Benzinga | Apr 23, 2021 08:07AM EDT

Purple Biotech Announces Dosing Of First Patient In Phase 1b/2 Clinical Trial Of CM24 In Advanced Cancer Patients

Purple Biotech (Nasdaq/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, today announced that the first patient has been dosed in a Phase 1b/2 clinical trial of CM24, a monoclonal antibody blocking CEACAM1, for the first time in combination with nivolumab (Opdivo(r)), a PD-1 inhibitor, in advanced cancer patients, with expansion cohorts in subjects with non-small cell lung cancer (NSCLC) and pancreatic cancer.

"The dosing of the first patient in this study, which is being conducted in clinical collaboration with Bristol Myers Squibb, is a critical achievement for the development of CM24," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. "Targeting CEACAM1 is a cutting-edge approach utilizing the most current knowledge of the interface of the myeloid and T-cell systems in the neoplastic phenotype. We look forward to the availability of preliminary data from the first part of this study which we expect to receive during the second half of this year."

The study is a Phase 1b/2 clinical trial with expansion cohorts in subjects with NSCLC and pancreatic cancer. CM24 will be dose escalated from 10mg/kg, targeting a 20mg/kg dose, in combination with nivolumab in Phase 1b, in patients with NSCLC, pancreatic cancer, ovarian carcinoma, colorectal adenocarcinoma, melanoma or thyroid carcinoma, with the primary objective of evaluating safety, PK and determining the recommended Phase 2 dose. In the Phase 2 component, patients with NSCLC will be treated with CM24 and nivolumab after first-line immuno-oncology failure, and patients with metastatic pancreatic adenocarcinoma will be treated with CM24, nivolumab and nab-paclitaxel (ABRAXANE(r)) after first-line therapy failure, with study endpoints being safety and preliminary efficacy. CEACAM1 level of expression, as well as a number of other immune and adhesion-related molecules, will be evaluated as potential biomarkers in the study.

The Phase 1b/2 study will be conducted in multiple countries, with sites anticipated in the U.S., E.U. and Israel. Additional information about the trial can be found at www.clinicaltrials.gov, NCT Identifier NCT04731467.