7 Hills Pharma has been awarded a two-year, $2 million Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the U.S. National Institutes of Health.

The SBIR funding will be used to support Phase 1 clinical trials of 7HP349, an oral, first in concept small molecule immunostimulant, which is designed to improve the effectiveness of immunotherapies, such as immuno-oncology drugs and infectious disease vaccines.

“We are honored to receive this grant,” said Lionel D. Lewis, MB BCh., M.D., Chief Medical Officer of 7 Hills Pharma. “NCI has continuously funded our 7HP349 program from concept through investigational new drug (IND) enabling studies and now to first in human testing. This funding will help us complete a Phase 1 safety and pharmacokinetics study of 7HP349.”

7HP349 is part of 7 Hills Pharma’s platform of small molecule integrin activators that promote cell adhesion, which is essential for immune system activation. By enhancing integrin mediated cell adhesion, 7 Hills Pharma’s compounds have the potential to enhance the antigen specific immune responses of immuno-oncology drugs and vaccines. The integrin activators act systemically and are delivered separately requiring no change to the administration of these immunotherapies.

“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 to augment the defective antigen presentation that results in poor outcomes in patients with PD-1 checkpoint inhibitor resistant solid tumors, and in elderly people vaccinated against influenza and possibly COVID-19,” Dr. Lewis said.

7 Hills Pharma’s COVID-19 program recently was selected by Johnson & Johnson Innovation – JLABS to participate in its Blue Knight collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to help battle the pandemic. BARDA is a component of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.