First hiccup for Basilea's anti-infective strategy as biotech hands back antifungal 9 months after licensing it
17 Jan 2023
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Source: FierceBiotech
An antifungal compound “did not meet Basilea’s stringent criteria for progressing into the development stage,” the company said.
There’s no turning back for Basilea’s pivot away from oncology to focus solely on anti-infectives, but the Swiss biotech’s decision to hand back an antifungal program only nine months after licensing it is a reminder it won’t always be easy.
Basilea licensed the preclinical program of novel first-in-class broad spectrum antifungals that showed activity on difficult-to-treat mold infections from Fox Chase Chemical Diversity Center (FCCDC) back in April. As part of the agreement, FCCDC, a U.S. company that conducts early-stage drug discovery research, received an undisclosed upfront payment from Basilea as well as the promise of potential milestone payments and royalties.
At the time, Basilea said the licensing deal showed the company’s commitment to its anti-infective-focused strategy. “The profile and the broad antifungal activity of the lead compound shown in preclinical studies are very promising,” Basilea Chief Scientific Officer Laurenz Kellenberger, Ph.D., said in the announcement. “We will now focus on completing the preclinical profiling of the lead compound, which will be decisive for the development strategy and positioning of this new class of antifungal agents.”
But the lead compound turned out to “not meet Basilea’s stringent criteria for progressing into the development stage,” the company admitted in financial guidance published Jan. 11. As a result, “the company decided to return the program to the licensor.”
Basilea has since confirmed to Fierce Biotech that the compound referred to in the document was in fact the FCCDC program.
It’s not the only time in recent memory that Basilea has checked the returns policy after it licensed a candidate. Last June, the biotech handed back cancer drug derazantinib to Merck & Co. Basilea had originally paid $10 million upfront to ArQule—later acquired by Merck—for an exclusive license to the FGFR inhibitor in 2018, but announced last year that a competitive industry landscape and evolving clinical data from open-label studies of the drug made it unable to meet all of the agreement terms.
The terminated agreement was part of an overall restructuring at Basilea that also included the decision not to expand studies for lisavanbulin, a tumor checkpoint controller. Instead, the restructured company pivoted from oncology to focus solely on anti-infectives, such as antibiotic Zevtera, which is already marketed in Europe and which the company now plans to submit for FDA approval in Staphylococcus aureus bacteremia and bacterial pneumonia in the next two to three months.
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