A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer (Triumph-02)

This is a multicenter, open Phase I/II study. The trial consists of two parts, Part1 is a dose-escalation/expansion study, Part2 is a combination of GLS-010 and GLS-010+GLS-012 with standard chemotherapy for advanced non-small-cell lung cancer respectively to assess preliminary efficacy at the combination dose.

开始日期2023-08-10

申办/合作机构

广州誉衡生物科技有限公司

CTR20221969 / Recruiting临床1/2期

GLS-012单药在标准治疗失败的进展期实体瘤患者中的安全性、耐受性以及初步疗效的Ⅰ/Ⅱ期研究（Triumph-01）

主要目的是评价GLS-012在标准治疗失败的进展期实体瘤患者中的安全性和耐受性。

开始日期2022-10-31

申办/合作机构

广州誉衡生物科技有限公司

100 项与重组全人抗LAG-3单克隆抗体(广州誉衡生物科技/无锡药明康德) 相关的临床结果

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100 项与重组全人抗LAG-3单克隆抗体(广州誉衡生物科技/无锡药明康德) 相关的转化医学

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100 项与重组全人抗LAG-3单克隆抗体(广州誉衡生物科技/无锡药明康德) 相关的专利（医药）

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项与重组全人抗LAG-3单克隆抗体(广州誉衡生物科技/无锡药明康德) 相关的文献（医药）

2024-11-01·NEUROPHARMACOLOGY

Intranasal LAG3 antibody infusion induces a rapid antidepressant effect via the hippocampal ERK1/2-BDNF signaling pathway in chronically stressed mice

Article

作者: Peng, Jie ; Zhu, Haojie ; Pan, Hainan ; Huang, Chao ; Lu, Xu ; Ren, Jie ; Li, Jinxin ; Ye, Minxiu ; Wang, Hanxiao ; Fang, Yunli

The decline of microglia in the dentate gyrus is a new phenomenon that may explain the pathogenesis of depression, and reversing this decline has an antidepressant effect. The development of strategies that restore the function of dentate gyrus microglia in under stressful conditions is becoming a new focus. Lymphocyte-activating gene-3 (LAG3) is an immune checkpoint expressed by immune cells including microglia. One of its functions is to suppress the expansion of immune cells. In a recent study, chronic systemic administration of a LAG3 antibody that readily penetrates the brain was reported to reverse chronic stress-induced hippocampal microglia decline and depression-like behaviors. We showed here that a single intranasal infusion of a LAG3 antibody (In-LAG3 Ab) reversed chronic unpredictable stress (CUS)-induced depression-like behaviors in a dose-dependent manner, which was accompanied by an increase in brain-derived neurotrophic factor (BDNF) in the dentate gyrus. Infusion of an anti-BDNF antibody into the dentate gyrus, construction of knock-in mice with the BDNF Val68Met allele, or treatment with the BDNF receptor antagonist K252a abolished the antidepressant effect of In-LAG3 Ab. Activation of extracellular signal-regulated kinase1/2 (ERK1/2) is required for the reversal effect of In-LAG3 Ab on CUS-induced depression-like behaviors and BDNF decrease in the dentate gyrus. Moreover, both inhibition and depletion of microglia prevented the reversal effect of In-LAG3 Ab on CUS-induced depression-like behaviors and impairment of ERK1/2-BDNF signaling in the dentate gyrus. These results suggest that In-LAG3 Ab exhibits an antidepressant effect through microglia-mediated activation of ERK1/2 and synthesis of BDNF in the dentate gyrus.

2024-10-01·PROTEIN EXPRESSION AND PURIFICATION

Screening, expression and anti-tumor functional identification of anti-LAG-3 nanobodies

Article

作者: Chen, Rui ; Wang, Liyan ; Xu, Guangxian ; Jiang, Dan

OBJECTIVE:

To screen and obtain specific anti-lymphocyte activation gene-3 (LAG3) nanobody sequences, purify and express recombinant anti-LAG3 nanobody, and verify its effect on promoting T cells to kill tumor cells.

