FDA Grants Fast Track Designation to 7HP349 for Anti-PD-1 Metastatic Melanoma

Fast track designation has been granted to 7HP349, 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.

The FDA has granted fast track designation to 7HP349, a 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, according to 7 Hills Pharma LLC (7HP).1

7HP349 is an oral therapy intended for use in combination with immunotherapy in order to improve the effectiveness of potentially any immunotherapeutic immune checkpoint inhibitors and infectious disease vaccines through a unique mechanism of action. It works as an allosteric activator of the integrins VLA-4 and LFA-1 which are essential elements that underlie 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 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 William Schary, PhD, vice president of clinical and regulatory affairs, 7 Hils Pharma, in a press release.

This fast track designation has been granted based on the successful completion of a phase 1 study (NCT04508179) which assessed the safety, tolerability and pharmacokinetics of 7HP349 in healthy male subjects.2

The first-in-human clinical trial was a placebo-controlled, sequential, dose escalation study, which administered both single and multiple oral doses of 7HP349 participants. Additionally, a separate, open-label food effect cohort was created and examined with the optimal pharmacokinetic dose (OPD).

The study was carried out in 3 parts. Part A was a single ascending dose (SAD) escalation study which looked at the safety, tolerability, and PK of 7HP349 after administration of single oral doses in the male subjects and defined the activators OPD. Part B was similar to Part A but instead of SAD, it was a multiple ascending dose (MAD) escalation study which examined 7HP349 following up to 5 oral tablets, once a day doses in subjects. Part C was a randomized, open label, two-treatment, three-period, crossover study which focused on determining the effect of the fed or fasting prandial state on the single dose PK of 7HP349.

The study enrolled 60 male participants ranging from ages 18-45. Participants were required to be healthy males with normal clinical chemistry, hepatic function, hematology, thyroid function, body mass index (BMI) of 19 to 30 kg/m2 inclusive, body weight not less than 60 kg, and a positive immune status.

The primary end point was safety and tolerability of 7HP349 with secondary end points including pharmacokinetics as assessed by maximum plasma concentration, plasma exposure, in urine, and by renal clearance to determine its OPD.

“We are proud that 7HP349 has been recognized by the FDA as a potential solution to substantially 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 Joseph Bailes, MD, co-founder and board member, 7 Hills Pharma, in the press release.

7 Hills Pharma’s Clinical-stage Novel Immunostimulant 7HP349 Granted FDA Fast Track Designation for Anti-PD-1-resistant Metastatic Melanoma. News Release. Biospace. March 8, 2022. Accessed March 9, 2022.
A phase 1 SAD and MAD study of the safety, tolerability and PK of 7HP349 in normal healthy male subjects. Clinicaltrials.gov. Accessed March 9, 2022. https://bit.ly/35CfZ3m