A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of CRB-601, a Monoclonal Antibody Against Integrin Avb8, in Patients with Advanced Solid Tumors

The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy or immune-priming radiotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein.
Researchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant&#39;s cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer.
Participants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy and immune-priming radiotherapy. For patients receiving the immune-priming radiotherapy they will receive three doses of radiotherapy focused on a single tumor.
There will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.

开始日期2024-10-01

申办/合作机构

Corbus Pharmaceuticals Holdings, Inc.

NCT06265727 / Recruiting临床1/2期

A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors

The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.
The main questions it aims to answer are:
What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701?
Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors.

开始日期2024-04-01

申办/合作机构

Corbus Pharmaceuticals Holdings, Inc.

[+1]

EUCTR2020-001762-11-HU / Not yet recruiting临床2/3期

An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials

开始日期2020-08-26

申办/合作机构

Corbus Pharmaceuticals Holdings, Inc.

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项与 Corbus Pharmaceuticals Holdings, Inc. 相关的文献（医药）

2023-12-01·The Journal of investigative dermatology

Validation of Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score and Other Efficacy Outcomes as Measures of Skin Disease in Dermatomyositis in the Lenabasum Phase 3 Trial

Article

作者: Kleitsch, Julianne ; White, Barbara ; Pandya, Rachita ; Werth, Victoria P ; Dan, Joshua

In the past decade, there have been six industry-sponsored phase 3 trials in adult patients with dermatomyositis (DM), primarily focusing on improving muscle weakness. However, skin disease is a cardinal manifestation of DM. This study evaluated the sensitivity of Cutaneous Dermatomyositis Disease Area and Severity Index Activity score, Cutaneous Dermatomyositis Activity Investigator Global Assessment, Total Improvement Score, and other outcome measures used in DM clinical trials to detect improvement in DM skin disease activity. Data analyzed from the lenabasum phase 3 trial in DM showed that improvement in Cutaneous Dermatomyositis Disease Area and Severity Index Activity score increased proportionately with the degree of patient- or physician-reported improvement in skin disease, consistently measuring improvement when clinically meaningful improvement was reported at weeks 16-52. In contrast, Cutaneous Dermatomyositis Activity Investigator Global Assessment measured little change from baseline with reported no improvement in skin disease but also a similar change from baseline with slight improvement. No Skindex-29+3 subscale performed well at reflecting increasing degrees of improvement in skin disease. Extramuscular Global Assessment and Total Improvement Score generally showed increasing levels of improvement as the degree of patient- and physician-reported improvement in skin disease increased, but these are composite measures and are not specific to improvement in DM skin disease. To measure clinically meaningful improvement in skin disease in a DM trial, Cutaneous Dermatomyositis Disease Area and Severity Index Activity score is the more sensitive outcome measure across time points.

2023-11-01·Obesity (Silver Spring, Md.)

Novel cannabinoid receptor 1 inverse agonist CRB‐913 enhances efficacy of tirzepatide, semaglutide, and liraglutidein the diet‐induced obesity mouse model

Article

作者: Brake, Rachael ; Blumen, Tracy ; Cohen, Yuval ; Ferreira, Suzie ; Kolodziej, Andrew ; Morningstar, Marshall

Abstract:

Objective:

Incretin receptor agonists are now standard of care in treating obesity. Their efficacy and tolerability might be further improved by combining them with compounds that offer orthogonal mechanisms of action. The cannabinoid type 1 receptor (CB1R) is a clinically validated therapeutic target in obesity, and several experimental CB1R inverse agonists have been shown to induce weight loss.

Methods:

This study characterizes a novel CB1R inverse agonist (CRB‐913) with similar preclinical potency to rimonabant but markedly reduced brain penetration. CRB‐913 was tested as monotherapy and in combination with tirzepatide, semaglutide, or liraglutide in the diet‐induced obesity (DIO) mouse model for body weight reduction.

