Accelerated designation has been granted to 7HP349, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma after treatment failure with a PD-1 inhibitor.
The FDA has granted expedited 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-4 inhibitor. 1, according to 7 Hills Pharma SARL (7HP).1
7HP349 is an oral therapy intended for use in conjunction with immunotherapy to enhance the efficacy of potentially all immunotherapeutic immune checkpoint inhibitors and infectious disease vaccines through a unique mechanism of action. It acts as an allosteric activator of VLA-4 and LFA-1 integrins which are essential elements underlying the rate-limiting steps of lymphocyte recruitment, extravascular trafficking, T-cell activation and effector functions.
“The FDA’s decision to grant Fast Track designation to 7HP349 underscores the critical unmet medical need still present in anti-PD-1 resistant melanoma. We are working to bring oncologists a whole new therapeutic modality to overcome resistance to ICI. Obtaining fast-track designation for our clinical lead molecule represents a significant step towards our goal of fully delivering on the 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 was granted based on the successful completion of a Phase 1 study (NCT04508179) that evaluated the safety, tolerability, and pharmacokinetics of 7HP349 in healthy male subjects.2
The first-in-man clinical trial was a sequential, placebo-controlled dose escalation study, which administered single and multiple oral doses to 7HP349 participants. Additionally, a separate, open-ended food-effect cohort was created and investigated with the optimal pharmacokinetic dose (OPD).
The study took place in 3 parts. Part A was a single ascending dose (SAD) escalation study that investigated the safety, tolerability, and pharmacokinetics of 7HP349 following administration of single oral doses in male subjects and defined OPD enhancers. Part B was similar to Part A, but instead of the SAD, it was a multiple dose escalation (MAD) study that investigated 7HP349 after up to 5 oral tablets, once daily in the subjects. Part C was a randomized, open-label, two-treatment, three-period, crossover study that focused on determining the effect of the fed or fasted prandial state on single-dose 7HP349 PK.
The study recruited 60 male participants between the ages of 18 and 45. Participants had to be healthy males with normal clinical chemistry, liver function, hematology, thyroid function, body mass index (BMI) of 19 to 30 kg/m2 inclusive, body weight of at least 60 kg and a positive immune status.
The primary endpoint was the safety and tolerability of 7HP349 with secondary endpoints including pharmacokinetics assessed by peak 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 significantly improve current state-of-the-art cancer immunotherapy. We are excited to have the opportunity to accelerate our development plans through improved flexibility and communication with the FDA,” said Joseph Bailes, MD, co-founder and board member of 7 Hills Pharma. , in the press release.