7MW4911 / Mabwell (Shanghai) Biosci - LARVOL DELTA

First-in-human Study of 7MW4911 in GI Cancer (clinicaltrials.gov) - P1/2 | N=200 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

First-in-human • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Mabwell…announced that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the National Medical Products Administration (NMPA) in China to initiate clinical study in patients with advanced solid tumors (PRNewswire)

New trial • Solid Tumor

Mabwell's CDH17-targeting ADC 7MW4911 Receives IND Clearance from FDA (PRNewswire) - "The clearance enables the initiation of Phase I/II study of 7MW4911 to evaluate the safety, pharmacokinetics, and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors....IND application of 7MW4911 has been accepted by China's National Medical Products Administration (NMPA)."

IND • New trial • Colorectal Cancer

Mabwell Announces IND Application Acceptance for CDH17-Targeting ADC 7MW4911 from Both NMPA and FDA (The Manila Times) - "Mabwell...announced that its proprietary CDH17-targeting antibody-drug conjugate (ADC), 7MW4911, has received Investigational New Drug (IND) application acceptance from China's National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the U.S. Food and Drug Administration (FDA)."

Preclinical • Colorectal Cancer • Gastric Cancer • Pancreatic Cancer

Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor. (PubMed, Cell Rep Med) - "Additionally, 7MW4911 showed favorable pharmacokinetics and a highest non-severely toxic dose (HNSTD) exceeding 20 mg/kg in cynomolgus monkeys, underscoring its promising safety profile. Together, these findings position 7MW4911 as a promising ADC candidate capable of enhancing therapeutic outcomes in GI cancers."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CDH17 • TOP1

7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers (AACR 2025) - "Immunohistochemistry (IHC) analysis confirmed CDH17 as a highly specific target, with expression observed in 100% (110/110) of colorectal, 77% (110/142) of gastric, and 55% (58/105) of pancreatic cancer samples. 7MW4911 demonstrated strong binding, efficient internalization, and potent cytotoxicity in CDH17-positive cell lines. In vivo, 7MW4911 showed substantial tumor growth inhibition (TGI), with TGI ranging from 29-97% in nine colorectal CDX models, 56-95% in three gastric models, and 81% in one pancreatic model."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CDH17

7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers (PRNewswire) - " In preclinical CDX and PDX models, 7MW4911 demonstrated robust antitumor activity and superior efficacy over MMAE-based ADCs in multidrug resistance models. Pharmacokinetic and safety studies in non-human primates support a favorable profile and a high non-severely toxic dose (HNSTD), enabling clinical advancement. 7MW4911 represents a differentiated and promising ADC candidate for GI cancers, with an IND submission to the NMPA and FDA planned for H2 2025."

IND • New trial • Preclinical • Gastrointestinal Cancer

Mabwell to Present results of 6 studies at the 2025 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Mabwell...announced that it will present results of 6 studies as poster presentation at the AACR Annual Meeting to be held in Chicago, USA, from April 25-30, 2025."

Preclinical • Acute Myelogenous Leukemia • Oncology • Solid Tumor