Results:

CRB‐913 demonstrated enhanced plasma exposure (3.8‐fold larger area under the curvelast) and reduced brain levels (9.5‐fold lower area under the curvelast) than rimonabant. CRB‐913 monotherapy yielded a dose‐dependent decrease in body weight in DIO mice reaching −22% within 18 days. In further DIO studies in combination with tirzepatide, semaglutide, or liraglutide, CRB‐913 (2.5 mg/kg) resulted in −32.6%, −28.8%, and −16.8% decreases in body weight on Day 18, respectively, with concomitant improvements in body fat content, liver triglycerides, and liver fat deposits.

Conclusions:

CRB‐913 in combination with incretin analogues could deliver meaningful improvements over current standards of care for obesity and related conditions.

2023-09-01·Arthritis & rheumatology (Hoboken, N.J.)

Efficacy and Safety of Lenabasum, a Cannabinoid Type 2 Receptor Agonist, in a Phase 3 Randomized Trial in Diffuse Cutaneous Systemic Sclerosis.

Article

作者: Jun, Jae-Bum ; Khanna, Dinesh ; White, Barbara ; Spiera, Robert ; Kafaja, Suzanne ; Distler, Oliver ; Denton, Christopher P ; de Vries-Bouwstra, Jeska ; Kuwana, Masataka ; Levy, Yair ; Sandorfi, Nora ; Furst, Daniel E ; Lee, Eun Bong ; Dgetluck, Nancy ; Jankowski, Tomasz ; Simms, Robert W ; Litinsky, Irena ; Stevens, Wendy ; Dinh, Quinn ; Chung, Lorina ; Mayes, Maureen ; Matucci-Cerinic, Marco ; Leszcyzński, Piotr ; Steen, Virginia ; Bloom, Bradley J ; Hummers, Laura ; Hsu, Vivien ; Gordon, Jessica ; Frech, Tracy M ; Finzel, Stephanie ; Constantine, Scott

OBJECTIVE:

This phase 3 study was undertaken to investigate the efficacy and safety of lenabasum, a cannabinoid type 2 receptor agonist, in patients with diffuse cutaneous systemic sclerosis (dcSSc).

METHODS:

A multinational double-blind study was conducted in 365 dcSSc patients who were randomized and dosed 1:1:1 with lenabasum 20 mg, lenabasum 5 mg, or placebo, each twice daily and added to background treatments, including immunosuppressive therapies (IST).

RESULTS:

The primary end point, the American College of Rheumatology combined response index in dcSSc (CRISS) at week 52 for lenabasum 20 mg twice a day versus placebo, was not met, with CRISS score of 0.888 versus 0.887 (P = 0.4972, using mixed models repeated measures [MMRM]). The change in the modified Rodnan skin thickness score (MRSS) at week 52 for lenabasum 20 mg twice a day versus placebo was -6.7 versus -8.1 (P = 0.1183, using MMRM). Prespecified analyses showed higher CRISS scores, greater improvement in MRSS, and lower decline in forced vital capacity in patients on background mycophenolate and those who were taking IST for ≤1 year. No deaths or excess in serious or severe adverse events related to lenabasum were observed.

CONCLUSION:

A benefit of lenabasum in dcSSc was not demonstrated. Most patients were treated with background IST, and treatment with mycophenolate mofetil in particular was associated with better outcomes. These findings support the use of IST in the treatment of dcSSc and highlight the challenge of demonstrating a treatment effect when investigational treatment is added to standard of care IST. These findings have relevance to trial design in SSc, as well as to clinical care.

160

项与 Corbus Pharmaceuticals Holdings, Inc. 相关的新闻（医药）

2024-10-29

·GlobeNewswire-Health Care

Corbus Pharmaceuticals to Present at the Guggenheim Securities Healthcare Innovation Conference

NORWOOD, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today announced that Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will participate in a fireside chat and one-on-one investor meetings at the Guggenheim Securities Healthcare Innovation Conference to be held November 11-13, 2024 in Boston, MA. Guggenheim Securities Healthcare Innovation ConferenceFormat: Fireside chat and one-on-one investor meetingsDate: November 12, 2024Time: 10:00 a.m. ETWebcast: Click here About Corbus Corbus Pharmaceuticals Holdings, Inc. is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook. Forward-Looking StatementsThis press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies. INVESTOR CONTACT: Sean MoranChief Financial OfficerCorbus PharmaceuticalsSean.moran@corbuspharma.com Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@lifesciadvisors.com

