhances throughput and reproducibility. nMS is particularly effective for evaluating PPI modulators and PROTAC efficacy, offering mechanistic clarity on compound modes of action and enabling structure–activity relationship (SAR) studies in complex biological contexts.

Practical Significance:

The real-world impact of nMS lies in its ability to accelerate preclinical drug discovery by enabling rapid, accurate characterization of drug–target interactions for challenging but therapeutically important proteins. It supports the development of novel antibiotics (e.g., targeting LPS transport or efflux pumps), anticancer agents (e.g., KRas–SOS disruptors, PROTACs), and modulators of epigenetic or signaling pathways. By facilitating direct observation of binding events in near-physiological conditions and even in crude cellular lysates, nMS improves hit validation, reduces false positives/negatives, and informs rational drug design across academia and industry.

📋 中文结构化总结 Chinese Structured Summary

中文

背景:

天然质谱(nMS)是一种在气相中保持非共价相互作用的生物物理技术,能够在接近天然状态下研究蛋白质复合物。该技术为蛋白质-配体及蛋白质-蛋白质相互作用(PPIs)、亚基化学计量比以及复合物组成提供了关键见解。在早期药物发现中,nMS日益展现出重要价值,尤其适用于表征传统方法难以分析的动态寡聚体和膜蛋白等挑战性靶标,因为等温滴定量热法(ITC)、表面等离子共振(SPR)、核磁共振(NMR)或X射线晶体学等方法存在蛋白标记、固定化或缺乏酶活性等局限性。

方法:

本文为综述文章,未呈现原创实验方法。作者通过整合已发表的研究成果,讨论了nMS在药物发现中的最新进展与应用。综述聚焦于三个主要领域:蛋白质-配体相互作用的评估、PPI调节剂的分析以及蛋白水解靶向嵌合体(PROTACs)的鉴定。重点介绍的技术包括纳升电喷雾电离(nESI)、尺寸排阻色谱联用nMS(SEC-nMS)、离子淌度质谱(IM-MS)、碰撞诱导去折叠(CIU)、串联质谱(MSⁿ)用于配体鉴定,以及变温nMS用于热力学分析。

结果:

nMS已成功应用于检测并定量蛋白质-配体相互作用,样品消耗量极低(皮摩尔级别),且无需标记或固定化。该技术可直接观测结合事件、计算解离常数(K_D)并识别别构机制。研究表明,nMS可用于天然产物文库筛选、膜蛋白-配体相互作用分析(如GPCRs、BAM复合物),以及直接从细胞裂解液中评估配体结合。nMS还可通过监测化合物诱导的蛋白质复合物解离或稳定化来有效评估PPI调节剂,已在LptH、M^pro、KRas–SOScat及14-3-3蛋白相互作用等体系中得到验证。此外,nMS能够捕获PROTAC介导降解通路中的三元复合物形成,揭示选择性与协同效应。

数据总结:

关键定量结果包括:针对32种恶性疟原虫蛋白的天然产物片段筛选中鉴定出96种潜在结合剂;K_D值处于低微摩尔范围(如1,2,3,4,6-五-O-没食子酰-β-D-葡萄糖与人碳酸酐酶I结合的K_D为27 µM;某JNK3配体为21 µM);IDO1抑制剂的VC50测量值与K_D相关;以及三元复合物的化学计量定量(如VCB–AT1–Brd4^BD2体系中E3连接酶:PROTAC:靶蛋白的最优比例为1:2:1)。nMS还揭示心磷脂可增强达罗巴汀A与BAM复合物的结合,Zn²⁺可稳定tb1AR–mini-Gs偶联,该作用可被EDTA消除并由ZnCl₂恢复。

结论:

nMS是早期药物发现中一种强有力的补充工具,克服了传统生物物理方法的关键局限性。它允许对天然蛋白质复合物进行直接、无标记分析,提供化学计量与热力学信息,并支持多种靶标类别(包括可溶性蛋白、膜蛋白及多亚基复合物)的命中验证。其与自动化技术(如芯片式nESI、SEC-nMS)的整合提高了通量与可重复性。nMS在评估PPI调节剂及PROTAC效能方面尤为有效,可阐明化合物作用机制,并在复杂生物环境中支持构效关系(SAR)研究。

实际意义:

nMS的实际价值在于其能够通过快速、准确地表征药物-靶标相互作用,加速临床前药物发现,尤其适用于治疗重要但具有挑战性的蛋白质。它支持新型抗生素(如靶向LPS转运或外排泵)、抗癌药物(如KRas–SOS抑制剂、PROTACs)以及表观遗传或信号通路调节剂的开发。通过在接近生理条件甚至粗提细胞裂解液中直接观测结合事件,nMS提高了命中验证的准确性,减少假阳性与假阴性结果,并为学术界和工业界的理性药物设计提供依据。

📖 英文全文 English Full Text

EN

Francesco Fiorentino 1,⇑, Dante Rotili 1,⇑, Antonello Mai 1,2

1 Department of Drug Chemistry and Technologies, Sapienza University of Rome,

Piazzale Aldo Moro 5, 00185 Rome, Italy 2 Pasteur Institute, Cenci-Bolognetti Foundation, Sapienza University of Rome,

Piazzale Aldo Moro 5, 00185 Rome, Italy Native mass spectrometry (nMS) is a biophysical method for studying protein complexes and can provide insights into subunit stoichiometry and composition, protein–ligand, and protein–protein interactions (PPIs). These analyses are made possible by preserving non-covalent interactions in the gas phase, thereby allowing the analysis of proteins in their native state. Consequently, nMS has been increasingly applied in early drug discovery campaigns for the characterization of protein– drug interactions and the evaluation of PPI modulators. Here, we discuss recent developments in nMS-directed drug discovery and provide a timely perspective on the possible applications of this technology in drug discovery.

Keywords: native mass spectrometry; protein–ligand interactions; protein–protein interactions; PROTAC; membrane proteins

Introduction Proteins are a fundamental part of living organisms, given their involvement in all cellular pathways. They control all aspects of life, including, but not limited to, regulation of gene expression, catalysis of biochemical reactions, signaling, and transportation of molecules essential for cellular metabolism.1 Therefore, non- covalent interactions between proteins and their partners (including other proteins, nucleic acids, lipids, carbohydrates, and small molecules) are at the core of myriad biological processes, such as transcriptional regulation, cell differentiation, immune response, cell adhesion, and inflammation. These interactions are governed by a variety of forces, including hydrogen bonds, electrostatic interactions, Van der Waals, and hydrophobic forces.2 Importantly, the characterization of protein–ligand inter- actions is at the core of the drug discovery process. In fact, elucidation of protein structures and dynamics and the quantification of the kinetic and thermodynamic

Francesco Fiorentino graduated in medici- nal chemistry from Sapienza University of

Rome in 2016. He received his PhD in bio- physical chemistry from the University of

Oxford in 2020 under the supervision of Dame Carol Robinson, working on the elu- cidation of the structure and regulation of membrane proteins using mass spectrom- etry. Following a 1-year postdoc in the same lab, he joined the Mai group at

Sapienza University of Rome as a postdoc- toral researcher. His research focuses on the application of native mass spectrometry and other biophysical techniques to investigate the protein complexes involved in the epigenetic regulation of cellular homeostasis and in bacterial membrane biogenesis.

Dante Rotili graduated in medicinal chem- istry from Sapienza University of Rome in

2003. He received his PhD in pharmaceuti- cal sciences from the same University in

2007. From 2009 to 2010, he was a research associate in the Department of Chemistry,

University of Oxford, where he worked in collaboration with Chris Schofield in the development of chemoproteomic probes for the characterization of 2-oxoglutarate- dependent enzymes.

In 2020, he was appointed an associate professor of medicinal chemistry at

Sapienza University of Rome. His research focuses mainly on the development of modulators of epigenetic enzymes with potential applications in cancer, neurodegenerative, metabolic, and infec- tious diseases.

Antonello Mai graduated in pharmacy from Sapienza University of Rome in 1984, from where he received his PhD in 1992 in pharmaceutical sciences under the super- vision of

M.

Artico.

In 1998, he was appointed associate professor of medicinal chemistry and, in 2011, full professor of medicinal chemistry at Sapienza University of Rome. His research interests include the synthesis and biological evaluation of new bioactive small-molecule compounds, in particular modulators of epigenetic targets, for use as chemotherapeutic agents against cancer, metabolic disorders, neurodegenerative diseases, and parasitic infections. In addition, he works in the fields of antibacterial/antimycobacterial, antiviral, and central nervous system agents.

Native mass spectrometry-directed drug discovery: Recent advances in investigating protein function and modulation

⇑Corresponding authors: Fiorentino, F. (f.fiorentino@uniroma1.it), Rotili, D. (dante.rotili@uniroma1.it).

Drug Discovery Today d Volume 28, Number 5 d May 2023

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1 parameters of protein–ligand binding constitute the earliest steps in the development of drugs that could be used to treat various pathologies.3

To date, a large toolbox of biophysical technologies is used during preclinical drug development to characterize protein–li- gand interactions in vitro, each with its own set of strengths and shortcomings. These include isothermal titration calorime- try (ITC),4 surface plasmon resonance (SPR),5 nuclear magnetic resonance (NMR) spectroscopy,6 and X-ray crystallography.7

Despite the tremendous advances obtained by using these tech- niques, significant technological problems in drug development persist. Indeed, some protein species, such as dynamic protein oligomers and membrane protein complexes, remain difficult to target despite their enormous therapeutic potential. The tran- sient nature of certain protein complexes, the instability of mem- brane proteins, and the possible lack of any enzymatic activity make these targets extremely challenging to investigate for drug development. Compounds that influence the function of these complicated targets cannot be easily evaluated by typical bio- physical methods, which provide information on the average solution properties of the system and might not inform on single binding events or ligand influence on oligomeric states. More- over, these approaches often require protein labeling or immobi- lization, which may alter the subtle equilibria being evaluated.

Hence, complementary methodologies that increase our under- standing of structural, thermodynamic, and kinetic features of drug action could accelerate preclinical drug development. nMS is a promising methodology to investigate protein–li- gand interactions that also allows the assessment of more chal- lenging targets. It is a technique that enables the preservation of non-covalent interactions and quaternary protein structure in the gas phase. Moreover, unlike conventional denaturing

MS, which often includes organic solvents and a low pH, nMS uses volatile, aqueous buffers at near-physiological pH and gen- tler voltages and ion transfer tube temperatures (usually

<200 C) compared with classic MS techniques. These differences with respect to other MS approaches contribute to the preserva- tion of the native or native-like structures of the studied protein complexes.8 This enables the quantification of dissociation con- stants for PPIs and protein–ligand interactions, the assessment of small-molecule mode of action, and the study of protein com- plex stoichiometry and subunit architecture and dynamics (Figure 1).9 nMS takes advantage of the milder nature of electrospray ion- ization (ESI) compared with other ionization methods [e.g., matrix-assisted laser desorption/ionization (MALDI), atmo- spheric pressure chemical ionization (APCI), or electron ioniza- tion (EI)] to transfer protein complexes from volatile buffered aqueous solutions into the gas phase and maintain the non- covalent interactions during this process.10–12 The most common ionization method used in nMS is nanoESI (nESI), a subtype of

ESI characterized by a smaller diameter of the capillary needle (usually 1–5 lm in nESI, whereas it reaches up to 0.5 mm in

ESI) orifice and very slow flow rates (10–50 nl/min),13 which

Buffer exchange + Ligand Sample loading (1-3 µL) nESI

Mass spectrometer 100 3000 3500 4000 4500 m/z 0 % 9+

8+ 10+ 11+ 2500 3000 3500 4000 4500 m/z 100 0 % 100

0 % 2000 3000 4000 5000 m/z 6000 9+ 6+ 13+ 12+ 11+

8+ 10+ 7+ 14+ 6+ 7+ 20 µM 0 µM 10 µM Protein–ligand interaction evaluation

Assessment of protein–protein interaction modulators

Assessment of PROTAC efficacy 20 µM 0 µM Drug Discovery Today

FIGURE 1 Typical workflow for the analysis of ligand binding via native mass spectrometry (nMS). The protein solution is first buffer exchanged into a water solution containing a volatile salt (usually ammonium acetate) using size exclusion chromatography (SEC) or dialysis. This step can be avoided when using nanoscale emitters. The protein is then incubated with increasing concentrations of the ligand of interest, and the mixture is injected into gold-coated emitters for mass spectrometric analysis. The resulting spectra show two peaks, one for the apo protein and one for the ligand-bound complex in the case of protein–ligand binding analysis. In the case of protein–protein interaction (PPI) modulators, the spectra will inform on the influence of the compounds on the assembly of multiprotein complexes. In the case of proteolysis-targeting chimeras (PROTACs), the spectra will show the formation of the protein–PROTAC–E3 ligase ternary complex.

