Preliminary results from ongoing Phase 1 study show no dose limiting toxicity was observed with ACE1702, allowing for ongoing dose escalation
ALAMEDA, Calif., Sept. 13, 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 announced that it will present new interim data from an ongoing Phase 1 study (NCT04319757) evaluating ACE1702, the company’s most advanced therapeutic candidate, in patients with advanced HER2 tumors, as an on demand e-Poster at the European Society of Medical Oncology (ESMO) 2021 Annual Congress being held virtually September 16-21, 2021.
Preliminary results from the ongoing clinical trial showed that seven patients treated across the first four dose levels with ACE1702 showed no clinical signs of dose limiting toxicity, such as cytokine release syndrome, neurotoxicity or graft versus host disease. The trial is enrolling patients with advanced HER2-expressing tumors to receive a low dose lymphodepletion (LD) regimen followed by assigned levels of escalating doses of ACE1702 in the range of 0.3-15 billion [B] cells/cycle. Dose escalation is continuing up to 15B cells/cycle with updated clinical data to be provided.
“We are excited to present the initial results from this ongoing study of ACE1702 and our first-in-human trial with an ACC-developed therapeutic candidate,” said Sonny Hsiao, Ph.D., chief executive officer and co-founder of Acepodia. “More than a decade after the foundational discovery of our unique ACC platform technology, this milestone reflects the hard work of our international teams as we continue to gain momentum in the clinical development of our breakthrough investigational off-the-shelf cell therapies.”
The accepted abstract (#1494) is currently available on the ESMO website and can be viewed here. Details of the on-demand e-poster are as follows:
- Presentation number: 1006P
- Presentation Title: ACE1702, a First in Class, Off the Shelf, Selected Natural Killer Cell [oNK] Product Using Antibody Cell Conjugation Technology [ACC], with Pre-clinical and Early Clinical Activity in HER2 < 3+ Tumors
- Date & Time: Available to view starting Thursday, September 16 at 8:30am CEST/2:30am EDT
Acepodia’s first-of-its-kind ACC platform technology can link more than 100,000 tumor-targeting antibodies to a variety of different activating and signaling receptors expressed on individual immune effector cells. The ACC platform, combined with Acepodia’s proprietary immune effector cells, increases binding strength against tumors that express low levels of tumor antigens to prevent tumor cell escape. This novel technology enables the company to develop antibody cell effector (ACE) therapies, such as ACE1702, which are potent and targeted, next-generation off-the-shelf cell therapies with the potential to treat a variety of solid tumors and hematologic cancers.
ACE1702 is an investigational next-generation cell therapy developed with Acepodia’s antibody-cell conjugation (ACC) platform, which conjugates the company’s proprietary off-the-shelf natural killer (oNK) cells with trastuzumab – a clinically-validated antibody that binds to HER2 – using complementary DNA linkers. The antibody cell effector (ACE) therapy, ACE1702, expresses high levels of multiple natural killer (NK) cell activation and signaling receptors, including CD16, with limited expression of inhibitory receptors. These features enhance the innate ability of NK cells to target and destroy tumors. In preclinical studies, ACE1702 showed excellent in vitro and in vivo potency against HER2-expressing cancers. In additional preclinical studies, ACE1702 was effective in targeting a broad range of HER2-expressing cancers, including those unaffected by current anti-HER2 therapies, and has also demonstrated an ability to overcome the immunosuppressive tumor microenvironment.
Acepodia is 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. Leveraging its ACC technology, the company links tumor-targeting antibodies to its proprietary immune effector cells, such gamma delta T cells and natural killer (NK) cells to create novel antibody cell effector (ACE) therapies, which have increased binding strength against tumors that express low levels of tumor antigens. Acepodia is made up of seasoned leadership and scientific experts dedicated to advancing its robust pipeline of off-the-shelf ACE therapies with the potential to bring innovative, effective and affordable cell therapies to a broad population of patients across a variety of solid tumors and hematologic cancers. For more information, visit https://www.acepodia.com and follow Acepodia on Twitter and LinkedIn.
Westwicke, an ICR company