Cellerant receives second BARDA contract for CLT-008

Cellerant Therapeutics Inc. (San Carlos, Calif.) said HHS's Biomedical Advanced Research and Development Authority awarded the company a second contract of up to five years to continue development of CLT-008 for acute radiation syndrome (ARS). The contract is worth up to $153.2 million and includes the $4.5 million remaining from the 2008 contract, which was worth up to $15.5 million. The new contract will support further clinical and commercial development of CLT-008, including scaling up manufacturing and expanded human safety trials. Cellerant is developing CLT-008 for ARS under FDA's Animal Rule, which allows marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans.

CLT-008, which is in preclinical testing for ARS, comprises cryopreserved human myeloid progenitor cells derived from adult stem cells. CLT-008 is also in Phase I testing to treat hematological malignancies in patients undergoing cord blood transplants. A Phase I trial of CLT-008 in neutropenia is expected to start this year. ...