KEYNOTE (GREEN) KEYNOTE (GREEN) Drug Discovery Today d Volume 28, Number 5 d May 2023

2 www.drugdiscoverytoday.com make nESI more amenable for studying protein complexes. In fact, given the smaller orifice, the initial droplet size is at least one order of magnitude smaller, thus reducing the energy and the number of fission events necessary to yield gas-phase ions.8

Decades of advances in mass analyzers and detectors made it pos- sible to transmit and detect intact proteins. Further develop- ments, including manipulation of pressure gradients within the instruments, enable the preservation of non-covalent interac- tions in the gas phase within the instrument.14,15 Moreover, the integration of nMS with multistage tandem MS (MSn) approaches enables the identification of unknown ligands bound to the target protein. In tandem MS experiments, the precursor ions are mass selected (e.g., in a quadrupole or ion trap) and then subjected to a specific type of activation [e.g., via collision- induced dissociation (CID) or electron-capture dissociation (ECD)]. Following dissociation, the ions are then analyzed according to their m/z. Depending on the used instrument, tan- dem MS experiments can be performed multiple times, thereby allowing for MSn experiments, which can then be used to iden- tify ligands dissociated from their protein partners based on their fragmentation pattern. In this regard, ground-breaking work by

Klassen et al. paved the way for both the evaluation of protein– ligand binding via nMS and the use of MSn experiments in drug discovery.16–19

The main advantages of nMS compared with other biophysi- cal techniques include the absence of any label or protein immo- bilization, low sample consumption (picomoles of protein are used for each measurement), direct measurement of interactions, and the capacity to distinguish distinct protein species within a heterogeneous population.9,20 Given these features, nMS is rec- ognized as a highly informative technology for early drug discov- ery campaigns. In particular, nMS provides assistance for NMR,

X-ray crystallography, and cryogenic electronic microscopy (cryo-EM) studies because it allows evaluation of the purity, homogeneity, and integrity of protein samples, as well as the measurement of complicated stoichiometries.9,21–23

Similar to other techniques, nMS has not only advantageous properties but also limitations, such as the presence of possible false negatives (gas-phase breakdown of hydrophobic interac- tions) and false positives (nonspecific binding). These constraints can be solved by optimizing sample preparation or nESI approaches24–26 and by using appropriate statistical methods to account for nonspecific interactions developing during the nESI process.16,27

Overall, nMS complements the existing portfolio of in vitro characterization methods and is considered a viable method for identifying, validating, and characterizing hit/lead compounds.

This application has been bolstered by advances in instrument technology, which facilitate the examination of bigger, more complicated protein complexes. Indeed, technological advances have resulted in ultra-high mass range spectrometers, which allow for the investigation of complexes formed between small molecules and large proteins, hence expanding the dynamic range of nMS.28–33 Moreover, the optimization of solubilization methods of membrane proteins is vital for the observation of intact membrane protein complexes in a mass spectrometer,34–

36 and has allowed the analysis of interactions between small molecules and membrane proteins,29,37–39 including G-protein- coupled receptors (GPCRs).24,40–42 Finally, nMS coupled with variable temperature nESI enabled the determination of thermo- dynamic parameters [Gibbs free energy upon binding (DG), enthalpy (DH), and entropy (-TDS)] of protein–ligand interac- tions and PPIs, which are important parameters to consider dur- ing drug development.43

In this review, we discuss the most recent applications of nMS for the analysis of protein–ligand interactions, the assessment of

PPI modulators, and the evaluation of the so-called ‘proteolysis- targeting chimeras’ (PROTACs) (Figure 1). We describe the wide applicability of nMS in early drug discovery and highlight the new advancements, future opportunities, as well as challenges of nMS for investigating protein function and modulation (Table 1).

Applications of native MS in drug discovery Protein–ligand interaction evaluation nMS coupled to nESI has been widely used to detect and quantify protein–ligand interactions, including small molecules, peptides, and, particularly in the case of membrane proteins, lipids.22,41,44–

48 Nonetheless, care should be taken when analyzing native mass spectra displaying non-covalent protein–ligand interactions and appropriate data analysis and statistical approaches should be used to account for nonspecific interactions arising during the

ESI process.27 For a complete overview of the accurate determina- TABLE 1

Summary of the advantages and challenges for the different applications of nMS in drug discovery.

Application Advantages Challenges Protein–ligand interaction evaluation

Calculation of KD values with minimal sample consumption

Observation of single binding events and quick identification of allosteric mechanisms

Assessment of protein–ligand interactions for multiple compounds in a single experiment

Experiments still relatively low throughput without use of chip-based nESI platforms

Possible experimental false negatives (gas-phase breakdown of hydrophobic interactions) or false positives (nonspecific binding)

Assessment of PPI modulators and PROTACs Observation of protein complex stoichiometry and compound- mediated disruption/stabilization with no need for labeling or immobilization

Evaluation of allosteric effects and cooperativity in context of protein oligomerization or multiprotein complex formation

Minimal sample consumption Experiments still relatively low throughput without use of chip-based nESI platforms

Multiprotein complexes in equilibrium with their subcomplexes or subunits can yield complex spectra that are difficult to interpret

KEYNOTE (GREEN) Drug Discovery Today d Volume 28, Number 5 d May 2023

KEYNOTE (GREEN) www.drugdiscoverytoday.com 3 tion of protein–ligand interactions using nMS, we refer the reader to recent reviews by Bennett and colleagues49 and Gavriili- dou et al., with the latter focusing primarily on high-throughput nMS for drug screening.50 nMS can successfully evaluate protein–ligand interactions in a reasonably medium-throughput way (100 ligands per hour) using a procedure known as bioaffinity MS. This approach involves the incubation of a ligand or combination of ligands with a protein of interest, with the resultant solution being examined directly by nMS. The identification of bound small molecules may be determined easily by measuring the difference in the mass-to-charge ratio (m/z) between the ligand-bound and apo protein peaks (Figure 1). The use of nMS for compound library screening is gaining increasing interest, as exemplified by the studies by Vu et al.51 and Nguyen et al.,52 which we discuss below. Hence, chip-based automated nESI platforms, such as the

NanoMate,53 are being increasingly used because they provide constant nESI conditions and greater reproducibility, along with augmented throughput. An example of this approach was pro- vided by Vu et al., who applied nMS to screen a library of natural product fragments against 62 Plasmodium falciparum proteins selected as potential malaria drug targets. Each protein was incu- bated with fragments at ligand:protein molar ratios varying from

5:1 to 20:1. This approach enabled the identification of 96 poten- tial binders, which formed complexes with 32 proteins. The 96 natural product fragments had different chemotypes and were different from the known antimalarial aminoquinolines, quino- lones, or diamidines. Interestingly, the technique managed to distinguish between promiscuous and nonpromiscuous pan- assay interference compounds (PAINS), such as polyphenols, epoxides, Michael acceptors, and b-lactams, thereby confirming the ability of nMS to capture specific interactions.51

More recently, Nguyen and coworkers integrated nMS and untargeted metabolomics to develop a method to identify natu- ral products that interact with potential drug targets.52 Specifi- cally, they incubated crude natural product extracts containing thousands of small molecules with the target proteins and applied a quick, low-volume gel filtration step using 0.5-ml desalting columns to remove unbound ligands. This was fol- lowed by nMS analysis to capture and quantify protein–ligand interactions (Figure 2a) and by the identification of the bound hits through metabolomics. To do so, they used nanoscale nESI emitters (internal diameter of 250 nm), which, differently from the widely used microscale emitters, are tolerant of the presence of salt and enable the analysis of complex mixtures, such as those containing thousands of natural products.25 Through this approach, the authors identified novel and known binders of human carbonic anhydrases (hCA), a family of metalloenzymes that catalyze CO2 hydration,54 which is attracting attention because it is implicated in the initiation and progression of sev- eral pathologies, including cancer.55 To determine the identity of the bound ligands, they performed MSn analysis with a linear ion trap (Figure 2a). This approach, already exploited for the identification of ligands bound to either soluble or membrane proteins,28,56 involved the isolation of the ligand-bound protein followed by dissociation and fragmentation of the ligand to gain a fragmentation spectrum (Figure 2a). This led to identification of 1,2,3,4,6-penta-O-galloyl-b-D-glucose (Figure 2b) as a new ligand of hCAI and the binding was later confirmed in nMS- based titration experiments, yielding a KD value of 27 lM.25

Agasid et al. also used nanoscale nESI emitters (internal diam- eter of 100 nm) for the analysis of GPCRs in buffers containing high concentrations of sodium ions.24 This allowed for the detec- tion of adenosine 2A receptor (A2AR) in lauryl maltose neopentyl glycol (LMNG) detergent micelles bound to up to seven sodium ions, as well as investigation of the effects of A2AR agonists (NECA and CGS21680) and antagonists (XAC and ZM241385) on sodium binding. Indeed, whereas both agonists abolished protein–sodium ion interaction, this was instead retained in the presence of both antagonists, in line with solution-based studies in which only inactive conformations maintain sodium ions in the allosteric binding pockets.57 The glucagon receptor was successfully observed in mixed micelles containing the recently developed first-generation, dendritic oligoglycerol deter- gent (G1)35,42 and cholesteryl hemisuccinate. The authors cap- tured glucagon binding, whereas no sodium adducts were observed this time. They also observed the binding of the nega- tive allosteric modulator NNC0666, which had been added dur- ing purification to stabilize the protein and the identity of which was confirmed via MSn on a Orbitrap-Ion Trap mass spectrometer.

Another interesting method used for the quantification of protein–ligand affinities was described by Ren and coworkers, who developed an online

SEC-nMS platform (Figure 2c).

Through this procedure, they calculated the KD values for the interaction of small-molecule inhibitors with the catabolic enzyme indoleamine 2,3-dioxygenase 1 (IDO1)58 and these val- ues were in line with chip-based53 nESI-nMS measurements. To do so, they incubated IDO1 with increasing concentrations (0.5–100 lM) of different ligands, followed by a 3-min SEC run coupled to a nESI-nMS system (Figure 2d, upper-left panel). Fur- thermore, one-shot competition experiments by mixing IDO1 with an equimolar mixture of two potential binders (called com- pounds 1 and 2 in the paper) indicated a higher abundance of

IDO1-1 adducts (Figure 2d, upper-right panel), in line with KD calculations. In addition, the authors analyzed protein–ligand interactions in the gas phase by performing in-source CID exper- iments. These are executed by increasing the collision voltage until full complex dissociation, allowing calculation of the

VC50 parameter (i.e., the collision voltage required to dissociate the protein–ligand complex by 50%), which was found to be independent from the protein:ligand ratio. Moreover, a higher

VC50 value was obtained for the more tightly bound ligand (com- pound 1), thus being in line with the measured KD values (Fig- ure 2d, lower panels). Overall, this method enabled accurate measurements in this system, with the main advantages relying on the automation and rapidity of the analysis and the mini- mization of the residence time in ammonium acetate. By con- trast, assessment of weak interactions might be hindered in cases in which the dissociation rate is fast enough to occur dur- ing the chromatographic separation. nMS has also been applied in conjunction with fluorescence thermal shift assays for the identification of new ligands of the serine/threonine kinase c-Jun N-terminal kinase 3 (JNK3).59 Fol- lowing identification of seven potential hits through fluores- cence thermal shift (FTS) assays, nMS was used to calculate the

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4 www.drugdiscoverytoday.com binding affinities of these compounds, which have a diverse sub- set of scaffolds, including N-(1H-pyrazol-4-yl)thieno[2,3-d]pyri midin-4-amine (four compounds), 5-(phenylamino)-1H-1,2,3- triazole-4-carboxamide (one compound), triazolmethypiperidine (one compound), and piperidinecarboxamide (one compound). nMS successfully captured protein–ligand interactions for four of these compounds, with 5, bearing a 5-(phenylamino)-1H- 1,2,3-triazole-4-carboxamide core, being the most tightly bound ligand, with a KD value of 21 lM.

