▎WuXi AppTec Content Team Report

Today (August 23), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Puzhong Discovery Pharmaceutical Technology (Shanghai) Co., Ltd.'s AMT-676 Injection Granted Clinical Approval for Advanced Solid TumorsAccording to publicly available information from Puzhong Discovery Pharmaceutical Technology (Shanghai) Co., Ltd., this is aAnti-CDH17 Antibody-Drug Conjugate (ADC), also a pan-gastrointestinal tumor investigational drug。

Multitude TherapeuticsIt is a clinical-stage company focused on the development of ADC drugs.Recently (August 20), the company just announced an international deal exceeding $1 billion for the ADC product ADCE-T02 targeting tissue factor (Anti-TF).Authorization Cooperation。

Screenshot source:CDE Official Website

Cadherin 17 (CDH17, also known as CA17) is a recent discoveryGastrointestinal Tumor Treatment FieldAn emerging target.Studies have shown that it plays an important role in the invasion and metastasis of various tumors, especially in digestive system tumors.CDH17It is a member of the cadherin family and can be detected in over 50% of tumor tissues ranging from stomach, pancreas, liver, esophagus to colorectal cancer, serving as one of the oncogenic drivers of human gastrointestinal tumorigenesis and cancer metastasis.

According to public channel inquiries, there are currently no innovative drugs targeting CDH17 approved for marketing globally. However, multiple innovative products are in Phase 1 clinical research, including drug types such as CAR-T products, bispecific antibodies, and ADCs.

AMT-676 is an ADC product in the research pipeline of Puzhong Discovery Pharmaceutical Technology (Shanghai) Co., Ltd. According toClinicalTrialsAccording to the official website, Puzhong Discovery Pharmaceutical Technology (Shanghai) Co., Ltd. has already initiated a first-in-human Phase 1 clinical study in Australia to evaluate the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), safety, tolerability, anti-drug activity, pharmacokinetics, pharmacodynamics, and immunogenicity of AMT-676 in patients with advanced solid tumors.

According to publicly available information, Puzhong Discovery Pharmaceutical Technology (Shanghai) Co., Ltd. currently has several ADC products in clinical research stages, including targeted ones.ADC for a new target.

▲Puzhong Discovery ADC Pipeline (Screenshot Source: Puzhong Discovery Official Website)

• Injectable AMT-151: AADC Targeting FRα, currently in the phase 1 study stage for patients with advanced solid tumors;

• AMT-253 for Injection:AADC Targeting MUC18, and is currently conducting Phase 1/2 studies for melanoma and other solid tumors;

• AMT-707 for Injection:For aADC Targeting CDH6, and is currently conducting a Phase 1 clinical study for solid tumors.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 AMT-707 (also known as CUSP06) globally outside of Greater China.

• AMT-116 for Injection:A Potential "First-in-Class" ADC Product Targeting Tumor-Associated Antigen CD44v9, and is currently conducting Phase 1/2 clinical trials for patients with advanced solid tumors.

• AMT-562 for Injection:ANovel ADC Targeting HER3, composed of a novel anti-HER3 antibody Ab562, a hydrophilicity-enhanced linker MC-VA-PABC, and the payload exatecan (Ixitican), is currently in Phase 1 clinical trials for advanced solid tumors.

• AMT-754: AADC Targeting Tissue Factor (TF)Adcendo has obtained the global exclusive development and commercialization rights for this product outside of Greater China (research and development code: ADCE-T02). The product has already been submitted for clinical trial in Australia and is expected to file for U.S. IND approval soon.

[1] Official of the Center for Drug Evaluation, National Medical Products Administration of ChinaWebsite. Retrieved Aug 23, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2] Puzhong Discovery Official Website. From https://www.multitudetherapeutics.info/