抗体药物偶联物

2024-10-16

·GlobeNewswire-Health Care

Corbus Announces Enrollment Completion of Dose Escalation Stage of Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC (CRB-701)

NORWOOD, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, announced today that it has completed enrollment of the dose escalation part of its bridging Phase 1 clinical trial of CRB-701 (SYS6002). The dose escalation part of this open label study (NCT06265727) is being conducted in the US and the UK. The three-part Phase 1 trial is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in patients with advanced solid tumors associated with high Nectin-4 expression. The Part A dose escalation of the Phase 1 study is evaluating four predetermined doses (1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg and 4.5 mg/kg) and will be followed by Part B (dose optimization) and Part C (dose expansion) that will determine recommended/optimized doses and seek preliminary efficacy signals. The company expects to share the first data from dose escalation in Q1 2025. About CRB-701CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. About CorbusCorbus Pharmaceuticals Holdings, Inc. is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Facebook, LinkedIn and X. Forward-Looking Statements This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies. INVESTOR CONTACT: Sean MoranChief Financial OfficerCorbus Pharmaceuticalssmoran@corbuspharma.com Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@lifesciadvisors.com

临床1期抗体药物偶联物

2024-10-15

·同写意

ADC被泼了一杯冷水

本届大会以“共建创新生态共赢产业未来”为主题，聚焦生物医药出海与国际化创新、创新药投融资、医疗器械等产业发展风向标，打造“高端化、国际化、专业化、立体化”的年度盛会。关于ADC的童话故事并不总是美好。 9月23日，阿斯利康和第一三共共同宣布TROP2靶点 ADC药物Datopotamab deruxtecan（Dato-DXd）在二/三线治疗HER2低表达或阴性乳腺癌患者的研究未达到总生存期的主要终点。而就在几天之前，同一款药在2024 WCLC大会上公布了其治疗二线NSCLC的OS获益结果：Dato-DXd组和多西他赛组的中位OS分别为12.9个月和11.8个月，HR为0.94，未达到统计学显著差异。这给本身就道阻且长的新药研发又投下了一道阴影。 