On September 30, 2021 GeoVax Labs Inc. shares were up 12% to $4.68 after the company said reported that it entered into an assignment and license agreement with PNP Therapeutics Inc., granting GeoVax exclusive rights to develop and commercialize Gedeptin, a novel patented product for the treatment of solid tumors (Press release, Southern Research Institute, SEP 30, 2021, View Source [SID1234590563]).
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The biotechnology company said the license provides exclusive worldwide rights to key intellectual property, including Gedeptin patents, know-how, regulatory filings, clinical materials and trademarks.
The patent portfolio covering Gedeptin was originally licensed from the University of Alabama at Birmingham and Southern Research Institute by PNP. Under the License, GeoVax will become the successor to PNP under its license agreement with UAB/SRI.
Detailed financial terms of the transaction weren’t disclosed, but include a combination of upfront payments, milestone fees, and royalties on net sales.
A Phase 1/2 trial, evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma, with tumors accessible for injection and no curable treatment options, is currently enrolling. The initial stage of the study is being funded by the U.S. Food and Drug Administration pursuant to its Orphan Products Clinical Trials Grants Program. The FDA also has granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.