Randomized Study of ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Progressed on Androgen Receptor (AR) Pathway Inhibition

In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.

开始日期2023-12-11

申办/合作机构

OncoC4, Inc.初创企业

[+1]

CTR20232927 / Recruiting临床3期

比较ONC-392与多西他赛治疗经PD-1/PD-L1抑制剂治疗后进展的转移性非小细胞肺癌受试者的两阶段、随机对照多中心III期临床研究

比较ONC-392与多西他赛治疗PD-(L)1抑制剂耐药非小细胞肺癌的有效性和安全性

开始日期2023-10-17

申办/合作机构

广州昂科免疫生物技术有限公司

NCT05671510 / Recruiting临床3期

Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors

The goal of this Phase 3 clinical trial is study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

开始日期2023-06-28

申办/合作机构

OncoC4, Inc.初创企业

[+1]

100 项与 Gotistobart 相关的临床结果

登录后查看更多信息

100 项与 Gotistobart 相关的转化医学

登录后查看更多信息

100 项与 Gotistobart 相关的专利（医药）

登录后查看更多信息

项与 Gotistobart 相关的文献（医药）

2023-11-01·Current opinion in urology

Pembrolizumab in mCRPC - Combination therapies as breakthrough to success?

Review

作者: Pircher, Andreas ; Plas, Stefan ; Heidegger, Isabel

PURPOSE OF REVIEW:

Immune checkpoint inhibitors (ICIs) have shown promising antitumor activity in various malignant diseases. This narrative review provides an update on ongoing clinical studies investigating the only FDA-approved ICI programmed death receptor 1 (PD-1) inhibitor pembrolizumab in mono- and combination therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).

RECENT FINDINGS:

Although most clinical trials investigating pembrolizumab as mono- or combinational therapy did not meet their primary endpoints, there exist subgroups of patients that demonstrate impressive responses rates justifying further investigation of ICI in prostate cancer. Beside combination of pembrolizumab with approved mCRPC agents, innovative approaches, like combining pembrolizumab with radioligands, deoxyribonucleic acid vaccines or innovative immunotherapeutic agents (i.e., ONC-392, AMG160, BXCL701) are ongoing exerting promising preliminary findings.

SUMMARY:

ICI monotherapy seems to be effective in a small biomarker-preselected population, however, there is evidence that especially novel ICI combination approaches can improve patient survival, which could ultimately refocus and revolutionize the treatment of mCRPC.

