FDA Accepts IND of NK Cell Therapy for HER2 Positive Solid Tumors

NEW YORK – Biotech company Acepodia said Thursday that the US Food and Drug Administration accepted the investigational new drug application for its new antibody-cell conjugate based immunotherapy, ACE1702, for patients with HER2-expressing solid tumors. 

The company develops treatments using its Antibody Cell-Conjugation (ACC) technology platform, which links tumor targeting antibodies to a human natural killer cell line with antitumor activity. ACE1702, Acepodia's lead product candidate, targets HER2-expressing tumors using anti-HER2 antibody conjugated to NK cells. 

"This novel approach allows us to circumvent the complexity and the limitations associated with CAR-T and traditional [natural killer]-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," Acepodia's CEO Sonny Hsiao said in a statement. "We look forward to advancing ACE1702 into its first clinical trial."

In preclinical studies, ACE1702 enhanced tumor-killing activities against HER2-positive human cancer cells. It has also shown a favorable safety profile in toxicology studies.