Multitude Therapeutics Announces CDE Approval of AMT-707, a Novel CDH6-Targeting ADC, for Clinical Trials in Advanced Solid Tumors

Dec 27, 2023 16:03 CST Updated 16:03

Multitude Therapeutics

Innovative Drug Developer

▎Edited by the WuXi AppTec content team

On December 26, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the investigational new drug AMT-707 Injection, submitted by Multitude Therapeutics, has been approved for clinical trials, intended for the development of treatment for advanced solid tumors.Public information shows that AMT-707 is a highly differentiatedAntibody-Drug Conjugates (ADC) Targeting CDH6。Puzhong Discovery Pharmaceutical Technology (Shanghai) Co., Ltd. has previously entered into a licensing agreement with OnCusp Therapeutics, granting the latter exclusive rights to develop and commercialize globally outside of Greater China.AMT-707(Also known asCUSP06）The right.

Screenshot source:CDE Official Website

CDH6 (cadherin-6 or K-cadherin) is highly expressed in ovarian and renal cancers, with increased expression also observed in patients with cholangiocarcinoma, gastric cancer, thyroid cancer, and other malignant tumors. Due to its high expression in tumor tissues and limited expression in normal tissues, and the rapid internalization of the ADC complex upon antibody binding, CDH6 is considered highly suitable as an ADC target.

AMT-707Composed of three parts: an antibody with strong CDH6 affinity, a protease-cleavable linker, and an exatecan payload (a topoisomerase-1 inhibitor).According to an earlier press release from OncoMed,AMT-707The linker used is specifically designed for the exatecan payload, generating highly stable and homogeneous ADCs.This payload is a weak substrate of BCRP/P-gp, which are drug efflux pumps responsible for chemotherapy resistance in many therapies.The researchers, through ingenious design,Including enhancing payload potency, amplifying the "bystander effect," improving linker stability, and potentially overcoming resistance mechanisms caused by BCRP/P-gp., making this product a highly differentiated CDH6-targeted ADC.

It is reported that in the preclinical development research,AMT-707Demonstrated better safety and developability, showing good anti-tumor activity in several in vivo cancer models with high and low CDH6 expression. In August 2023, OncureMed announcedAMT-707（CUSP06）The project has received FDA approval to initiate a Phase 1 clinical trial in the United States. The Phase 1 clinical trial will evaluate its safety and tolerability in dose escalation to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RDE) in patients with platinum-resistant/refractory ovarian cancer and other advanced solid tumors.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Dec 26, 2023, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Angke Pharmaceuticals' CUSP06 Receives U.S. FDA Approval to Initiate Phase I Clinical Trial for Ovarian Cancer and Other Solid Tumors. Retrieved Apr 15, 2023, from https://mp.weixin.qq.com/s/u2rdnlsiZzDGNuipWL-tCw

[3] PuPuzhong Discovery and OncoMed Reach Overseas Licensing Agreement for Potential Highly Differentiated CDH6-Targeted Antibody-Drug Conjugate (ADC). Retrieved Jun 8, 2022, from https://mp.weixin.qq.com/s/4NS9ZNgbqoWqEYQSz0U87Q

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