GST Exemption Announced for Cancer Treatment Gene Therapy

AIIMS Develops Affordable CAR-T Cell Therapy for Multiple Myeloma

Sangamo Therapeutics and Astellas Collaborate on Innovative Gene Therapy for Neurological Diseases

FDA Clears IND for Arbor Biotechnologies’ ABO-101 Gene Editing Therapeutic for Primary Hyperoxaluria Type 1

Fortis Healthcare Acquires Stake in Agilus Diagnostics

FDA Approves BRAFTOVI® Combination Regimen as First-Line Treatment for BRAF V600E-Mutant Metastatic Colorectal Cancer

The Role of Big Data in Precision Medicine

Caris Life Sciences Celebrates 1,000+ Precision Medicine Studies, Advancing Cancer Research and Patient Outcomes

OncoHelix and Qualisure Diagnostics Partner to Bring Thyroid GuidePx® Test to Canadian Patients

Gates Foundation Invests $50 Million in Tessera Therapeutics to Advance Gene Therapy for Sickle Cell Disease

FDA Approves Ensartinib (Ensacove) as First-Line Treatment for ALK-Positive NSCLC

Guardant Health and Boehringer Ingelheim Collaborate to Advance Liquid Biopsy CDx for HER2-Targeted Therapy in NSCLC

Cartherics Receives $300K G-Rex Grant to Advance Cancer Cell Therapy Manufacturing

Roche Revolutionizes Mass Spectrometry Diagnostics with Launch of cobas® Mass Spec Solution

Complete Genomics Partners with Eurofins Clinical Enterprise to Expand Sequencing Service Offerings

Home
/
update
/
details

Mabwell's Nectin-4-Targeting ADC 9MW2821 Receives FDA Fast Track Designation for Locally Advanced or Metastatic Breast Cancer

NextEdge Admin

13 Jul 2024

2 min 17 sec

Breast Cancer,Antibody,Targeted Therapy,Tumors,Treatment

Mabwell, an innovative biopharmaceutical company, announced that its novel Nectin-4-targeting antibody-drug conjugate (ADC), 9MW2821, has received Fast Track Designation (FTD) from the U.S. FDA for treating locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC). The FDA's FTD aims to expedite the development and review of drugs for serious conditions, potentially leading to quicker market approval.

Within six months, 9MW2821 has obtained multiple FDA designations, including FTD for advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) and recurrent or metastatic cervical cancer (CC) following platinum-based chemotherapy. Additionally, it received Orphan Drug Designation (ODD) for esophageal cancer (EC). These designations underscore the drug's innovative potential and its promise in treating various tumors, facilitating its accelerated development and paving the way for potential priority review.

9MW2821 is Mabwell's first site-specific conjugated Nectin-4-targeting ADC, created using their proprietary ADC platform and automated high-throughput hybridoma antibody discovery technology. It is the first Chinese-developed Nectin-4-targeting ADC to enter clinical studies and the first globally to show clinical efficacy in CC, EC, and breast cancer. The drug employs site-specific antibody modification through advanced conjugation technology, allowing it to bind specifically to Nectin-4 on tumor cell membranes. Upon binding, it is internalized, releasing a cytotoxic drug that induces tumor cell apoptosis.

9MW2821's rapid accumulation of regulatory designations highlights its therapeutic promise, aiming to provide new treatment options for patients with these challenging cancers.