GeoVax Labs Inc. (NASDAQ: GOVX) stock declined by 3.46% at the last close whereas the GOVX stock price rises by 32.06% in the after-hour trading session. GeoVax Labs is a clinical-stage biotechnology business that uses a proprietary Modified Vaccinia Ankara-Virus like Particle (MVA-VLP)-based vaccination platform to create human vaccines targeting infectious illnesses and cancer.
GOVX stock’ Significant Development
GeoVax Labs has signed an Assignment and License Agreement with PNP Therapeutics, giving GeoVax the right to manufacture and market Gedeptin, a unique patented medication for the treatment of solid tumours.
Gedeptin patents, know-how, regulatory filings, clinical materials, and trademarks are all covered by the License, which grants exclusive worldwide rights. PNP acquired the patent portfolio for Gedeptin from the University of Alabama at Birmingham and the Southern Research Institute (SRI). Under the terms of the licence, GeoVax will take over PNP’s licence arrangement with UAB/SRI. The transaction’s financial details were not published in detail, although they involve a mix of upfront payments, milestone fees, and royalties on total sales.
The Gedeptin therapy cycle has three intra-tumoral injections of Gedeptin over a two-day period, accompanied by a three-day infusion of the prodrug fludarabine phosphate. In a Phase 1 dose-ranging trial, the safety of a single cycle of Gedeptin treatment was shown to be well accepted, with evidence of tumour size shrinkage in patients with solid tumours.
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A Phase 1/2 study is presently recruiting patients with recurrent head and neck squamous cell carcinoma (HNSCC) with tumour accessible for injection and no curative therapeutic alternatives to assess the safety and effectiveness of multiple rounds of Gedeptin therapy. The FDA is funding the first stage of the investigation through its Orphan Products Clinical Trials Grants Program. Gedeptin was also given orphan drug designation by the FDA for the intra-tumoral therapy of anatomically accessible oral and pharyngeal malignancies, such as tumours of the lip, tongue, gums, floor of mouth, salivary gland, and other oral cavities.
