7 Hills Pharma has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s lead clinical-stage immunostimulant 7HP349, combined with a CTLA-4 inhibitor, to treat unresectable or metastatic malignant melanoma if treatment with a PD-1 inhibitor has failed. Melanoma is a dangerous type of skin cancer, and when it is unresectable, it cannot be completely removed through surgery alone. Metastatic melanoma occurs when the cancerous cells from the original tumor spread by traveling through the lymph or blood circulation and form new tumors elsewhere. 7HP349 is an oral therapy created to be used in combination with an immunotherapy and, through a unique mechanism of action, betters the effectiveness of any potential immunotherapeutic, including, but not limited to, immune checkpoint inhibitors (ICI) and infectious disease vaccines. The therapy is an allosteric activator of the integrins VLA-4 and LFA-1, which are vital elements in the generation of an effective antigen-specific immune response and underlie rate-limiting steps in lymphocyte recruitment, extravascular trafficking, T cell activation and effector functions. 7 Hills Pharma is a clinical-stage immunotherapy company developing a platform of novel, oral small molecules to treat cancer and prevent infectious diseases.

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