Caladrius Biosciences’ Prospective Merger Partner, Cend Therapeutics, Announces Collaboration Agreement with Roche to Evaluate CEND-1 in Combination with Immunotherapy to Treat Pancreatic Cancer
11 Aug 2022
CollaborateAntibodySmall molecular drugCell TherapyImmunotherapy
BASKING RIDGE, N.J. and SAN DIEGO, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”) and Cend Therapeutics, Inc. (“Cend”), today announced Cend’s execution of a collaboration agreement with F. Hoffmann-La Roche Ltd. (“Roche”) to evaluate Cend’s lead investigational drug, CEND-1, in combination with atezolizumab (Tecentriq®), Roche’s PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”). Under the terms of the agreement, Roche will be responsible for operational management of the trial while Cend and Roche share equally in the costs of the CEND-1 treatment arms in the study.
“We are extremely pleased to work with Roche, a global leader in oncology, to explore the potential of CEND-1 in combination with chemotherapy and immunotherapy for the treatment of pancreatic cancer,” stated David Slack, Chief Executive Officer of Cend. “We are committed to exploring applications of CEND-1 to improve clinical outcomes for patients with this deadly disease. This collaboration represents a desire to explore a novel combination that may enable immunotherapy to benefit pancreatic cancer patients, who, to date, have not benefited broadly from this important emerging class of anti-cancer treatments.”
“We are truly delighted to report progress regarding the development of CEND-1 supported by our collaboration agreement with Cend. Caladrius’ commitment of resources, including its investment in Cend, provide support for this collaboration. We are excited to work with Roche as Caladrius and Cend combine to form Lisata Therapeutics,” stated David Mazzo, Ph.D., Chief Executive Officer of Caladrius. “We hope that this collaboration is the harbinger of many similar collaborations with other partners as we work to expand the application of CEND-1 across different tumor types and in combination with different anti-cancer agents.”
Phase 1b clinical results with Cend’s investigational drug, CEND-1, in combination with standard-of-care chemotherapy regimen of gemcitabine and nab-paclitaxel, have been previously reported and recently published in Lancet Gastroenterology and Hepatology
(https://www.thelancet.com/journals/langas/article/PIIS2468-1253(22)00197-2/fulltext). Additionally, a controlled Phase 2b clinical trial of the CEND-1/gemcitabine/nab-paclitaxel regimen in first-line mPDAC recently has been initiated and plans for treatment combinations in Phase 1b/2 clinical trials in additional solid tumor indications are being actively planned.
About Morpheus Phase 1b/2 study of CEND-1 in combination with Atezolizumab in mPDAC
The co-funded evaluation of CEND-1 in combination with atezolizumab will be conducted as part of Roche's Morpheus Platform. The Morpheus Platform is a collection of Phase 1b/2 clinical trials in multiple high unmet need cancer indications including pancreatic cancer, designed to assess safety and early efficacy to enable more rapid and efficient development of novel cancer immunotherapy combinations.
The trial including CEND-1 will be a Phase 1b/2, open-label, randomized, multi-national study in patients with first-line mPDAC. It will add Roche’s anti-PD-L1 (programmed death ligand-1) checkpoint inhibitor drug, atezolizumab, to the CEND-1/gemcitabine/nab-paclitaxel regimen. The study includes three arms to compare the atezolizumab/CEND-1/gemcitabine/nab-paclitaxel versus CEND-1/gemcitabine/nab-paclitaxel regimen or gemcitabine/nab-paclitaxel alone and will be conducted at sites across the United States as well as in Germany, Spain and South Korea.
About Pancreatic Cancer
Pancreatic cancer is the third leading cause of cancer-related death with very poor five-year survival. Globally, pancreatic cancer accounts for over 430,000 deaths each year, including over 48,000 in the United States. Pancreatic ductal adenocarcinoma (PDAC) is characterized by marked desmoplasia that creates a dense capsule or stroma around the tumor that contributes to drug resistance due, in part, to poor anti-cancer drug delivery to tumor tissue.
About CEND-1
CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumor vasculature by its affinity for alpha-v integrins that are selectively expressed in tumor but not healthy tissue vasculature. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by proteases expressed in the tumor microenvironment to release a peptide fragment, called a CendR fragment, which binds to a second receptor, neuropilin-1, to activate a novel uptake pathway (the CendR pathway) that allows anti-cancer drugs to penetrate solid tumors. The ability of CEND-1 to modify the tumor microenvironment to enhance delivery and efficacy of co-administered drugs has been demonstrated in models of a range of solid tumors. CEND-1 has also been shown in animal models of pancreatic and other cancers to alter the tumor microenvironment to decrease immunosuppression selectively within the tumor, which may enable a patient’s immune system and immunotherapies to fight cancer with greater effectiveness.
About Caladrius Biosciences
Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of innovative therapies designed to treat or reverse disease. The Company’s current product candidates include: XOWNA® (CLBS16), the subject of both a recently completed positive Phase 2a study and an ongoing Phase 2b study (www.freedom-trial.com) in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”); CLBS12 (HONEDRA® in Japan), recipient of a SAKIGAKE designation in Japan and eligible for early conditional approval for the treatment of critical limb ischemia (“CLI”) and Buerger’s disease based on the results of an ongoing clinical trial; and CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease (“DKD”). For more information on the Company, please visit www.caladrius.com.
The Company recently announced that it has signed a definitive merger agreement with Cend Therapeutics, Inc. (www.cendrx.com) to form Lisata Therapeutics. Upon closing, Lisata will be a publicly-traded company with an advanced clinical development pipeline and strong balance sheet, which is expected to fund development compounds to their next development milestone. The merger is expected to close in the third quarter of 2022.
About Cend Therapeutics
Cend is a privately held, clinical-stage drug discovery and development company focused on a novel approach to enable more effective treatments for solid tumor cancers. The CendR Platform™ provides a tumor-targeted tissue penetration capability to specifically enhance drug delivery to tumors. Cend is also applying its technology to alter immunosuppression selectively within the tumor microenvironment to enable a patient’s immune system and immunotherapies to fight cancer with greater effectiveness. For more information on Cend, please visit www.cendrx.com.
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