eClinical Technology and Industy News

Acepodia Presents Positive Interim Phase 1 Feasibility Data for Antibody Cell Effector Therapy, ACE1702, in Advanced HER2-Positive Tumors

Excerpt from the Press Release:

Interim results from ongoing Phase 1 dose-escalation study demonstrate safety and tolerability of repeat dosing with ACE1702, a novel, off-the-shelf natural killer cell therapy

Initial results show potential for anti-tumor activity

Dose escalation is continuing up to 15 billion cells per cycle to determine the recommended starting dose to further evaluate the effectiveness of ACE1702

ALAMEDA, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) — Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care, today reported new interim data from an ongoing Phase 1 dose escalation study demonstrating feasibility with ACE1702, the company’s most advanced investigational antibody effector cell therapy (ACE), in development for patients with advanced HER2-positive tumors. Initial results from this first-in-human study show that repeat dosing of ACE1702 was safe and well-tolerated across the first four dose levels, comprising 9 billion cells per cycle at dose level four (DL4). No clinical signs of dose limiting toxicity (DLT), such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GvHD) have been reported so far.

These data are available to view in an on-demand e-Poster (presentation number 1006P) as part of the European Society of Medical Oncology (ESMO) 2021 Virtual Congress starting today, Thursday, September 16, 2021.

“Current cell therapies hold promise for a range of diseases, but many remain limited in use due to toxicities associated with high or repeat therapeutic dosing,” said principal investigator Sarina A. Piha-Paul, M.D., associate professor, Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. “The initial feasibility and safety findings from the ACE1702 study are encouraging as they suggest that this approach to cell therapy may enable more treatment options in the future for difficult-to-treat diseases, including lower-expressing HER2-positive tumors. As the study advances, we will work to determine optimal dosing for this investigational drug and continue to explore its therapeutic potential.”

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