Cellerant Therapeutics won a $36.4 million Biomedical Advanced Research and Development Authority (BARDA) grant to support advanced development of allogeneic cell-based therapy CLT-008, for the treatment of acute radiation syndrome (ARS). This third year of funding follows on from $80 million already awarded over an initial two years, and is part of a five-year award that could be worth $169.9 million.
CLT-008 is an off-the-shelf cryopreserved cell-based therapy comprising human myeloid progenitor cells derived from hematopoietic stem cells, which can mature in vivo into functional granulocytes, platelets, and red blood cells. For ARS applications the product is expected to provide hematopoietic cell support after exposure to ionizing radiation. Cellerant says preclinical studies suggest a single dose could effectively treat ARS in an emergency situation, even when administered up to five days post-exposure.
The latest grant will support ongoing clinical trials, process development, and manufacturing, as well as nonclinical studies needed to attain approval of CLT-008 for the ARS indication. However, the BARDA funding will also enable Cellerant to continue ongoing clinical trials with CLT-008 for cancer indications. In addition, the firm is developing CLT-008 as a treatment for chemotherapy-induced neutropenia, and for facilitating engraftment of cord blood transplants in cancer patients.
The first Phase I cancer study is evaluating CLT-008 in patients undergoing cord blood transplants for hematological cancers, for whom treatment using CLT-008 is hoped to engender rapid production of neutrophils and platelets and facilitate long-term engraftment. A second Phase I/II study is evaluating CLT-008 in acute leukemia patients with chemotherapy-induced neutropenia.