TROP2之热门，加上阿斯利康/第一三共二度牵手带来的背书，使Dato-DXd成为DS-8201之后，下一款被业内寄予厚望的ADC药物。如今在两个重磅适应症的开发上却不断接连失守，这也导致阿斯利康股价在上个月直接跌去近13%。 Dato-DXd的霉运不是个例。今年年初，另一款TROP2的ADC药物——吉利德的Trodelvy，同样在治疗转移性NSCLC的研究中未达到总体生存期的主要终点。5月30日，公司宣布该药在尿路上皮癌的关键III期临床失败。阿斯利康和吉利德都曾在这两款ADC药物上倾注心血。 Dato-DXd 当年的总交易额高达60亿美元；而Trodelvy则是吉利德通过豪掷210亿美元收购Immunomedics得来。如今，这两款药物的开发受挫可能会影响未来的商业化兑现，也多少松动了一些ADC领域曾经承载的行业期待。对此，关注ADC领域多年的投资人陈漫（化名）并没有表现出过多担心。“没达到主要终点不意味着ADC的效果不好或者TROP2的靶点不行，而是因为这些大适应症的治疗手段其实已经很丰富了，效果也都比较好，这一点很难避免对结果造成干扰。” 比如，在上文提到的Dato-DXd治疗HER2低表达或阴性乳腺癌患者的临床中，化疗对照组里有14.2% 的患者接受了ADC 治疗，而 Dato-DXd 组的的比例为4.1%，而众所周知，已经获批的ADC药物DS-8201对于该适应症的效果强劲，因此大概率提升了对照组的总生存期。两家MNC的暂时失利所敲响的，并不是热门ADC靶点开发的丧钟，而是警钟：不仅提醒同一跑道的参赛者们在临床设计上需要更为谨慎；同时在适应症的选择上，也要注意到“大癌种”背后的开发风险。 1 热门靶点的“陨落” ADC药物，尤其是一些热门靶点的开发，由于其良好的成药性和通畅的商业前景，在这两年总体低迷的生物医药市场撑起了半壁江山。然而，进入2024年，随着其中的领先者们进入赛事后半程，对于这些药物的临床结果业内产生了不少争议。除了上文提到的TROP2靶点ADC以外，类似的还有Claudin18.2、HER3等。 8月6日，Elevation公布了其Claudin18.2 ADC药物EO-3021的最新临床结果：在15名胃癌患者中，ORR仅为20%，比起之前数据大幅滑落；而HER3靶点方面，备受期待的第一三共/默沙东HER3-DXd虽然在这个月被宣布达到了PFS主要终点，但并未披露具体数据，引起了一些外界猜测。加上今年宜联生物/BioNTech的同靶点临床造成三名受试者因副作用死亡，使得HER3 ADC的安全性问题受到质疑。这些泛癌靶点，因为其适应症潜力而成为热门选择。根据不完全统计，仅国内进入临床阶段的ADC管线中，HER2靶点、TROP2靶点、Claudin18.2靶点就分别有29款、15款、12款药物。之所以热门靶点的ADC药物在中国大火，也是因为“早期数据比较容易看到结果”，因而适合走BD路线。 “Elevation的ADC就是从石药买过去的，在中国的临床数据ORR能达到接近50%。”陈漫说。“这其实给了Elevation一些不切实际的乐观预期，在入组的时候就没怎么挑患者。但其实在中国的早期结果那么好，有很大程度的原因就是受试者都是靶点表达率高的。” 而即使ORR表现出色，在OS尚未成熟之前，ADC药物的临床结果也很容易落入“先甜后苦”的境地。比如Dato-DXd 的PFS和ORR数据都很不错：比起化疗组中位 PFS 延长了两个月，ORR提升了13.5%。但这依然没能改变“OS一出，全盘皆输”的命运。 “因为时间拉得长，OS特别容易受到后续治疗的影响，因此不太好进行比较。”陈漫提到。“我们确实注意到这一现象，一些ADC药物的PFS数据和OS数据并不匹配，就算是8201也有这个问题，只是不明显。当然，公司提到的后续治疗造成的影响，是有可能的，但也有可能是药副作用的长期影响。这一点还有待进一步研究。” 目前，由于PFS受FDA承认可作为支持加速审批的替代终点，因此以Dato-DXd为代表的药物并无上市方面的掣肘。然而，不可否认的是，笼罩在其OS数据上的疑云，必将为其未来商业化的道路设置障碍。 2 未来临床该怎么做意识到前路凶险的阿斯利康，在最近的Dato-DXd相关管线中，做起了亡羊补牢的工作。其中之一便是重新选择了生物标志物。 9月11日，阿斯利康宣布，公司通过定量连续评分法（QCS）计算的 TROP2 归一化膜比值（NMR），可用于预测接受Dato-DXd治疗的晚期或转移性NSCLC患者的临床治疗结果。基于这一全新的生物标志物，公司对NSCLC 的Ⅲ期试验进行了回顾性分析，Dato-DXd 在 QCS-NMR 阳性肿瘤患者中的疗效远优于阴性肿瘤患者。