FDA Grants Fast Track to BioNTech and DualityBio's Prostate Cancer Drug BNT324/DB-1311

BioNTech SE and Duality Biologics recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to their next-generation antibody-drug conjugate (ADC) candidate BNT324/DB-1311. This designation aims to expedite the development and regulatory review for treating patients with advanced or metastatic castration-resistant prostate cancer (CRPC) who have not responded to standard systemic treatments.

BNT324/DB-1311 targets the transmembrane glycoprotein B7-H3, an immune checkpoint protein overexpressed in various tumors and linked with disease progression and poor prognosis. The drug is currently undergoing Phase 1/2 clinical trials to evaluate its efficacy and safety in patients with advanced solid tumors.

According to Prof. Özlem Türeci, Chief Medical Officer and Co-Founder of BioNTech, the FDA's Fast Track designation underscores the potential of BNT324/DB-1311 in treating advanced CRPC. Türeci noted that while hormone therapy initially benefits patients with metastatic prostate cancer, many progress to CRPC within 18-24 months, resulting in a poor prognosis and a 5-year survival rate of approximately 36%. The targeted ADC immunotherapy offered by BNT324/DB-1311 could significantly improve outcomes for these patients.

Vivian Gu, Chief Medical Officer at DualityBio, highlighted that this is the third asset from their strategic collaboration with BioNTech to receive FDA Fast Track designation, emphasizing its potential to address unmet medical needs for B7-H3 expressing cancers. Preliminary data from the ongoing Phase 1/2 trial has shown promising antitumor activity and manageable safety in patients with advanced solid tumors.

The FDA’s Fast Track process is designed to facilitate the development and expedite the review of new drugs and vaccines aimed at treating serious conditions and addressing unmet medical needs. The designation for BNT324/DB-1311 is based on preliminary safety and efficacy data from its ongoing Phase 1/2 clinical trial. This designation allows for more frequent interactions with the FDA, thereby supporting development and expediting the regulatory review process.

BioNTech and DualityBio’s collaboration has seen all three of their clinical-stage ADC candidates receive FDA Fast Track designation. Another candidate, BNT323/DB-1303, which targets the Human Epidermal Growth Factor Receptor 2 (HER2), is in Phase 1/2 trials for advanced solid tumors and a global Phase 3 trial for metastatic breast cancer. BNT323/DB-1303 has received both Fast Track and Breakthrough Therapy designations from the FDA for endometrial cancer treatment. Additionally, BNT325/DB-1305, targeting the trophoblast cell-surface antigen 2 (TROP2), received Fast Track designation in January 2024 for treating platinum-resistant ovarian epithelial cancer.

BNT324/DB-1311, a topoisomerase-I-inhibitor-based ADC candidate, focuses on the immune checkpoint protein B7-H3. This glycoprotein is crucial in anti-tumor immune responses and influences the tumor microenvironment. It is highly expressed in various solid tumors but has limited presence in healthy tissues, often correlating with disease progression and poor patient prognosis. Preclinical studies have shown BNT324/DB-1311’s antitumor activity in multiple solid tumor models, and preliminary data from the ongoing Phase 1/2 trial supports its antitumor activity and manageable safety profile in patients with advanced solid tumors.

BioNTech is an innovative immunotherapy company pioneering advanced treatments for cancer and other serious diseases. They utilize a wide range of computational and therapeutic drug platforms to rapidly develop novel biopharmaceuticals. Their oncology portfolio includes mRNA-based therapies, chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies, ADC therapeutics, and small molecules. BioNTech collaborates globally with numerous pharmaceutical companies to advance their diverse pipeline of oncology and infectious disease treatments.

DualityBio, a clinical-stage company, focuses on next-generation ADC therapeutics for cancer and autoimmune diseases. They have established multiple ADC technology platforms with global intellectual property rights and have advanced several assets into global clinical studies. DualityBio continues to innovate in protein engineering and ADC technologies, developing new “super ADC” molecules, including diverse payload classes and bispecific ADCs.