7 Hills Pharma, a clinical-stage immunotherapy company focused on the development of drugs for treatment and prevention of cancer and infectious diseases, announced today the first healthy volunteers have been dosed in a Phase 1 trial of 7HP349, the company’s first-in-concept immunostimulant to improve the effectiveness of immunotherapies.

The first-in-human study will test the safety, tolerability, and pharmacokinetics of 7HP349, an oral small molecule. 7HP349 is designed to activate integrins, enhancing cell adhesion for stronger immune responses to vaccinations, such as those for COVID-19 and influenza, and immuno-oncology drugs, such as checkpoint inhibitors.

“This is a milestone for our company and the Texas Heart Institute (THI),” said Upendra Marathi, Ph.D., MBA, President and CEO of 7 Hills Pharma. “The scientists at THI illuminated the essential role of integrin-mediated cell adhesion in the immune system and discovered compounds that directly activate selective integrins to stabilize the cell-to-cell interactions required for a strong immune response to immunotherapies.”

Immunotherapies indirectly activate integrins, but in many instances do not independently promote adequate cell adhesion, resulting in unstable cell-to-cell interactions with antigen-presenting cells or T cells. This defective cell adhesion may contribute to why influenza vaccines don’t protect more than 50 percent of people over 65 and why immuno-oncology drugs fail in 70% of cancer patients.

Lionel Lewis, MB BCh., M.D., Chief Medical Officer of 7 Hills Pharma, said, “If the Phase 1 trial of 7HP349 is successful we expect to move into Phase 2 trials next year to evaluate the use of 7HP349 in combination with influenza and COVID-19 vaccines and immune checkpoint inhibitors.”

Darren Woodside, Ph.D., Vice President for Research at THI, 7 Hills Pharma co-founder and an inventor of the company’s technology, said, “7HP349 represents the first of its kind immunostimulant to be developed for deployment with vaccines and immuno-oncology drugs. If successful this integrin activator could be a game-changer by significantly increasing the number of patients who benefit from these immunotherapies.”

7HP349 is part of 7 Hills Pharma’s platform of small molecule integrin activators licensed from THI and patented for use with any therapeutic antibody, any checkpoint inhibitor for immuno-oncology, and any vaccine. The Company received a two-year, $2 million Small Business Innovation Research grant from the U.S. National Institutes of Health to support the Phase 1 trial.

About 7 Hills Pharma
7 Hills Pharma is focused on the development of novel and cost-efficient immunomodulatory agents that leverage well-known integrin biology to drive and enhance essential steps in the immune system.  The company’s lead programs are designed to improve the effectiveness of immuno-oncology therapies including checkpoint inhibitors, vaccines, and cord blood transplantation in the treatment of cancers and infectious diseases.  

About Texas Heart Institute (THI)
The Texas Heart Institute, founded by world-renowned cardiovascular surgeon Dr. Denton A. Cooley in 1962, is a nonprofit organization dedicated to reducing the devastating toll of cardiovascular disease through innovative and progressive programs in research, education, and improved patient care.

THI’s scientists and physicians conduct fundamental biomedical, translational, and clinical research in cardiology, cardiovascular surgery, molecular-based medicine, stem cell, and gene therapy, and regenerative medicine both independently and in collaboration with organizations worldwide. As global leaders of patient care for nearly six decades, Texas Heart Institute has been ranked among the top cardiovascular centers in the United States by U.S. News & World Report for the past 30 years.

THI is dedicated to spreading awareness and sharing updates on ways to prevent, treat, and defeat cardiovascular disease. With over 10 million visitors coming to its website from around the world every year, www.texasheart.org is just one of the ways THI is helping to educate people on the importance of heart health.