7 Hills Pharma Announces the Completion of a Landmark Phase I Trial of Immunostimulant to Improve Immuno-Oncology Drugs, COVID-19 and Influenza Vaccines

HOUSTON, Nov. 01, 2021 (GLOBE NEWSWIRE) -- 7 Hills Pharma LLC (“7 Hills” or “7HP”), a clinical-stage drug development company bringing to market a platform of unique, first-in-concept oral small molecules to augment immunotherapies for solid tumor cancers as well as infectious disease vaccinations, today announced that it has successfully completed its Phase I clinical trial to evaluate 7HP349, their lead molecule. 7HP349 is the first clinical candidate to emerge from 7HP’s proprietary and differentiated platform of allosteric integrin agonists. The study was supported by a $2 million Small Business Innovation Research grant from the U.S. National Cancer Institute.

This first-in-human study was a placebo controlled, randomized study that evaluated the safety, tolerability, and pharmacokinetics of 7HP349 in 60 healthy subjects. No treatment-related adverse events were observed throughout the Single Ascending Dose and Multiple Ascending Dose portions of the study at exposures exceeding 9x therapeutic levels.

“We are encouraged by the favorable results, which demonstrated that 7HP349 was orally bioavailable and well-tolerated,” said 7 Hills Pharma Chief Medical Officer, Lionel Lewis, MB BCh., MD.   “We have defined the Phase II dose and schedule to augment an antigen-specific cellular and humoral response, and are poised to initiate Phase I/IIa clinical trials investigating the utility of 7HP349 in multiple indications, including the treatment of PD-1 refractory solid tumors, augmentation of prophylactic influenza vaccination in the elderly, and SARS-CoV-2 vaccination in immunocompromised patients.”

About 7 Hills Pharma LLC

7 Hills Pharma is a clinical-stage immunotherapy company developing a platform of novel, oral small molecules for the treatment of cancer and prevention of infectious diseases. Our compounds are first-in-concept integrin activators that leverage a unique mechanism of action to stabilize the cell-cell interactions required to mount an effective immune response. Our lead clinical candidate, 7HP349, is the only reported systemically safe immune stimulant that can activate both cellular and humoral immunity. For more information, visit http://www.7hillspharma.com.


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