The Biomedical Advanced Research and Development Authority (BARDA) has commissioned Cellerant Therapeutics over five years for $153.2 million to develop CLT-008 for the treatment of acute radiation syndrome (ARS). Under the terms of this cost plus fixed-fee contract, Cellerant will receive up to $63.3 million in the two-year base period of performance. It would obtain the remaining $89.9 million if BARDA exercises all options over the following three years.
The money will cover substantial costs associated with developing and commercializing CLT-008 for ARS, according to Cellerant. Strategies will include scaling up manufacturing, expanded human safety trials, and pivotal, nonclinical effectiveness studies in animals through licensure.
CLT-008 is being developed under FDA’s Animal Efficacy Rule. This approval pathway requires demonstration of efficacy in representative animal models and use of human trials for safety and metabolism testing.
Cellerant received its first contract from BARDA in September 2008. The government exercised all options, and the company obtained approximately $11 million to develop and advance CLT-008 from preclinical studies to Phase I studies.
CLT-008 is a cryopreserved, cell-based therapy that contains human myeloid progenitor cells derived from adult stem cells that have the ability to mature into functional granulocytes, platelets, and red blood cells in vivo. In ARS applications it 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, according to Cellerant.
The company is also studying CLT-008 in patients undergoing cord blood transplants for the treatment of hematological malignancies. Phase I studies are ongoing to evaluate the drug’s ability to produce neutrophils and platelets in vivo and facilitate long-term engraftment. CLT-008 is also in preclinical development as a treatment for chemotherapy-induced neutropenia.
Cellerant also has a cancer stem cell antibody discovery program focused on the treatment of acute myelogenous leukemia, multiple myeloma, and myelodysplastic syndrome.