FDA has granted orphan drug designation to the drug-device startup Bionaut Labs (Los Angeles) for the company’s lead therapeutic program, BNL-101, for the local treatment of malignant gliomas.
BNL-101 is a drug-device combination that brings together remote-controllable microscale robotics and the chemotherapy agent doxorubicin.
In March, the startup received $20 million in funding from Khosla Ventures.
The orphan drug designation from FDA covers intrinsic pontine glioma in pediatric and adult patients.
“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, in a statement.
[Related: How Bionaut Labs aims to tackle brain tumors with microrobots]
The company’s chief science officer, Alex Kiselyov, notes that gliomas remain challenging to treat. “Receiving orphan drug designation from the FDA is an important regulatory milestone as we believe it validates our Bionaut-based approach,” Kiselyov said in prepared remarks. “We look forward to advancing our BNL-101 therapeutic program into the clinic.”