这一举动实际上达到了一箭双雕的作用。首先，这为Dato-DXd在此前不尽如人意的获益结果做了辩解——公司只是没有很好地选择患者，未来会有所改善；其次，因为此前Dato-DXd 的疾病进展获益仅在非鳞状NSCLC患者中得到确认，而这一新的生物标志物可以重新覆盖部分鳞状NSCLC患者（在此前临床试验中，44%的鳞状患者为QCS-NMR阳性），从而扩大未来的应用市场。 “这种做法当然为后来的研究者打了一个样。但是目前很难得到广泛的承认，因为它的数据来源完全只基于一家公司的一项试验。”陈漫说道。“但如果未来的算法成本变低，这样做的公司肯定会越来越多，因为这能得到更有利的数据，必然会带来竞争。”他补充说道。除了在生物标志物上做文章以外，在毒性/疗效、高表达/低表达人群中平衡和取舍，同样是一门学问。 ADC中的linker，如果不稳定将导致非肿瘤组织的全身统性毒性，但如果太稳定，则会造成药物进入细胞后不能顺利释放，进而影响最终疗效。同样的，在实际的临床给药中，如何将剂量控制在毒性和疗效双双达标的完美区间里，也是如今ADC药企需要小心求证的一步。而学会在高表达/低表达人群中选患者也尤为重要。像上文所提到的中国biotech那样，保守地挑选高表达患者，纵使能做出优秀的数据，但适用面比较狭窄；而如果不做刻意筛选，虽然可以大大增加适应症的拓展潜力，但也要承担像Elevation那样的滑铁卢风险。 3 中国ADC的机会 Dato-DXd和Trodelvy所栽的跟头，并没有让同靶点药物背后的企业受到影响。 “因为ADC是一个技术差异特别大的领域，所以即使是同靶点，所面临的现实都是完全不同的，不同适应症上的不确定性也特别大。”陈漫解释道。行业并没有陷入哀怨中；相反，领先者们的暂时跌倒，让竞争者们的超越之心更加激奋。科伦博泰和默沙东合作的TROP2 ADC药物SKB264（MK-2870）正在以难以想象的规模展开版图。截至今年6月，该药物已经累计在全球开展了10项Ⅲ期实验。由于进展速度不如Dato-DXd和Trodelvy，这款药物曾经不太被业内看好；但今年的风波过后，SKB264竟然一跃成为具有BIC品相的黑马。 ADC之间的竞争非常残酷。以上三款TROP2产品都将拓扑异构酶Ⅰ抑制剂作为其有效载荷，这就带来了耐药问题。一款ADC药物，很难作为另一款ADC药物的后续或辅助治疗，甚至换药也不行。正是因为这个原因，很多针对有治疗经验的患者的临床试验，都会将先前接触过拓扑异构酶Ⅰ化疗的患者排除出去。因此，未来中国的ADC产业若想继续发展，就必须首先保证产品的不可替代性。实现不可替代的路有很多，但哪一条都不好走：要么是在疗效和安全性上建立绝对优势，要么是在联合用药上展现优势，要么是在研发难度较高的靶点和适应症上让自己成为最早上市的那个。从去年开始，中国的ADC biotech开始在一些较小众的靶点上渐渐活跃起来。比如Nectin-4这一领域，去年巨石生物与Corbus Pharmaceuticals就达成了总金额6.925亿美元的授权。一些企业如迈威生物等，临床速度始终保持在第一梯队。在适应症上，大癌种虽然前景广阔，但一方面面临竞争压力大的问题，另一方面在ADC单药依然未能挤进一线治疗的现状下，考虑到其研发成本，市场回报率其实也很有限。因此，在较小适应症上拼速度，成为了如今很多biotech的选择。比如，在TROP2 ADC的开发上，Dato-DXd和Trodelvy这两个巨头将目光对准了乳腺癌和肺癌两大适应症。而中国的biotech则关注到了未被青睐的领域：卵巢癌。今年3月，恒瑞的TROP2 ADC产品SHR-A1921获得FDA快速通道资格，首个适应症定为卵巢癌；在此之前，同样布局TROP2治疗卵巢癌的还有BioNTech和映恩生物的BNT323/DB-1303。这种路线在很大程度上缓解了中国ADC在全球背景下的生存压力；当然，属于中国biotech之间的内部竞争，就又是另外一个故事了。同写意媒体矩阵，欢迎关注↓↓↓

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药物(靶点)	适应症	全球最高研发状态

SYS6002 ( nectin-4 )	晚期恶性实体瘤更多	临床1/2期
CRB-601 ( TGF-β x αvβ8 )	晚期恶性实体瘤更多	临床1/2期
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