Cellerant Therapeutics Inc. has announced that it has been awarded $47.5 million under a second option exercised by the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services.
The award will support the continued advanced development of CLT-008, a first-in-class, allogeneic, cell-based therapy for the treatment of hematopoietic sub-syndrome of Acute Radiation Syndrome (ARS). This funding is in addition to the $116.4 million committed under the two-year base period and the first option, and is part of the total obligated contract valued at $163.8 million.
This additional funding will support Cellerant's CLT-008 development program by providing funds for its randomized Phase 2 clinical trial in patients with acute myeloid leukemia (AML), and the nonclinical studies required for approval in treating ARS.
If licensed by the U.S. Food and Drug Administration (FDA), the federal government could buy CLT-008 for the Strategic National Stockpile under Project Bioshield. Project Bioshield is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.
"We are pleased that the federal government continues to support our efforts in this successful public-private partnership with BARDA," said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. "The exercise of this second option reflects recognition of the importance of this first-in-kind therapy to serve an unmet medical need to reduce the infection-related complications from severe neutropenia caused by chemotherapy or exposure to radiation. These funds allow for the initiation and completion of a randomized Phase 2 trial in AML by building on efficacy signals observed to date in the clinic. We look forward to continuing to work with BARDA to advance CLT-008 development towards approval."
Consistent with BARDA's commitment to supporting multi-use products that have both commercial and biodefense applications, this funding allows Cellerant to continue its clinical trials with CLT-008 for cancer applications.
The Company has recently completed early phase studies in patients with AML and in patients undergoing an umbilical cord blood transplant where CLT-008 was safely tolerated in 75 patients.
Preliminary efficacy signals with respect to mucositis and febrile episodes suggest that CLT‐008‐derived myeloid effector cells may migrate to chemotherapy- or radiation‐damaged mucosal tissues to mitigate infection risk.
Based on this concept, Cellerant will be initiating a randomized Phase 2 clinical trial to demonstrate a decrease in risks of febrile neutropenia and infections related to chemotherapy treatment for AML.
In ARS applications, CLT-008 is intended to provide hematopoietic cellular support after exposure to ionizing radiation such as from a nuclear or radiological weapon, or from a nuclear accident.
Various nonclinical studies conducted to date suggest that a single dose of CLT-008 could reduce mortality from ARS in an emergency situation, and could be administered up to five days post-exposure to radiation. There is currently no FDA-approved medical countermeasure to treat ARS.