ElsaLys Biotech has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for inolimomab (Leukotac®) for the treatment of adults with steroid-refractory acute graft-versus-host disease (aGvHD), a complication of hematopoietic stem cell transplantation.

Inolimomab is a monoclonal antibody that targets the interleukin-2 receptor (IL-2). The investigational immunotherapy prevents IL-2 from binding to the surface of the donor’s overactive T-cells by linking specifically to the alpha chain of the receptor (CD25), thereby inhibiting proliferation. 

The BLA submission includes data from a randomized, controlled, parallel-group, phase 3 study (INO-107 – EUDRACT 2007-005009-24) that compared inolimomab to antithymocyte globulin (ATG) in 100 adult patients with steroid-refractory aGvHD. The primary objective was to evaluate overall survival at 1 year without changing baseline allocated therapy. 

Based on findings presented at EBMT2018, the study did not achieve the primary objective, however, inolimomab was associated with a 37% increase in overall survival at 1 year compared with ATG (HR 0.628 [90% CI, 0.389-1.015]; P =.055). Additionally, a more favorable safety profile was observed with inolimomab vs ATG.

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“This is an important milestone for ElsaLys Biotech as we are one step closer towards potentially bringing inolimomab to patients, responding to an increasing health need,” said Dr Christine Guillen, CEO and co-founder of ElsaLys Biotech. “We look forward to working with the FDA throughout its review process.”

The application review will be conducted under the FDA’s Real-Time Oncology Review pilot program.

For more information visit elsalysbiotech.com.