METHODS:

Based on the camel derived natural nanobody phage display library constructed by the research group, the biotinylated LAG3 antigen was used as the target, and the anti-LAG3 nanobody sequences were screened by biotin-streptavidin liquid phase screening, phage-ELISA and sequencing. The sequence-conjμgated human IgG1 Fc fragment was obtained, the recombinant anti-LAG3 nanobody expression vector was constructed, the expression of the recombinant anti-LAG3 nanobody was induced by IPTG and purified, and the characteristics and functions of the recombinant anti-LAG3 nanobody were verified by SDS-PAGE, Western blot, cytotoxicity assay, etc. RESULTS: One anti-LAG3 nanobody sequence was successfully screened, and the corresponding recombinant anti-LAG3 nanobody-expressing bacteria were constructed. The results of SDS-PAGE, Western blot and cytotoxicity assay showed that the recombinant anti-LAG3 nanobody was successfully expressed, which was specific, and it could promote the killing ability of T cells against tumor cells, and the optimal concentration was 200 μg/mL.

CONCLUSION:

The recombinant anti-LAG3 nanobody screened and expressed has specific and auxiliary anti-tumor cell effects, which lays a foundation for its subsequent application.

2023-01-01·Frontiers in oncology

Abscopal effect observed in visceral and osseous metastases after liver SBRT in combination with nivolumab and relatlimab for sinonasal mucosal melanoma-a case report.

作者: Moya-Brown, Karen ; Spieler, Benjamin ; Mihaylov, Ivaylo B ; Cerbon, Danielle

Background:

Primary sinonasal mucosal melanoma (SNMM) is a rare, aggressive histology usually diagnosed at advanced stages and associated with poor prognosis. Evidence regarding etiology, diagnosis, and treatment mainly derives from case reports, retrospective series, and national databases. In the treatment of metastatic melanoma, anti-CTLA-4 and anti-PD-1 checkpoint blockade increased 5-year overall survival from ~10% (prior to 2011) to ~50% (between 2011 and 2016). In March of 2022, the FDA approved the use of relatlimab, a novel anti-LAG3 immune checkpoint inhibitor, for the treatment of melanoma.

Case presentation:

A 67-year-old woman with locally advanced SNMM underwent debulking surgery, adjuvant RT, and first-line immunotherapy (ImT) with nivolumab but developed local progression. The patient started a second course of ImT with nivolumab and ipilimumab, but this was discontinued after two cycles due to an immune-related adverse event (irAE, hepatitis with elevated liver enzymes). Interval imaging identified visceral and osseous metastases including multiple lesions in the liver and in the lumbar spine. She went on to receive a third course of ImT with nivolumab and the novel agent relatlimab with concurrent stereotactic body radiation therapy (SBRT) to the largest liver tumor only, delivered in five 10-Gy fractions using MRI guidance. A PET/CT performed 3 months after SBRT demonstrated complete metabolic response (CMR) of all disease sites including non-irradiated liver lesions and spinal metastatic sites. After two cycles of the third course of ImT, the patient developed severe immune-related keratoconjunctivitis and ImT was discontinued.

Conclusion:

This case report describes the first complete abscopal response (AR) in an SNMM histology and the first report of AR following liver SBRT with the use of relatlimab/nivolumab combination ImT for metastatic melanoma in the setting of both visceral and osseous lesions. This report suggests that the combination of SBRT with ImT potentiates the adaptive immune response and is a viable path for immune-mediated tumor rejection. The mechanisms behind this response are hypothesis-generating and remain an area of active research with exceedingly promising potential.

项与重组全人抗LAG-3单克隆抗体(广州誉衡生物科技/无锡药明康德) 相关的新闻（医药）

2024-06-17

·Science Daily

New study suggests cancer drug could be used to target protein connection that spurs Parkinson's disease