Recently, D’Amico et al. described an ion mobility-nMS (IM- MS) method coupled to droplet microfluidics for analyzing pro- tein–ligand interactions by assessing the influence of ligand

Drug Discovery Today FIGURE 2 Evaluation of protein-ligand interactions. (a) Schematic indicating the key steps necessary for the identification of small molecules bound to the target protein via native mass spectrometry (nMS) following incubation with extracts containing thousands of natural products. (b) Structure of 1,2,3,4,6-penta-O- galloyl-b-D-glucose. (c) Schematic of workflow used for size exclusion chromatography (SEC)-nMS. (d) Evaluation of the binding affinity between IDO1 and two small molecules via SEC-nMS (upper panels) along with measurement of the VC50 constant and demonstration that the VC50 value is independent from the protein:ligand ratio (lower panels). (e) Structure of darobactin A. (f) Mass spectra of the b-barrel assembly machinery (BAM) complexes in the presence of both cardiolipin (CL) and darobactin (DB) (left panel). Central panel: expansion of the 23+ charge state to focus on CL, darobactin, and CL + darobactin binding to BAM. Right panel: quantification of the darobactin-bound peak intensities relative to the corresponding darobactin-free species. Adapted, with permission, from 52 (a), 58 (d), and 66 (f).

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KEYNOTE (GREEN) www.drugdiscoverytoday.com 5 binding on protein stability in the gas phase.60 Before mass spec- trometric analysis, IM enables the separation of protein ions based on their size and shape within a drift tube filled with neu- tral gas under the influence of a weak electric field. The time that it takes for an ion to travel through the drift tube is proportional to its collision cross-section (CCS), which refers to the rotation- ally averaged projection area of the ion.61 Following optimization of the microfluidics system for sample introduction in the mass spectrometer, the authors performed collision-induced unfolding (CIU) assays on the protein lysine deacylase SIRT5, a promising target for the development of modulators that could serve as potential drugs in many pathologies.62–64 CIU experiments, com- prising analysis of the change in drift time in the IM cell as a func- tion of collision voltage, enable the detection of subtle changes in protein structure and stability.65 In the case of SIRT5, CIU finger- prints indicated the presence of three different states and two transition regions, corresponding to a compact native-like struc- ture and two unfolded states accessed during the CIU experiment.

Hence, CIU experiments were used to screen a small library of 96 small molecules against SIRT5. These assays are based on the notion that compound binding to the target protein increases its stability and, thus, higher voltages would be necessary to unfold the protein. This screen identified 24 compounds capable of increasing the median collision voltage necessary to reach both

CIU transitions (CIU50s), indicating that these molecules exert a stabilizing effect on SIRT5. Five of these molecules were also tested for their inhibitory potency, with the compounds exhibit- ing the greatest SIRT5 inhibitory activity also causing the largest shifts in CIU50 for the first transition, whereas the opposite trend was observed for the second transition. Based on the assumption that these compounds are

SIRT5-competitive inhibitors (although no data were reported in the paper), the authors sug- gested that the first transition represents the unfolding of the sub- strate binding domain, while the second transition may represent the unfolding of SIRT5 Zn2+-binding domain. However, further research will be required to corroborate these claims. Although this technology decreases data acquisition time and sample con- sumption, a significant decrease in sensitivity was found owing to the increased flow rates and emitter sizes necessary for interfac- ing with the microfluidic platform. Overall, these authors pre- sented a novel method for screening small molecules against protein targets, and it would be interesting to extend its applica- tion to other protein systems.

An intriguing example of the application of nMS to mem- brane protein–ligand binding as provided by Kaur et al., who cap- tured the interaction between the b-barrel assembly machinery (BAM) complex and the recently discovered peptide-based antibiotic darobactin A (Figure 2e).66 The BAM complex, which comprises five subunits, including the outer membrane (OM) protein BamA and the lipoproteins BamB–E, promotes the fold- ing and insertion of OM proteins in the OM of Gram-negative bacteria. nMS experiments indicated that the BAM complex pref- erentially interacts with negatively charged lipids, such as phos- phatidylglycerol (PG) and cardiolipin (CL). Interestingly, CL binding to the BAM complex was shown to enhance its affinity for darobactin A, as demonstrated by the spectra indicating that darobactin preferentially binds to Bam-CL compared with the apo BAM complex (Figure 2f).

Finally, nMS has also been applied for the analysis of protein– ligand interactions directly from cell lysates and enabled evalua- tion of overexpressed proteins directly from crude samples with- out purification.67

Rogawski and colleagues applied this approach to the kinase domain of Bruton’s tyrosine kinase (BTK_KD) overexpressed in HEK293T cells. They first incubated

BTK_KD-overexpressing cells with either the covalent drug ibru- tinib or its non-covalent counterpart, ibrutinib-NH2, then resus- pended the cell pellets in 150–300 mM ammonium acetate and lysed the resulting suspension, which was centrifuged and fur- ther diluted before nMS analysis. Through this method, the authors captured the interaction between BTK_KD and both ibrutinib and ibrutinib-NH2. The same approach was then trans- lated to other BTK ligands (pluripotin, LY2409881, vemurafenib, and PP-121) and enabled the authors to rank their binding affini- ties, with pluripotin being the tightest binder. Overall, this method has the potential to be used to validate hit/lead com- pound cellular target engagement, although it still requires pro- tein overexpression, which could alter the physiological state of the studied cellular system and impair off-target binding iden- tification. Nonetheless, it is a promising orthogonal approach to conventional assays, such as in-cell NMR and cellular thermal shift assays (CETSA), because, unlike these assays, it allows for direct observation of protein–ligand binding and could be used to evaluate drug combinations. Along the same line, Olinares et al.68 previously described a workflow that enables the analysis of protein assemblies directly from cell lysates, without the requirement for overexpression, by combining affinity isolation with antibody-conjugated beads and nMS. Therefore, it would be intriguing to combine the methods described by Rogawski et al. and by Olinares et al. to explore the influence of small mole- cules on protein complexes.

Assessment of protein–protein interaction modulators nMS has also been extensively used for evaluation of both dis- ruptors and stabilizers of PPIs. To this end, the Robinson group applied nMS to both soluble and membrane proteins to clarify the mode of action of known drugs and to support the develop- ment of novel potential PPI disruptors.69–71 For instance, this approach was applied by Fiorentino and coworkers to the Pseu- domonas aeruginosa lipopolysaccharide (LPS) transport (Lpt) pro- tein LptH to gain insights into its monomer/dimer equilibrium and PPI disruption via small molecules.69 The Lpt system is a multiprotein complex formed by seven different proteins respon- sible for LPS transport from the inner membrane to the OM.72

Among them, the periplasmic protein LptA forms an oligomeric bridge connecting the two membranes and is pivotal for the translocation pathway. In the multidrug-resistant opportunistic pathogen P. aeruginosa, the ortholog of LptA, LptH, forms dimers in solution.73 Using nMS, the authors quantified the monomer– dimer equilibrium of LptH and assessed the potency and efficacy of the antimicrobial peptide thanatin and small-molecule disrup- tors, obtaining information on their structure–activity relation- ships (SARs). Specifically, nMS experiments indicated that LptH exists mainly as a dimer, which is disrupted by thanatin as well as the known LPS transport inhibitor IMB-881.69 Based on its structure, the authors evaluated a library of

5-carboxy-8- hydroxyquinoline derivatives bearing a small acyl side chain.

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6 www.drugdiscoverytoday.com nMS experiments revealed that short (up to five carbons) acyl chains had higher disruption activity, and that protecting car- boxyl and hydroxyl groups via methylation and methoxymethy- lation, respectively, increased compound activity (Figure 3a).69

This study presented a new method for evaluating LptA/H PPI disruptors and led to the identification of new quinoline-based hit compounds, which represent the basis for the development of novel LPS transport inhibitors.

A similar approach was used to evaluate the effects of allos- teric inhibitors on the dimerization of the severe acute respira- tory syndrome-coronavirus

2 (SARS-CoV-2) main protease (Mpro). Mpro is the enzyme responsible for cleaving along the two viral polypeptides to release the nonstructural proteins nec- essary for replication. Through nMS, El-Baba et al. showed that

Mpro is preferentially a dimer in solution and then analyzed the effect of four fragments74 on the monomer–dimer equilibrium.70

Notably, one compound (x1187), which had been indicated to bind to the dimer interface,74 was shown to disrupt the dimeric assembly (Figure 3b). Conversely, the three remaining com- pounds, which had previously been shown to interact with a solvent-exposed surface,74 had no effect on Mpro dimerization.

Further nMS-based kinetic experiments indicated that the frag- Drug Discovery Today

FIGURE 3 Assessment of protein-protein interaction (PPI) disruptors. (a) Mass spectra showing the effect of the quinoline derivative 2e on LptH monomer/dimer equilibrium and relative quantification (right panel). (b) Native mass spectra of Mpro (5 lM) in the presence of increasing equivalents of x1187. (c) Upper panel: native mass spectrum of Mpro (5 lM) in the presence of the 11-mer substrate (50 lM) at t = 30 s. Peaks labeled ‘TSAVLQ’ and ‘+substrate’ indicate acyl– enzyme complex and the non-covalent enzyme–substrate complex, respectively. Central panel: mass spectra of the 15+ charge state at three representative times showing the substrate cleavage reaction. Inset: plot of the relative abundance of the enzyme-substrate complex as a function of time. Lower panel: bar chart indicating the half-lives of the enzyme-substrate complex in the presence of the tested small molecules. (d) Structure of ARS-1620 (upper panel). Mass spectra recorded following addition of ARS-1620 (10 lM) to preincubated mixtures of 1 lM SOScat with 3 lM of KRasG12C–GDP (central panel) or KRasG12C–

GTP (lower panel). (e) Structure of Kobe0065 (upper panel). Mass spectra recorded following addition of Kobe0065 (2.5 lM) to preincubated mixtures of

1 lM SOScat with 3 lM KRas–GTP (central panel) or KRasG13D–GTP (lower panel). (f) Structure of BAY-293 (upper panel). Mass spectra recorded following addition of BAY-293 (2.5 lM) to preincubated mixtures of 1 lM SOScat with 3 lM KRas–GTP (central panel) or KRasG13D–GTP (lower panel). (g) Structure of BI- 3406 (upper panel). Mass spectra recorded following addition of BI-3406 (2.5 lM) to preincubated mixtures of 1 lM SOScat with 3 lM KRas–GTP (central panel) or KRasG13D–GTP (lower panel). Peaks corresponding to KRas, SOScat, binary, and ternary complexes are colored in purple, chartreuse, cyan, and orange, respectively. Adapted, with permission, from 70 (c) and 76 (f).

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KEYNOTE (GREEN) www.drugdiscoverytoday.com 7 ments could increase the lifetime of the enzyme–substrate com- plex, thereby slowing the rate of substrate processing by up to

40% (Figure 3c).70 This work highlights the versatility of nMS, which was used to acquire thermodynamic and kinetic informa- tion on the effects of small molecules on the monomer–dimer equilibrium and enzymatic processing. More recently, Zhu et al. used a nMS-based bioaffinity selection method to screen for small molecules obtained from crude herbal extracts against

Mpro.75 They identified the three flavonoids (baicalein, scutel- larein, and ganhuangenin) as Mpro ligands with KD values in the low micromolar range. These compounds did not alter the dimeric assembly of Mpro, but could still inhibit its enzymatic activity, with IC50 values in line with the measured KDs.

