Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has signed a contract valued at up to $153 million over five years with 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, to develop CLT-008, a cellular therapy for the treatment of Acute Radiation Syndrome (ARS).
“We believe Cellerant is at the forefront of the development of a solution for ARS and we share BARDA's commitment to developing CLT-008 as an effective countermeasure to support our biodefense interests.”
Under terms of this cost plus fixed fee development contract, Cellerant will receive up to $63.3 million in the two-year base period of performance and up to an additional $89.9 million in three option years, if exercised by BARDA, for a total contract value of $153.2 million. This award covers substantial costs associated with developing CLT-008 for ARS.
This contract is awarded by BARDA for advanced product development and will support Cellerant's CLT-008 clinical and commercial strategy, including scaling up manufacturing, expanded human safety trials and pivotal, non-clinical effectiveness studies in animals, through licensure. 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 delighted to have been awarded this new contract from BARDA," said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. "We believe Cellerant is at the forefront of the development of a solution for ARS and we share BARDA's commitment to developing CLT-008 as an effective countermeasure to support our biodefense interests."
CLT-008 is currently in a Phase 1 study in patients undergoing cord blood transplants for the treatment of hematological malignancies. CLT-008 is intended to rapidly produce neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation.
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 preclinical studies conducted to date suggest that a single dose of CLT-008 could provide effective treatment for ARS in an emergency situation, and can be administered up to five days post-exposure to radiation. CLT-008 is being developed under the U.S. Food and Drug Administration's Animal Efficacy Rule for ARS. This approval pathway requires demonstration of efficacy in representative animal models and safety and metabolism testing in human clinical trials. There is currently no FDA approved medical countermeasure to treat ARS.
This new contract follows Cellerant's first contract with BARDA awarded on September 16, 2008. Under terms of its first BARDA contract, the government has exercised all available options and Cellerant has received approximately $11M in funding to date to develop and advance CLT-008 from preclinical studies to Phase 1 clinical studies.
Source : Cellerant Therapeutics