项与 Gotistobart 相关的新闻（医药）

2024-06-23

·药渡

欧洲杯来了！哪些国家最有望夺得“最佳药物管道”奖杯？

来源：药渡撰文：Maskey 编辑：哦呼欧洲杯激战正酣，各国球队为了荣誉和胜利而奋力拼搏。但如果换个角度，设想一下，若是让这些参加欧洲杯的国家在“最佳药物管道”这一特殊领域展开角逐，谁又将脱颖而出，问鼎桂冠呢？目前，世界各地的制药公司都在竞相开发最具创新性和最有效的常见人类疾病治疗方法。他们进行临床前研究和临床试验，希望他们的治疗方法能得到监管机构的批准。监管机构会为可能治疗严重疾病的新型试验药物授予突破性疗法认定和快速通道认定。近年来，越来越多的新型治疗方法（如细胞和基因疗法、单克隆抗体和抗体-药物偶联物）已获得监管机构的批准[1]。因此，制药公司正在加大对这些创新疗法的开发投入。一些最大的制药公司位于欧洲，所有这些公司都在建立庞大的创新疗法药物管线。图1.近年来美国食品药品监督管理局(FDA)批准的新分子实体（NME）和生物制剂的数量【1】图2.获得批准的单克隆抗体百分比【2】德国拜耳是德国领先的制药公司之一。老年性黄斑变性药物阿柏西普、前列腺癌药物达罗他胺、抗凝药物利伐沙班和慢性肾病药物Finerenone是其产品组合中最有价值的药物。该公司正在开发33种新疗法，其中19种疗法正在进行1期临床试验，3种疗法正在进行2期临床试验[3]。该公司正在测试几种创新的重组腺相关病毒 (rAAV) 基因疗法，用于治疗亨廷顿氏病、帕金森氏病和庞贝氏病。另一家德国制药公司勃林格殷格翰正在临床试验中测试40多种药物[4]。该公司已经开发出用于治疗多种疾病的小分子药物、T细胞接合剂和癌症疫苗。该公司的产品组合中包括有效的治疗药物，包括肺纤维化药物尼达尼布和抗糖尿病药物恩格列净。默克集团是另一家德国制药公司，正在开发10多种用于治疗癌症、自身免疫性疾病和疟疾的药物[5]。其药物管线中一些有前景的在研药物包括小分子药物Enpatoran、抗体药物偶联物M9140和免疫检查点抑制剂avelumab。 BioNtech也是一家德国大型生物制药公司，与辉瑞公司成功开发了COVID-19疫苗BNT162b2(Comirnaty)。该公司还在对患有不同类型癌症（如结直肠癌和胰腺导管腺癌）的患者测试癌症疫苗Autogene Cevumeran[6]。BioNTech SE正在临床试验中测试30多种治疗方法，包括mRNA治疗、细胞疗法、基于蛋白质的疗法和小分子免疫调节剂。这些治疗方法旨在治疗癌症和传染病。其管道中最有前途的候选药物之一是单克隆抗体Gotistobart，正在非小细胞肺癌患者中进行测试。该公司开发的其他重要药物包括双特异性抗体Acasunlimab、BNT312/GEN1042和BNT327/PM8002。德国规模较小的生物制药公司也在努力扩大其药物研发线。Ethris开发了一种新型吸入式mRNA治疗药物ETH47，用于治疗呼吸道病毒感染。海德堡制药公司研发线中的一种主要候选药物是用于治疗多发性骨髓瘤的抗体-药物偶联物HDP-101。Affimed开发了用于治疗非小细胞肺癌的双特异性先天细胞接合剂AFM24。Atai Life Sciences研发线中有几种用于治疗抑郁症和焦虑症的药物。法国法国最大的制药公司赛诺菲拥有庞大的药物管线，包括60多种临床阶段治疗药物[7]。该公司正在开发双特异性抗体、疫苗、单克隆抗体、NK细胞接合剂、酶替代疗法和基因疗法。其最畅销的药物是与Regeneron合作开发的单克隆抗体度匹鲁单抗。该药物已被批准用于多种适应症，例如特应性皮炎、嗜酸性食管炎和哮喘。其投资组合中的另一项重要资产是与阿斯利康合作开发的呼吸道合胞病毒 (RSV) 疫苗nirsevimab。其管线中的几种药物，如小分子药物SAR441566、单克隆抗体Amlitelimab和单克隆抗体Frexalimab，都有可能获得监管部门的批准并成为变革性的治疗方法。法国还有几家不太知名的制药公司，包括Genfit、Abivax和Enterome，它们正在研发新的创新疗法。Genfit正在开发治疗胆管癌和高氨血症的新疗法。今年6月，FDA加速批准其药物Elafibranor，用于治疗原发性胆汁性胆管炎。Amolyt Pharma的药物管线包括治疗肢端肥大症和甲状旁腺功能减退症的药物。Enterome正在开发新的基于肽的免疫疗法，用于治疗惰性非霍奇金淋巴瘤和胶质母细胞瘤。Abivax已开发小分子药物obefazimod，用于治疗溃疡性结肠炎和克罗恩病。Antabio正在开发治疗铜绿假单胞菌感染和医院内感染的药物。Ipen的临床阶段管线中有10多种药物，包括治疗偏头痛、阿拉吉耶综合征、多发性骨髓瘤和胆道闭锁的药物[8]。英国英国-瑞典制药公司阿斯利康拥有最大的药物管线之一，拥有超过90种不同的临床阶段治疗药物[9]。该公司正在开发用于治疗癌症、呼吸系统疾病、代谢疾病、肾脏疾病和心血管疾病的新药。它拥有非常强大的肿瘤学产品组合，包括抗体药物偶联物trastuzumab deruxtecan和酪氨酸激酶抑制剂奥希替尼。该公司还通过购买和公司收购在其管线中增加了嵌合抗原受体T细胞(CAR-T)疗法、呼吸道合胞病毒疫苗和2型糖尿病药物。其与第一三共联合开发的抗体药物偶联物Datopotamab deruxtecan可能很快会在美国获得监管部门的批准。