Adial Pharmaceuticals (ADIL) Announces Positive Pre-Clinical Data for PNV2 as a Drug Candidate for Triple Negative Breast Cancer

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced positive pre-clinical data for PNV2 in an animal model of triple negative breast cancer (TNBC). Based on the strength of this data, Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, Inc., plans to advance PNV2 as the lead compound for its cancer program.

PNV2 was tested in a metastatic breast cancer model with the primary endpoint being the amount of cancer metastases into the lungs after 28 days following orthotopic implantation of breast cancer.

Study highlights:

• Luciferase-engineered triple-negative breast cancer (TNBC) cells MDA-MB-231 were implanted in the mammary fat pad in female mice.
• Tumors grew over 28 days and were treated intratumorally three times a week.
• An active group (n=10) was treated with PNV2 in solution and a control group (n=10) was treated with only the solution.
• Metastasis into the lungs was then determined by measuring the amount of luciferase activity, which indicates the amount of cancer in the lungs.
• In the control group, 30% of the mice had large, well-established secondary tumors (i.e., metastatic, invasive tumors) in their lungs with luciferase activity of greater than 1585 AU in each mouse, while the PNV2 group appeared to have no large secondary tumors in the lungs of any mouse and luciferase activity of not more than 356 AU in any mouse.

Dr. Julien Dimastromatteo, Purnovate’s Vice President, Research, commented, “This pre-clinical data is encouraging, as we seem to have demonstrated a reduction in metastases and cancer invasion into the lungs following treatment with PNV2. This data confirms prior research on the anti-cancer properties of adenosine analogs. However, historically, the solubility of these compounds has been a barrier to developing an effective therapy. This latest research around PNV2 is particularly exciting as we believe we have overcome the solubility challenges. We plan to conduct additional pre-clinical research with a goal of advancing PNV2 into clinical trials in 2022.”

William Stilley, Adial’s Chief Executive Officer, stated, “The Purnovate adenosine platform continues to demonstrate broad potential across a wide range of indications and is exceeding expectations. We are especially encouraged by this latest data in triple negative breast cancer following the recent pain data. We look forward to aggressively pursuing the full potential of the Purnovate Adenosine Platform and are evaluating the best strategy to achieve full value for our shareholders from the Platform, while we remain laser focused at Adial on obtaining our Phase 3 data on AD04 for treatment of Alcohol Use Disorder.”

PNV2 has been tested to be more than 1000-fold selective over the adenosine A1 receptor, which is known to have cardiovascular and central nervous system effects that have limited the usefulness of adenosine analogs as treatments. Historically, when selectivity has been achieved over the A1 receptor, water solubility has decreased, making effective tissue distribution in the human body (made largely of water) difficult to achieve. However, PNV2 has demonstrated solubility more than 50 times greater than other known selective adenosine compounds of the same class. Solubility is often an important characteristic of successful drug candidates, and Purnovate believes solubility is a particularly important characteristic in determining the drug development potential of molecules of this class.

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