Decision based on positive interim Phase 1b data in pancreatic ductal adenocarcinoma (PDAC)

Purple Biotech Ltd. (“Purple Biotech”, or the “Company”) (NASDAQ/TASE: PPBT), a clinical-stage company focused on developing first-in-class, effective and durable therapies by harnessing the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced the initiation of the Phase 2 portion of its ongoing study of CM24, a first-in-class monoclonal antibody with the potential to treat multiple cancers. The Phase 2 is an open-label, multicenter study in subjects with metastatic pancreatic cancer (PDAC) to evaluate the safety and tolerability of CM24 in combination with the PD-1 inhibitor Opdivo® (nivolumab) and chemotherapy. The primary study endpoint is to evaluate preliminary efficacy in 2nd line PDAC. The phase 2 portion of the study (NCT04731467) is being conducted as part of Purple Biotech’s clinical collaboration with Bristol Myers Squibb. The companies together made the determination to prioritize PDAC over non-small cell lung cancer (NSCLC) based on the positive interim data. Accordingly, this decision will allow an increase in the number of subjects that will be participating, and will accelerate this part of the study, and the updated timeline to complete this trial is within 2023.

“Pancreatic ductal adenocarcinoma, or pancreatic cancer, has one of the highest mortality rates of all cancers and affects tens of thousands of patients each year. While progress has been made in understanding and treating pancreatic cancer, more effective treatments are needed. It is exciting to have CM24 and Opdivo® showing a confirmed partial response in a patient with pancreatic cancer with an MSS tumor, where other immune checkpoint inhibitors have failed to show response to date. In addition, the safety profile of CM24 in combination with nivolumab and the positive efficacy signals in advanced patients with very poor prognosis in the study are encouraging, and support the advancement of the clinical study in patients with pancreatic cancer,” said Erkut Borazanci, MD, Deputy Director Oncology and Clinical Investigator at HonorHealth Research Institute, Scottsdale, AZ.

“We are thrilled at the progress being made to help move this treatment forward in the clinical trial process for the potential benefit of patients with pancreatic cancer,” said Gil Efron, President and CFO of Purple Biotech. “We are thankful for our partners at BMS for collaborating with us on this study and their support. Importantly, the decision to prioritize the PDAC study will extend the cash runway of Purple Biotech through the end of 2024,” added Efron.

This announcement follows the release of interim safety and efficacy results from the Phase 1b portion of the study of CM24 in combination with Opdvio® shared at the American Association for Cancer Research (AACR) Annual Meeting in April. Information shared demonstrated a favorable safety profile. Six Grade 3 adverse events (AEs) that were unrelated to CM24 or nivolumab and no Grade 4 AEs or deaths were reported. Encouraging signals of efficacy in advanced patients with PDAC were reported (n=8, ORR=12%, DCR=37%), with one confirmed partial response in a patient with metastatic pancreatic cancer, as well as three patients with stable disease, including two patients with pancreatic cancer and one patient with papillary thyroid cancer. All patients but one received two prior lines of treatment for their metastatic disease.

OPDIVO® is a trademark of Bristol-Myers Squibb Company.