Biontech News

BioNTech and DualityBio Granted FDA Fast Track Designation for Antibody-Drug

BioNTech and DualityBio Collaborate on Novel Antibody-Drug Conjugate

BioNTech SE and DualityBio, Inc. have announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to their investigational antibody-drug conjugate (ADC), DTB348.

DTB348 is designed to target CD38, a surface protein expressed on multiple myeloma cells. The ADC combines a humanized monoclonal antibody that binds to CD38 with a cytotoxic payload that inhibits cancer cell division.

Clinical Significance of DTB348

The FDA's Fast Track designation is reserved for drugs that have the potential to address unmet medical needs in serious or life-threatening conditions. The designation allows for expedited development and review of DTB348, with potential benefits for patients with multiple myeloma.

DTB348 is currently being evaluated in a Phase Ib clinical trial in patients with relapsed or refractory multiple myeloma. The trial is assessing the safety, tolerability, and efficacy of DTB348 as a treatment for this aggressive blood cancer.

BioNTech's Expertise in Immunotherapy

BioNTech is a leading biotechnology company with expertise in the development of immunotherapies, including mRNA-based vaccines and antibody-drug conjugates. The company's pipeline includes several promising candidates for the treatment of cancer and infectious diseases.

The collaboration with DualityBio highlights BioNTech's commitment to developing innovative treatments that address unmet medical needs. By combining their expertise in immunotherapy with DualityBio's platform for ADC development, the companies aim to bring DTB348 to patients as quickly as possible.

About BioNTech

BioNTech is a global biotechnology company that develops and manufactures immunotherapies for the treatment and prevention of cancer and infectious diseases. The company was founded in 2008 and is headquartered in Mainz, Germany. BioNTech is committed to unlocking the potential of the human immune system to fight disease.