Moghadamchargari and coworkers recently used nMS to inves- tigate interactions between the oncoprotein KRas and the catalytic domain of the guanine nucleotide exchange factor Son of Seven- less (SOScat), which is responsible for reloading KRas with GTP.76

The KRas isoform investigated was human KRas4B (residues 1–

169), referred to as KRas for the sake of simplicity. The authors investigated the binding of SOScat to wild-type KRas, as well as three oncogenic mutants (G12C, G13D, and Q61H). In this con- text, they examined the effect of the covalent KRasG12C inhibitor

ARS-162077 and three known small-molecule KRas–SOS disruptors (Kobe0065,78 BAY-293,79 and BI-340680) on the interaction between SOScat and different KRas variants (Figure 3d–g). The authors demonstrated that ARS-1620 could react with GDP- loaded KRasG12C, but showed limited reactivity in the presence of GTP (Figure 3d). In line with this, ARS-1620 could disrupt the

KRasG12C–GDP/SOScat complex, but was ineffective against the

KRasG12C–GTP/SOScatassociation(Figure3d).Kobe0065(IC50=20- lM), reported as a KRas-GTP ligand,78 was unable to disrupt the

KRas–GTP or KRasG12D–GTP interactions with SOScat (Figure 3e) and could not abolish SOScat binding to KRasG12C. Different from

Kobe0065, BAY-293 (IC50 = 21 nM) and BI-3406 (IC50 = 5 nM) have been reported to bind directly to SOScat.79,80 BAY-293 could not disrupt the SOScat interaction with either KRas–GTP (Figure 3f, middle panel), KRasG12C–GTP, or KRasG12D–GTP (Figure 3f, lower panel), whereas it was effective for unloaded KRas and KRasG12C.

Similarly, BI-3406 (tested at 2.5 lM) acted as a KRas/SOScat disrup- tor (Figure 3g, middle panel) but could not disrupt the KRasG12D/

SOScat interaction (Figure 3g, lower panel) and was effective only at 20 lM, 4000 its reported IC50. This study not only advanced our understanding of KRas/SOS interactions, but also provided key insights into the modes of action of known KRas/SOS disrup- tors, none of which were effective in the presence of GTP-loaded

KRas. Overall, this report exemplifies the power of nMS in clarify- ing drug modes of action, thereby providing a foundation for the development of optimized modulators.

Bolla et al. elucidated the influence of chlorhexidine, a com- mon antiseptic, on the oligomerization of the chlorhexidine efflux pump AceI from Acinetobacter baumannii and on its tran- scriptional regulator AceR.71 nMS experiments demonstrated that AceI exists in a pH-dependent monomer–dimer equilibrium, with the functional form being the dimeric AceI. Interestingly, this equilibrium is altered by chlorhexidine, which increases AceI dimer formation, thereby facilitating the functional form of the efflux pump. Further nMS experiments revealed that the tran- scriptional regulator AceR exists mostly as a dimer, although a small fraction of tetramers is also present in solution. nMS data also showed that A. baumannii RNA polymerase constitutively binds the promoter region upstream of AceI. When AceR was introduced into the system, its dimeric form competitively inter- acted with the DNA fragment, inhibiting the RNA polymerase promoter binding, thus impairing AceI transcription. Interest- ingly, chlorhexidine addition increased the amount of tetrameric

AceR, which is unable to interact with DNA, thereby allowing

RNA polymerase to bind the promoter and start transcription.71

Overall, by assessing the influence of small molecules on pro- tein–protein and protein–nucleic acid interactions, nMS revealed crucial insights into the mechanism of antibiotic drug resistance.

This approach could be expanded to the identification of small molecules acting either as AceI dimerization disruptors or as antagonists of the AceR–chlorhexidine interaction, therefore contributing to the discovery of novel antibacterial agents for the treatment of chlorhexidine-resistant bacteria infections.

Bellamy-Carter and coworkers recently used nMS to investi- gate the influence of different small molecules acting as stabiliz- ers of the interactions between the eukaryotic regulatory protein

14-3-3r and three of its binding partners: the tumor suppressor p53, the leucine-rich repeat kinase 2 (LRRK2), and the estrogen receptor a (ERa).81 nMS experiments demonstrated that 14-3- 3r is a dimer with the highest affinity for ERa followed by LRRK2 and p53 (Figure 4a–c, upper panels). The fungal diterpenoid gly- coside fusicoccin A (Figure 4d), known to stabilize the interac- tions between 14-3-3r and its partners to a different extent,82–

84 was shown to further increase the abundance of the 14-3- 3r/ERa complex. while having little or no effect in the case of p53 and LRRK2, respectively (Figure 4a–c). Interestingly, the nMS spectra revealed that the fusicoccin A effect increased in the presence of a higher ERa concentration, thereby suggesting a cooperative binding mode, whereby fusicoccin A preferentially interacts with the 14-3-3r/ERa complex rather than with the sin- gle subunits. Finally, the authors screened a drug cocktail of potential 14-3-3r PPI stabilizers. Incubation of 14-3-3r/ERa with a cocktail of seven different molecules indicated that the only compound able to stabilize the interaction is fusicoccin A and, to a lesser extent, its biosynthetic deacetoxy precursor fusicoccin

J. This work highlights the utility of nMS as a screening approach for PPI stabilizers because it can not only provide a measurement of their potency, but also enable elucidation of subtle aspects, such as cooperative binding.

Recent work by Yen et al., resulting from a collaboration between Oxford University and OMass Therapeutics scientists, exemplified the ability of nMS to capture the effects of ligand binding to the turkey b1-adrenergic receptor (tb1AR), which influ- ence its coupling to different G proteins.85 Initial measurements performed at a ligand:tb1AR 50:1 molar ratio enabled the deriva- tion of significant SARs by demonstrating that isoprenaline could induce 100% complex formation between tb1AR and an engi- neered mini-G stimulatory (mini-Gs) protein, whereas com- pounds lacking the essential moieties for receptor binding were less effective (Figure 4e, upper panel). Among these derivatives, orciprenaline, in which the para-hydroxy group of isoprenaline is moved to the meta position, displayed a 60% reduction in mini-Gs coupling. Similarly, 1-phenyl-2-(2-propylamino)ethan- 1-ol, lacking both the catechol hydroxy groups, abolished 90%

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8 www.drugdiscoverytoday.com (g) (e) (b) (c) (f) (a)

Fusicoccin A (d) Drug Discovery Today FIGURE 4 Assessment of protein-protein interaction (PPI) stabilizers. (a) Structure of fusicoccin A. (b–d) Deconvoluted mass spectra showing the interaction between

14-3-3r (monomer concentration 5 lM) and each interacting partner [p53 (b), leucine-rich repeat kinase 2 (LRRK2) (c), and estrogen receptor alpha (Era) (d),

25 lM] in the absence or in the presence of 5 lM fusicoccin A. Bar charts show the stoichiometry of the PPIs detected by native mass spectrometry (nMS). (e)

Mass spectra showing the interaction between tb1AR (5 lM) and mini-Gs (6 lM) in the presence of isoprenaline, orciprenaline, 1-phenyl-2-(2- propylamino)ethan-1-ol, and isopropyldopamine (250 lM). (f–g) Mass spectra showing the interaction between tb1AR (5 lM) and mini-Gs (f) or mini-Gi/s (g) (6 lM) in the presence of the full agonists isoprenaline, norepinephrine, carmoterol, and the partial agonist dobutamine (25 lM). The peaks assigned to tb1AR-mini-Gs complex, tb1AR, mini-Gs, and tb1AR-mini-Gi/s complex are depicted in orange, blue, gray, and magenta respectively. The structures of each compound are indicated alongside each spectrum. Adapted, with permission, from 81 (b–d) and 85 (e–g).

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KEYNOTE (GREEN) www.drugdiscoverytoday.com 9 mini-Gs coupling (Figure 4e, central panels). Moreover, isopropy- ldopamine, lacking the b-hydroxy group, completely abolished mini-Gs coupling (Figure 4e, lower panel). Further nMS experi- ments performed at a ligand:tb1AR 5:1 molar ratio recapitulated the effects of full agonists (isoprenaline, norepinephrine, and carmoterol), partial agonists (dobutamine and salbutamol), and antagonists (cyanopindolol, carazolol, and carvedilol) by show- ing that full agonists are capable of inducing 100% tb1AR-mini- Gs complex formation, whereas partial agonists were less effec- tive, and antagonists could not enable mini-Gs coupling (Fig- ure 4f). In addition, experiments in the presence of mini-Gi/s protein [in which the helix 5 motif of mini-Gs was replaced with the sequence of the G inhibitory (Gi) protein] enabled the assess- ment of agonist-biased signaling. nMS data showed that isopre- naline could induce mini-Gi/s coupling, whereas carmoterol was less effective and norepinephrine could not stimulate mini-Gi/s coupling at all (Figure 4g). Competition experiments in the presence of both mini-Gs and mini-Gi/s further demon- strated that isoprenaline preferentially induces mini-Gs coupling.

Interestingly, the authors also showed that Zn2+ has a key role in stabilizing the tb1AR-mini-Gs complex formation. In line with this, treatment with the divalent cation chelator ethylenedi- aminetetraacetic acid (EDTA) abolished tb1AR–mini-Gs interac- tions, which were reinstated by treatment with

ZnCl2.

Drug Discovery Today FIGURE 5 Evaluation of proteolysis-targeting chimeras (PROTACs). (a) Schematic of the protein degradation mechanism promoted by PROTACs. By interacting with an

E3 ligase and the protein of interest (POI), PROTACs physically bring the two proteins into proximity, thereby promoting POI ubiquitination and consequent proteasomal degradation. (b) Structures of the VHL-recruiting PROTACs AT1 and MZ1. (c) Mass spectra showing the interaction between the VCB complex (5 lM) and AT1 (10 lM) (upper panel); Brd4BD2 (5 lM) and AT1 (10 lM) (central panel); and VHL/elongin-B/elongin-C (VCB) (5 lM), AT1 (10 lM), and Brd4BD2 (5 lM) (lower panel). Bar charts provide the quantification of the relative abundance of each species. (d) Mass spectra showing the interaction between VCB (5 lM) and AT1 (10 lM) (upper panel); Brd4BD1 (5 lM) and AT1 (10 lM) (central panel); and VCB (5 lM), AT1 (10 lM), and Brd4BD1 (5 lM) (lower panel). Bar charts provide the quantification of the relative abundance of each species. Adapted from 87 (c,d).

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10 www.drugdiscoverytoday.com Molecular dynamics (MD) suggested that Zn2+ ions promote the structural transition during the formation of complexes between

G-proteins and receptors, and subsequent site-directed mutagen- esis studies showed that tb1AR mutants with decreased Zn2+ binding were also characterized by reduced mini-Gs coupling.

In this study, no protein–drug interactions were detected because the voltages used to enable the liberation of tb1AR from deter- gent micelles led to dissociation of the small molecules.

Nonetheless, this study demonstrates the ability of nMS to guide drug design by monitoring the effect of potential drugs on speci- fic pharmacological pathways (e.g., GPCR–G-protein coupling) rather than directly detecting protein–ligand interactions.

