Acepodia Initiates a Phase 1 Clinical Trial Evaluating Allogeneic NK Cell Therapy ACE1702 for Treatment of Solid Tumors
• ACE1702 is the first antibody-conjugated NK cell therapy in clinical development for the treatment of HER2-expressing solid tumors
• Clinical trial expected to enroll up to 24 patients across the U.S.
SAN FRANCISCO and TAIPEI, Taiwan, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Acepodia, a biotechnology company developing novel off-the-shelf cell therapies against solid-tumor and hematologic cancers, today announced that it has dosed the first patient in its Phase 1 open-label, dose escalation study of ACE1702, a natural killer cell (NK cell) therapy being developed as a treatment for HER2-expressing solid tumors. The first patient was dosed at The University of Texas MD Anderson Cancer Center in Houston, Texas. The study will evaluate the safety and tolerability, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing solid tumors not amenable to surgery or other therapeutic options. The study is expected to enroll 12 to 24 patients at multiple leading oncology sites in the United States, including Peninsula Cancer Institute in Newport News, Virginia.
“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,” said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. “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.”
Dr. Mark Gilbert, senior vice president of research and development at Acepodia added: “Today, treatments for solid tumors are severely limited in their effectiveness due to an inability to overcome the immunosuppressive tumor microenvironment, and Acepodia’s technology could represent a solution to this long-standing therapeutic obstacle. 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. 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.”
ACE1702 is an allogeneic, off-the-shelf NK cell therapy developed using Acepodia’s ACC technology that can link tumor-targeting antibodies directly to the surface of its proprietary NK (oNK) cell line, an allogeneic cell line specifically selected for its unique receptor expression profile with elevated levels of activating receptors and low levels of inhibitory receptors to maximize tumor-killing potency. Conjugated with an anti-HER2 antibody at the site of oNK cell receptors, ACE1702 is designed to overcome the limitations of current cancer cell therapies by enhancing the innate ability of NK cells to not only target but destroy HER2-expressing tumors. ACE1702 could have the potential to impact the way solid tumors are treated given its potency and the ease of quickly scaling up production on demand. In preclinical studies, ACE1702 has demonstrated significant potential to combat tumors expressing varying levels of HER2.
Additional information on the ACE1702 study is available at clinicaltrials.gov (NCT04319757)
ACE1702 is Acepodia’s lead clinical product candidate developed from the company’s natural killer (oNK) cell line and proprietary Antibody-Cell Conjugation (ACC) platform. It targets human HER2-expressing solid tumors using anti-HER2 antibody-conjugated oNK cells. In preclinical studies, ACE1702 demonstrated a favorable safety profile in GLP toxicology studies and enhanced tumor-directed cytotoxicity against HER2 IHC 1+, 2+ and 3+ human cancer cells both in vitro and in vivo. ACE1702 is currently being studied in a Phase 1 clinical trial in the United States.
Acepodia is a privately held U.S.-Taiwan biotechnology company reshaping the field of cell therapies through a flexible and integrated approach to biologic design with a primary focus on oncology. The company’s platform is rooted in its proprietary off-the-shelf natural killer (oNK) cell line that has been selected for its potent anti-tumor activity. Acepodia’s drug development platform is designed to augment oNK cells’ tumor affinity through both chimeric antigen receptor technology as well as its unique ACC (Antibody Cell-Conjugation) technology that links tumor-targeting antibodies to the surface proteins of oNK cells.
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