Fast Track Designation Granted to Novel Immunostimulant 7HP349 in Anti–PD-1 Resistant Melanoma


7HP340 was granted fast track designation in combination with an anti–CTLA-4 treatment by the FDA for patients with unresectable or malignant melanoma for whom PD-1 inhibition therapy has failed.

The FDA has granted fast track designation to the immunostimulant 7HP349 in combination with CTLA-4 inhibition for the treatment of patients with unresectable or malignant melanoma after a PD-1 inhibitor therapy has failed to lead to antitumor activity, according to a press release from the drugs developer 7 Hills Pharma LLC.1

7HP349 is used in combination with immunotherapy to enhance treatment effectiveness. The treatment is an allosteric activator of integrins VLA-4 and LFA-1, which are necessary factors for production of antigen-specific immune response. VLA-4 and LFA-1 lead to rate-limiting steps in lymphocyte recruitment, extravascular trafficking, T-cell activation, and effector functions.

“FDA’s decision to grant 7HP349 Fast Track designation underscores the critical unmet medical need still present in antiPD-1-resistant melanoma. We are working to bring oncologists a completely new therapeutic modality to overcome [immune checkpoint inhibitor] 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 William Schary, MD, who is vice president of Clinical and Regulatory Affairs at 7 Hills Pharma.

Currently, phase 1/2a trials are planned to determine utility of the treatment in PD-1 inhibitor–refractory solid tumors.2 The fast track designation comes after completion of a first-in-human study (NCT04508179), which evaluated the safety, tolerability, and pharmacokinetics of 7HP349.

In the trial of healthy male subjects, 60 patients were treated with 7HP349 or placebo in a randomized, double-blind, sequential single- and multiple-ascending, dose-escalated fashion.

The primary end point was safety and tolerability, with secondary end points of pharmacokinetics.

Patients were eligible for treatment if they were men ages 18 to 45 years with normal clinical chemistry, hepatic function, hematology, and thyroid function and had a body mass index of 19 kg/m2 to 30 kg/m2 inclusive and body weight not less than 60 kg.

“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,” Joseph Bailes, MD, co-founder and board member of 7 Hills Pharma, said of the designation.


1. 7 Hills Pharma’s clinical-stage novel immunostimulant 7HP349 granted FDA fast track designation for anti-PD-1-resistant metastatic melanoma. News Release. 7 Hills Pharma LLC. March 8, 2022. Accessed March 21, 2022.

2. 7 Hills Pharma announces the completion of a landmark phase I trial of immunostimulant to improve immune-oncology drugs, COVID-19, and influenza vaccines. News Release. November 1, 2021. Accessed March 21, 2022.

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