In studies with genetically engineered mice, researchers say they have identified a potentially new biological target involving Aplp1, a cell surface protein that drives the spread of Parkinson's disease-causing alpha-synuclein. In studies with genetically engineered mice, Johns Hopkins Medicine researchers say they have identified a potentially new biological target involving Aplp1, a cell surface protein that drives the spread of Parkinson's disease-causing alpha-synuclein. The findings, published May 31 in Nature Communications, reveal how Aplp1 connects with Lag3, another cell surface receptor, in a key part of a process that helps spread harmful alpha-synuclein proteins to brain cells. Those protein buildups are hallmarks of Parkinson's disease. Notably, the researchers say, Lag3 is already the target of a combination cancer drug approved by the U.S. Food and Drug Administration (FDA) that uses antibodies to "teach" the human immune system what to seek and destroy. "Now that we know how Aplp1 and Lag3 interact, we have a new way of understanding how alpha-synuclein contributes to the disease progression of Parkinson's disease," says Xiaobo Mao, Ph.D., associate professor of neurology at the Johns Hopkins University School of Medicine and a member of the Institute for Cell Engineering. "Our findings also suggest that targeting this interaction with drugs could significantly slow the progression of Parkinson's disease and other neurodegenerative diseases." Mao co-led the research along with Ted Dawson, M.D., Ph.D., Leonard and Madlyn Abramson Professor in Neurodegenerative Diseases at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Institute for Cell Engineering, Valina Dawson, Ph.D. and Hanseok Ko, Ph.D., professors of neurology at the school of medicine and members of the Institute for Cell Engineering. Long-standing studies have shown that by clumping together and forming protein deposits, misfolded alpha-synuclein proteins journey from brain cell to brain cell, killing those responsible for producing a neurotransmitter called dopamine, and causing Parkinson's disease to progress through a type of "programmed" cell death that Johns Hopkins researchers have identified. The process, parthanatos (from the Greek word for "death"), leads to impairments in movement, emotional regulation and thinking. Aplp1's bond with Lag3 on the cell's surface enables healthy brain cells to absorb traveling clumps of alpha-synuclein, leading to cell death, the researchers say. In mouse studies published in 2016 and 2021, Mao and Dawson's team identified Lag3's role in binding with alpha-synuclein proteins, causing Parkinson's disease to spread. However, those studies indicated that another protein was partially responsible for the cell's absorption of misfolded alpha-synuclein. "Our work previously demonstrated that Lag3 wasn't the only cell surface protein that helped neurons absorb alpha-synuclein, so we turned to Aplp1 in our most recent experiments," says Valina Dawson. To determine whether Aplp1 indeed contributed to the spread of harmful alpha-synuclein proteins, researchers used a line of genetically engineered mice lacking either Aplp1 or Lag3 or both Aplp1 and Lag3. In mice without Aplp1 and Lag3, cell absorption of the harmful alpha-synuclein protein dropped by 90%. After injecting mice with the Lag3 antibody, they found that this drug also blocks the interaction of Aplp1 and Lag3, meaning healthy brain cells could no longer absorb disease-causing alpha-synuclein clumps. The researchers say the Lag3 antibody nivolumab/relatlimab, a drug FDA approved in 2022 for cancer treatment, could play a role in preventing cells from absorbing alpha-synuclein. "The anti-Lag3 antibody was successful in preventing further spread of alpha-synuclein seeds in the mouse models and exhibited better efficacy than Lag3-depletion because of Aplp1's close association with Lag3," Ted Dawson says. This research has potential applications in treating other neurodegenerative conditions that have no cures, Mao says. In Alzheimer's disease, which is associated with symptoms of memory loss, mood instability and muscle problems, tau proteins become misfolded and clump together in neurons at high levels, worsening the condition. In Alzheimer's research, Mao says scientists could try to target Lag3 -- which also binds with the dementia-related tau protein -- with the same antibody. With the success of using the Lag3 antibody in mice, Ted Dawson says the next steps would be to conduct anti-Lag3 antibody trials in mice with Parkinson's disease and Alzheimer's disease. The Johns Hopkins researchers are also looking into how they could prevent unhealthy cells from releasing disease-causing alpha-synuclein in the first place. Other researchers on this study are Hao Gu, Donghoon Kim, Yasuyoshi Kimura, Ning Wang, Enquan Xu, Ramhari Kumbhar, Xiaotian Ming, Haibo Wang, Chan Chen, Shengnan Zhang, Chunyu Jia, Yuqing Liu, Hetao Bian, Senthilkumar Karuppagounder, Fatih Akkentli, Qi Chen, Longgang Jia, Heehong Hwang, Su Hyun Lee, Xiyu Ke, Michael Chang, Amanda Li, Jun Yang, Cyrus Rastegar, Manjari Sriparna, Preston Ge, Saurav Brahmachari, Sangjune Kim, Shu Zhang, Haiqing Liu, Sin Ho Kweon, Mingyao Ying and Han Seok Ko from Johns Hopkins; Yasushi Shimoda from the Nagaoka University of Technology; Martina Saar and Ulrike Muller from Heidelberg University; Creg Workman and Dario Vignali of the University of Pittsburgh School of Medicine and Cong Liu of the Chinese Academy of Sciences. This work was supported by grants from the National Institutes of Health (R01NS107318, R01AG073291, R01AG071820, 1135 RF1NS125592, K01AG056841, R21NS125559, R01NS107404, P01AI108545, R01AI144422), the Parkinson's Foundation, the Maryland Stem Cell Research Foundation, the American Parkinson Disease Association, the Uehara Memorial Foundation, the JPB Foundation, the Adrienne Helis Malvin Medical Research Foundation, and the Parkinson's Disease Foundation.

