Purple Biotech Ltd. (PPBT) Begins Initiation of Phase 1b/2 Clinical Trial of CM24 for Treatment of Multiple Advanced Cancers

March 19, 2021 8:04 AM EDT

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Purple Biotech Ltd. (NASDAQ: PPBT) today announced the initiation of a Phase 1b/2 clinical trial evaluating CM24, a monoclonal antibody blocking CEACAM1, in advanced cancer patients, with expansion cohorts in subjects with non-small cell lung cancer (NSCLC) and pancreatic cancer. The trial will be conducted in clinical collaboration with Bristol Myers Squibb.

“The initiation of this Phase 1b/2 clinical trial represents an important milestone for our CM24 development program,” said Michael Schickler, Ph.D., Head of Clinical Operations and Regulatory Affairs of Purple Biotech. “In a Phase 1a monotherapy study, CM24 demonstrated good safety and a signal of efficacy, with a 33% disease control rate with up to 10mg/kg dosing. Moreover, pharmacokinetic (PK) and pharmacodynamic modelling demonstrated target saturation expected at higher doses of CM24 on a two-week schedule. The Phase 1b/2 study will be conducted in multiple countries, with sites anticipated in the U.S., E.U. and Israel, and we expect preliminary data from the first part of the study in the second half of this year.”

“CEACAM1 levels are prognostic in a number of cancers, and relate to multiple mechanisms of action in neoplastic disease, from oncogenesis to influencing the tumor microenvironment,” said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. “Based on its profile and the compelling Phase 1a data, we believe this study, which will evaluate CM24 at higher doses in combination with nivolumab in NSCLC patients and in combination with nab-paclitaxel and nivolumab in pancreatic cancer patients, will provide important data on blocking CEACAM1 in these critical unmet medical needs.”

CM24 will be dose escalated from 10mg/kg, targeting the 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 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.

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