Assessment of PROTAC efficacy PROTACs are heterobifunctional molecules constituted by an E3 ligase-recruiting moiety connected via a linker to a warhead that binds the protein of interest (POI). PROTACs bring an E3 ligase and a

POI into proximity, thus promoting POI poly- ubiquitination and proteasomal-mediated degradation, and are then released and recycled to induce the degradation of a new

POI (Figure 5a), displaying a catalytic mode of action.86 Com- pared with classical inhibitors, they usually show higher potency and selectivity, prolonged pharmacodynamic effects, and the ability to evade most resistance mechanisms based on target mutations. The most targeted E3 ligases are Cereblon, usually tar- geted by thalidomide and derivatives, and the Von Hippel–Lin- dau protein (VHL), usually targeted by the small-molecule

VH032 and related compounds.86 Over the years, specialized protocols in biochemical and bio- physical methods have been devised to characterize the forma- tion of the POI–PROTAC–E3 ligase ternary complex to assess in vitro the potential of PROTACs. These include ITC and SPR, which provide key information on the thermodynamics and kinetics of PROTAC binding. More recently, nMS has been indi- cated as a powerful tool to capture POI–PROTAC–E3 ligase tern- ary complex formation. Through nMS, Beveridge et al. captured the interaction between the E3 ligase complex VHL/elongin-B/ elongin-C (VCB), a bromodomain and extra-terminal domain (BET) protein (Brd3BD2, Brd4BD1, or Brd4BD2) and the PROTACs

AT1 and MZ1 [the POI ligand of which is the pan-BET inhibitor (+)-JQ1] (Figure 5b).87 Native mass spectra indicated that both

AT1 and MZ1 preferentially form a ternary complex with Brd4BD2 (Figure 5c,d show the AT1-induced VCB-Brd4BD2 and VCB- Brd4BD1 complex formation, respectively), with AT1 being more selective than MZ1, in line with published data.88 Optimal bind- ing was reached when the E3 ligase:PROTAC:POI molar ratio was

1:2:1 (5 lM:10 lM:5 lM), whereas a 20 lM PROTAC concentra- tion led to the so-called ‘Hook effect’, comprising a decrease in ternary complex formation in the presence of high PROTAC con- centrations, which promote binary interactions. Moreover, by comparing the ternary complex formation with a highly cooper- ative POI (Brd4BD2, a = 4.7) and a less cooperative one (Brd4BD1, a = 0.2), nMS experiments captured cooperative PROTAC bind- ing (i.e., binding of the PROTAC to the first protein complex enhances the affinity for the second one, thereby facilitating ternary complex formation over the binary ones; compare Fig- ure 5c and d). Specifically, when AT1 (10 lM) was mixed with

5 lM VCB, the ternary complex fraction was 0.2, whereas it was 0.5 for both Brd4BD2 and Brd4BD1 at the same concentra- tions. Notably, when the three components were incubated together at a ligase:PROTAC:POI 1:2:1 molar ratio, the ternary complex was observed to a much higher extent with Brd4BD2 (0.82) than with Brd4BD1 (0.65), thus confirming what had previ- ously been observed in other experiments (Figure 5c,d).88 Finally, competition experiments in the presence of three (Brd3BD2,

Brd4BD1, and Brd4BD2) or five (Brd3BD2, Brd4BD1, Brd4BD2,

Brd2BD2, and BrdT) BET family members simultaneously, con- firmed both the preferential binding of AT1 and MZ1 toward

Brd4BD2 and the higher selectivity of AT1.87 More recently, Sternicki and colleagues used nMS to assess the complex formation between VCB and either Brd4BD1 or Brd4BD2 induced by GNE-987,89 a recently developed VHL-recruiting

Brd4-targeting PROTAC.90,91 The authors showed that GNE-987 targets Brd4BD1 preferentially, with a complex ratio of 0.70 when

GNE-987 (7.81 lM) was mixed with equimolar amounts of VCB and Brd4BD1 (9 lM). At the same concentrations, the complex ratio for Brd4BD2 was 0.34, with maxima reached when GNE- 987 was increased up to 15.625 and 31.25 lM (0.44 and 0.45, respectively). Conversely, when GNE-987 was tested at these concentrations in the presence of Brd4BD1, the ‘hook effect’ was apparent, and the ternary complex ratio decreased to

0.55.89 These data are in accordance with SPR measurements, which indicate a much higher ternary complex half-life (t1/2) for Brd4BD1, although the magnitude of the difference between the amount of ternary complex formed for Brd4BD1 compared with Brd4BD2 as measured by nMS is not as large as the window of difference in SPR t1/2 measurements, in which Brd4BD1 t1/2 is

100-fold longer than that of Brd4BD2.91 Nevertheless, nMS pro- vided a steady-state equilibrium measurement, whereas SPR mea- sured a real-time kinetic event; thus, each measurement is unique and influenced by different factors.

A subsequent study by Song and colleagues described nMS experiments on the VCB–MZ1–Brd4BD2 complex on a Fourier- transform ion cyclotron resonance (FT-ICR) mass spectrometer and demonstrated that the VCB–MZ1–Brd4BD2 ternary complex dissociates following application of increasing CID voltages, which cause ejection of MZ1, whereas the VCB–Brd4BD2 com- plex, not observed in solution in the absence of MZ1, is retained.

Further increases in CID voltages induced the release of the peripheral subunit Brd4BD2.92 IM-MS experiments performed on a quadrupole/ion mobility separation/time-of-flight (Q-IMS- ToF) instrument suggested that the 13+ and 12+ charge states observed in the initial experiments assume a more compact con- formation, compared with the 15+ charge state, which exists as an extended conformer, whereas the 14+ charge state is a mix- ture of the two. In line with this, the application of increasing collision voltages caused the preferential dissociation of MZ1 from the more compact conformers and the preferential ejection of BRD4BD2 from the more extended ones. These data demon- strate that higher charge states are characterized by greater

Coulombic repulsions and PPIs, whereas the low charge states assume a native-like conformation. To this end, the evidence that VCB and Brd4BD2 maintain their interactions even after

MZ1 ejection supports the presence of specific intermolecular interactions between VCB and Brd4BD2, as described in the corre- sponding crystal structure.88 The specific non-covalent interac- KEYNOTE (GREEN)

Drug Discovery Today d Volume 28, Number 5 d May 2023

KEYNOTE (GREEN) www.drugdiscoverytoday.com 11 tions between the two proteins during the CID experiments might vary from those found in the gas phase. Therefore, although these studies provide a valuable starting point, they need to be validated with orthogonal experiments. Nonetheless, these three studies demonstrate that PROTAC efficacy can be suc- cessfully probed via nMS, and the integration of different approaches and instruments could provide insights into both binding affinities and structural features.

Concluding remarks The progress that has been achieved in the technology of mass spectrometers has paved the way for nMS to evolve into a remarkably flexible tool for analyzing protein–protein and pro- tein–small molecule interactions. Its great sensitivity, ease of use, speed, broad dynamic range, and minimal sample consump- tion make it an essential component of the biophysical toolbox widely used for early drug screening campaigns. As the numbers of research groups and studies using nMS for drug discovery applications expand and, consequently, more researchers are trained in this area, the investigation of protein–ligand interac- tions by nMS will become increasingly regular in drug discovery. nMS will become progressively integrated with other methods, such as ITC, SPR, and structural techniques, such as X-ray crystal- lography and cryo-EM, offering unparalleled insights into pro- tein–ligand binding and PPI modulation, which will have a substantial influence on future drug development processes.

The increased use of nMS in drug discovery should take place with an understanding of the underlying origins of possible experimental false negatives (gas-phase breakdown of hydropho- bic interactions) and false positives (nonspecific binding). To this end, future developments in sample preparation, ionization techniques, and equipment should help to successfully over- come these limitations. Nonetheless, nMS analysis is unique in capturing the effects that ligand binding has in solution, such as impacts on protein complex formation,85 oligomerization,69 or enzyme–substrate/co-substrate binding.70 Moreover, by either monitoring direct ligand binding or the effect of protein–ligand interactions, nMS-based competitive-binding assays can also easily define the specificity of a potential drug for a given binding site. Furthermore, binding sites can be distinguished using the right experimental parameters, showing complicated allosteric processes.70,76,85,93 In addition, the use of nonvolatile buffers or salts, buffer additives such as charge-reducing agents, and the development of innovative detergents and membrane mimetics in the case of membrane proteins, should help to preserve labile native-like protein–small molecule complexes for nMS detection.

In line with this, recent studies demonstrated the feasibility of analyzing both soluble and membrane proteins directly from cell lysates,67,94 or membrane vesicles,95,96 respectively, thus prevent- ing potential artifacts that might arise from sample preparation.

Given that processing the complex spectra generated by these techniques remains time-consuming and difficult to interpret, advances in data analysis are crucial in this context for enabling the full development of nMS analysis of cell lysates and mem- brane vesicles. To this end, initial steps have been taken toward the development of software for analyzing intricate mass spec- tra.97,98 The integration of currently available software platforms with machine learning and artificial intelligence approaches will accelerate nMS spectral interpretation and allow the pharmaceu- tical sector to adopt nMS as a standard technique.

Given its great potential in capturing PPIs, we anticipate that nMS will have an ever-increasing role in assessing the potency and mode of action of small molecules functioning as PPI mod- ulators, including PROTACs. In some circumstances, measuring the interaction between two (or more) proteins remains difficult and requires the presence of specific tags or immobilization. By contrast, nMS permits the direct observation of these interac- tions, quantification of complex formation, analysis of coopera- tive binding, and accurate assessment of the stoichiometry of multiprotein complexes or oligomers. Therefore, a single experi- ment yields a plethora of information on the influence of a small molecule on the stability of protein complexes. As seen in the case studies included herein, several groups are already using nMS for the evaluation of PPI modulators, and we anticipate that the pharmaceutical industry will adopt nMS for these applica- tions. To this end, chip-based automated nESI platforms, such as the previously mentioned NanoMate,53 are pivotal for increas- ing the throughput of nMS experiments and enabling its applica- tion to small-molecule libraries.

Authors’ contributions All authors contributed to this article.

Declaration of interests The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Data availability No data was used for the research described in the article.

Acknowledgments This work was supported by Italian Ministry of University

FISR2019_00374 MeDyCa (A.M.), ‘Sapienza’ Ateneo Project

2021 n. RM12117A61C811CE (D.R.), Regione Lazio Progetti di

Gruppi di Ricerca 2020 – A0375-2020-36597 (D.R.). F.F. is sup- ported by the EU’s Horizon Europe program under the Marie

Skłodowska-Curie grant agreement EpiPolyPharma 101062363.

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📖 中文全文 Chinese Full Text

中文

Francesco Fiorentino 1,⇑, Dante Rotili 1,⇑, Antonello Mai 1,2 1 罗马大学药物化学与技术系,意大利罗马,Piazzale Aldo Moro 5, 00185 2 罗马大学巴斯德研究所Cenci-Bolognetti基金会,意大利罗马,Piazzale Aldo Moro 5, 00185

**天然质谱(nMS)指导的药物发现:研究蛋白质功能与调控的最新进展**

天然质谱(nMS)是一种用于研究蛋白质复合物的生物物理方法,可提供关于亚基化学计量与组成、蛋白质-配体及蛋白质-蛋白质相互作用(PPIs)的见解。通过保留气相中的非共价相互作用,这些分析成为可能,从而允许在天然状态下分析蛋白质。因此,nMS在早期药物发现活动中越来越多地应用于蛋白质-药物相互作用的表征和PPI调节剂的评估。在此,我们讨论了nMS指导的药物发现的最新进展,并对该技术在药物发现中的可能应用提供了及时的展望。

**关键词:** 天然质谱;蛋白质-配体相互作用;蛋白质-蛋白质相互作用;PROTAC;膜蛋白

**引言** 蛋白质是生物体的基本组成部分,参与所有细胞通路。它们控制着生命的各个方面,包括但不限于基因表达的调控、生物化学反应的催化、信号传导以及细胞代谢必需分子的运输。1 因此,蛋白质与其伙伴(包括其他蛋白质、核酸、脂质、碳水化合物和小分子)之间的非共价相互作用是无数生物过程的核心,如转录调控、细胞分化、免疫应答、细胞粘附和炎症。这些相互作用由多种力控制,包括氢键、静电相互作用、范德华力和疏水作用。2 重要的是,蛋白质-相互作用的表征是药物发现过程的核心。事实上,阐明蛋白质结构和动力学以及量化蛋白质-配体结合的动力学和热力学参数是开发可用于治疗各种病理的药物的最早期步骤。3

