Peloton Therapeutics announced dosing of the first patient in a Phase 2 trial evaluating the efficacy and safety of lead investigational oncology agent, PT2977, to treat von Hippel-Lindau (VHL) disease-associated kidney cancer. PT2977 is a once-daily, oral inhibitor of HIF-2α, a transcription factor that has been implicated in the development and progression of renal cell carcinoma (RCC).
“The initiation of this Phase 2 trial is an important milestone for Peloton and a critical step towards helping patients with this rare condition which can have serious lifelong health consequences,” said Mohammad Hirmand, M.D., Peloton’s Chief Medical Officer. “The safety, pharmacokinetics, and clinical activity that we have observed in a Phase 1 trial of PT2977 provides insights into its potential to improve outcomes for patients with kidney cancer. We look forward to continuing clinical evaluation of this novel oral HIF-2α inhibitor.”
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The primary objective of the Phase 2 trial is to evaluate the efficacy of PT2977 for the treatment of VHL disease-associated renal tumors as measured by overall response rate. Secondary objectives include duration of response, time to response, progression free survival, and time to surgery for VHL disease-associated renal tumors. The trial will also evaluate the efficacy of PT2977 in other VHL disease-associated tumor types as well as the safety and pharmacokinetics of PT2977. Patients will be evaluated radiologically approximately every 12 weeks while continuing in the study.
Peloton’s drug discovery and development efforts focus on identifying novel compounds capable of modulating complex protein-protein interactions that drive disease which have eluded conventional small molecule approaches. Peloton has the only clinical stage small-molecule inhibitors of HIF-2α, and PT2977 has demonstrated a favorable profile in a Phase 1 study in patients with advanced solid tumors including RCC.