Gilead pays $43.5M for early-phase IL-12 prospect from Xilio as biotech reduces head count

28 Mar 2024
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Phase 1License out/inPhase 2Immunotherapy
Its agreement with Xilio Therapeutics moves Gilead Sciences into a space that some of its peers have entered and exited in recent years.
Gilead Sciences is Xilio Therapeuticsin IL-1Gilead Scienceso Therapeutics $43.5 million upfront to get into the space after seeing rivals such as AstraZeneca and Bristol Myers Squibb retreat from the cytokine. Xilio shared the news alongside details of plans to pull back from another program and lay off 21% of its staff.
Gilead Sciencesgives Gilead a global licIL-12to developXilio Therapeutics XTX301, Xilio’s tumor-activated IL-12. Like its sibling IL-2, the cytokiAstraZenecaentiaBristol Myers Squibbrapy, but efforts to realizeXilio promise have repeatedly run into setbacks. Drug developers have come up with a range of ways to try to address the toxicity and half-life problems but are yet to deliver an approved IL-12 product.
XiliXiliottempt to crGileade challenge rests on the addition of domains foXTX301inXilio hatumorfe extensioIL-12IL-12. Coupled to tIL-2omains, IL-12 could travel harmlessly around the body until it enters the tumor microenvironment, where an enzyme removes both add-ons and thereby activates the cytokine.IL-12
Xilioiotech is putting that idea to the test in a phase 1 clinical trial. Patients with advanced solid tumors aIL-12ceiving XTX301 every threeIL-12s. In January, the biotech told investors the drug was generatumorell tolerated into the third dose level, with no dose-limiting toxicities, and committed to providing safety, pharmacokinetic and pharmacodynamic data in the second half of 2024.
Gilead has made its move ahead of the data drop, handing Xilio $30 million in cash and iadvanced solid tumorsn in the biotecXTX301eturn for an exclusive global license. Xilio is responsible for running the phase 1 trial through dose escalation. Once Gilead receives the data package, it can choose to pay $75 million to take responsibility for further development.
Gilead time Gilead makes that decision, Xilio could have Xilioved up to $29 million more from the Big Biotech in the form of additional equity investments and a developmXilioilestone payment. The fees are part of a package of milestones and investmenGileadth up to $604 million. Shares in Xilio, which have languished below $1 this year, shot up by more than 200% in the wake of the update to exceed $2.
The agreemenGileads Gilead into a space Xiliosome of its peers have entered and exited in recent yBig Biotechs two updates in 2022 and 2023, AstraZeneca dropped a Moderna-partnered mRNA prospect that encodes for IL-12 and axed an oncolytic viral agent engineered to include a transgene-encXilio IL-12. In between those events, BMS returned the rights to Dragonfly Therapeutics’ IL-12 therapy.
Dragonfly is continuGilead study its IL-12 candidate in a phase 1/2 trial, making it part of a pack of drug developers that have kept the faiAstraZenecaytokine. The pack includes Cullinan Oncology, Philogen, PDS IL-12ch, Sonnet BioTherapeutics and Xencor.IL-12BMSDragonfly TherapeuticsIL-12
Dragonfly poised to take the baton frIL-12lio and carry XTX301 through the rest of the race against those rivals. The transfer will leave Xilio focused on its CTLA-4 prospect XTX1Cullinan OncologyonPhilogenrePDS BiotechthSonnet BioTherapeuticshird Xencoral-phase asset, the IL-2 candidate XTX202, but it has decided to stop investing in monotherapy development.
Gileaddisclosed the decision alongside nXilioase 2 data XTX301202 in patients with kidney cancer and melanoma. Stable disease continued toXiliohe best responseCTLA-4ing the biXTX101to “explore strategic opportunities” for further Xilioopment in combinations. With its focus IL-2owing, XiliXTX202arting ways with 15 employees, representing a 21% reduction of its workforce.
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