Fox Chase Chemical Diversity Center, Inc.

A deal with Pfizer follows a busy few weeks that saw Basilea Pharmaceutica acquire an invasive mold infection drug from Gravitas Therapeutics and an endolysin antibacterial from Tonabacase. Only two and a half years after Pfizer acquired infectious disease biotech Amplyx for an undisclosed sum, the Big Pharma has sold the lead antifungal asset from that deal to Basilea Pharmaceutica. In its third deal in a month, Basilea is handing over $37 million upfront for the rights to the broad-spectrum antifungal, called fosmanogepix, as well as the rights to a preclinical antifungal compound. Today’s deal means the Swiss biotech will be liable to pay up to $110 million to Pfizer in commercial milestones should the drug reach the market. Basilea is also taking on the obligations and rights from previous agreements for the drug, which add up to $396 million in various development, regulatory and commercial milestone payments. Fosmanogepix has remained in phase 2 development for the treatment of a fungal disease called candidemia and invasive mold infections since Amplyx came under Pfizer’s wing, but Basilea plans to kick-start a phase 3 trial in mid-2024. Pfizer will retain the right of first negotiation for the commercial license to fosmanogepix if it clears phase 3 trials. It won’t be Basilea’s first interaction with Pfizer, however—the Big Pharma secured the Europe rights to Basilea’s approved antifungal Cresemba back in 2017 and also has the license in China. Basilea CEO David Veitch hailed today’s deal as a “transformative transaction for us.” As well as Cresemba, the company also owns the antibiotic Zevtera, and Veitch said gaining fosmanogepix “provides a strong commercial near-term opportunity beyond our currently marketed anti-infectives.” It follows a busy few weeks of dealmaking that saw Basilea acquire an invasive mold infection drug from Gravitas Therapeutics and an endolysin antibacterial from South Korea’s Tonabacase. “We have now executed three transactions over the course of the last few weeks that have significantly strengthened our clinical-stage portfolio, and we continue to see interesting opportunities for further transactions in the future,” Veitch added. The recent deals are the latest example of Basilea’s pivot away from oncology to focus solely on anti-infectives, a move that got off to a bumpy start at the beginning of the year when preclinical profiling of an antifungal program purchased from Fox Chase Chemical Diversity Center for an undisclosed fee led the company to hand the asset back. 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 Zevtera, which is already marketed in Europe and is now awaiting an FDA decision.

GR-2397 has had its fair share of owners, having been acquired by Gravitas Therapeutics from Brickell Biotech in 2021. Basilea Pharmaceutica is hoping to have better luck in its second attempt to build out its anti-infective pipeline, handing over $2 million for Gravitas Therapeutics’ clinical-stage antifungal. GR-2397 is being developed to treat invasive mold infections caused by the Aspergillus species. Invasive aspergillosis is most likely to affect immunocompromised patients, such as those being treated for blood cancer, and can be life-threatening. Gravitas has previously branded the therapy as “conferring rapid fungicidal activity, low propensity for P450 drug-drug interactions, and activity against difficult-to-treat resistant fungal pathogens.” The San Diego-based biotech has already put various intravenous doses of the therapy through a phase 1 trial to test its safety. Basilea said it will conduct its own preclinical profiling of GR-2397, which it will rename BAL2062, before launching a planned phase 2 study in 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,” Basilea Chief Medical Officer Marc Engelhardt, M.D., said in the Oct. 19 release. As well as the small $2 million upfront, the Swiss biotech will be eligible to pay Gravitas up to $1.75 million in pre-approval milestone payments and up to a further $67 million in biobucks, should the therapy be accepted by regulators and reach the market, on top of royalties. Basilea CEO David Veitch described today’s licensing deal as “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.” GR-2397 has already had its fair share of owners, having been acquired by Gravitas from Brickell Biotech in 2021, although its origins lie with Astellas. Basilea’s pivot away from oncology to focus solely on anti-infectives got off to a bumpy start at the beginning of the year, after the biotech’s preclinical profiling of an antifungal program it bought from Fox Chase Chemical Diversity Center for an undisclosed fee led the company to hand the asset back. 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 is now awaiting an FDA decision.

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.