葛兰素史克 (GSK) 已开发出60多种用于治疗艾滋病毒、癌症、传染病以及呼吸道和免疫疾病的药物。该公司最近开发的最成功的治疗方法之一是呼吸道合胞病毒疫苗Arexvy，该疫苗已获得FDA批准用于50岁以上的人群[10]。该公司在开发高效疫苗方面有着良好的记录，例如Gardasil、Arexvy和 Shingrix。今年，GSK收购了一家新兴生物制药公司Aiolos Bio，该公司开发了一种新型哮喘药物。 Verona Pharma开发了一种用于治疗慢性阻塞性肺病的药物Ensifentrine，今年可能会获得FDA的批准。Ellipses Pharma正在对2期临床试验中的四种药物进行评估[11]。该公司正在研发不同类别的药物，例如用于治疗癌症的双重抑制剂、纳米颗粒-药物偶联物和选择性雄激素受体调节剂 (SARM)。Evox Therapeutics正在临床前研究中开发外泌体递送的腺相关病毒(AAV) 基因疗法，用于治疗苯丙酮尿症和心血管疾病[12]。瑞士罗氏的研发管线中有70多种药物[13]。该公司开发的转化疗法之一是双特异性单克隆抗体Faricimab，用于治疗糖尿病性黄斑水肿和新生血管性年龄相关性黄斑变性。其他成功获得监管部门批准的重要治疗方法是抗体-药物偶联物polatuzumab vedotin-piiq双特异性单克隆抗体Emicizumab和双特异性抗体glofitamab-gxbm。其阿尔茨海默氏症药物gantenerumab在3期临床试验中未能显示出疗效。该公司已将小分子抑制剂camonsertib和双特异性抗体RG6286等抗癌药物从其管线中移除。罗氏正在优先考虑那些更有可能获得监管机构批准的治疗方法。诺华是全球销售额最大的制药公司之一。其药物研发管线中有超过60种治疗方法[14]。其研发管线包括单克隆抗体、CAR-T疗法、基因疗法、小分子抑制剂、合成小干扰RNA (siRNA) 和其他治疗不同疾病的药物。其产品组合中的重要资产是心力衰竭组合药物Sacubitril/valsartan、多发性硬化症药物 Ofatumumab、乳腺癌药物ribociclib和高脂血症药物inclisiran。其布鲁顿氏酪氨酸激酶(BTK)抑制剂remibrutinib很有可能被批准用于治疗慢性自发性荨麻疹。 ADC Therapeutics正在临床试验中测试大约3种治疗方法[14]。该公司开发了抗体药物偶联物loncastuximab tesirine-lpyl，该药物已获得FDA加速批准，用于治疗大B细胞淋巴瘤。Alentis Therapeutics的研发管线中有大约4种治疗方法，包括抗体药物偶联物和单克隆抗体[15]。图3.销售额最高的制药公司和治疗方法【16】丹麦丹麦制药公司诺和诺德是欧洲最大的制药公司之一。诺和诺德的药物管线包括35多种药物，其中大多数药物正在对患有非酒精性脂肪性肝炎和糖尿病等慢性疾病的患者进行测试[17]。其最成功的药物是用于治疗肥胖症和糖尿病的索马鲁肽。诺和诺德开发了一种每周一次的糖尿病药物胰岛素Icodec，该药物已获准在欧洲使用。Genmab有10多种治疗方法正在临床试验中测试。它与辉瑞联合开发了抗体-药物偶联物tisotumab vedotin，该药物已获准用于治疗宫颈癌。其T细胞结合双特异性抗体epcoritamab也已获准用于治疗弥漫性大B细胞淋巴瘤。比利时比利时生物制药公司Union Chimique Belge (UCB)正在开发用于治疗系统性红斑狼疮和严重纤维肌痛综合征等神经和自身免疫性疾病的药物。其研发管线中有大约10种小分子药物和单克隆抗体[18]。其药物bimekizumab已在美国获批用于治疗斑块状银屑病。荷兰荷兰制药公司Argenx开发了抗体片段efgartigimod，该片段已获批用于治疗全身性重症肌无力。该公司正在对患有干燥综合征和特发性炎症性肌病的患者进行efgartigimod测试。该公司正在研发的另一种药物是单克隆抗体Empasiprubart，该药物已被开发用于治疗多灶性运动神经病。总之，欧洲几家大型制药公司正在开发用于多种疾病的一流和一流药物。这些公司通过研究、收购和与其他公司的联合合作建立了强大的药物管线。在这些欧洲国家中，德国、英国、瑞士和法国都有成熟和新兴的生物制药公司，专注于开发创新疗法。大多数公司都开发出了有效的治疗方法，并已在许多国家获准使用。编者按：在这场假想的“最佳药物管道”欧洲杯中，每个国家都有机会展现自己的实力和风采，我们都期待看到其在“赛场”上展现出最佳的状态。未来我们应给予各国更多在医药研究上付出与收获的关注，以及他们为全人类的健康福祉所作出的杰出贡献。