Cend Therapeutics Announces First Patient Treated in Phase 2b Trial of CEND-1 led by Australasian Gastro-Intestinal Trials Group

SAN DIEGO, June 09, 2022 (GLOBE NEWSWIRE) — Cend Therapeutics, Inc. (“Cend”) today announced that the first patient has been treated in the Phase 2b study of CEND-1, Cend’s lead investigational drug, in patients with first-line metastatic pancreatic ductal adenocarcinoma.

The ASCEND trial is a 125-patient, double-blind, randomized, placebo-controlled clinical trial, and is being conducted at up to 40 sites in Australia and New Zealand. Designed and led by the Australasian Gastro-Intestinal Trials Group (“AGITG”) in collaboration with the NHMRC Clinical Trial Centre at the University of Sydney, Cend will provide funding, study drug and regulatory support.

“Building on the encouraging safety and antitumor activity in pancreatic cancer patients in Phase 1b, this trial represents an important next step in advancing this potentially meaningful new treatment approach to benefit pancreatic cancer patients,” said Andrew Dean, MD, Principal Investigator for the study.

“Dosing the first patient in our Phase 2b trial represents a significant accomplishment for our team as we have worked diligently to achieve this milestone,” stated Harri Järveläinen, Chief Operating Officer of Cend. “Pancreatic cancer has one of the highest mortality rates of all cancers and affects hundreds of thousands of patients each year. While progress has been made in understanding and treating pancreatic cancer, more effective treatments are needed. We are thrilled at the progress being made to help move CEND-1 forward in the clinical trial process for the potential benefit of patients with pancreatic cancer. We are thankful to AGITG for conducting this study.”

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 tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin-1, to activate a novel uptake pathway that allows anticancer drugs to more selectively 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.

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.

The Company recently announced that it has signed a definitive merger agreement with Caladrius Biosciences, Inc. (NASDAQ: CLBS and www.caladrius.com). The merger is expected to close in the third quarter of 2022.

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. We currently are developing first-in-class autologous cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.