Novel Cell Based Therapies as Treatment for Chemotherapy and Radiation

Dr Ram Mandalam, CEO of Cellerant Therapeutics (www.cellerant.com) talked about Cellerant’s portfolio of products based on the regulation of the hematopoietic (blood-forming) system at www.bio2devicegroup.org event.

 

Cellerant is developing a novel, cell based medicine (Myeloid Progenitors/ CLT-008) as a treatment for chemotherapy and radiation induced neutropenia.  Neutopenia is a common side effect of chemotherapy or acute radiation that results in a decreased level of a type of white blood cells called neutophils.  These type of white blood cells protect us from bacterial and fungal infections.  Current mode of treatment to boost the immune system is through administration of G-CSF to help the bone marrow recover its ability to produce white blood cells but it is not without challenges.

 

CLT-008 consists of myeloid progenitor cells of the blood forming system that do not have the stem cell ability to self-renew and are restricted to creating mature myeloid cells, that include neutrophils, red blood cells and platelets.  Additionally, CLT-008 does not contain any detectable T-cells and hence GVHD is not expected.  Once infused, they can differentiate into mature cells and is expected to last for 2-3 weeks.  This is an off-the-shelf, cryopreserved product that can be potentially used for the treatment of chemotherapy and radiation induced neutropenia.  It is administered to patients who do not have an active immune system.  The cells have been shown to prevent fungal infections, enhance engraftment and protect from radiation in pre-clinical models.  Cellerant is developing CLT-008 for the treatment of neutropenia in AML patients and for the treatment of victims when they are exposed to radiation.  Mandalam shared pre-clinical data demonstrating that the myeloid progenitors can be administered 5-7 days post exposure to lethal levels of radiation and increase survival.  It is expected that in the event of mass casualty, it would be required to have a drug that can be administered at least 2 days post exposure as access to the victims in the first 24 hours may be difficult.  CLT-008 administration is expected to be via the intravenous route and would require minimal infrastructure.

 

Mandalam shared data on IND-enabling pre-clinical studies indicating the product to be safe and showing efficacy (increased survival) among mice suffering high levels of radiation.  He shared details on the ongoing clinical studies and also discussed the company’s financial status.  Cellerant has received two rounds of funding from BARDA, the Biomedical Advanced Research and Developmental Authority.  Mandalam also discussed the company’s product pipeline, including the antibody program targeting cancer stem cells in AML.  The program was followed by Q&A.