One Advanced Pancreatic Cancer Patient Demonstrated a Partial Response in First Dose Cohort in Combination with Nivolumab
Patient Enrollment in Second Dose Cohort Complete
Study Expanding to Additional Sites in U.S. and Israel
REHOVOT, Israel, Sept. 13, 2021 (GLOBE NEWSWIRE) — 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 provided an update on its ongoing Phase 1b/2 clinical trial of CM24, a monoclonal antibody blocking CEACAM1, in combination with nivolumab (Opdivo®), a PD-1 inhibitor, in advanced cancer patients, with expansion cohorts in subjects with non-small cell lung cancer (NSCLC) and in combination with nivolumab and nab-paclitaxel (Abraxane®) in pancreatic cancer.
In a Trials in Progress poster at the ESMO 2021 Congress, which will be held on September 16-21, 2021, Purple Biotech will present an overview and the design of the ongoing Phase 1b/2 study. The poster is titled, “A Phase 1b Study of CM24 in Combination with Nivolumab in Adults with Advanced Solid Tumors, followed by a Phase 2a study of CM24 in Combination with Nivolumab in NSCLC, and in Combination with Nivolumab and nab-paclitaxel in Pancreatic Cancer.”
Top-line data from the first dose cohort of CM24 10mg/kg included a partial response demonstrated in a patient with refractory advanced pancreatic cancer previously treated with two lines of therapy following two courses of treatment with CM24 in combination with nivolumab 480mg/kg. Additionally, there were no dose-limiting toxicities or serious adverse events observed in any of the three patients enrolled in the first cohort of the study.
“We are encouraged by the early data from the first cohort of this study, which showed combination agent safety, as well as a partial response in one patient,” said Bertrand C. Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. “The responsive patient showed a 40 percent reduction in tumor size following two courses of treatment with CM24 10mg/kg in combination with nivolumab. In addition, levels of CA19-9 tumor marker dropped by 56%, which was comparable to baseline levels. These results are especially compelling given that pancreatic tumors without high levels of microsatellite instability or deficient mismatch repair, such as the responsive patient, typically do not respond to immuno-oncology agents.”
Enrollment in the second dose cohort (15mg/kg) has successfully concluded. Moreover, the Phase 1b/2 study is being expanded to additional sites in the U.S. and Israel.
“The top-line data from the first cohort of this study reinforce our confidence in the potential of CM24 to be a safe and effective treatment for advanced cancer patients. Moreover, we are pleased with the high level of interest in this study from some of the leading academic centers in the world and look forward to completing this dose-escalation study by year-end, as planned,” said Isaac Israel, Chief Executive Officer of Purple Biotech.
The study is a Phase 1b/2 clinical trial with expansion cohorts in subjects with NSCLC and pancreatic cancer. CM24 is dose escalated (3+3 design) from 10mg/kg, in combination with nivolumab, 480mg q4w, 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 advanced/metastatic pancreatic adenocarcinoma will be treated with CM24, nivolumab, and nab-paclitaxel (Abraxane®) 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, biochemical and adhesion-related molecules, will be evaluated as potential biomarkers in the study.
Additional information about the trial can be found at www.clinicaltrials.gov, NCT Identifier NCT04731467.
The trial is being conducted under a clinical collaboration and supply agreement with Bristol Myers Squibb. Purple Biotech is the sponsor of the trial.
Opdivo® is a trademark of Bristol-Myers Squibb Company.
Abraxane® is a trademark of Abraxis BioScience, LLC, a Bristol Myers Squibb company.
About Purple Biotech
Purple Biotech Ltd. is a clinical-stage company developing first-in-class therapies by overcoming tumor immune evasion and drug resistance. The Company’s oncology pipeline includes NT219 and CM24. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. The Company 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. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in selected cancer indications in a phase 1b study followed by a phase 2 for the treatment of non-small cell lung cancer and pancreatic cancer. The Company 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. The Company’s corporate headquarters are located in Rehovot, Israel. For more information, please visit https://www.purple-biotech.com.
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