迄今为止,在临床前药物开发过程中使用了大量的生物物理技术工具箱来表征体外蛋白质-配体相互作用,每种技术都有其自身的优势和不足。这些技术包括等温滴定量热法(ITC)、4 表面等离子体共振(SPR)、5 核磁共振(NMR)光谱学6 和X射线晶体学。7 尽管使用这些技术取得了巨大进展,但药物开发中仍然存在重大的技术问题。事实上,某些蛋白质物种,如动态蛋白质寡聚体和膜蛋白复合物,尽管具有巨大的治疗潜力,但仍然难以靶向。某些蛋白质复合物的瞬时性质、膜蛋白的不稳定性以及可能缺乏任何酶活性,使得这些靶点对于药物开发的研究极具挑战性。影响这些复杂靶点功能的化合物不能通过典型的生物物理方法轻松评估,这些方法提供系统平均溶液性质的信息,但可能无法告知单个单个结合事件或配体对寡聚状态的影响。此外,这些方法通常需要蛋白质标记或固定化,这可能会改变正在评估的微妙平衡。因此,增加我们对药物作用的结构、热力学和动力学特征理解的互补方法可以加速临床前药物开发。

nMS是一种有前景的研究蛋白质-配体相互作用的方法,也允许评估更具挑战性的靶点。它是一种能够在气相中保留非共价相互作用和蛋白质四级结构的技术。此外,与通常包括有机溶剂和低pH值的常规变性MS不同,nMS使用挥发性水溶液缓冲液,在接近生理pH值以及更温和的电压和离子传输管温度(通常<200°C)下操作,与经典MS技术相比。这些与其他MS方法的差异有助于保留所研究蛋白质复合物的天然或类天然结构。8 这使得能够量化PPIs和蛋白质-配体相互作用的解离常数、评估小分子作用模式,以及研究蛋白质复合物化学计量和亚基结构与动力学(图1)。9

nMS利用电喷雾电离(ESI)相对于其他电离方法[例如,基质辅助激光解吸电离(MALDI)、大气压化学电离(APCI)或电子电离(EI)]更温和的特性,将蛋白质复合物从挥发性缓冲水溶液转移到气相,并在此过程中维持非共价相互作用。10-12 nMS中最常用的电离方法是纳升ESI(nESI),它是ESI的一个亚型,特点是毛细管针头直径更小(通常在nESI中为1-5 µm,而在ESI中可达0.5 mm)和非常慢的流速(10-50 nl/min),13 这使得nESI更适合研究蛋白质复合物。事实上,由于孔径更小,初始液滴尺寸至少小一个数量级,从而减少了产生气相离子所需的能量和裂变事件次数。8

质谱分析器和检测器数十年的进步使得完整蛋白质的传输和检测成为可能。进一步的发展,包括仪器内压力梯度的操控,使得在仪器内气相中保留非共价相互作用成为可能。14,15 此外,nMS与多级串联MS(MSn)方法的整合使得能够鉴定与靶蛋白结合的未知配体。在串联MS实验中,前体离子被质量选择(例如,在四极杆或离子阱中),然后经受特定类型的活化[例如,通过碰撞诱导解离(CID)或电子捕获解离(ECD)]。解离后,离子根据其m/z进行分析。根据所使用的仪器,串联MS实验可以多次进行,从而允许进行MSn实验,然后可用于根据碎裂模式鉴定从其蛋白质伙伴解离的配体。在这方面,Klassen等人的开创性工作为通过nMS评估蛋白质-配体结合以及在药物发现中使用MSn实验铺平了道路。16-19

nMS相对于其他生物物理技术的主要优势包括无需任何标记或蛋白质固定化、样品消耗低(每次测量使用皮摩尔级蛋白质)、直接测量相互作用,以及区分异质群体中不同蛋白质物种的能力。9,20 鉴于这些特征,nMS被认为是早期药物发现活动的高度信息化技术。特别是,nMS为NMR、X射线晶体学和冷冻电子显微镜(cryo-EM)研究提供帮助,因为它允许评估蛋白质样品的纯度、均一性和完整性,以及复杂化学计量的测量。9,21-23

与其他技术类似,nMS不仅具有优势特性,也存在局限性,例如可能存在假阴性(疏水相互作用的气相分解)和假阳性(非特异性结合)。这些限制可以通过优化样品制备或nESI方法24-26 以及使用适当的统计方法来解释nESI过程中产生的非特异性相互作用来解决。16,27

总体而言,nMS补充了现有的体外表征方法组合,被认为是鉴定、验证和表征命中/先导化合物的可行方法。仪器技术的进步促进了这一应用的应用,这些进步有助于检查更大、更复杂的蛋白质复合物。事实上,技术进步导致了超高质量范围质谱仪的出现,允许研究小分子与大蛋白质之间形成的复合物,从而扩展了nMS的动态范围。28-33 此外,膜蛋白溶解方法的优化对于在质谱仪中观察完整膜蛋白复合物至关重要,34-36 并已允许分析小分子与膜蛋白之间的相互作用,29,37-39 包括G蛋白偶联受体(GPCRs)。24,40-42 最后,nMS与可变温度nESI的结合使得能够确定蛋白质-配体相互作用和PPIs的热力学参数[结合吉布斯自由能(ΔG)、焓(ΔH)和熵(-TΔS)],这些参数在药物开发过程中是重要的考虑因素。43

在本综述中,我们讨论了nMS在分析蛋白质-配体相互作用、评估PPI调节剂和评估所谓的“靶向嵌合体”(PROTACs)方面的最新应用(图1)。我们描述了nMS在早期药物发现中的广泛应用,并强调了nMS在研究和调控蛋白质功能方面的新进展、未来机遇和挑战(表1)。

**药物发现中天然MS的应用**

**蛋白质-配体相互作用评估** 与nESI联用的nMS已被广泛用于检测和量化蛋白质-配体相互作用,包括小分子、肽,特别是在膜蛋白的情况下,还包括脂质。22,41,44-48 然而,在分析显示非共价蛋白质-配体相互作用的天然质谱时应谨慎,应使用适当的数据分析和统计方法来解释ESI过程中产生的非特异性相互作用。27 关于使用nMS准确测定蛋白质-配体相互作用的完整概述,我们参考了Bennett及其同事49 和Gavriilidou等人的近期综述,后者主要侧重于高通量nMS用于药物筛选。50

nMS可以成功评估蛋白质-配体相互作用,通量适中(约每小时100个配体),使用一种称为生物亲和MS的方法。这种方法涉及将配体或配体组合与目标蛋白质一起孵育,然后通过nMS直接检查所得溶液。通过测量配体结合与载脂蛋白峰之间的质荷比(m/z)差异,可以容易地确定结合的小分子的身份(图1)。nMS用于化合物库筛选的应用越来越受关注,例如Vu等人51 和Nguyen等人52 的研究,我们将在下面讨论。因此,基于芯片的自动化nESI平台,如NanoMate,53 正被越来越多地使用,因为它们提供恒定的nESI条件和更高的重复性,同时提高了通量。这种方法的一个例子由Vu等人提供,他们应用nMS筛选针对62个恶性疟原虫蛋白质的天然产物片段库,这些蛋白质被选为潜在的疟疾药物靶点。每个蛋白质与片段以5:1至20:1的配体:蛋白质摩尔比孵育。这种方法使得能够鉴定出96个潜在的结合剂,它们与32个蛋白质形成复合物。这96个天然产物片段具有不同的化学型,与已知的抗疟氨基喹啉、喹啉或二脒不同。有趣的是,该技术能够区分混杂和非混杂的泛测定干扰化合物(PAINS),如多酚、环氧化物、迈克尔受体和β-内酰胺,从而证实了nMS捕获特异性相互作用的能力。51

最近,Nguyen及其同事将nMS与非靶向代谢组学相结合,开发了一种方法来鉴定与潜在药物靶点相互作用的天然产物。52 具体而言,他们将含有数千个小分子的粗天然产物提取物与目标蛋白质一起孵育,并使用0.5 ml脱盐柱进行快速、低体积的凝胶过滤步骤以去除未结合的配体。随后进行nMS分析以捕获和量化蛋白质-配体相互作用(图2a),并通过代谢组学鉴定结合的命中物。为此,他们使用了纳米级nESI发射器(内径约250 nm),与广泛使用的微米级发射器不同,它们耐受盐的存在,并能够分析复杂混合物,例如含有数千个天然产物的混合物。25 通过这种方法,他们鉴定出1,2,3,4-五-O-没食子酰-β-D-葡萄糖(图2b)作为hCAI的新配体,结合随后在基于nMS的滴定实验中得到证实,产生KD值为27 µM。25

Agasid等人还使用了纳米级nESI发射器(内径约100 nm)来分析在高钠离子浓度缓冲液中的GPCRs。24 这允许检测在十二烷基麦芽糖新戊二醇(LMNG)去污剂胶束中结合多达七个钠离子的腺苷2A受体(A2AR),以及研究A2AR激动剂(NECA和CGS21680)和拮抗剂(XAC和ZM241385)对钠结合的影响。事实上,两种激动剂都消除了蛋白质-钠离子相互作用,而在两种拮抗剂存在下则保留了这种相互作用,与基于溶液的研究一致,其中只有非活性构象在变构结合口袋中维持钠离子。57 在最近开发的第一代树枝状寡聚甘油去污剂(G1)35,42 和胆固醇半琥珀酸酯的混合胶束中成功观察到胰高血糖素受体。作者捕获了胰高血糖素结合,而这次未观察到钠加合物。他们还观察到了负变构调节剂NNC0666的结合,该调节剂在纯化过程中加入以稳定蛋白质,其身份通过Orbitrap-离子阱质谱仪上的MSn得到确认。

另一种用于量化蛋白质-配体亲和力的有趣方法由Ren及其同事描述,他们开发了一个在线SEC-nMS平台(图2c)。通过这种方法,他们计算了小分子抑制剂与分解代谢酶吲哚胺2,3-双加氧酶1(IDO1)相互作用的KD值,58 这些值与基于芯片的53 nESI-nMS测量结果一致。为此,他们将IDO1与不同浓度的配体(0.5-100 µM)孵育,然后进行3分钟SEC运行,与nESI-nMS系统联用(图2d,左上面板)。此外,通过混合IDO1与两种潜在结合物(在论文中称为化合物1和2)的等摩尔混合物进行一次性竞争实验,表明IDO1-1加合物的丰度更高(图2d,右上面板),与KD计算一致。此外,作者通过执行源内CID实验分析了气相中的蛋白质-配体相互作用。这些通过增加碰撞电压直到完全复合物解离来执行,允许计算VC50参数(即,解离蛋白质-配体复合物50%所需的碰撞电压),发现该参数与蛋白质:配体比无关。此外,对于结合更紧密的配体(化合物1)获得了更高的VC50值,因此与测量的KD值一致(图2d,下面板)。总体而言,该方法使得在该系统中能够进行准确测量,主要优势在于分析的自动化和快速性以及在乙酸铵中停留时间的减少。相比之下,在解离速率快到足以在色谱分离过程中发生的情况下,弱相互作用的评估可能会受到阻碍。

nMS也已与荧光热位移测定结合应用,用于鉴定丝氨酸/苏氨酸激酶c-Jun N末端激酶3(JNK3)的新配体。59 在通过荧光热位移(FTS)测定鉴定出七个潜在命中物后,nMS用于计算这些化合物的结合亲和力,这些化合物具有不同的支架,包括N-(1H-吡唑-4-基)噻吩并[2,3-d]嘧啶-4-胺(四个化合物)、5-(苯氨基)-1H-1,2,3-三唑-4-甲酰胺(一个化合物)、三唑甲基哌啶(一个化合物)和哌啶甲酰胺(一个化合物)。nMS成功捕获了其中四个化合物的蛋白质-配体相互作用,其中5,带有5-(苯氨基)-1H-1,2,3-三唑-4-甲酰胺核心,是结合最紧密的配体,KD值为21 µM。