2023-12-18

·FiercePharma

Bristol Myers Squibb's Opdualag comes up short in late-stage colorectal cancer trial

Despite the early end in colorectal cancer, Opdualag studies in tumor types will continue, BMS said. Bristol Myers Squibb’s PD-1/LAG3 combo Opdualag has more than proved its worth in melanoma since its first-in-class approval in 2022. Now, the drug's first venture outside the melanoma arena has come up short, as the company scrapped a phase 3 trial in metastatic colorectal cancer (mCRC). After a planned analysis by an independent data monitoring committee, the trial, coded Relativity-123, was deemed unlikely to meet its primary endpoints in the treatment of microsatellite-stable (MSS) mCRC patients whose disease has progressed following at least one prior line of therapy, BMS said in a press release. Bristol's move to end the study was not attributed to any safety concerns, the company said. Studies of the combo in other tumor types will continue “as planned.” “While we know immunotherapies have historically demonstrated limited efficacy in MSS colorectal cancers, we had hoped to demonstrate meaningful clinical benefit in this patient population and are disappointed in this outcome,” vice president and global program lead Jeffrey Walch, M.D., Ph.D., noted in the release. “We continue to be committed to the development of I-O therapies, including Opdivo (nivolumab) and Yervoy (ipilimumab).” In a Monday note to clients, William Blair analyst Matt Phipps, Ph.D., said he had always had low expectations for LAG3-containing therapies in mCRC given their weak data in early-phase trials. Instead, the analyst called upcoming phase 2 results in first-line non-small cell lung cancer (NSCLC) the “more important” near-term readout. “The Opdualag launch in metastatic melanoma has been strong, and with exclusivity well into the 2030s, Opdualag offers a meaningful opportunity to extend the PD-1 franchise for Bristol Myers,” Phipps wrote. Opdualag, which is a combo of BMS’ PD-1 inhibitor Opdivo and LAG3 antibody relatlimab, scored its initial approval last March in unresectable or metastatic melanoma. Since then, the company has shown the drug’s benefits in several melanoma patient groups, proving consistency in trial endpoints across patient subgroups, Mark Rutstein, M.D., vice president of Opdivo development at BMS, said in an interview at the time. The company has projected over $4 billion in 2029 sales from Opdualag.

