7 Hills Pharma Announces FDA Clearance of IND Application for Immune Stimulant

7 Hills Pharma announced the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for 7HP349, a first-in-class, oral integrin activator that has the potential to augment antigen-specific immune responses. The FDA completed its 30-day safety review and granted approval to proceed with a proposed Phase 1 healthy volunteer study to support solid tumor and infectious disease indications.

Integrin cell adhesion molecules such as α4β1 and αLβ2 are essential for a productive immune response. They are critical for antigen presentation and immune priming. 7 Hills Pharma has developed small molecule compounds that can be systemically administered and activate these integrins, serving as adjuvants enhancing antigen specific immune responses. The lead compound, 7HP349, was developed based on platform technology licensed from the Texas Heart Institute, Houston, TX.

Dr. Peter Vanderslice, Director, Molecular Cardiology Research Laboratories, at Texas Heart Institute, is a co-inventor of the platform technology.

"Advancing 7HP349 into the clinic, validates the Texas Heart Institute’s approach to basic research in which discoveries made here are rapidly translated into the clinical arena. Since these integrins are co-stimulatory molecules and essential for priming the immune system, 7HP349 may have clinical applications for indications beyond cancer, including influenza," Dr. Vanderslice said.

7 Hills Pharma has developed a family of small molecule compounds and expects to initiate the Phase 1 study of its lead compound, 7HP349, in the Fall of 2020. The Company is monitoring the potential impact of the COVID-19 pandemic on clinical trial initiations, and will provide additional updates as needed.

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