New Treatment Approved for Malignant Gliomas

By News Release


Bionaut Labs has received orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of malignant gliomas. BNL-101 is for the local treatment of all malignant gliomas, including diffuse intrinsic pontine glioma in pediatric and adult patients. It’s a drug-device combination comprised of doxorubicin as the active drug component together with the company's Bionaut microscale robots.

A Bionaut is a novel treatment modality that uses remote-controlled microscale robots to deliver biologics, nucleic acids, small molecule, gene or cellular therapies locally to targeted CNS disease areas.

“The granting of orphan drug designation for BNL-101 represents a significant milestone for Bionaut Labs as it recognizes the potential of our approach to transform the standard of care for devastating CNS diseases like malignant gliomas,” said Michael Shpigelmacher, co-founder and CEO, Bionaut Labs. “The award of orphan drug designation is the first step in a program of regulatory optimization that Bionaut Labs has initiated to allow us to move BNL-101 into the clinic in the swiftest and most effective way possible. We believe BNL-101 has the potential to play a significant role in shifting the treatment paradigm for malignant gliomas, and we look forward to continuing to work with the FDA as we fulfill our mission of helping patients suffering from debilitating brain diseases who lack treatment options.”

“Gliomas remain some of the most devastating tumors for which there are few, if any, effective treatment options and for which there remains significant unmet medical need,” said Alex Kiselyov, chief science officer, Bionaut Labs. “Receiving orphan drug designation from the FDA is an important regulatory milestone as we believe it validates our Bionaut-based approach. We look forward to advancing our BNL-101 therapeutic program into the clinic.”