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NAYA Biosciences has entered into a binding letter of intent to acquire Florida Biotechnologies, Inc. a gene therapy company focusing on the treatment of mitochondrial diseases.

The therapy’s strong intellectual property is focused on the modification to traditional AAV gene therapy, in which a mitochondrial targeting sequence is added to the capsid, which allows for localization to the mitochondria. The modification can be used on AAV2-AAV9 and provided via different routes of administration.

The first-generation product has been evaluated in a phase I trial and a 2nd generation product with improved mitochondrial targeting has demonstrated curative results without any serious adverse events noted in preclinical studies for LHON.

The program has received over $6 million in grant funding to date and qualifies for Regenerative Medicine Advanced Therapy (RMAT) designation and multiple priority FDA review vouchers. The combination of multiple orphan indications, multiple routes of administration, and multiple AAV serotypes applicable supports a broad gene therapy platform for mitochondrial orphan diseases.


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