临床3期上市批准临床2期免疫疗法

2023-09-01

·生物制品圈

议程发布 | 第六届金秋十月抗体药产业发展大会

抗体行业在过去几十年中经历了快速而显著的发展，成为生物医药领域中一个快速发展且备受关注的领域。自20世纪80年代第一种单克隆抗体药物（Muromonab-CD3）获得批准以来，许多抗体药物已经被批准用于各种疾病的治疗，包括肿瘤、免疫性疾病和感染性疾病等。市场上已经有数十种成功抗体药物，并且在临床开发和研究中有更多的候选药物，预计未来将有更多新药上市。如今，除了传统的单克隆抗体，越来越多的新型抗体技术被陆续开发出来，包括双特异性抗体、多克隆抗体、人源化抗体、重组抗体、抗体偶联药物等。这些新技术使得抗体药物具有更高的特异性、亲和力、稳定性和生产可行性，拓宽了抗体的应用范围。在2023年里，抗体药领域又有哪些新的变革和研究进展呢？让我们来细细数一数。2023年抗体领域重大事件回顾01一月1月5日，埃格林医药与百度智能云签署合作协议，以夯实公司AI药物研发的数字化基础，强化AI药物研发平台建设以及推动药物临床研发的智能化升级。1月16日，百奥泰施瑞立®（托珠单抗注射液）上市申请获得NMPA批准，适应症为类风湿关节炎（RA）、全身型幼年特发性关节炎（sJIA）、细胞因子释放综合征（CRS）。1月18日，宜明昂科自研的国内首个靶向人CD47的SIRPαFc融合蛋白药物（项目编号: IMM01）联合硼替佐米和地塞米松治疗多发性骨髓瘤的Ib/Ⅱa期临床研究获得国家药品监督管理局 (NMPA)许可，进一步奠定了宜明昂科在CD47靶点药物研究开发领域的领跑者地位。1月19日, 岸迈生物靶向靶向 CD3 和 ROR1的双特异性抗体EMB-07的IND申报获得CDE的临床默示许可，适应症为恶性肿瘤（包括局部晚期/转移性实体瘤或复发性/难治性淋巴瘤）。1月29日，宜明昂科自主研发的、同时靶向CD47和CD20的双特异性抗体-受体重组蛋白药物(项目编号：IMM0306)，联合来那度胺治疗复发/难治CD20阳性B细胞非霍奇金淋巴瘤（B-NHL）的Ib/IIa期临床研究获得国家药品监督管理局 (NMPA)许可。02二月2月9日，广州誉衡生物科技有限公司与华辉安健（北京）生物科技有限公司，共同宣布建立临床研究合作伙伴关系。双方将就誉衡生物的抗PD-1单克隆抗体赛帕利单抗注射液（商品名：誉妥®）和华辉安健的抗TIGIT单克隆抗体HH-101注射液展开联合治疗临床研究，旨在评估该联合用药在多种实体肿瘤患者中的有效性和安全性。2月10日，诺纳生物与Mythic Therapeutics签订基于HCAb的抗体发现合作协议，通过此次合作，诺纳生物将为Mythic Therapeutics提供其专有的全人源重链抗体（HCAb）转基因小鼠平台和抗体生成服务，作为Mythic Therapeutics专有的FateControl™抗体工程方法的输入，该平台将用于为各种癌症研发下一代ADC药物。2月16日，南京维立志博自主研发、拥有全球知识产权的1类新药抗MUC16和CD3双特异抗体注射用LBL-033的临床试验申请已获得中国国家药品监督管理局临床试验默认许可，是截至目前国内首家申报临床的同靶点CD3双抗。2月23日，乐普生物和康诺亚生物共同宣布与阿斯利康就潜在世界首创Claudin 18.2抗体偶联药物CMG901达成全球独家授权协议。根据许可协议，阿斯利康将负责CMG901的全球研发、制造和商业化。03三月3月28日君实生物与康联达生技在新加坡成功举办签约仪式。双方共同宣布，将设立合资公司在东南亚地区9个国家，包括泰国、文莱、柬埔寨、印度尼西亚、老挝、马来西亚、缅甸、菲律宾、越南，对抗PD-1单抗药物特瑞普利单抗（拓益®）进行合作开发和商业化。3月15日，宜明昂科自主研发的ADCC加强型CTLA-4抗体药物 (项目编号:IMM27M）联合以PD-1为靶点的替雷利珠单抗在晚期实体瘤患者中的Ib/II期临床研究获得国家药品监督管理局 (NMPA)许可。3月2日，康宁杰瑞与斯微（上海）生物科技股份有限公司（以下简称“斯微生物”）近日建立战略合作伙伴关系，重点开展肿瘤领域双特异性抗体药物及mRNA疫苗药物的临床研发合作。