Purple Biotech reports interim, preliminary results from NT219 Phase 1/2 study

Purple Biotech provides clinical updates from its dose escalation portion of the Phase 1/2 study of NT219, a first in class dual inhibitor of Insulin receptor substrate 1/2 and Signal Transducer and Activator of Transcription 3 and provides its outlook for planning the next clinical development steps with NT219 for second-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head & Neck. The Phase 1/2 study, an open-label, dose escalation and expansion study is designed to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of NT219 as a monotherapy and in combination with Erbitux, in patients with R/M SCCHN, or with advanced colorectal cancer. Forty-nine patients were enrolled in five dose levels; 27 in the monotherapy arm, and 22 in the combination therapy with cetuximab. Patients in both cohorts were dosed to the highest NT219 dose level of 50mg/kg. No dose-limiting toxicities were reported in either cohort and NT219 was well tolerated as a monotherapy and in combination with cetuximab. A dose-dependent increase in drug exposure of NT219 was reported. The exposure achieved at the highest dose level of 50mg/kg was within the efficacy range of the human equivalent dose level as predicted from preclinical models. Inhibition of intra-tumoral IRS 1/2 and STAT3, NT219’s targets, was demonstrated in patients’ biopsies. Among the four R/M SCCHN patients dosed at 50mg/kg of NT219 in combination with cetuximab, that were evaluable for efficacy, two patients demonstrated confirmed partial response by response evaluation criteria in solid tumors 1.1. Other results from the Phase 1/2 study will be provided at one of the upcoming medical conferences. Treatment options for patients who had progressed following treatment with immunotherapy in first line R/M SCCHN are limited, with mostly cetuximab and chemotherapy currently available. The Company is in the process of designing a Phase 2 study of NT219 in combination with cetuximab in 2L R/M SCCHN. Such a study may evaluate NT219 in combination with cetuximab with or without standard of care chemotherapy following progression after immunotherapy in first line treatment.