BioNTech Bags FDA Breakthrough Therapy Designation For BNT323/DB-1303

(RTTNews) - BioNTech SE (BNTX) together with Duality Biologics, announced that the FDA granted Breakthrough Therapy designation for BNT323/DB-1303, to treat advanced endometrial cancer in patients who have previously undergone treatment with immune checkpoint inhibitors.

BNT323/DB-1303 is a new type of drug called an antibody-drug conjugate (ADC) candidate targeting the Human Epidermal Growth Factor Receptor 2 (HER2), a cell surface protein that is found in various tumor types.

The company stated that the FDA's decision was based on positive results from a Phase 1/2 study (NCT05150691) of BNT323/DB-1303 in patients with HER2-expressing advanced endometrial cancer.

Vivian Gu, M.D., Chief Medical Officer at DualityBio, said, "We believe BNT323/DB-1303 has the potential to serve as a new therapeutic option for patients with HER2 expressing advanced endometrial carcinoma including both patients with high and low expression levels of HER2. We are committed to advancing BNT323/DB-1303 to improve outcomes for patients in late disease stages."