参考文献（可上下滑动）： [1] Senior, M. (2023). Fresh from the biotech pipeline: fewer approvals, but biologics gain share. nature biotechnology, 41(2), 174. [2] Walsh, G., & Walsh, E. (2022). Biopharmaceutical benchmarks 2022. Nature Biotechnology, 40(12), 1722-1760. [3] Bayer (2024, 30 April ). Pharmaceuticals Pipeline Overview and Progress. https://www.bayer.com/sites/default/files/ph-rd-pipeline-2024-05-final-1.pdf [4] Boehringer Ingelheim (n.d.). Boehringer Ingelheim Human Pharma Clinical Pipeline. https://www.boehringer-ingelheim.com/bipdf/pipeline-february-2024 [5] Merck Group (n.d.). HEALTHCARE PIPELINE. https://www.merckgroup.com/en/research/healthcare-pipeline.html [6] BioNTech SE (2024, 7 April). Three-year Phase 1 Follow-Up Data for mRNA-based Individualized Immunotherapy Candidate Show Persistence of Immune Response and Delayed Tumor Recurrence in Some Patients with Resected Pancreatic Cancer. https://investors.biontech.de/news-releases/news-release-details/three-year-phase-1-follow-data-mrna-based-individualized [7] Sanofi (n.d.). Our Pipeline. https://www.sanofi.com/en/our-science/our-pipeline [8] Ipsen (n.d.). Pipeline. https://www.ipsen.com/pipeline/ [9] AstraZeneca (n.d.). Our pipeline. https://www.astrazeneca.com/our-therapy-areas/pipeline.html#cvrm [10] GSK. (2024, 7 June). US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-expanded-age-indication-for-gsk-s-arexvy-the-first-rsv-vaccine-for-adults-aged-50-59-at-increased-risk/#:~:text=GSK%20plc%20(LSE%2FNYSE%3A,who%20are%20at%20increased%20risk. [11] Ellipses Pharma (n.d.). PORTFOLIO. https://ellipses.life/portfolio/ [12] Evox Therapeutics (n.d.). Pipeline. https://www.evoxtherapeutics.com/pipeline/ [13] Johnston, I (2024, 24 April). Roche cuts drug pipeline in effort to revitalise business. Financial Times https://www.ft.com/content/d2dfc0c4-85e0-4cf5-b926-c10d630b2772 [14] ADC Therapeutics (n.d.). Our Pipeline. https://www.adctherapeutics.com/our-pipeline/ [15] Alentis Therapeutics (n.d.). Novel therapies for cancer and fibrosis. https://alentis.ch/pipeline/ [16] Verdin, P. (2024). Top companies and drugs by sales in 2023. Nature reviews. Drug Discovery. [17] Novo Nordisk (n.d.). R&D pipeline. https://www.novonordisk.com/science-and-technology/r-d-pipeline.html [18] UCB (n.d.). PIPELINE. https://www.ucb.com/our-science/pipeline *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！点击下方“药渡“，关注更多精彩内容美国Arthrosi公司创新药AR882溶解痛风石，2期临床试验成果亮相2024欧洲风湿病学大会全球First-in-class！迪哲医药戈利昔替尼重磅获批 2024年上半年FDA批准药物或新适应症（下）点击蓝字关注我们

