Acepodia Announces FDA Clearance of IND for its NK Cell Therapy Drug Candidate ACE1702 to Treat Patients with HER2-expressing Solid Tumors
ACE1702 is a potential off-the-shelf cell therapy developed using Acepodia’s Antibody-Cell Conjugation technology
Acepodia, a biotechnology company developing cancer immunotherapy based on its novel ACC™ (Antibody Cell-Conjugation) technology platform, today announced it has received clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate a Phase 1 clinical study of its natural killer (NK) cell therapy and lead drug candidate ACE1702 in patients with HER2-expressing solid tumors.
“The FDA’s clearance of our IND for ACE1702 is a major milestone for Acepodia that represents an important initial validation of our ACC™ platform, which can link any antibody, including those that have already proven effective in targeting tumors, to proprietary off-the-shelf natural killer cell line (oNK cells) without the need for genetic engineering,” said Sonny Hsiao, Ph.D., chief executive officer of Acepodia, and the inventor of ACC™ while at University of California, Berkeley. “This novel approach allows us to circumvent the complexity and the limitations associated with CAR-T and traditional NK based cell therapies. ACC™ significantly improves manufacturing costs and has the potential to generate a cost-effective cancer treatment that can deliver increased benefit to patients. We look forward to advancing ACE1702 into its first clinical trial.”
ACE1702 is Acepodia’s lead clinical product candidate developed from the Company’s proprietary ACC™ platform. It targets human HER2-expressing solid tumors using anti-HER2 antibody conjugated oNK cells. ACE1702 has demonstrated enhanced tumor cell killing activities both in vitro and in vivo, while maintaining a favorable safety profile in GLP toxicology studies. In preclinical studies, ACE1702 has shown enhanced tumor-killing activities against HER2 IHC 1+, 2+ and 3+ human cancer cells.
Acepodia is a privately held US-Taiwan biotechnology company committed to developing safe, effective, and affordable immunotherapeutic medicines targeting diseases with significant unmet medical needs, with a primary focus on oncology. Acepodia’s proprietary ACC™ (Antibody Cell-Conjugation) technology platform links tumor targeting antibodies to the surface of a novel and proprietary human NK cell line that have been specifically selected for their potent antitumor activity. The ACC technology can be seamlessly combined with currently available antibodies allowing for the rapid development of new targeted therapies in multiple indications, without the need for genetic engineering.
Jason Braco, Ph.D.