Basilea Pharmaceutica is making a strategic move to bolster its anti-infective pipeline, this time with a $2 million investment in Gravitas Therapeutics’ clinical-stage antifungal candidate, GR-2397.
GR-2397 is designed to combat invasive mold infections caused by the Aspergillus species, primarily affecting immunocompromised patients, including those undergoing blood cancer treatment, where the infections can pose a severe threat to life.
Previously, Gravitas has touted this therapy for its rapid fungicidal activity, low potential for P450 drug interactions, and efficacy against resilient fungal pathogens. The San Diego-based biotech has already advanced the candidate through a phase 1 trial, primarily focused on its safety profile. Basilea, on the other hand, is planning to conduct its independent preclinical assessment of GR-2397, which it intends to rename as BAL2062. Following this evaluation, a phase 2 study is planned for the first half of 2025.
“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.”
– Marc Engelhardt, M.D., Basilea Chief Medical Officer
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In addition to the initial $2 million investment, Basilea has the potential to make further payments, including up to $1.75 million in pre-approval milestone payments and potentially up to an additional $67 million in milestone payments upon regulatory acceptance and market entry. Royalties will also apply.
“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.”
– David Veitch, CEO, Basilea
Notably, GR-2397 has undergone changes in ownership, having been acquired by Gravitas from Brickell Biotech in 2021, although its roots trace back to Astellas.
This move by Basilea signifies a shift away from oncology to focus exclusively on anti-infectives. Earlier this year, the company’s preclinical evaluation of an antifungal program acquired from Fox Chase Chemical Diversity Center resulted in returning the asset. This change was part of a broader restructuring at Basilea, which also included the decision not to expand studies for lisavanbulin, a tumor checkpoint controller. Instead, the company has chosen to pivot toward anti-infectives, with a focus on antibiotics like Zevtera, already marketed in Europe and awaiting an FDA decision.