基因疗法疫苗突破性疗法信使RNA临床1期

2024-04-23

·BioSpace

OncoC4 Announces FDA Clearance of IND Application for Novel SIGLEC 10 Immune Checkpoint Inhibitor ONC-841 for Solid Tumors

ONC-841 is a potential first-in-class SIGLEC 10 antibody designed to block an innate and potentially adaptive immune checkpoint and prevent cancer evasion of immune cells Anti-tumor T cells, NK cells and macrophages can be rejuvenated within the tumor microenvironment following ONC-841 treatment Preliminary Phase 1 data on safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected 2H 2025 ROCKVILLE, Md., April 23, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer, today announced that the United States Food and Drug Administration (“FDA”) has cleared the investigational new drug (“IND”) application for ONC-841, a potential first-in-class SIGLEC 10 blocking antibody for the treatment of solid tumors. “SIGLEC 10 is an immune checkpoint that inhibits the activation of both innate and adaptive immune cells. In cancer, this can lead to reduced anti-tumor immunity within the tumor microenvironment (“TME”), creating a protected setting for cancer cells to thrive,” said Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4. “ONC-841 is designed to block this immune checkpoint to rejuvenate immune cell activity for tumor destruction within the TME. We are excited to begin clinical development of ONC-841 in advanced solid tumors.” SIGLEC 10 has an authentic immunoreceptor tyrosine-based inhibitory motif, which is distinct from some other Siglecs such as SIGLEC 15. ONC-841 is a humanized antagonist anti-SIGLEC 10 monoclonal antibody and, to our knowledge, is the first SIGLEC 10 antagonist to enter clinical development. OncoC4 discovered SIGLEC 10 negatively regulates antibody-dependent cell mediated cytotoxicity (ADCC) in addition to other known functions. ONC-841 was selected and developed based on the ability to enhance antibody-dependent CD16a signaling, a surrogate for ADCC and function of natural killer (NK) cells and macrophages, key innate immune cells involved in tumor killing. Preclinical studies supporting the IND application demonstrated ONC-841 increased the phagocytosis of cancer cells and improved the function of tumor-infiltrating T cells. Additional in vivo syngeneic and xenograft tumor models showed enhanced immune rejection of tumor cells following treatment with ONC-841. Preliminary Phase 1 data on safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected in the second half of 2025. About OncoC4 Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the potential treatment of cancer. Its most advanced program is BNT316/ONC392 (gotistobart), a Phase 3, next generation anti-CTLA-4 antibody that is designed to allow CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 has two first-in-class clinical stage SIGLEC programs, including AI071, a Phase 2 ready SIGLEC agonist designed for difficult to treat immune related adverse events, and ONC-841, a Phase 1 ready SIGLEC 10 antagonist for the treatment of solid tumors. OncoC4’s portfolio also includes preclinical programs targeting the CD24 cancer immune evasion pathway. More information: . CONTACTS OncoC4 Investor Contact: Alexandra Folias LifeSci Advisors afolias@lifesciadvisors.com Media Contact: Mari Purpura LifeSci Advisors mpurpura@lifesciadvisors.com

