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

— With Encouraging Safety and Anti-tumor Activity for AO-176 Monotherapy in Phase 1 Trial, Advancing AO-176 in Combination with Anti-PD-1 —

BRISBANE, CA and ST. LOUIS, MO, February 9, 2021 – Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck, known as MSD outside of the United States and Canada.

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 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, 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).

About Arch Oncology

Arch Oncology, Inc. is a privately-held, clinical-stage immuno-oncology company focused on the discovery and development of potential best-in-class antibody therapies for the treatment of patients with solid tumors and hematologic malignancies. The Company’s next-generation anti-CD47 antibodies are highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class. Arch Oncology’s lead product candidate AO-176 is in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and with multiple myeloma, both as monotherapy and in combination with standard therapies. In addition, the Company is advancing a pipeline of antibody programs for the treatment of cancer. For more information please visit www.archoncology.com.

Media Contact:
Amy Figueroa, CFA
For Arch Oncology

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