Mabwell to Present 9MW2821 Clinical Data and Progress at 2024 ASCO Annual Meeting

Mabwell, a biopharmaceutical company listed on the Shanghai Stock Exchange (688062.SH), has shared promising updates on its Phase I/II clinical trial of 9MW2821, a pioneering ADC (antibody-drug conjugate) targeting Nectin-4 for treating various advanced solid tumors. These findings will be presented at the 2024 ASCO Annual Meeting.

As of April 1, 2024, the Phase II trial at a 1.25 mg/kg dose involved 240 patients across different cancer types:

Urothelial Carcinoma (UC)
Among 37 patients assessed, the objective response rate (ORR) reached 62.2%, and the disease control rate (DCR) was 91.9%. The median progression-free survival (mPFS) stood at 8.8 months, while the median overall survival (mOS) was 14.2 months.

Cervical Cancer (CC)
Among 53 patients evaluated, 51% had previously undergone platinum-based chemotherapy with bevacizumab, and 58% had received platinum-based chemotherapy and an immune checkpoint inhibitor. The ORR was 35.8%, and the DCR reached 81.1%. The mPFS was 3.9 months; mOS was not yet reached. For patients with intense Nectin-4 tumor cell staining (3+), the ORR was 43.6% among the 39 patients evaluated.

Esophageal Cancer (EC)
Out of 39 patients, the ORR was 23.1%, and the DCR was 69.2%. The mPFS was 3.9 months, and the mOS was 8.2 months. Thirty-seven of these patients had previously been treated with platinum-based chemotherapy and immunotherapy.

Triple-negative Breast Cancer (TNBC)
Among 20 patients with advanced or metastatic TNBC, the ORR was 50.0%, and the DCR was 80.0%. The mPFS was 5.9 months, and mOS was not yet reached. Notably, one patient achieved complete response (CR), maintaining CR for 20 months.

Safety Profile
Common treatment-related adverse events in the 1.25 mg/kg dose group were decreases in white blood cell counts (50.8%, with 23.3% ≥grade 3), neutrophil counts (46.3%, with 27.9% ≥grade 3), and anemia (43.8%, with 8.3% ≥grade 3). Other notable events included increased levels of aspartate aminotransferase (42.1%, with 2.9% ≥grade 3), alanine aminotransferase (35.4%, with 2.1% ≥grade 3), and conditions like asthenia, rash, decreased appetite, nausea, hyperglycemia, and others. These findings suggest 9MW2821 has a manageable safety profile.

About 9MW2821
9MW2821 is the first ADC developed by a Chinese company to enter clinical studies targeting Nectin-4, showing clinical efficacy in cervical, esophageal, and breast cancers. It has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

The drug utilizes proprietary technology for site-specific antibody modification. Post-injection, it binds to Nectin-4 on the tumor cell membrane, internalizes, releases cytotoxic drugs, and induces tumor cell apoptosis.

About Mabwell
Mabwell is a biopharmaceutical firm committed to innovative medicine development, covering the entire pharmaceutical industry chain. Since 2017, the company has built an advanced R&D system with 14 pipeline products at various stages, including 10 novel drug candidates. Mabwell operates in therapeutic areas like oncology, autoimmune diseases, metabolic disorders, ophthalmologic diseases, and infectious diseases. Three products have already been approved and commercialized. The company also engages in major national scientific projects and runs a GMP-compliant manufacturing facility in Taizhou, with a large-scale base in Shanghai underway. Mabwell's mission is "Explore Life, Benefit Health," and its vision is “Innovation, from ideas to reality.”

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