FDA Grants RMAT Designation To Cellerant’s “Off-The-Shelf” Romyelocel-L Cell Therapy

Cell therapy to protect against infection due to abnormally low levels of blood neutrophil cells (shown stained above). Source: Mekis, no changes made, CC0 Creative Commons.

Cellerant Therapeutics Inc., is a clinical-stage company developing innovative cell and antibody-based immunotherapies for hematologic malignancies and other blood-related disorders. Cellerant’s romyelocel-L (human myeloid progenitor cells) “off-the-shelf” cell therapy does not require HLA matching and is designed to prevent bacterial and fungal infections during neutropenia; abnormally low levels of neutrophils.

Neutropenia can result from chemotherapy regimens, particularly those for acute myeloid leukemia (AML) and other hematologic malignancies. Neutropenia also occurs during acute radiation syndrome. Cellerant has completed a randomized, controlled Phase 2 clinical trial of romyelocel-L in patients with AML which showed that romyelocel-L reduces infections and days in hospital.

The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for romyelocel-L for the prevention of serious bacterial and fungal infections in patients with de novo AML undergoing induction chemotherapy.

The FDA granted RMAT designation based on Cellerant’s randomized, controlled Phase 2 trial of romyelocel-L in newly diagnosed AML patients who underwent induction chemotherapy. Results from the trial showed that romyelocel-L reduced the incidence of bacterial and fungal infections and days in the hospital. Cellerant intends to advance romyelocel-L to a pivotal Phase 3 clinical study.

The RMAT designation provides similar advantages as breakthrough therapy designation, including early interactions with the FDA to discuss potential ways to accelerate the development of a therapy towards regulatory approval.

Cellerant’s romyelocel-L program has also been supported by federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services. Cellerant is also developing a treatment for AML by selectively targeting and killing leukemic stem and blast cells using a novel antibody drug-conjugate, the CLT030 product.

“Receiving RMAT designation for romyelocel-L is an important milestone and recognition by the FDA of the potential of romyelocel-L to serve this unmet medical need,“ … “We look forward to working with the FDA to advance development of romyelocel-L.” – Ram Mandalam, President and CEO of Cellerant.

 

Source:

  1. https://www.businesswire.com/news/home/20180702005248/en