Basilea Pharmaceutica is embarking on its second endeavor to bolster its anti-infective pipeline, investing $2 million to secure Gravitas Therapeutics’ clinical-stage antifungal drug. This pharmaceutical, formerly GR-2397, is designed to combat invasive mold infections attributed to the Aspergillus species.
Invasive aspergillosis poses the greatest threat to individuals with compromised immune systems, particularly those undergoing treatment for blood cancer, as it can potentially be life-threatening.
Gravitas has previously characterized this therapeutic as possessing attributes like rapid fungicidal activity, a low likelihood of engaging in drug-drug interactions through the P450 pathway, and efficacy against drug-resistant fungal pathogens that are challenging to treat.
The biotech company, headquartered in San Diego, has already subjected the drug to several intravenous dosing trials during its phase 1 trial phase to assess its safety. Basilea, on the other hand, has expressed its intention to undertake independent preclinical profiling of GR-2397, which they intend to rebrand as BAL2062, before initiating a planned phase 2 study scheduled for the first half of 2025.
In a press release, Basilea’s Chief Medical Officer, Marc Engelhard commended the potential of BAL2062, stating that its innovative mode of action, resulting in rapid fungicidal effects in vitro, could render it a valuable treatment option for challenging invasive mold infections.
Apart from the initial $2 million payment, the Swiss pharmaceutical company stands to make additional payments to Gravitas, including up to $1.75 million in pre-approval milestone payments and a possible $67 million in biobucks if the drug attains regulatory approval and enters the market, in addition to royalties. David Veitch, the CEO of Basilea, characterizes this licensing deal as the first step in their strategy to expand their clinical-stage anti-infectives portfolio, augmenting their existing products, Cresemba and Zevtera.
GR-2397 has changed hands several times in the past, initially originating from Astellas, and then being acquired by Gravitas from Brickell Biotech in 2021. Basilea had initially ventured into oncology before transitioning to a primary focus on anti-infectives.
This adjustment encountered early challenges when their preclinical profiling of an antifungal program obtained from Fox Chase Chemical Diversity Center led to the relinquishment of the asset. This transition included not expanding studies for lisavanbulin, a tumor checkpoint controller, as the restructured company shifted its focus exclusively to anti-infectives. Among their marketed products, Zevtera, an antibiotic, has already gained a foothold in the European market and currently awaits FDA approval.