Arch Oncology Presents New Preclinical T-ALL Data on Highly-differentiated Anti-CD47 Antibody AO-176 at AACR 2021

— Late-breaking presentation highlights preclinical data for AO-176 in T-ALL —

BRISBANE, Calif., April 10, 2021 (GLOBE NEWSWIRE) — Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, today announced the presentation of new preclinical data on AO-176 in pediatric acute lymphoblastic leukemia (T-ALL) during a late-breaking poster presentation at the AACR Annual Meeting 2021. This research was funded by a grant from the National Cancer Institute (NCI), part of the National Institutes of Health, to the Pediatric Preclinical Testing Consortium (PPTC).

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. Currently, AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and hematologic malignancies, both as monotherapy and in combination with standard therapies.

“At AACR this year, we are presenting preclinical data in two new hematologic indications, showing AO-176’s strong therapeutic potential in lymphoma and pediatric T-ALL,” said Daniel Pereira, Ph.D., Chief Scientific Officer of Arch Oncology. “AO-176 demonstrated significant single-agent in vivo anti-leukemic activity in pediatric T-lineage ALL PDX models. Our antibody delayed disease progression and decreased human leukemia infiltration of murine spleens to increase overall survival in mice inoculated with T-ALL cells, suggesting that targeting CD47 in T-ALL may be a promising therapeutic approach. AO-176 has highly-differentiated mechanisms that show the potential to offer an improved efficacy and safety profile among anti-CD47 agents in development for patients and we are excited to continue to advance this novel therapy in the clinic for patients with solid tumors and hematologic malignancies.”

Richard Lock, Ph.D., Lead Investigator for this study and Head of the Blood Cancers Theme and Group Leader of the Leukaemia Biology Group at Children’s Cancer Institute, one of the NCI funded PPTC institutions, added “AO-176 exhibited impressive single-agent in vivo activity for a monoclonal antibody against highly-aggressive experimental models of pediatric T-cell acute lymphoblastic leukemia. Given its novel mechanisms of action and single-agent activity, there is great interest in next testing AO-176 in combination with standard-of-care drugs against experimental models of high-risk pediatric leukemia.”

American Association for Cancer Research (AACR) Annual Meeting 2021
Late-Breaking Poster Presentation Title: The differentiated CD47 monoclonal antibody AO-176 exhibits significant in vivo activity against xenograft models of pediatric acute lymphoblastic leukemia (ALL) (Abstract # LB171)
Session Category: Immunology
Session Title: Therapeutic Antibodies, Including Engineered Antibodies

Poster Presentation Title: AO-176, a highly differentiated clinical stage anti-CD47 antibody, is efficacious in pre-clinical models of lymphoma (Abstract #954)
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents

Information on the abstracts is available on AACR’s website.

These poster presentations are available at https://archoncology.com/our-pipeline/sci-pubs/.

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 is engineered to block 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) in preclinical models, resulting in immunogenic cell death. Importantly, in these models 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 hematologic malignancies, both as monotherapy and in combination with standard therapies. In a Phase 1 trial in solid tumors, AO-176 demonstrated encouraging early tolerability and 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 hematologic malignancies, 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.

Contact:
Amy Figueroa, CFA
For Arch Oncology
afigueroa@archoncology.com