7MW3711 / Mabwell (Shanghai) Biosci - LARVOL DELTA

Phase I/II study of 7MW3711, a novel B7-H3-targeting antibody-drug conjugate (ADC), in patients with advanced solid tumors (ESMO 2025) - P1/2 | "All PC pts had previously progressed after receiving docetaxel and endocrine therapy. Conclusions The safety profile of 7MW3711 was acceptable.7MW3711 demonstrated promising antitumor activity in several tumor types. The dose optimization and expansion study is continuing to establish the RP2D for 7MW3711."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

Mabwell Announces Latest Clinical Results of Novel B7-H3-Targeting ADC 7MW3711 to Be Presented at 2025 ESMO Congress (The Manila Times) - "Among 54 patients treated at 4.0 mg/kg or above and reaching tumor assessment, 19 partial responses (PRs) or complete responses (CRs) were observed. 7 patients with esophageal cancer (EC) were enrolled at 4.0 mg/kg or above and achieved an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 100%...No dose-limiting toxicities (DLTs) were observed in the dose escalation phase, and the maximum tolerated dose (MTD) has not yet been reached."

P1/2 data • Esophageal Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with lung cancer. (ASCO 2025) - P1/2 | "The data indicated encouraging efficacy of 7MW3711 in SCLC and Sq-NSCLC. The safety profile showed adequate tolerability. The dose optimization and expansion study is continuing to establish the RP2D for 7MW3711."

Clinical • P1/2 data • Anemia • Esophageal Cancer • Heart Failure • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276

Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with advanced solid tumors. (ASCO 2025) - P1/2 | "All PC pts had previously progressed after receiving docetaxel and endocrine therapy... The data indicated encouraging efficacy of 7MW3711 in advanced EC, OC and PC. The safety profile showed adequate tolerability. The dose optimization and expansion study is continuing to establish the RP2D for 7MW3711."

Clinical • Metastases • P1/2 data • Anemia • Breast Cancer • Esophageal Cancer • Genito-urinary Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • CD276

Combined a B7-H3-targeting antibody-drug conjugate, 7MW3711, and PARP inhibitors synergistically potentiates the antitumor activity in B7-H3-positive cancers (AACR 2025) - "In vivo, mice bearing ovarian and SCLC tumor xenografts were treated with the combination of 7MW3711 and PARPi. Evaluation of the drug resistance ability in cell lines expressing P-gp revealed 7MW3711 exhibited > 3-fold more potent than DS7300 (B7-H3-directed DXd ADC), indicating that 7MW3711 has a lower efflux efficiency in drug-resistant strains. These data provide evidence for the potential utility of 7MW3711 combination with PARPi for treatment of B7-H3-expressing tumors and support the rationale for further clinical studies."

Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • H2AX

A B7-H3-targeting antibody-drug conjugate, 7MW3711, and PARP inhibitors synergistically potentiate the antitumor activity in B7-H3-positive cancers (PRNewswire) - "Mabwell combines its self-developed 7MW3711 with PARP inhibitors to explore the synergistic antitumor activity of the ADC+PARPi combination strategy in preclinical solid tumor models. In this study, the synergistic antitumor activity shown by 7MW3711 in combination with PARPi suggests that it is a promising strategy to combine DNA damage repair inhibitor and B7-H3-targeting ADC for the treatment of B7-H3-positive solid tumors. The data provide evidence for the potential utility of 7MW3711 combination with PARPi for treatment of B7-H3-expressing tumors and support the rationale for further clinical application."

Preclinical • Oncology • Solid Tumor

Mabwell Announces NMPA Approval to Initiate Clinical Trial of novel B7-H3-targeting ADC for Advanced Solid Tumors in Combination with PD-1 Inhibitor (PRNewswire) - "Mabwell...announced its novel B7-H3-targeting ADC (R&D code: 7MW3711) has been approved by the NMPA to enter Phase Ib/II clinical trial in combination with a PD-1 Inhibitor, with or without antitumor therapies, for the treatment of advanced solid tumors....The approved phase Ib/II clinical trial aims to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic profile of 7MW3711 in combination with a PD-1 inhibitor..."

New P1/2 trial • Solid Tumor

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

FDA Grants Orphan Drug Designation to 7MW3711 (PRNewswire) - "Mabwell...announced that its self-developed novel B7-H3-targeting ADC (R&D code: 7MW3711) has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA), for the treatment of small cell lung cancer....7MW3711 is a novel B7-H3-targeting ADC developed by Mabwell's IDDC platform."

Orphan drug • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Mabwell to Present ADC Platform IDDC and the Latest Study Results of Multiple Novel ADCs at the 14th World ADC London (PRNewswire) - "Mabwell...announced that it will present its next generation ADC platform IDDC and the latest study results of multiple novel ADCs (9MW2821, 7MW3711, 9MW2921) developed based on this platform as poster presentation at the 14th World ADC London from March 12-15, 2024 local time."

Clinical data • Esophageal Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Mabwell Receives IND Approval from FDA for Novel B7-H3 ADC 7MW3711 (PRNewswire) - "Mabwell...announced that its clinical trial application of B7-H3 targeting ADC (R&D code: 7MW3711) for advanced malignant solid tumor was approved by the U.S. Food and Drug Administration (FDA). 7MW3711 is developed by Mabwell's next-generation antibody-drug conjugate platform IDDC™. The clinical trial of 7MW3711 has been initiated in China."

IND • Oncology • Solid Tumor

A Study of 7MW3711 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=164 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=281 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

ADC clinical progress | Maiwei Biotechnology completed the first patient administration of two innovative ADC drugs [Google translation] (eBiotrade.com) - "Maiwei Biotech...announced its independently developed innovative drug targeting Trop-2 ADC (R&D The first patient has recently been dosed with the innovative drug targeting B7-H3 ADC (codename: 9MW2921) (codename: 7MW3711)."

Trial status • Oncology • Solid Tumor

A Study of 7MW3711 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=164 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Metastases • New P1/2 trial • Oncology • Solid Tumor

A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=281 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Metastases • New P1/2 trial • Oncology • Solid Tumor

Maiwei Biological: 7MW3711 for injection has obtained the approval notice for drug clinical trials [Google translation] (Stockstar) - "News from the financial world on July 17, Maiwei Biology announced that recently, Maiwei (Shanghai) Biotechnology Co., Ltd. received the 'Notice of Drug Clinical Trial Approval' approved and issued by the State Drug Administration, and the clinical trial of 7MW3711 for injection was approved."

New trial • Oncology

Maiwei Biology: 7MW3711 Clinical Trial Application for Injection Accepted [Google translation] (Finet Group) - "On May 10, Maiwei Biological announced that the application for clinical trials of 7MW3711 for injection was accepted. 7MW3711 is a new antibody-conjugated drug targeting B7-H3, targeting advanced solid tumors."

New trial • Oncology • Solid Tumor