• The status is based on preclinical data and data from an ongoing phase 1/2 study for BNT324/DB-1311; preliminary phase 1/2 clinical data showed anti-tumor activity and a controllable safety profile in patients with advanced or metastatic solid tumors1^{, 2}
• With the fast-track status, the development of BNT324/DB-1311 can be derived from closer cooperation with the American Medicines Agency (U.S. Food and Drug Administration, "FDA") to support further development and accelerate regulatory review
• Prostate cancer is the second most common cancer-associated cause of death in men worldwide3, which is often diagnosed only at an advanced stage of the disease; patients with metastatic castration-resistant prostate cancer (mCRPC), an advanced form of prostate cancer, have a 5-year survival rate of about 36%⁴
• All three clinical antibody-drug conjugates ("ADCs") candidates from BioNTechs and DualityBio's strategic partnership have received the fast-track status of the FDA; this emphasizes the potential of the companies' ADC technology 

BioNTech SE and Duality Biologics announced that the U.S. Medicines Agency (U.S. Food and Drug Administration, "FDA") has granted fast-track status to BNT324/DB-1311 for the treatment of patients with advanced/inoperable or metastatic castration-resistant prostate cancer ("CRPC") in whom the disease has progressed during or after standard therapy. BNT324/DB-1311 is an innovative antibody-drug conjugate ("ADC") candidate directed against the transmembrane glycoprotein B7-H3. B7-H3 is an immune checkpoint protein that is overexpressed in a number of tumor types and has been associated with the progression of tumor diseases and a poor prognosis. The candidate is currently being studied in a clinical 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-directed ADC candidate for the treatment of advanced CRPC. While patients with metastatic prostate cancer initially respond to hormone therapy, in most patients the tumor disease progresses after 18-24 months and they develop CRPC, an advanced form of prostate cancer that brings a poor prognosis for these patients. The 5-year survival rate for patients with metastatic CRPC is only about 36%," said Prof. Dr. Özlem Türeci, Chief Medical Officer and co-founder of BioNTech. "It is our goal to further advance the development of BNT324/DB-1311 with our partner DualityBio. We believe that a targeted ADC immunotherapy approach has the potential to improve results for patients in advanced stages of the disease."

"BNT324/DB-1311 is the third candidate from our strategic collaboration to receive the fast-track status of the FDA. This emphasizes the candidate's potential to meet an unmet medical need for novel treatment options for B7-H3-expressing cancers," said Dr. Vivian Gu, Chief Medical Officer at DualityBio. Preliminary data from our ongoing phase 1/2 study have shown anti-tumor activity and a controllable safety profile for BNT324/DB-1311 in patients with advanced solid tumors. With the status and support of the FDA, we aim to accelerate the further development of BNT324/DB-1311."

Fast-Track is a procedure to facilitate the development and acceleration of the testing of new drugs and vaccines intended for the treatment or prevention of serious diseases and have the potential to address an unmet medical need. The FDA's decision is based on preliminary data from an ongoing phase 1/2 study with BNT324/DB-1311 in patients with advanced or metastatic solid tumors. With the fast-track status, the development of BNT324/DB-1311 can benefit from closer cooperation with the FDA to support the development of BNT324/DB-1311 and accelerate its regulatory review.

All three ADC candidates from the global strategic collaboration of BioNTech and DualityBio are in clinical evaluation and have received the fast-track status of the FDA. The main product candidate from the collaboration, BNT323/DB-1303, an innovative ADC candidate, is directed against the Human Epidermal Growth Factor Receptor 2 ("HER2"). The candidate is currently being studied in a phase 1/2 study in patients with advanced solid tumors and in a phase 3 study in patients with metastatic breast cancer. The BNT323/DB-1303 program received fast-track status and breakthrough therapy status from the FDA for the treatment of uterine cancer in 2023. In January 2024, the companies' ADC candidateBNT325/DB-1305, which is directed against trophoblast cell surface antigen 2 ("TROP2"), received the FDA's fast-track status for the treatment of platinum-resistant, epithelial ovarian cancer.