最近,D'Amico等人描述了一种离子迁移率-nMS(IM-MS)方法,与液滴微流控联用,通过评估配体结合对蛋白质在气相中稳定性的影响来分析蛋白质-配体相互作用。60 在质谱分析之前,IM使得能够根据蛋白质离子在充满中性气体的漂移管中的大小和形状在弱电场影响下进行分离。离子通过漂移管所需的时间与其碰撞截面(CCS)成正比,CCS指的是离子的旋转平均投影面积。61 在优化微流控系统以将样品引入质谱仪后,作者对蛋白质赖氨酸脱酰酶SIRT5进行了碰撞诱导去折叠(CIU)测定,SIRT5是开发可作为许多病理潜在药物的调节剂的有前景的靶点。62-64 CIU实验包括分析作为碰撞电压函数的IM池中漂移时间的变化,使得能够检测蛋白质结构和稳定性的细微变化。65 在SIRT5的情况下,CIU指纹图谱显示了三种不同状态和两个转变区域,对应于紧凑的类天然结构和在CIU实验过程中进入的两种去折叠状态。因此,CIU实验被用于筛选针对SIRT5的96个小分子的小文库。这些测定基于化合物与靶蛋白结合增加其稳定性,因此需要更高电压使蛋白质去折叠的概念。该筛选鉴定出24种能够增加达到两个CIU转变(CIU50s)所需中位碰撞电压的化合物,表明这些分子对SIRT5发挥稳定作用。其中五种分子也测试了其抑制效力,表现出最大SIRT5抑制活性的化合物也引起第一个转变的CIU50最大偏移,而第二个转变则观察到相反的趋势。基于这些化合物是SIRT5竞争性抑制剂的假设(尽管论文中未报告数据),作者提出第一个转变代表底物结合结构域的去折叠,而第二个转变可能代表SIRT5 Zn2+结合结构域的去折叠。然而,需要进一步研究来证实这些主张。尽管该技术减少了数据采集时间和样品消耗,但由于与微流控平台接口所需的增加流速和发射器尺寸,发现灵敏度显著降低。总体而言,这些作者提出了一种筛选针对蛋白质靶点的小分子的新方法,将其应用扩展到其他蛋白质系统将是有趣的。

nMS应用于膜蛋白-配体结合的一个有趣例子由Kaur等人提供,他们捕获了β-桶组装机制(BAM)复合物与新发现的肽类抗生素达罗巴汀A(图2e)之间的相互作用。66 BAM复合物由五个亚基组成,包括外膜(OM)蛋白BamA和脂蛋白BamB-E,促进革兰氏阴性菌OM中OM蛋白的折叠和插入。nMS实验表明,BAM复合物优先与带负电的脂质相互作用,如磷脂酰甘油(PG)和心磷脂(CL)。有趣的是,CL与BAM复合物的结合被证明增强了其对达罗巴汀A的亲和力,如光谱所示,达罗巴汀优先结合Bam-CL,而不是载脂蛋白BAM复合物(图2f)。

最后,nMS也已应用于直接从细胞裂解物分析蛋白质-配体相互作用,使得能够从粗样品中评估过表达的蛋白质而无需纯化。67 Rogawski及其同事将这种方法应用于在HEK293T细胞中过表达的布鲁顿酪氨酸激酶(BTK_KD)的激酶结构域。他们首先将过表达BTK_KD的细胞与共价药物伊布替尼或其非共价对应物伊布替尼-NH2一起孵育,然后将细胞沉淀重悬于150-300 mM乙酸铵中,裂解所得悬浮液,离心并稀释后进行nMS分析。通过这种方法,作者捕获了BTK_KD与伊布替尼和伊布替尼-NH2之间的相互作用。然后将相同的方法应用于其他BTK配体(pluripotin、LY2409881、vemurafenib和PP-121),使得能够对其结合亲和力进行排序,其中pluripotin是结合最紧密的。总体而言,该方法有可能用于验证命中/先导化合物的细胞靶点参与,尽管它仍然需要蛋白质过表达,这可能改变所研究细胞系统的生理状态并损害脱靶结合鉴定。尽管如此,它是一种有前景的正交方法,与常规测定如细胞内NMR和细胞热位移测定(CETSA)相比,因为它允许直接观察蛋白质-配体结合,并可用于评估药物组合。沿着同样的思路,Olinares等人68 先前描述了一种工作流程,通过将亲和分离与抗体偶联珠子和nMS结合,使得能够直接从细胞裂解物分析蛋白质组装,而无需过表达。因此,将Rogawski等人和Olinares等人描述的方法结合起来,探索小分子对蛋白质复合物的影响将是有趣的。

**蛋白质-蛋白质相互作用调节剂的评估** nMS也被广泛用于评估PPIs的破坏剂和稳定剂。为此,Robinson小组将nMS应用于可溶性和膜蛋白,以阐明已知药物的作用模式并支持新型潜在PPI破坏剂的开发。69-71 例如,Fiorentino及其同事将这种方法应用于铜绿假单胞菌脂多糖(LPS)转运(Lpt)蛋白LptH,以深入了解其单体/二聚体平衡以及通过小分子进行的PPI破坏。69 Lpt系统是由七种不同蛋白质形成的多蛋白复合物,负责将LPS从内膜转运到OM。72 其中,周质蛋白LptA形成连接两个膜的寡聚桥,对易位途径至关重要。在多重耐药的机会性病原体P. aeruginosa中,LptA的同源物LptH在溶液中形成二聚体。73 使用nMS,作者量化了LptH的单体-二聚体平衡,并评估了抗菌肽thanatin和小分子破坏剂的效力和功效,获得了关于其构效关系(SARs)的信息。具体而言,nMS实验表明LptH主要以二聚体存在,该二聚体被thanatin以及已知的LPS转运抑制剂IMB-881破坏。69 基于其结构,作者评估了一系列带有小酰基侧链的5-羧基-8-羟基喹啉衍生物。nMS实验揭示,短(最多五个碳)酰基链具有更高的破坏活性,并且通过甲基化和甲氧基甲基化分别保护羧基和羟基增加了化合物活性(图3a)。69 该研究提出了一种评估LptA/H PPI破坏剂的新方法,并导致了基于喹啉的新命中化合物的鉴定,这些化合物代表了开发新型LPS转运抑制剂的基础。

类似的方法被用于评估变构抑制剂对严重急性呼吸综合征冠状病毒2(SARS-CoV-2)主要蛋白酶(Mpro)二聚化的影响。Mpro是负责切割两条病毒多肽以释放复制所需的非结构蛋白的酶。通过nMS,El-Baba等人表明Mpro在溶液中优先为二聚体,然后分析了四个片段74 对单体-二聚体平衡的影响。70 值得注意的是,一种化合物(x1187),已被指示结合二聚体界面,74 被显示破坏二聚体组装(图3b)。相反,其余三种化合物,先前显示与溶剂暴露的表面相互作用,74 对Mpro二聚化没有影响。进一步的基于nMS的动力学实验表明,这些片段可以增加酶-底物复合物的寿命,从而将底物处理速率减慢多达40%(图3c)。70 这项工作突出了nMS的多功能性,它被用于获取小分子对单体-二聚体平衡和酶处理影响的热力学和动力学信息。最近,Zhu等人使用基于nMS的生物亲和选择方法筛选针对Mpro的粗草药提取物中获得的小分子。75 他们鉴定了三种黄酮类化合物(黄芩素、野黄苓素和甘黄苓素)作为Mpro的配体,KD值在低微摩尔范围内。这些化合物没有改变Mpro的二聚体组装,但仍可以抑制其酶活性,IC50值与测量的KD一致。

Moghadamchargari及其同事最近使用nMS研究了致癌蛋白KRas与鸟嘌呤核苷酸交换因子Son of Sevenless(SOScat)的催化结构域之间的相互作用,SOScat负责用GTP重新加载KRas。76 所研究的KRas亚型是人类KRas4B(残基1-169),为简单起见称为KRas。作者研究了SOScat与野生型KRas以及三种致癌突变体(G12C、G13D和Q61H)的结合。在此背景下,他们检查了共价KRasG12C抑制剂ARS-162077 和三种已知的小分子KRas-SOS破坏剂(Kobe0065、78 BAY-29379 和BI-340680)对SOScat与不同KRas变体相互作用的影响(图3d-g)。作者证明ARS-1620可以与GDP负载的KRasG12C反应,但在GTP存在下反应性有限(图3d)。与此一致,ARS-1620可以破坏KRasG12C-GDP/SOScat复合物,但对KRasG12C-GTP/SOScat结合无效(图3d)。Kobe0065(IC50=20 µM),被报道为KRas-GTP配体,78 无法破坏KRas-GTP或KRasG12D-GTP与SOScat的相互作用(图3e),并且不能消除SOScat与KRasG12C的结合。与Kobe0065不同,BAY-293(IC50 = 21 nM)和BI-3406(IC50 = 5 nM)被报道直接结合SOScat。79,80 BAY-293无法破坏SOScat与KRas-GTP(图3f,中间面板)、KRasG12C-GTP或KRasG12D-GTP(图3f,下面板)的相互作用,而对未负载的KRas和KRasG12C有效。类似地,BI-3406(在2.5 µM下测试)作为KRas/SOScat破坏剂(图3g,中间面板),但不能破坏KRasG12D/SOScat相互作用(图3g,下面板),并且仅在20 µM下有效,是其报道IC50的4000倍。这项研究不仅增进了我们对KRas/SOS相互作用的理解,而且为已知的KRas/SOS破坏剂的作用模式提供了关键见解,其中没有一种在GTP负载的KRas存在下有效。总体而言,该报告例证了nMS在阐明药物作用模式方面的能力,从而为开发优化的调节剂提供了基础。

Bolla等人阐明了氯己定(一种常见防腐剂)对鲍曼不动杆菌氯己定外排泵AceI寡聚化及其转录调节因子AceR的影响。71 nMS实验证明AceI以pH依赖的单体-二聚体平衡存在,功能形式为二聚体AceI。有趣的是,这种平衡被氯己定改变,氯己定增加AceI二聚体形成,从而促进外排泵的功能形式。进一步的nMS实验揭示,转录调节因子AceR主要以二聚体存在,尽管溶液中也存在少量四聚体。nMS数据还显示,A. baumannii RNA聚合酶组成型结合AceI上游的启动子区域。当AceR被引入系统时,其二聚体形式与DNA片段竞争相互作用,抑制RNA聚合酶启动子结合,从而损害AceI转录。有趣的是,氯己定添加增加了四聚体AceR的量,四聚体AceR无法与DNA相互作用,从而允许RNA聚合酶结合启动子并开始转录。71 总体而言,通过评估小分子对蛋白质-蛋白质和蛋白质-核酸相互作用的影响,nMS揭示了抗生素耐药机制的关键见解。这种方法可以扩展到鉴定作为AceI二聚化破坏剂或AceR-氯己定相互作用拮抗剂的小分子,从而有助于发现用于治疗氯己定耐药细菌感染的新型抗菌剂。

Bellamy-Carter及其同事最近使用nMS研究了不同小分子作为真核调节蛋白14-3-3r与其三个结合伙伴(肿瘤抑制因子p53、富含亮氨酸重复激酶2(LRRK2)和雌激素受体α(ERa))之间相互作用的稳定剂的影响。81 nMS实验证明14-3-3r是二聚体,对ERa的亲和力最高,其次是LRRK2和p53(图4a-c,上面板)。真菌二萜糖苷镰刀菌素A(图4d),已知以不同程度稳定14-3-3r与其伙伴之间的相互作用,82-84 被显示进一步增加14-3-3r/ERa复合物的丰度。而在p53和LRRK2的情况下分别具有很小或没有影响(图4a-c)。有趣的是,nMS光谱揭示,在较高ERa浓度存在下,镰刀菌素A效应增加,因此表明协同结合模式,其中镰刀菌素A优先与14-3-3r/ERa复合物相互作用,而不是与单个亚基相互作用。最后,作者筛选了潜在的14-3-3r PPI稳定剂的药物混合物。将14-3-3r/ERa与七种不同分子的混合物孵育表明,唯一能够稳定相互作用的化合物是镰刀菌素A,在较小程度上是其生物合成去乙酰氧基前体镰刀菌素J。这项工作突出了nMS作为PPI稳定剂筛选方法的效用,因为它不仅可以提供其效力的测量,而且能够阐明细微方面,如协同结合。

