A2 Bio Secures FDA Orphan Drug Designation for New Cell Therapy Program A2B530 Targeting Colorectal Cancer
Monday, March 04, 2024
A2 Biotherapeutics, Inc. (A2 Bio) has recently revealed that their cell therapy product, A2B530, has secured Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for treating a specific subset of colorectal cancer patients. This designation marks a significant milestone for A2 Bio, acknowledging the potential of their innovative approach to addressing unmet medical needs.
A2B530 is an autologous cell therapy developed using A2 Bio's proprietary TmodTM platform. This platform employs a unique dual-receptor design, comprising an activator targeting tumor cells and a blocker safeguarding normal cells. By selectively targeting tumor cells while protecting healthy ones, A2B530 aims to overcome a fundamental challenge in cancer treatment, particularly in solid tumors.
The therapy is intended for germline heterozygous HLA-A02(+) patients with colorectal cancer expressing carcinoembryonic antigen (CEA) and lacking HLA-A02 expression. A2B530 consists of an activator targeting CEA and a blocker targeting HLA-A*02.
Enrollment is currently underway in the EVEREST-1 (NCT05736731) study, a Phase 1/2 trial evaluating the safety and efficacy of A2B530 across colorectal, pancreatic, and non-small cell lung cancers.
Dr. William Go, Chief Medical Officer of A2 Bio, highlighted the significance of FDA's Orphan Drug Designation, emphasizing the urgent need for improved therapies in colorectal cancer. This recognition underscores A2 Bio's dedication to leveraging their innovative technology platform to develop effective treatments for challenging cancers.
Orphan Drug Designation provides A2 Bio with various incentives for the development of A2B530, including tax credits for clinical trials, exemptions from prescription drug user fees, and potential market exclusivity for up to seven years upon regulatory approval. This designation further supports A2 Bio's efforts to advance novel therapies for rare diseases and conditions affecting a limited patient population.
Source: businesswire.com
