Purple Biotech Ltd. (“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 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. Preliminary Data from First Part of Study is expected to be available in second half of 2021.
“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.
About Purple Biotech
Purple Biotech Ltd. (formerly Kitov Pharma Ltd.) (the “Company”; NASDAQ/TASE: KTOV) is a clinical-stage company developing first-in-class therapies by overcoming tumor immune evasion and drug resistance. Purple Biotech’s oncology pipeline includes NT219 and CM24. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. Purple Biotech is currently advancing NT219 as a monotherapy treatment of solid tumors, followed by a dose escalation of NT219 in combination with cetuximab for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) or colorectal adenocarcinoma in a phase 1/2 study, and an expansion phase of NT219 at its recommended phase 2 level in combination with cetuximab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. CM24 is a humanized monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple pathways. Purple Biotech is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in selected cancer indications in a phase 1 study followed by a phase 2 for the treatment of non-small cell lung cancer and pancreatic cancer. Purple Biotech has entered into a clinical collaboration agreement, as amended, with Bristol Myers Squibb for the planned phase 1/2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab (Opdivo®) in patients with non-small cell lung cancer and in combination with nivolumab in addition to nab-paclitaxel (ABRAXANE®) in patients with pancreatic cancer. Purple Biotech is also the owner of Consensi®, an FDA-approved fixed-dose combination of celecoxib and amlodipine besylate, for the simultaneous treatment of osteoarthritis pain and hypertension that was approved by the FDA for marketing in the U.S. Consensi® is being sold in the U.S. by Burke Therapeutics, the marketing partner of the Company’s U.S. distributor, Coeptis Pharmaceuticals. The Company has also partnered to commercialize Consensi in China and South Korea. The Company has recently relocated its corporate headquarters imminently to Rehovot, Israel. For more information, please visit http://www.purple-biotech.com.
Deputy CEO & Chief Financial Officer, Purple Biotech
email: IR at purple-biotech.com
Investor Relations Contact:
email: chuck at lifesciadvisors.com
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