7 Hills Pharma Announces FDA Clearance of Investigational New Drug Application for 7HP349, a First-in-Class Immune Stimulant  

​​Phase 1 Healthy Volunteers Study Expected to Begin in Fall of 2020

Houston, TX, (April 14, 2020) 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 that 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,” Dr. Vanderslice said, “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.”

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.
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 cycle.  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.  For more information, visit www.7hillspharma.com.

Media Contacts:
Robert Williams