First Patient Dosed in Phase 1 Study of NK Cell Therapy, ACE1702

August 19, 2020

The study is designed to evaluate the safety and tolerability, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing solid tumors.

Acepodia announced that it has dosed the first patient in its open-label, dose escalation, phase 1 study of ACE1702, a natural killer (NK) cell therapy being developed as a treatment for patients with HER2-expressing solid tumors.

The first patient was dosed at The University of Texas MD Anderson Cancer Center in Houston, Texas.

“The initiation of this trial represents a significant milestone for our company, marking the first clinical study of an allogeneic NK cell therapy generated using Acepodia’s proprietary ACC technology,” Sonny Hsiao, PhD, chief executive officer, president, and co-founder of Acepodia, said in a press release. “ACE1702 utilizes our potent natural killer cell line, oNK, and leverages the power of our ACC platform to enhance its anti-tumor activity, resulting in an off-the-shelf therapy which we believe has the potential to deliver the effectiveness necessary to combat solid tumors. Importantly, our allogenic therapies can be manufactured at large scale, which can ultimately improve patients’ access to potentially life-saving treatments.”

The study is designed to evaluate the safety and tolerability, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing solid tumors, for which surgery or other therapeutic options cannot be utilized. The study is anticipated to enroll 12 to 24 patients across multiple oncology sites in the US.

ACE1702 is an allogeneic, off-the-shelf NK cell therapy developed using Acepodia’s antibody-cell conjugation technology that can link tumor-targeting antibodies directly to the proprietary NK (oNK) cell line. ACE1702 is designed to not only target but destroy HER2-expressing tumors.

“As customary in a phase 1 trial, we must first evaluate safety of our therapy. Now, 45 days after the first patient received repeat doses of ACE1702, we are very encouraged that there were no adverse events, including no graft versus host disease or cytokine release syndrome which have been observed with other cell therapy approaches,” Mark J. Gilbert, MD, senior vice president of Research and Development at Acepodia, said in the release. “We look forward to advancing ACE1702 in the clinic and exploring the potential of our unique approach to cell therapies for the treatment of solid tumors, which constitute 90% of new cancer cases per year.”

Notably, in preclinical studies, ACE1702 demonstrated a favorable safety profile in good laboratory practice (GLP) toxicology studies and enhanced tumor-directed cytotoxicity against human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 1+, 2+ and 3+ human cancer cells both in vitro and in vivo.

Reference:

Acepodia Initiates a Phase 1 Clinical Trial Evaluating Allogeneic NK Cell Therapy ACE1702 for Treatment of Solid Tumors [news release]. San Francisco and Taipei, Taiwan. Published August 18, 2020. Accessed August 18, 2020. https://www.globenewswire.com/news-release/2020/08/18/2079823/0/en/Acepodia-Initiates-a-Phase-1-Clinical-Trial-Evaluating-Allogeneic-NK-Cell-Therapy-ACE1702-for-Treatment-of-Solid-Tumors.html