On February 9, 2021 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, reported that it has entered into a clinical trial collaboration and supply agreement with Merck, known as MSD outside of the United States and Canada (Press release, Arch Oncology, FEB 9, 2021, View Source;utm_medium=rss&utm_campaign=arch-oncology-to-collaborate-with-merck-on-phase-1-2-clinical-trial-of-anti-cd47-antibody-ao-176-in-combination-with-keytruda-pembrolizumab-in-patients-with-select-solid-tumors [SID1234574788]).
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Under this collaboration, Arch Oncology is expanding its ongoing Phase 1/2 clinical trial to evaluate AO-176, the Company’s novel anti-CD47 antibody, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with select solid tumors. This part of the study will include patients with relapsed, platinum-resistant ovarian cancer, endometrial cancer, and gastroesophageal cancer. The open-label, multi-center, dose-escalation study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary efficacy of AO-176, first as a monotherapy, then in combination with chemotherapy (paclitaxel), and now in combination with KEYTRUDA (pembrolizumab). As a monotherapy, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity in patients with select solid tumors.
"This collaboration with Merck is part of our commitment to conducting a broad clinical development program to evaluate AO-176’s potential for patients," said Jackie Walling, MBChB, Ph.D., Chief Medical Officer of Arch Oncology. "In our Phase 1 trial, we saw encouraging anti-tumor activity for AO-176 as a single agent. These results led us to expand our clinical development program to explore different combination therapy approaches. Combining either PD-1 or PD-L1 checkpoint inhibition with a CD47 blockade has strong scientific rationale and in our preclinical studies resulted in enhanced anti-tumor activity over monotherapy alone. We are excited to advance AO-176 as we aim to deliver new cancer treatments to broader groups of patients."
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About AO-176
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 View Source
AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and multiple myeloma, both as monotherapy and in combination with standard therapies. In a Phase 1 trial in solid tumors, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity when administered as a single agent. Additional information about these trials may be found at www.clinicaltrials.gov using the trial identification number NCT03834948 (solid tumors) or NCT04445701 (multiple myeloma).