Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company developing innovative therapies designed to treat or reverse disease, and Cend Therapeutics, Inc. (“Cend”), a privately-held, clinical-stage drug discovery and development company developing a novel approach to enable more effective treatments for solid tumor cancers, pursuant to a collaboration agreement entered into by each company in connection with their recently announced and pending merger to form Lisata Therapeutics, today announced that The Lancet Gastroenterology and Hepatology has published data from the Phase 1b study of CEND-1, Cend’s lead investigational drug, in combination with gemcitabine and nab-paclitaxel for the treatment of first-line, metastatic pancreatic ductal adenocarcinoma (“mPDAC”). The study was published online on June 5, 2022, and can be accessed by visiting https://www.thelancet.com/journals/langas/onlinefirst.
The publication details the results of an open-label, multi-center, Phase 1b trial conducted in 31 patients in the safety population and 29 patients in the efficacy population. The objectives of the study were to determine the safety, tolerability, pharmacokinetics, and preliminary efficacy of CEND-1 in combination with gemcitabine and nab-paclitaxel in patients with mPDAC.
“Pancreatic cancer has always been one of the most difficult tumors to treat. The protective meshwork, or tumor stroma, that surrounds the cancer cells has proved a difficult barrier for chemotherapy drugs to penetrate. In this first-in-human study using the new treatment modality, it appears that CEND-1 may overcome this barrier, and although the sample size was small, we were extremely excited to see such a significant response rate and prolonged progression-free survival with a number of long-term survivors,” said Andrew Dean, M.D., lead investigator at the St. John of God Hospital, Subiaco, Australia. “I believe CEND-1 has the potential to provide a substantial benefit as part of a combination treatment and look forward to the results of the ongoing expansion studies.”
“We are proud to have the very encouraging results of our Phase 1b study of CEND-1 in pancreatic cancer published in a prestigious peer-reviewed journal,” stated Harri Järveläinen, Chief Operating Officer of Cend. “These results reinforce our belief that CEND-1 could become a transformative new medicine for the treatment of pancreatic cancer and other difficult-to-treat solid tumor cancers.”
The data in the publication expand on the preliminary findings presented at the 2020 European Society for Medical Oncology (ESMO) Congress. Importantly, the new results suggest a potential for marked and durable improvement in treatment effectiveness in combination with standard-of-care (“SoC”) drugs for mPDAC. Principal results include:
- CEND-1 was well tolerated; no dose-limiting toxicities were identified; safety of the combination was consistent with SoC alone
- Pharmacokinetic profile in the target range that is associated with optimal efficacy
- Median Progression-Free Survival 9.7 months
- Median Overall Survival 13.2 months (after extended follow-up of patients continuing treatment)
- Overall Response Rate (Partial Response (PR) + Complete Response (CR) = Objective Response Rate (ORR) 59%
- Disease Control Rate (Stable Disease + PR + CR = DCR) at 16 weeks 90%
- CA19-9 circulating tumor biomarker reductions of 50% or greater in 91% of patients
“We are very pleased to share the peer-reviewed Phase 1b clinical data for CEND-1, the same data that contributed heavily to our support for the proposed merger with Cend,” stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Caladrius, expected to hold the same position at Lisata Therapeutics after the merger closes. “I believe that the encouraging results indicate the benefit this potential new medicine can bring to patients with significant unmet medical needs and we look forward to continuing to maximally exploit the potential of CEND-1 as part of the treatment for an array of solid tumor cancers and in combination with a variety of therapies, including immunotherapies.”