免疫疗法临床申请临床1期临床2期临床3期

2024-04-02

·GlobeNewswire-Health Care

OncoC4 Expands Scientific Advisory Board with Appointment of Heather A. Wakelee, MD, FASCO

Dr. Wakelee is a world-renowned expert in the research and treatment of lung cancerOncoC4’s SAB now includes 6 distinguished scientists, industry experts, and key opinion leaders in oncology and immunotherapy ROCKVILLE, Md., April 02, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer, today announced the appointment of thoracic medical oncologist Heather A. Wakelee, MD, FASCO to the OncoC4 Scientific Advisory Board (SAB) made up of distinguished scientists, industry experts, and key opinion leaders in oncology and immunotherapy. Dr. Wakelee, currently a Professor of Medicine and Chief of the Division of Oncology at Stanford University, and Deputy Director of the Stanford Cancer Institute, brings over 20 years of experience in clinical strategy. “We are honored to welcome Heather to the OncoC4 SAB, an international expert with decades of leadership experience in the treatment of lung cancer,” said Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4. “Her research and clinical understanding in thoracic oncology will provide invaluable guidance as we advance multiple clinical products, including gotistobart, a late-stage next-generation CTLA-4 inhibitor for immunotherapy-resistant non-small cell lung cancer.” Dr. Wakelee added, "OncoC4 is developing novel immunotherapies targeting CTLA-4 and CD24 to break cancer resistance. By leveraging universal pathways, OncoC4 has the potential to change the treatment paradigm for many common and aggressive cancers with high unmet needs. I am excited to join the OncoC4 SAB at this important stage, and partner with the team to help shape the clinical development of their innovative clinical and preclinical pipeline.” Heather A. Wakelee, MD, FASCO brings over 20 years of clinical experience specializing in the treatment of lung cancer, thymoma, and mesothelioma. Currently she serves as Deputy Director of the Stanford Cancer Institute and is the Division Chief of Medical Oncology. She was the President of the International Association for the Study of Lung Cancer (IASLC) and is active in several national and international organizations related to lung cancer and thymoma. She remains actively engaged in lung cancer and thymoma clinical trials, translational work and population sciences used to explore these diseases. She is the Principal Investigator on numerous clinical trials and has held advisory board roles with multiple international pharmaceutical companies. Dr. Wakelee is a board-certified physician in medical oncology. She completed a fellowship in oncology and a residency in internal medicine at Stanford University. She holds a medical degree from Johns Hopkins University, and a Bachelor of Arts from Princeton University in Molecular Biology. OncoC4’s SAB, made up of transformative leaders in cancer and immunology include: Michael Caligiuri, MD (Chair) – President, City of Hope Medical Center An international leader in hematology and oncology and Fellow of the National Academy of Medicine who also served as President of the American Association for Cancer Research (AACR) Lieping Chen, PhD – Endowed Professor, Yale University Fellow of the National Academy of Science (NAS) whose discovery of B7H1/PD-L1 ushered in a new era in patient care of cancer Jeffrey S Weber, MD PhD – Deputy Director, New York University Cancer Fellow of the AACR Academy who performed the first randomized studies that unequivocally demonstrated the power of immunotherapy to treat cancer Kunliang Guan, PhD – Emeritus Professor, University of California, San Diego (UCSD) OncoC4 co-founder who was awarded the John D. and Catherine D. MacArthur Fellowship for his pioneering contributions in key cancer biology pathways Kun He, PhD – President R&G, US Master statistician responsible for overseeing the final statistical review of pivotal studies during his time at the Food and Drug Agency (FDA) Heather A. Wakelee, MD, FASCO – Professor of Medicine and Chief of the Division of Oncology at Stanford University, and Deputy Director of the Stanford Cancer Institute Past President of the IASLC and global expert in the clinical treatment of thoracic malignancies About OncoC4Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the potential treatment of cancer. Its most advanced program is BNT316/ONC392 (gotistobart), a Phase 3, next generation anti-CTLA-4 antibody that is designed to allow CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 has two first-in-class clinical stage siglec 10 programs, including AI071, a Phase 2 ready siglec 10 agonist designed for difficult to treat immune related adverse events, and ONC841, a Phase 1 ready siglec 10 antagonist for the treatment of solid tumors. OncoC4’s portfolio also includes preclinical programs targeting the CD24 cancer immune evasion pathway. More information: www.oncoc4.com. CONTACTS OncoC4Investor Contact:Alexandra FoliasLifeSci Advisorsafolias@lifesciadvisors.comMedia Contact:Mari PurpuraLifeSci Advisorsmpurpura@lifesciadvisors.com

