FDA Grants Bionaut Labs Orphan Drug Designation to BNL-101 for the Treatment of Malignant Gliomas in Pediatric and Adult Patients

LOS ANGELES, June 23, 2021 /PRNewswire/ -- Bionaut Labs, a company focused on revolutionizing the treatment of central nervous system disorders (CNS) with its Bionaut™ precision medicine treatment modality, today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for BNL-101 for the local treatment of all malignant gliomas including diffuse intrinsic pontine glioma in pediatric and adult patients. BNL-101 is a drug-device combination comprised of doxorubicin as the active drug component together with the company's Bionaut™ microscale robots.

"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."

The FDA's Office of Orphan Drug Products grants orphan drug status to support development of drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation provides benefits to drug developers designed to support the development of drugs and biologics for small patient populations with unmet medical needs. These benefits include assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees, and seven years of marketing exclusivity.

About Bionaut™ Treatment
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. Through precise targeting, Bionaut™ therapeutics could offer better efficacy and safety that cannot be achieved by other traditional treatment or delivery modalities.

Bionauts™ can be constructed in different designs with custom geometries and surface characteristics. Smaller than a millimeter, they contain moving parts controlled remotely by a magnetic controller, allowing them to safely reach the target and release a therapeutic payload from the cargo compartment. Engineering flexibility provides a broad foundation for designing Bionaut™ therapies for nearly any disease of interest.

Bionaut Labs has demonstrated safe and controlled navigation of its therapeutic Bionaut™ to and from the treatment locus in the brain, in a large animal in vivo model. Furthermore, the Company has successfully treated human glioma tumors established in mice, utilizing guided delivery of therapeutic cargos directly into these tumors to eliminate systemic toxicity. These results pave the way to the clinical trials of the Bionaut™ platform.

About Bionaut Labs
Bionaut Labs is focused on revolutionizing the treatment of central nervous system disorders with its Bionaut™ precision medicine treatment modality that uses remote-controlled microscale robots to deliver biologics, nucleic acids, or small molecule therapies locally to targeted disease areas. With the Bionaut™ medical modality, Bionaut Labs can transform the way the biopharmaceutical industry develops treatments, allowing the Company to engineer the therapeutic index for better efficacy and safety. Led by a world-class team of medical, engineering, and drug development experts, Bionaut Labs' headquarters is in Los Angeles, California, with additional R&D sites in Israel and at the Max Planck Institute in Germany. For more information, please visit www.bionautlabs.com.

SOURCE Bionaut Labs

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