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First-in-class antifungal has demonstrated fungicidal activity against clinically important molds such as Aspergillus.
October 19, 2023
By: Anthony Vecchione
Basilea Pharmaceutica Ltd, a commercial-stage biopharmaceutical company, has entered into an asset purchase agreement with Gravitas Therapeutics Inc. for GR-2397, a clinical-stage antifungal compound with a novel mechanism of action, targeting invasive mold infections caused by Aspergillus species. BAL2062 (formerly GR-2397) is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains. Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses. The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US FDA for invasive aspergillosis. Basilea is paying $2 million in upfront payments. Under the asset purchase agreement with Gravitas, Basilea assumes the rights and obligations under a license agreement with Astellas Pharma Inc. who owns patents relating to BAL2062 (formerly GR-2397) and takes over an agreement with Fresh Tracks Therapeutics Inc., who previously owned the asset that was acquired by Gravitas. Upon achievement of defined milestones, Basilea will make total pre-approval milestone payments of up to $1.75 million and up to $67 million in total approval and commercialization milestone payments. In addition, Basilea will pay royalties on sales. David Veitch, CEO of Basilea, said: “This is the first transaction in the implementation of our strategy to expand our clinical-stage anti-infectives pipeline and to complement our portfolio of marketed products, Cresemba and Zevtera. We are looking forward to developing this asset.” Marc Engelhardt, chief medical officer of Basilea, added: “With GR-2397, now referred to as BAL2062, we are adding an antifungal compound to our pipeline that has already completed a clinical phase 1 study. Based on its novel mechanism of action which results in rapid fungicidal activity in vitro, BAL2062 could become a valuable treatment option against difficult-to-treat invasive mold infections.”
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