7 Hills Pharma Receives Orphan Drug Designation
for Lead Product, 7HP349, in Treatment of Malignant Melanoma

7HP349 is an oral small molecule immunostimulant designed to improve

effectiveness of immunotherapies such as immuno-oncology drugs

Houston, TX, (November 17, 2020) - 7 Hills Pharma, a clinical stage immunotherapy company focused on the development of drugs for the treatment and prevention of cancer and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to 7HP349, the company’s first-in-concept immunostimulant, for treatment of malignant melanoma stages IIB to IV.

7HP349 is an orally delivered small-molecule drug that activates integrins, enhancing cell adhesion and improving immune priming for stronger responses to immunotherapies, such as immune checkpoint inhibitors for solid tumor cancers and vaccines for infectious diseases, including COVID-19 and influenza.

The FDA’s orphan drug designation is intended to advance development of promising new therapies for rare diseases affecting fewer than 200,000 people in the U.S. Among the benefits are seven years of market exclusivity and tax credits for clinical trial expenditures.

The National Organization for Rare Diseases reports that malignant melanoma is thought to affect about 40,000 people every year in the U.S. According to the American Cancer Society, melanoma accounts for about 1% of skin cancers, but causes a large majority of skin cancer deaths. The average age of diagnosis is 65.

Immunotherapies, such as immune checkpoint inhibitors, have become standard of care for melanoma and other cancers, but they are not effective in many patients. Although they may indirectly activate integrins, in many instances they do not independently promote adequate cell adhesion.

This deficiency in cell adhesion leads to insufficient immune priming resulting in resistance to immuno-oncology drugs, such as PD-1 checkpoint inhibitors. Anti-PD-1 resistance may be a significant cause of the failure of these immunotherapies in over 70% of cancer patients. Inadequate immune priming may also be the reason for the lack of protection provided by flu vaccines in more than 50 percent of people over 65.

In malignant melanoma, anti-PD-1 resistance is a significant unmet need. Moreover, high treatment costs and significant toxicities of checkpoint inhibitors have led to increased attrition among patients, resulting in further cancer progression and limited additional treatment options.

By directly activating integrins to enhance cell adhesion and improve immune priming, 7HP349 has the potential to significantly increase the number of patients who benefit from checkpoint inhibitors and vaccines.

Phase 1 safety trials of 7HP349 were launched in October 2020. If successful, Phase 2 trials of the immunostimulant with checkpoint inhibitors to treat malignant melanoma and augment COVID-19 and influenza vaccines are expected to begin in 2021.

 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. For more information, visit http://www.7hillspharma.com

Media Contacts:
Dan Eramian
Opus Biotech Communications

Charles Craig
Opus Biotech Communications