MAINZ – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”) today announced that the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for BNT324/DB-1311 for the treatment of patients with advanced/unresectable, or metastatic castration-resistant prostate cancer (“CRPC”) who have progressed on or after standard systemic regimens. BNT324/DB-1311 is a next-generation antibody-drug conjugate (“ADC”) candidate targeting the transmembrane glycoprotein B7-H3, an immune checkpoint protein which is overexpressed in a range of tumor types and has been associated with disease progression and poor prognosis for patients. The candidate is currently being evaluated in an ongoing Phase 1/2 study (NCT05914116) in patients with advanced solid tumors.
“The FDA’s decision is a recognition of the potential of our B7-H3-targeting ADC candidate for the treatment of advanced CRPC. While patients with metastatic prostate cancer initially respond to hormone therapy, most patients progress after 18-24 months and develop CRPC, an advanced form of prostate cancer, leading to a poor prognosis for these patients. The 5-year survival rate for patients with metastatic CRPC is only around 36%,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. “We are committed to further advancing BNT324/DB-1311 with our partner DualityBio and believe that a targeted ADC immunotherapy approach has the potential to improve outcomes for patients at advanced stages of the disease.”
“BNT324/DB-1311 is the third asset in our strategic collaboration which has received FDA Fast Track designation, highlighting the potential of the candidate to fill an unmet medical need for novel treatment options for B7-H3 expressing cancers,” said Vivian Gu, M.D., Chief Medical Officer at DualityBio. “Preliminary data from our ongoing Phase 1/2 trial has demonstrated antitumor activity and a manageable safety profile of BNT324/DB-1311 in patients with advanced solid tumors. With the designation and support by the FDA, we seek to expedite further development of BNT324/DB-1311.”
Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The designation is based on preliminary safety and efficacy data from an ongoing Phase 1/2 trial with BNT324/DB-1311 in patients advanced or metastatic solid tumors. With the Fast Track designation, the development of BNT324/DB-1311 can benefit from more frequent engagement with the FDA, to support the development and expedite the regulatory review of BNT324/DB-1311.
All three clinical stage ADC candidates in BioNTech’s and DualityBio’s global strategic partnership have received FDA Fast Track designation. The lead candidate in the collaboration, BNT323/DB-1303, a next-ADC candidate targeting the Human Epidermal Growth Factor Receptor 2 (“HER2”), is being evaluated in a Phase 1/2 trial in patients with advanced solid tumors and a global Phase 3 clinical trial in patients with metastatic breast cancer. The BNT323/DB-1303 program received the Fast Track designation and Breakthrough Therapy designation from the FDA for the treatment of endometrial cancer in 2023. In January 2024, the companies’ ADC candidate targeting the trophoblast cell-surface antigen 2 (“TROP2”), BNT325/DB-1305, received FDA Fast Track designation for the treatment of patients with platinum-resistant ovarian epithelial cancer.