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NuvOx Receives Notice from the Breakthrough DOD Award for its Immuno-Oncology Program

On February 11th, 2022,-- NuvOx Pharma received notice from the Department of Defense (DOD) office of the Congressionally Directed Medical Research Programs (CDMRP) that the Company has been awarded a grant from the Breast Cancer Research Program Breakthrough Award. The grant would fund a translational research program aiming to develop the Company’s drug, NanO2™ in combination with immunotherapy treatment of triple negative breast cancer (TBNC).

Pavani Chalasani, MD, MPH, Associate Professor of Medicine at the University of Arizona, member of the Clinical and Translational Oncology Program at the Arizona Cancer Center, a specialist in breast cancer, is co-Principal Investigator (PI) on the grant. Dr. Chalasani said, “Triple negative breast cancer (TNBC) is a fatal disease afflicting about 20-25,000 new patients each year in the US. Chemotherapy is the usual stay of treatment but despite that there is a higher proportion of patients who have disease relapse and it becomes terminal in them. Immunotherapy as a treatment of cancer has been a breakthrough therapy for certain cancers, and started showing some benefit in a subset of patients with TNBC. A preliminary pre-clinical study performed at the University of Arizona Cancer Center showed that NanO2 has great promise for improving response to immunotherapy in TNBC. I am excited to be involved in this project and I look forward to moving this treatment into the clinic.”

Dr. Evan Unger, President and CEO of NuvOx, PI on the grant, and Professor Emeritus at the University of Arizona said, “We are very appreciative of the DOD for recommending this study for funding. The review and award of this grant supports our scientific hypothesis that reversal of tumor hypoxia has potential to augment immunotherapy treatment of cancer. Pending successful completion of these studies, we hope to bring this new treatment into the clinic. Tumor hypoxia, or low oxygen level in tumor tissue, is a potent barrier to effective immunotherapy. In our preliminary studies in TNBC, co-administration of NanO2TM with immunotherapy resulted in highly significant tumor reduction compared to immunotherapy alone. We previously performed a clinical trial in brain cancer patients and showed that NanO2 reversed tumor hypoxia and increased survival in association with chemoradiation. Rapid translation into studies in immunotherapy cancer treatment should be feasible.”

NuvOx has allowance from the FDA for a Phase IIb clinical trial of NanO2 in 87 brain cancer patients and has received a grant from the National Cancer Institute to help fund this trial. The Company also completed a clinical trial of NanO2 in acute ischemic stroke, showing safety and efficacy. The FDA has allowed a Phase II trial of NanO2 in stroke.

Disclaimer: Certain statements in this release may constitute “forward-looking statements.” When used in this release, words like “may,” “will,” “can,” “should,” “expect,” “anticipate,” “believe,” “project,” or “intend” and other similar expressions are intended to identify forward-looking statements. Statements regarding future events and developments and future performance, as well as our expectations, beliefs, plans or projections, are forward-looking statements which reflect only our predictions, assumptions, and estimates regarding future events and circumstances. Actual events or results may differ as a result of risks and uncertainties facing us. The forward-looking statements are based on current expectations as of the date of these statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information or otherwise.

This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs through the (Breast Cancer Research Program) under pre- Award No. BC211398. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

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