Mabwell Unveils Promising ADCs Clinical Data for 2025 ASCO Annual Meeting

Mabwell's Clinical Innovations Shining at ASCO 2025

Mabwell, a leading biopharmaceutical company based in Shanghai, is gearing up to present its significant clinical findings at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Among the highlights of its presentation are the clinical data for several antibody-drug conjugates (ADCs) that demonstrate promising efficacy in treating various types of cancer.

About the Presentation

Taking center stage will be the data from the phase Ib/II clinical study of Mabwell's novel ADC 9MW2821, also known as Bulumtatug Fuvedotin (BFv). This drug targets Nectin-4 and has been tested in combination with Toripalimab for patients suffering from locally advanced or metastatic uroepithelial carcinoma. Impressively, it has achieved an objective response rate (ORR) of 87.5% in a group of 40 initially untreated patients. Not only does this study show promising results, but it also marks the only oral presentation on urothelial carcinoma selected from Chinese research to be showcased at ASCO.

Mabwell is also presenting the clinical data for two additional ADCs: 7MW3711, targeting B7-H3, and 9MW2921, targeting Trop-2. Data for both will be shown through poster presentations. These ADCs have demonstrated good safety profiles and target a range of cancers, including esophageal, lung, and prostate cancers.

Encouraging Results from 9MW2821

The phase Ib/II study exploring 9MW2821 has yielded remarkable results. Patients were given a treatment comprised of 1.25 mg/kg of 9MW2821 coupled with 240 mg of Toripalimab. As of December 19, 2024, the study reached an ORR of 87.5%, with 80% of those responses confirmed. The overall disease control rate (DCR) was an impressive 92.5%. Given these figures, researchers are optimistic about the drug's potential, especially as it gains recognition as a clinical-stage pioneer among Chinese companies specifically targeting Nectin-4. This ADC is also notably the first of its kind to show clinical data in cervical, esophageal, and breast cancers.

Currently, there are three Phase III clinical trials in progress for 9MW2821. Its combination therapies have received a Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) in China and Fast Track Designations (FTD) from the U.S. FDA for multiple indications.

A Deep Dive into 7MW3711 and 9MW2921

Alongside the results for Nectin-4, Mabwell's B7-H3 targeting ADC, 7MW3711, has also shown significant promise. In a phase I/II clinical study involving advanced solid tumors, 43 patients were enrolled, and the study demonstrated that even at higher doses, adverse reactions were manageable. The ORR for several cancers, including 60% for ovarian cancer, provides hope for various treatment protocols.

Meanwhile, 9MW2921 showcased its robust anti-tumor activity in an advanced solid tumor study, achieving a 42.1% ORR and 84.2% DCR, highlighting its potential benefit in treating endometrial and gastric cancers.

The Path Ahead for Mabwell

Mabwell’s commitment to innovation and patient-centered research aligns with its mission to provide effective and accessible therapies for global health issues. Engaging actively in significant clinical trials and establishing robust manufacturing capabilities reflects Mabwell's strategy of advancing cancer treatment technologies through its state-of-the-art Interchain-Disulfide Drug Conjugate (IDDC™) platform.

As we await more news from ASCO 2025, these developments offer a glimpse into a future where innovative ADC therapies could reshape cancer care, providing hope to countless patients worldwide. With continued focus on research and development, Mabwell is setting benchmarks in the biopharmaceutical industry.

For more information on Mabwell’s groundbreaking initiatives and their pipeline products, visit their website at www.mabwell.com/en.