7 Hills Pharma’s Clinical-stage Novel Immunostimulant 7HP349 Granted FDA Fast Track Designation for Anti-PD-1-resistant Metastatic Melanoma

HOUSTON, March 08, 2022 (GLOBE NEWSWIRE) — 7 Hills Pharma LLC (“7 Hills” or “7HP”), a clinical-stage drug development company bringing to market a platform of unique, first-in-class oral small molecules which augment the activity of a broad range of immunotherapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to 7HP349, 7HP’s lead clinical-stage immunostimulant, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor. FDA’s Fast Track program is intended to speed the development and expedite regulatory review of drugs that fulfill unmet medical needs in the treatment of serious conditions. Fast Track designation offers a variety of benefits to accelerate the development process, including more frequent meetings and correspondence with the FDA as well as eligibility for accelerated approval and priority review, assuming relevant criteria are met. 7HP349 is designed as an oral therapy to be used in combination with an immunotherapy to improve the effectiveness of potentially any immunotherapeutic, including, but not limited to immune checkpoint inhibitors (ICI) and infectious disease vaccines, through a unique mechanism of action. 7HP349 is an allosteric activator of the integrins VLA-4 and LFA-1, which are essential elements in the generation of an effective antigen-specific immune response. These integrins underlie rate-limiting steps in lymphocyte recruitment, extravascular trafficking, T cell activation and effector functions. Following a successful first-in-human Phase I clinical trial completed in 4Q2021, 7HP349 will be entering Phase Ib/IIa trials in PD-1 refractory solid tumors and influenza vaccination of the elderly. “FDA’s decision to grant 7HP349 Fast Track designation underscores the critical unmet medical need still present in anti-PD-1-resistant melanoma. We are working to bring oncologists a completely new therapeutic modality to overcome ICI resistance. Achieving Fast Track designation for our lead clinical molecule represents a meaningful step toward our goal of delivering the full promise of immunotherapy,” said Dr. William Schary, 7 Hills VP of Clinical and Regulatory Affairs. “We are proud that 7HP349 has been recognized by the FDA as a potential solution to substantively improve upon current state-of-the-art cancer immunotherapy. We are excited to have the opportunity to accelerate our developmental plans through enhanced flexibility and communication with FDA,” said Dr. Joseph Bailes, 7 Hills co-founder and board member. About 7 Hills Pharma LLC 7 Hills Pharma is a clinical-stage immunotherapy company developing a platform of novel, oral small molecules for the treatment of cancer and prevention of infectious diseases. Our compounds are first-in-concept allosteric integrin activators that leverage a unique mechanism of action to stabilize the cell-cell interactions required to mount an effective immune response. Our lead clinical candidate, 7HP349, is the only reported systemically safe immune stimulant that can activate both cellular and humoral immunity. For more information, visit http://www.7hillspharma.com. CONTACT: 7 Hills Pharma Media Contact: Rob Bent [email protected]