Muzastotug

- Sanofi to exercise option on third SAFEbody discovery program and sponsor combination clinical trial with muzastotug - Company expects proceeds to extend cash runway into 2027 July 01, 2025 -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced strategic investment and option exercise by Sanofi (Euronext: SAN FP). Sanofi has agreed to make strategic investment of up to US$25 million in Adagene. The Company plans to use the proceeds to fund its research and development activities, including clinical development of muzastotug (ADG126), an anti-CTLA-4 SAFEbody, through a randomized phase 2 trial in microsatellite stable colorectal cancer (MSS CRC). To further explore the clinical potential of muzastotug, Adagene will supply Sanofi with muzastotug to evaluate the safety, efficacy, pharmacokinetics and biomarker data in combination with other anticancer therapies in over 100 patients in a phase 1/2 clinical trial in advanced solid tumors. Adagene continues to own worldwide commercial rights to muzastotug. Sanofi has also exercised its option to select a third SAFEbody discovery program, utilizing Adagene’s proprietary masking technology and antibody engineering expertise. The bispecific therapeutic, with undisclosed targets, will be engineered by Adagene and induces an option exercise fee, as well as milestones and royalties as per the 2022 partnership agreement with Adagene. “Expanding our partnership with Sanofi highlights the potential of our SAFEbody platform and the clinical proof of concept for ADG126, our masked anti-CTLA-4 program and the most advanced of its kind,” said Peter Luo, Chairman, CEO and President of R&D at Adagene. “This strategic partnership reinforces our shared vision of ADG126’s promise in advanced solid tumors, including MSS CRC, where dose-limiting challenges have hindered anti-CTLA-4 therapies. We value our trusted relationship with Sanofi.” As of December 31, 2024, the Company had audited cash and cash equivalents of US$85.2 million. The proceeds from the investment of Sanofi, together with the current cash and cash equivalents, are expected to be sufficient to fund planned operations into 2027. Following the equity investment and strategic collaborations, a Sanofi representative will join Adagene’s Scientific Advisory Board (SAB), which provides strategic advice on the scientific and clinical aspects of the Company’s activities. Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational biology and artificial intelligence to design novel antibodies that address globally unmet patient needs. The company has forged strategic collaborations with reputable global partners that leverage its SAFEbody® precision masking technology in multiple approaches at the vanguard of science. Powered by its proprietary Dynamic Precision Library (DPL) platform, composed of NEObody™, SAFEbody, and POWERbody™ technologies, Adagene’s highly differentiated pipeline features novel immunotherapy programs. The company’s SAFEbody technology is designed to address safety and tolerability challenges associated with many antibody therapeutics by using precision masking technology to shield the binding domain of the biologic therapy. Through activation in the tumor microenvironment, this allows for tumor-specific targeting of antibodies in tumor microenvironment, while minimizing on-target off-tumor toxicity in healthy tissues. Adagene’s lead clinical program, ADG126 (muzastotug), is a masked, anti-CTLA-4 SAFEbody that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC). Validated by ongoing clinical research, the SAFEbody platform can be applied to a wide variety of antibody-based therapeutic modalities, including Fc empowered antibodies, antibody-drug conjugates, and bi/multi-specific T-cell engagers. The content above comes from the network. if any infringement, please contact us to modify.

7月1日，天演药业宣布，赛诺菲（Sanofi）将对公司进行战略投资，并启动双方SAFEbody安全抗体合作框架下的第三个SAFEbody开发项目。根据协议，赛诺菲拟向天演进行总额最高可达2500万美元的战略投资，资金将主要用于推进产品研发，重点支持抗CTLA-4 SAFEbody安全抗体Muzastotug（ADG126）在微卫星稳定型结直肠癌（MSS CRC）中的2期临床试验。根据天演药业新闻稿介绍，为进一步评估Muzastotug的临床潜力，天演将向赛诺菲供药，用于开展一项针对晚期实体瘤患者的1/2期联合用药临床试验，评估联用的安全性、疗效以及药代动力学和生物标志物等，预计入组超过100例患者。Muzastotug的全球商业化权益仍归天演所有。此外，赛诺菲启动双方SAFEbody合作框架下的第三个抗体开发项目。该项目将基于天演的专有安全掩蔽技术与抗体工程平台开发一款靶点未披露的双特异性抗体。根据2022年签署的合作协议，赛诺菲将就该项目支付选择权费用，并按协议支付开发里程碑款项及基于销售额的分级特许权使用费。天演药业联合创始人、首席执行官兼研发总裁罗培志博士表示，“我们高度重视与赛诺菲建立的长期互信与合作关系。本次战略合作凸显了SAFEbody安全抗体平台在提升肿瘤免疫治疗效果方面的潜力，并体现了抗CTLA-4安全抗体ADG126在临床概念验证中的积极进展。ADG126在掩蔽型抗体疗法中处于全球临床开发的领先阶段，有望突破传统抗CTLA-4疗法因剂量限制带来的疗效瓶颈，充分释放其在包括MSS型结直肠癌在内的晚期实体瘤中的治疗潜能。”参考资料：[1] 天演药业宣布获得赛诺菲2500万美元战略投资.From https://mp.weixin.qq.com/s/-9-5fH4cVEO8fUnOiWgATw免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。