RARE Daily

Naya Bio Acquires Florida Biotech’s Gene Therapy Program for Leber’s Hereditary Optic Neuropathy

January 24, 2024

Rare Daily Staff

Naya Biosciences said it will pay $20 million to acquire Florida Biotechnologies, a company developing therapeutics for mitochondrial genetic diseases that includes a clinical stage gene therapy program for Leber’s hereditary optic neuropathy.

“We are impressed by the initial safety and efficacy of the AAV gene therapy developed by Florida Biotechnologies and the University of Miami for the treatment of LHON, a rare and debilitating genetic disease with no currently approved therapeutic regimen,” said Naya Chairman and CEO Daniel Teper. “Naya is committed to accelerating clinical development and Early Patient Access to this breakthrough therapy, which has the potential to achieve curative results in patients with progressive vision loss and blindness.”

The therapy’s 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 1 trial and a second-generation product with improved mitochondrial targeting has demonstrated curative results without any serious adverse events noted in preclinical studies for LHON.

Naya entered into a binding term sheet with Florida Biotechnologies Inc. to acquire all of the outstanding capital stock of Florida Biotechnologies for $20 million in shares of Naya post-merger with its planned merger with Invo Biosciences. Florida Biotechnologies is also eligible for an additional $5 million or one million shares each worth $5.00, upon achievement of certain milestones. The Florida Biotechnologies Transaction is contingent on the closing of the Invo merger, expected in the first quarter of 2024, and sufficient financing to further develop the gene therapy programs from Florida Biotechnologies.

Photo: Daniel Teper, chairman and CEO of Naya

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