Yen等人最近的工作,来自牛津大学与OMass Therapeutics科学家的合作,例证了nMS捕获配体结合对火鸡β1-肾上腺素能受体(tb1AR)影响的能力,该影响调节其与不同G蛋白的偶联。85 在配体:tb1AR 50:1摩尔比下进行的初始测量通过证明异丙肾上腺素可以诱导tb1AR与工程化微型G刺激(mini-Gs)蛋白之间100%的复合物形成,而缺乏受体结合必需基团的化合物效果较差,从而推导出显著的SARs(图4e,上面面板)。在这些衍生物中,奥西那林,其中异丙肾上腺素的对位羟基移动到间位,显示mini-Gs偶联减少60%。类似地,1-苯基-2-(2-丙氨基)乙-1-醇,缺乏两个儿茶酚羟基,消除了90%的mini-Gs偶联(图4e,中间面板)。此外,异丙多巴胺,缺乏β-羟基,完全消除了mini-Gs偶联(图4e,下面面板)。在配体:tb1AR 5:1摩尔比下进行的进一步nMS实验概括了完全激动剂(异丙肾上腺素、去甲肾上腺素和卡莫特罗)、部分激动剂(多巴酚丁胺和沙丁胺醇)和拮抗剂(氰基吲哚洛尔、卡维地洛和carvedilol)的效应,显示完全激动剂能够诱导100%的tb1AR-mini-Gs复合物形成,而部分激动剂效果较差,拮抗剂不能实现mini-Gs偶联(图4f)。此外,在mini-Gi/s蛋白[其中mini-Gs的螺旋5基序被G抑制(Gi)蛋白的序列替换]存在下的实验使得能够评估激动剂偏向信号传导。nMS数据显示异丙肾上腺素可以诱导mini-Gi/s偶联,而卡莫特罗效果较差,去甲肾上腺素根本不能刺激mini-Gi/s偶联(图4g)。在mini-Gs和mini/Gi/s两者存在下的竞争实验进一步证明异丙肾上腺素优先诱导mini-Gs偶联。有趣的是,作者还显示Zn2+在稳定tb1AR-mini-Gs复合物形成中起关键作用。与此一致,用二价螯合剂乙二胺四乙酸(EDTA)处理消除了tb1AR-mini-Gs相互作用,该相互作用通过用ZnCl2处理恢复。

分子动力学(MD)表明Zn2+离子促进G蛋白与受体之间复合物形成过程中的结构转变,随后的定点突变研究表明,具有降低Zn2+结合的tb1AR突变体也表现出降低的mini-Gs偶联。在这项研究中,没有检测到蛋白质-药物相互作用,因为用于使tb1AR从去污剂胶束中释放的电压导致小分子解离。尽管如此,这项研究证明了nMS通过监测潜在药物对特定药理途径(例如,GPCR-G蛋白偶联)的影响而不是直接检测蛋白质-配体相互作用来指导药物设计的能力。

**PROTAC功效的评估** PROTACs是异双功能分子,由通过连接子连接到靶向目标蛋白(POI)的弹头的E3连接酶招募部分组成。PROTACs将E3连接酶和POI带入邻近,从而促进POI多泛素化和蛋白酶体介导的降解,然后被释放并循环以诱导新POI的降解(图5a),显示催化作用模式。86 与经典抑制剂相比,它们通常显示出更高的效力和选择性、延长的药效学效应以及逃避基于靶点突变的大多数耐药机制的能力。最常靶向的E3连接酶是Cereblon,通常由沙利度胺及其衍生物靶向,以及Von Hippel-Lindau蛋白(VHL),通常由小分子VH032和相关化合物靶向。86

多年来,在生物物理方法中设计了专门的方案来表征POI-PROTAC-E3连接酶三元复合物的形成,以评估PROTACs的体外潜力。这些包括ITC和SPR,它们提供关于PROTAC结合热力学和动力学的关键信息。最近,nMS被指示为捕获POI-PROTAC-E3连接酶三元复合物形成的有力工具。通过nMS,Beveridge等人捕获了E3连接酶复合物VHL/elongin-B/elongin-C(VCB)与溴结构域和额外末端域(BET)蛋白(Brd3BD2、Brd4BD1或Brd4BD2)以及PROTACs AT1和MZ1[其POI配体是泛BET抑制剂(+)-JQ1]之间的相互作用(图5b)。87 天然质谱表明,AT1和MZ1都优先与Brd4BD2形成三元复合物(图5c,d分别显示AT1诱导的VCB-Brd4BD2和VCB-Brd4BD1复合物形成),AT1比MZ1更具选择性,与已发表的数据一致。88 当E3连接酶:PROTAC:POI摩尔比为1:2:1(5 µM:10 µM:5 µM)时达到最佳结合,而20 µM PROTAC浓度导致所谓的“钩状效应”,包括在高PROTAC浓度下三元复合物形成减少,这促进二元相互作用。此外,通过比较具有高度协同性POI(Brd4BD2,a = 4.7)和较低协同性POI(Brd4BD1,a = 0.2)的三元复合物形成,nMS实验捕获了协同PROTAC结合(即,PROTAC与第一个蛋白质复合物的结合增强对第二个的亲和力,从而促进三元复合物形成超过二元复合物;比较图5c和d)。具体而言,当AT1(10 µM)与5 µM VCB混合时,三元复合物分数为0.2,而在相同浓度下,Brd4BD2和Brd4BD1均为约0.5。值得注意的是,当三种组分以连接酶:PROTAC:POI 1:2:1摩尔比一起孵育时,与Brd4BD1(0.65)相比,三元复合物在Brd4BD2(0.82)中观察到高得多的程度,从而证实了先前在其他实验中观察到的结果(图5c,d)。88 最后,在同时存在三个(Brd3BD2、Brd4BD1和Brd4BD2)或五个(Brd3BD2、Brd4BD1、Brd4BD2、Brd2BD2和BrdT)BET家族成员的情况下进行的竞争实验,证实了AT1和MZ1对Brd4BD2的优先结合以及AT1的更高选择性。87

最近,Sternicki及其同事使用nMS评估了VCB与Brd4BD1或Brd4BD2之间由GNE-987诱导的复合物形成,GNE-987是最近开发的VHL招募Brd4靶向PROTAC。90,91 作者显示GNE-987优先靶向Brd4BD1,当GNE-987(7.81 µM)与等摩尔量的VCB和Brd4BD1(9 µM)混合时,复合物比率为0.70。在相同浓度下,Brd4BD2的比率为0.34,当GNE-987增加至15.625和31.25 µM时达到最大值(分别为0.44和0.45)。相反,当在这些浓度下在Brd4BD1存在下测试GNE-987时,“钩状效应”明显,三元复合物比率降至约0.55。89 这些数据与SPR测量一致,SPR显示Brd4BD1的三元复合物半衰期(t1/2)长得多,尽管通过nMS测量的Brd4BD1与Brd4BD2形成的三元复合物量的差异幅度不如SPR t1/2测量中的差异窗口大,其中Brd4BD1 t1/2比Brd4BD2长100倍。91 然而,nMS提供了稳态平衡测量,而SPR测量了实时动力学事件;因此,每种测量都是独特的,并受不同因素影响。

Song及其同事随后的一项研究描述了VCB-MZ1-Brd4BD2复合物在傅里叶变换离子回旋共振(FT-ICR)质谱仪上的nMS实验,并证明VCB-MZ1-Brd4BD2三元复合物在应用增加CID电压后解离,导致MZ1排出,而VCB-Brd4BD2复合物(在MZ1不存在下溶液中未观察到)被保留。CID电压的进一步增加诱导了外围亚基Brd4BD2的释放。92 在四极杆/离子迁移分离/飞行时间(Q-IMS-ToF)仪器上进行的IM-MS实验表明,在初始实验中观察到的13+和12+电荷态采取更紧凑的构象,与15+电荷态相比,后者作为延伸构象存在,而14+电荷态是两者的混合物。与此一致,增加碰撞电压的应用导致MZ1从更紧凑构象体的优先解离和BRD4BD2从更延伸构象体的优先排出。这些数据证明,较高电荷态以更大的库仑排斥和PPIs为特征,而低电荷态采取类天然构象。为此,VCB和Brd4BD2在MZ1排出后仍维持其相互作用的证据支持VCB与Brd4BD2之间存在特异性分子间相互作用,如相应晶体结构中所述。88 在CID实验过程中,两个蛋白质之间的特异性非共价相互作用可能与气相中发现的不同。因此,尽管这些研究提供了有价值的起点,但它们需要用正交实验进行验证。尽管如此,这三项研究表明,PROTAC功效可以通过nMS成功探测,不同方法和仪器的整合可以提供对结合亲和力和结构特征的见解。

**结论** 质谱仪技术取得的进步为nMS发展成为分析蛋白质-蛋白质和蛋白质-小分子相互作用的非凡灵活工具铺平了道路。其高灵敏度、易用性、速度、宽动态范围和最小样品消耗使其成为广泛用于早期药物筛选活动的生物物理工具箱的重要组成部分。随着使用nMS进行药物发现应用的研究小组和研究的数量增加,以及因此更多研究人员接受该领域培训,通过nMS研究蛋白质-配体相互作用将在药物发现中变得越来越常规。nMS将越来越多地与其他方法整合,如ITC、SPR和结构技术,如X射线晶体学和cryo-EM,提供对蛋白质-配体结合和PPI调节的空前见解,这将对未来的药物开发过程产生重大影响。

nMS在药物发现中的增加使用应在理解可能的实验假阴性(疏水相互作用的气相分解)和假阳性(非特异性结合)的根本起源的情况下进行。为此,样品制备、电离技术和设备方面的未来发展应有助于成功克服这些限制。然而,nMS分析在捕获配体结合在溶液中的影响方面是独特的,例如对蛋白质复合物形成、85 寡聚化69 或酶-底物/辅底物结合的影响。70 此外,通过监测直接配体结合或蛋白质-配体相互作用的影响,基于nMS的竞争结合测定也可以容易地定义潜在药物对给定结合位点的特异性。此外,可以使用正确的实验参数区分结合位点,显示复杂的变构过程。70,76,85,93 此外,非挥发性缓冲液或盐的使用、缓冲添加剂如电荷减少剂,以及在膜蛋白情况下创新去污剂和膜模拟物的开发,应有助于维持不稳定的类天然蛋白质-小分子复合物用于nMS检测。与此一致,最近的研究证明了直接从细胞裂解物分析可溶性和膜蛋白的可行性,67,94 或分别从膜囊泡分析,95,96 从而防止可能由样品制备引起的潜在伪影。鉴于处理这些技术产生的复杂光谱仍然耗时且难以解释,数据分析的进展对于实现nMS分析细胞裂解物和膜囊泡的全面发展至关重要。为此,已经朝着开发用于分析复杂质谱的软件迈出了初步步骤。97,98 将当前可用的软件平台与机器学习和人工智能方法整合将加速nMS光谱解释,并使制药行业能够将nMS作为标准技术采用。

鉴于其在捕获PPIs方面的巨大潜力,我们预计nMS在评估作为PPI调节剂(包括PROTACs)的小分子的效力和作用模式方面将发挥越来越大的作用。在某些情况下,测量两个(或多个)蛋白质之间的相互作用仍然困难,需要特定标签或固定化的存在。相反,nMS允许直接观察这些相互作用,量化复合物形成,分析协同结合,并准确评估多蛋白复合物或寡聚体的化学计量。因此,单个实验产生关于小分子对蛋白质复合物稳定性影响的大量信息。如本文包含的案例研究所见,几个小组已经在使用nMS评估PPI调节剂,我们预计制药行业将采用nMS用于这些应用。为此,基于芯片的自动化nESI平台,如前文提到的NanoMate,53 对于提高nMS实验的通量以及使其能够应用于小分子文库至关重要。

**作者贡献** 所有作者都参与了本文的工作。

**利益冲突声明** 作者声明,该研究是在没有任何可能被视为潜在利益冲突的商业或财务关系的情况下进行的。

**数据可用性** 本文描述的研究未使用任何数据。

**致谢** 这项工作得到了意大利大学部FISR2019_00374 MeDyCa(A.M.)、'Sapienza' Ateneo项目2021 n. RM12117A61C811CE(D.R.)、Regione Lazio Progetti di Gruppi di Ricerca 2020 – A0375-2020-36597(D.R.)的支持。F.F.得到欧盟Horizon Europe计划Marie Skłodowska-Curie资助协议EpiPolyPharma 101062363的支持。