Celdara Medical, LLC announced today that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of CM-CS1 in patients with Acute Myeloid Leukemia (AML)/Advanced Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM).
Celdara Medical plans to initiate a Phase I dose escalation trial to establish the safety of CM-CS1 in patients with advanced malignancies. CM-CS1 is an autologous chimeric antigen receptor (CAR) T cell therapy which employs NKG2D, a natural killer (NK) cell receptor, to target ligands which are present on most tumor types, including hematologic cancers as well as solid tumors.
"We are very pleased with FDA’s expeditious review and decision. This is an important milestone in our company’s history, and marks the beginning of a highly promising clinical development program,” said Jake Reder, Ph.D., Celdara Medical’s cofounder and CEO. "CM-CS1 has the biological potential to open the CAR T cell therapy space considerably, both in terms of the breadth of targetable indications but also in terms of what we expect will be novel, more patient-friendly options for clinical use. This trial is the first step in determining the extent to which this potential can be realized."
"The translation of this work into the clinic in collaboration with the Celdara Medical team has been incredibly rewarding," said Charles Sentman, Ph.D., inventor of CM-CS1 and Professor of Microbiology and Immunology at the Geisel School of Medicine at Dartmouth. "This approach is a novel strategy for immunotherapy that attacks both the tumor and the microenvironment that supports it. The applications of this type of gene and cell therapy are just beginning. My goal is for Dartmouth’s new Center for Synthetic Immunity to lead in the creation of new cell therapies that can help patients with many of the most difficult to treat diseases."
Michael Fanger, Ph.D., Celdara Medical’s cofounder and CSO, commented, “The team – led by Dr. Joana Murad – did a fantastic job of bringing a complex IND together under tight timelines and budget. We’re eager to begin our first in human study to determine the safety of this therapy for patients with few treatment options.”
Research reported in this press release was supported by the National Heart, Lung and Blood Institute of the National Institutes of Health under award number R44HL099217-03. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
About Celdara Medical, LLC
Celdara Medical was founded by Drs. Jake Reder and Michael Fanger in 2008, and is headquartered at the Dartmouth Regional Technology Center (DRTC) in Lebanon, NH. Celdara Medical builds academic and early-stage innovations into high-potential medical companies, identifying discoveries of exceptional value at the earliest stages and moving them toward the market. Celdara Medical partners with inventors and their institutions, providing the developmental, financial, and business acumen required to bridge discovery and profitability. With robust funding options, a diverse and high impact Programmatic pipeline, and partnerships with world-class academic institutions and industry leaders, Celdara Medical navigates all aspects of a complex industry, accelerating science to improve human health.