04四月4月2日，石药集团开发的ADC药物 CPO301的IND申请已获得FDA批准，可在美国开展临床试验，以评估CPO301用于治疗EGFR基因突变或EGFR过表达的晚期肺癌的安全性、药物动力学及初步疗效。4月10日，泽璟制药在研产品注射用ZG006的IND申请获得FDA批准，目标适应症为小细胞肺癌和其它实体瘤。ZG006是全球第一个针对DLL3表达肿瘤的三特异性抗体（CD3×DLL3×DLL3），具有成为同类首创（First-in-Class）分子的潜力。目前全球尚无同类产品获批上市。4月11日，杭州百凯生物医药有限公司和南京维立志博生物科技有限公司宣布，双方将联合开发多个创新型ADC生物新药。4月17日，汉康生技（HanchorBio）宣布，其自主研发的创新融合蛋白HCB101获得美国FDA授予新药临床试验（IND）许可，即将开展多地区多中心的临床试验。此药将用于治疗晚期实体瘤及复发难治性非霍奇金淋巴瘤4月18日，诺纳生物与圣路易斯华盛顿大学的Michael S. Diamond医学博士达成合作协议，共同发现目前很少或没有人类单克隆抗体(mAbs)的病毒靶点，如西方马脑炎病毒(WEEV)、狂犬病和发热伴血小板减少综合征病毒(SFTSV)。4月20日，石药集团开发的ADC药物SYS6010已获得CDE批准，可开展于中国的临床研究，适应症为晚期实体瘤。4月23日，泽璟制药自研的注射用ZGGS15（LAG-3/TIGIT）双特异性抗体IND申请获得CDE批准，用于治疗晚期实体瘤患者。ZGGS15是全球首个获批并即将进入临床试验的抗LAG-3/TIGIT双特异性抗体。4月24日，基石药业正在美国和澳洲进行I期临床研究的潜在同类最佳药物CS5001（ROR1 ADC）用于治疗晚期实体瘤和淋巴瘤的国际多中心I期临床研究CS5001-101日前在中国完成首例患者入组。4月27日，苏州宜联生物医药有限公司（宜联生物）宣布与再鼎医药有限公司达成战略合作和全球独家许可协议。通过本次合作，宜联生物将YL212项目，即新一代DLL3抗体偶联药物（ADC）的全球开发及商业化权益独家授予再鼎医药及其子公司。4月27日，再鼎医药有限公司宣布与宜联生物达成战略合作和全球独家许可协议。通过此次YL212（一种新型DLL3 ADC）项目的合作，将进一步拓展再鼎医药的肺癌管线和全球肿瘤管线。 05五月5月6日，奥赛康药业自研注射用ASKG915的IND申请获得CDE批准，将于近期开展临床试验。注射用ASKG915是一款PD-1抗体/IL-15前药双功能融合分子，拟用于治疗晚期实体瘤。5月7日，君实生物与瑞迪博士实验室（Dr. Reddy’s）达成合作，在拉丁美洲、印度、南非对君实生物自主研发的抗PD-1单抗药物特瑞普利单抗注射液开展研发与商业化合作。此外，瑞迪博士实验室可选择将许可范围扩大至涵盖澳大利亚及新西兰以及其他多个国家。5月9日，康宁杰瑞与石药集团共同宣布，HER2双特异性抗体注射液（研发代号：KN026）联合注射用多西他赛（白蛋白结合型）用于一线治疗HER2 阳性复发转移性乳腺癌的注册临床试验申请在中国获批。5月11日，诺纳生物宣布与PharmaEssentia创新研究中心就诺纳专有的Harbour Micefully人抗体转基因小鼠平台达成战略合作协议5月19日，泰州迈博太科药业的注射用奥马珠单抗生物类似药CMAB007获批上市，这是国内首款获批上市的奥马珠单抗生物类似药。5月23日，诺纳生物与OPKO Health的ModeX Therapeutics达成抗体发现协议，ModeX Therapeutics将使用诺纳生物的平台以支持ModeX开发多特异性抗体疗法。06六月6月5日，国内老牌CRO上市企业博济医药科技股份有限公司与深圳埃格林医药有限公司签订战略合作协议，双方秉持“优势互补、互利共赢”的原则，利用人工智能（AI）在临床试验领域展开战略合作，旨在用AI解决临床阶段影响药物研发和成本瓶颈问题，打造创新药临床研发服务新标杆。