Florida-based NAYA Biosciences has entered into a binding letter of intent to acquire Florida Biotechnologies.

The news comes following NAYA’s plans to create an oncology division as part of its merger with Florida-based INVO Biosciences. The merger is expected to close in Q1 2024, as per a 10 November 2023 press release.

NAYA will acquire all outstanding shares of Florida Biotech for $20m in shares of the NAYA post-INVO merger. Florida Biotech will also be eligible to receive $5m in milestone-based payments, as per a 24 January press release. The deal is contingent on the INVO and NAYA merger closing and the merged company having “sufficient financing to further develop the gene therapy programs from Florida Biotech”.

Florida Biotech’s pipeline consists of adeno-associated virus (AAV) vector gene therapies against mitochondrial genetic diseases. The company's lead candidate is AAV gene therapy for Leber hereditary optic neuropathy (LHON), a rare mitochondrial disorder that causes progressive visual loss due to optic neuropathy in young males.

The LHON gene therapy was developed in collaboration with the University of Miami. The first generation of the therapy has been evaluated in a Phase I trial, with the second-generation product with demonstrating “curative results without any serious adverse events” in preclinical studies for LHON.

The LOHN gene therapy programme received over $6m in grants and qualifies for Regenerative Medicine Advanced Therapy (RMAT) designation and multiple US Food and Drug Administration (FDA) priority review vouchers, as per the company.

NAYA Oncology also brought two clinical-stage bispecific antibody assets for the treatment of hepatocellular carcinoma and multiple myeloma (MM) from Cytovia Therapeutics in preparation for the INVO merger in October 2023. The company published preclinical data for the NY-338/CYT-338, a CD38-targeted Flex-NK bispecific antibody, for the treatment of MM was published as an abstract in the 2023 American Society of Hematology's (ASH) meeting supplement of Blood in December 2023.

NAYA plans to start clinical trials for both bispecific antibody therapies in 2024. The first-in-human Phase I study for NY-338 in patients with relapsed/refractory MM is currently in preparation.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva. 

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