Purple Biotech Ltd. (PPBT) stock prices were up by 2.15% as of the market closing on May 26th, 2021, bringing the price per share up to USD$4.76 at the end of the trading day. Subsequent pre-market fluctuations saw the price dip by a marginal 1.05%, bringing it down to USD$4.71.
CM24 Trial Commences Patient Dosing
The company announced on April 23rd, 2021 that the first dosing of the first patient in the Phase 1b/2 clinical trial of CM24, a monoclonal antibody blocking CEACAM1. The treatment was administered in conjunction with the PD-1 inhibitor, nivolumab, in patients with advanced cancer. The study had expansion cohorts in subjects with non-small cell lung cancer (NSCLC) and pancreatic cancer.
The initial dosing of the first patient as a part of the study being conducted in clinical collaboration with Bristol Myers Squibb is a critical milestone in the development of CM24. The targeting of CEACAM1 is an innovative approach that makes use of up-to-date knowledge of the interface of the myeloid and T-cell systems in the neoplastic phenotype. The company is keenly anticipating the availability of preliminary data from the first part of the study before the end of the fiscal year.
The Phase 1b/2 clinical trial reported having expansion cohorts in subjects with pancreatic cancer and NSCLC. The dosage of CM24 will be doubled from 10 to 20mg/kg and will be administered in combination with nivolumab in Phase 1b. Patients who the dose will be administered to will have NSCLC, pancreatic cancer, ovarian carcinoma, colorectal adenocarcinoma, melanoma, or thyroid carcinoma. The primary objective of the upped dosage in the study will be to evaluate the safety of CM24, PK, and determining the recommended Phase 2 dose.
The Phase 2 component of the study will see CM24 and nivolumab being used to treat patients with NSCLC after first-line immune-oncology failure. Patients with metastatic pancreatic adenocarcinoma will be administered the same mix plus nab-paclitaxel after first-line therapy failure. The study will have safety and preliminary efficacy as its endpoints. Potential biomarkers such as CEACAM1 level of expression and a host of other immune and adhesion-related molecules will be evaluated as a part of the study.
Future Outlook for PPBT
With the development of CM24 underway, PPBT is poised to capitalize on the pending FDA approval and commercialization of the treatment. The company is keen to push for the commercialization of its leading drug candidate in an effort to facilitate further growth. Current and potential investors are hopeful that the company will manage to leverage the resources at its disposal to facilitate significant and sustained increases in shareholder value.