6月8日，石药集团自研的同类首创ADC药物CPO301的I期临床试验申请已获加拿大卫生部批准，用以评估CPO301于晚期实体瘤(包括非小细胞肺癌)的安全性、药物代谢动力学及初步疗效。6月8日，泽璟制药在研产品注射用ZGGS15（LAG-3/TIGIT）双特异性抗体IND申请获得FDA批准，用于治疗晚期实体瘤。6月12日，百奥泰BAT6026注射液的IND申请获得CDE批准，将在特应性皮炎患者中开展I/II临床试验。6月12日，南京维立志博自主研发、拥有全球知识产权的1类新药抗MUC16/CD3双特异抗体注射用LBL-033治疗卵巢癌等恶性肿瘤的Ⅰ/Ⅱ期临床试验申请已经获得FDA批准。目前，国内外尚无靶向MUC16的抗体产品获批上市。6月13日，誉衡生物公司研发的GLS-012联合赛帕利单抗，再获国家药品监督管理局（NMPA）临床试验许可，适应症为恶性肿瘤。这意味着GLS-012的联合方案即将进入临床试验阶段。6月13日，中国生物制药宣布，已与鸿运华宁达成合作协议，共同开发双靶点减重创新药GMA106，鸿运华宁将从交易中获得最高5700万美元的首付款与里程碑付款等，而中国生物制药则将获得GMA106在大中华区的独家开发和商业化权益，正式进军千亿减重市场。6月14日，齐鲁制药自研双特异性抗体注射用QLS32015获得CDE临床默示许可，适应症为多发性骨髓瘤。6月16日，百奥泰生物制药股份有限公司宣布已与Biomm S.A.就BAT2206（一款参照喜达诺®乌司奴单抗开发的生物类似药）签署授权许可及商业化协议。根据协议条款，Biomm将拥有BAT2206在巴西市场的独家分销权及销售权。6月20日，百奥泰在研药品BAT1308注射液联合含铂化疗±贝伐珠单抗在宫颈癌患者中开展II/III期临床试验的申请获得CDE批准。6月20日，维立志博与鼎康生物达成战略合作，推进中国临床申报及供样，百济神州与鼎康生物达成战略合作，推进境外临床申报及供样。6月26日，百奥泰生物制药股份有限公司宣布已与Mega Lifesciences就BAT1706（一款参照安维汀®贝伐珠单抗开发的生物类似药）签署授权许可及商业化协议。根据协议条款，Mega将拥有BAT1706在印度尼西亚市场的独家分销权及销售权，百奥泰将负责BAT1706的开发、生产和商业化供应。6月26日，石药集团附属公司上海津曼特生物科技有限公司自主研发的抗体药物JMT203已获CDE批准，可以在中国开展临床研究。6月28日，FDA已批准君实生物开展抗BTLA单抗tifcemalimab（产品代号：TAB004/JS004）联合特瑞普利单抗作为局限期小细胞肺癌（LS-SCLC）放化疗后未进展患者的巩固治疗的随机、双盲、安慰剂对照、国际多中心III期临床研究。6月30日，再鼎医药和合作伙伴argenx宣布国家药品监督管理局（NMPA）已经批准了同类首创的FcRn拮抗剂卫伟迦™（艾加莫德α注射液）的生物制品上市许可申请，与常规治疗药物联合，用于治疗乙酰胆碱受体（AChR）抗体阳性的成人全身型重症肌无力（gMG）患者。07七月7月3日，晟斯生物自主研发的I类创新药“注射用培重组人凝血因子IX-Fc融合蛋白”（代号：SS327）收到国家药品监督管理局核准签发的《药物临床试验批准通知书》，即将在12岁以上青少年和成年血友病B患者（先天性九因子缺乏）中开展临床研究。7月4日，君实生物宣布与植恩生物签署合作协议，双方将在中国大陆地区对抗PCSK9单抗药物昂戈瑞西单抗（产品代号：JS002）进行商业化合作。7月17日，百奥泰在研药品BAT4706注射液联合BAT1308注射液治疗晚期实体瘤的临床试验申请获得CDE批准。7月25日，汉康生技（HanchorBio）宣布其自主研发的创新融合蛋白HCB101在中国台湾获得当地卫生福利部食品药物管理署（TFDA）授予的新药临床试验（IND）许可，即将开展多地区多中心的临床试验。此药将用于治疗晚期实体瘤及复发难治性非霍奇金淋巴瘤。7月26日，石药集团与马来西亚最大的上市综合性医药集团发马制药集团就mRNA疫苗及高端制剂领域的合作达成战略共识。