高管变更免疫疗法临床1期临床3期AACR会议

100 项与 Gotistobart 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
转移性非小细胞肺癌	临床3期	美国	广州昂科免疫生物技术有限公司	2023-06-15
转移性非小细胞肺癌	临床3期	比利时	广州昂科免疫生物技术有限公司	2023-06-15
转移性非小细胞肺癌	临床3期	加拿大	广州昂科免疫生物技术有限公司	2023-06-15
转移性非小细胞肺癌	临床3期	法国	广州昂科免疫生物技术有限公司	2023-06-15
转移性非小细胞肺癌	临床3期	德国	广州昂科免疫生物技术有限公司	2023-06-15
转移性非小细胞肺癌	临床3期	意大利	广州昂科免疫生物技术有限公司	2023-06-15
转移性非小细胞肺癌	临床3期	韩国	广州昂科免疫生物技术有限公司	2023-06-15
转移性非小细胞肺癌	临床3期	西班牙	广州昂科免疫生物技术有限公司	2023-06-15
转移性去势抵抗性前列腺癌	临床2期	美国	OncoC4, Inc.初创企业	2023-12-11
肿瘤	临床2期	美国	BioNTech SE	2023-03-20

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04140526 (PRESERVE-001, ASCO2023) 人工标引	临床1/2期	非小细胞肺癌	33	Gotistobart	廠觸願齋觸蓋艱艱廠願(窪鑰壓淵憲蓋簾觸鹽選) = 衊網網鹽齋膚鬱遞壓蓋簾製壓糧鹽糧選衊醖壓 (鹹鏇壓蓋醖網網獵觸觸 ) 更多	积极	2023-05-31
NCT04140526 (ONC-392-001, SITC2022) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	13	ONC 392 3 mg/kg	範積鬱顧鹹網鹽齋糧醖(糧壓範糧艱糧鹹選鏇衊) = 6.0 mg/kg ONC-392+ 200 mg of pembrolizumab Q3W 餘鏇膚淵鹹艱顧簾顧齋 (衊淵餘鏇鹽鏇鹹築齋艱 )	积极	2022-11-01
NCT04140526 (ONC-392-001, SITC2022) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	13	Pembrolizumab+ONC 392 6 mg/kg		积极	2022-11-01
NCT04140526 (SITC2022) 人工标引	临床1/2期	卵巢癌	32	ONC 392	獵顧餘網糧鏇鹹選衊簾(構憲築構窪鑰製醖鏇醖) = 醖鏇餘觸壓壓夢網齋範鬱齋壓蓋糧窪襯觸鹽製 (願選壓獵鏇構淵襯齋蓋 ) 更多	积极	2022-11-01
NCT04140526 (ONC-392-001, SITC2021) 人工标引	临床1/2期	肿瘤	10	Gotistobart	餘遞鏇獵糧顧壓膚廠蓋(願鹽鬱獵鹽簾鏇齋網衊) = 鬱獵鏇艱餘觸蓋蓋夢築憲簾蓋艱鏇鏇衊鹹鏇膚 (製膚淵簾製積鏇鹽網構 ) 更多	积极	2021-11-11