— With Encouraging Safety and Anti-tumor Activity for AO-176 Monotherapy in Phase 1 Trial, Expanding into Chemotherapy Combination Phase 1/2 Trial —
Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, today announced the expansion of AO-176’s clinical development into a Phase 1/2 chemotherapy combination trial for patients with select solid tumors. AO-176 is an anti-CD47 antibody with a potential best-in-class profile that works by blocking the “don’t eat me” signal and also by directly killing tumor cells, with preferential binding to tumor versus normal cells.
“With encouraging evidence of AO-176’s safety and anti-tumor activity as a single agent, we are expanding this trial to further evaluate this therapy in combination with chemotherapy in patients with select solid tumors,” said Julie Hambleton, M.D., Interim President and Chief Executive Officer of Arch Oncology. “In the Phase 1 dose-escalation study, we established the recommended dose for Phase 2 development. In addition, we generated important clinical data on the safety and efficacy profile of AO-176 in patients with select solid tumors and we plan to submit these data to a medical meeting next year. With patient dosing underway with AO-176 in combination with chemotherapy, we are making significant progress developing AO-176 broadly for patients with solid tumors as well as hematologic malignancies.”
Howard A. “Skip” Burris, III, M.D., President, Clinical Operations, Chief Medical Officer, and Principal Investigator, Sarah Cannon Research Institute, commented, “There is a growing body of preclinical and clinical data for AO-176, demonstrating this therapy’s highly-differentiated clinical profile among anti-CD47 therapeutics in development. As drugs against this target have demonstrated robust clinical activity, we are eager to assess this new combination treatment approach for patients with solid tumors who need better options for their disease.”
This open-label, multi-center, dose-escalation Phase 1/2 trial is evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AO-176 in combination with paclitaxel in patients with gastric, endometrial, and platinum-resistant ovarian cancers.
Across the United States, leading cancer treatment clinical trial sites are participating in this trial. For additional information, please visit www.clinicaltrials.gov using the trial identification number NCT03834948.
AO-176 is a humanized anti-CD47 IgG2 antibody with a potential best-in-class profile. AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of innate checkpoint inhibitors. AO-176 works by blocking the “don’t eat me” signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 has additional mechanisms, including directly killing tumor cells and inducing DAMPs (Damage Associated Molecular Patterns), resulting in Immunogenic Cell Death. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). Publications and presentations on AO-176 can be found at https://archoncology.com/our-pipeline/sci-pubs/.
AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and multiple myeloma. In a Phase 1 trial in solid tumors, AO-176 demonstrated encouraging safety