7月31日，杭州尚健生物技术有限公司自主研发的首个1类创新ADC药物注射用SG2918临床试验申请获得国家药品监督管理局（NMPA）受理，拟定适应症为恶性肿瘤。该项目是全球同靶点首个申报临床的ADC药物。7月31日，南京维立志博自主研发、拥有全球知识产权的1类新药抗GPRC5D/CD3双特异性抗体LBL-034治疗复发/难治性多发性骨髓瘤的首次临床试验申请近期分别获得NMPA（中国国家药品监督管理局）和FDA（美国食品药品监督管理局）的批准。目前，国内外尚无靶向GPRC5D的抗体产品获批上市。7月31日，泽璟制药自研的首个三特异性抗体注射用ZG006(CD3×DLL3×DLL3)的IND申请获得CDE批准，其适应症为晚期实体瘤。08八月8月17日，石药集团附属公司Novarock Biotherapeutics Limited自主研发的CLDN6-CD137双特异性抗体药物NBL-028的IND申请已获FDA批准，可在美国开展用于治疗包括但不限于睾丸癌、卵巢癌、非小细胞肺癌及子宫内膜癌等CLDN6表达晚期肿瘤的临床试验。8月21日，石药集团分别与英硅智能（上海）科技有限公司和深圳晶泰科技有限公司在创新药研发人工智能（AI）领域达成战略合作协议。基于协议，石药集团将充分应用自身深厚的药物研发经验，结合英硅智能、晶泰科技在创新药研发领域领先的AI技术平台，聚焦于具有高度临床需求的战略品种，以AI辅助药物设计，提高新药筛选效率和成功率，共同推动本集团创新药物的研发。8月21日，合肥瀚科迈博生物技术有限公司于日前完成数千万元A+轮融资。本次融资由国元股权投资、国元创新投资、讯飞创投及深圳生众投资共同参与。本次所获资金将用于公司各在研管线的临床前和临床研究，以加速推进肿瘤免疫治疗药物的开发和商业化。今年是COVID-19大流行趋于稳定后的第一年，人民生活逐渐走向正轨，经济也在缓慢但有力的复苏之中，而各抗体企业也依然在不断奋进、不断突破、不断超越，使抗体领域蓬勃发展，硕果累累。为促进抗体行业的交流与创新，2023年10月14-15日第六届金秋十月抗体产业发展大会如约而至。会议旨在为研究人员提供一个互动交流的平台，有助于推动抗体产业的进一步发展。会议内容时间：2023年10月14-15日地点：苏州（酒店定向通知）规模：600-800人主办单位：生物制品圈、抗体圈指导单位：康维讯生物、夏尔巴生物会议费用：免费FREE!（仅收取50元报名定金，含参会学习、茶歇、会议手册，定金概不退还），9月15日报名定金提高到100元，先到先得，报完即止，超过9月20日预登记将收取会议费！报名方式：扫描下方二维码或点击文章最底部“阅读原文”→ 填写表格 → 报名成功（报名志愿者，承担一定工作，请慎重考虑，免交定金）！组委会获得报名信息后，根据报名信息进行初筛，并进一步与报名者沟通确认，实现精准邀请。最终有机会进入大会微信群（严格审核通过）。日程安排更多嘉宾仍在邀请中。。。。。。第一届精彩回顾第二届精彩回顾第三届精彩回顾第四届精彩回顾第五届精彩回顾识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

临床申请临床1期临床2期

100 项与重组全人抗LAG-3单克隆抗体(广州誉衡生物科技/无锡药明康德) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
晚期非小细胞肺癌	临床2期	中国	广州誉衡生物科技有限公司	2023-08-10
晚期恶性实体瘤	临床2期	中国	广州誉衡生物科技有限公司	2022-10-31
肿瘤	临床前	中国	Wuxi Biologics (Cayman), Inc.	2020-04-01

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05909436 (Triumph-01, SITC2023)	临床1/2期	局部晚期黑色素瘤	17	GLS-012 monotherapy	廠醖憲鏇蓋願淵衊顧憲(繭襯簾鬱網範觸選膚範) = happened in 2 patients 餘齋積繭餘衊齋構膚範 (鹽夢夢願壓觸獵衊範醖 )	积极	2023-11-02