Alpelisib

Eli Lilly is buying Scorpion Therapeutics but will spin out its non-PI3Kα pipeline assets to create a new company. \n Eli Lilly is reenergizing its attempt to challenge Novartis and Roche for a breast cancer market, kicking off the J.P. Morgan Healthcare Conference with a deal to buy Scorpion Therapeutics’ PI3Kα pipeline for up to $2.5 billion.Novartis won FDA approval for its PI3Kα inhibitor Piqray in 2019. Roche’s Itovebi joined the party late last year. Lilly’s attempt to follow its peers took a hit last year when it axed LOXO-783 after comparing clinical data on the molecule to its next-generation candidates. At the time, Lilly’s chief scientific officer Daniel Skovronsky, M.D., Ph.D., said a next-generation prospect would enter the clinic in 2025.The Scorpion deal secures Lilly a clinical-phase candidate ahead of schedule. Scorpion published phase 1 data on its candidate STX-478 last year, generating early evidence that the molecule may have an edge over Piqray and Itovebi and hold its own against Relay Therapeutics’ rival next-generation prospect.Lilly has persuaded Scorpion to part with the candidate and the rest of its work on the PI3Kα pathway in return for up to $2.5 billion in upfront payments and milestones. The Big Pharma is buying Scorpion but will spin out its non-PI3Kα pipeline assets to create a new company. Scorpion’s staffers will join the new company, which will be owned by the biotech’s current shareholders and Lilly. STX-478 and Lilly’s internal PI3Kα candidates are designed to be more selective than Piqray and Itovebi, both of which hit both the wild-type and mutant forms of PI3Kα. Inhibition of the wild-type enzyme in healthy tissue can result in metabolic dysfunction and ultimately cause dose-limiting toxicities, leading Lilly, Scorpion and others to design molecules that selectively target the mutant PI3Kα enzyme.Lilly said last year that LOXO-783 didn’t cause hyperglycemia—an adverse event associated with Piqray and Itovebi—in the clinic but questioned whether the efficacy was good enough in the months before dropping the candidate.Scorpion reported (PDF) a 23% response rate in breast cancer patients when STX-478 was used as a single agent. All cases of hyperglycemia, diarrhea and rash—adverse events associated with inhibition of wild-type PI3Kα—were grade 1 or 2. 

Eli Lilly has turned to a biotechnology startup for help building its pipeline of cancer drugs, agreeing on Monday to purchase an experimental cancer drug from privately held Scorpion Therapeutics for as much as $2.5 billion.As part of the deal, Scorpion will spin out a new, independent company that will hold its other assets as well as inherit its employees. Lilly will take a minority stake in the new company, which will be owned by Scorpions current shareholders, among them Atlas Venture, Vida Ventures and Omega Funds.Current Scorpion CEO Adam Friedman will lead the new company along with other members of the startups management.The acquisition hands Lilly a medicine, dubbed STX-678, that is aimed at tumors driven to growth by mutations to a gene called PI3Ka. So-called PI3Ka mutations are among the most common drivers of cancer, affecting more than 160,000 people diagnosed each year with breast, gynecological and head and neck cancers in the U.S., according to Scorpion.A handful of medicines already available, like Novartis Piqray and AstraZenecas Truqap, as well as others in clinical development also target PI3Ka mutations.Scorpion has claimed its drug could be more selective and potent than existing PI3Ka inhibitors, which block normal, or wild-type, PI3Ka and as a result are tough to tolerate. Existing drugs also dont readily reach the brain tissue into which many solid tumors spread. Scorpion says its drug might overcome these limitations and has advanced the treatment into a Phase 1/2 trial in multiple tumor types, among them a common form of breast cancer.Scorpion has been collaborating with Pfizer to study STX-678 together with a so-called CDK4 inhibitor. Lilly sells a drug, called Verzenio, that similarly targets CDK4 alongside a related protein.The deal will expand a cancer drug division Lilly has poured considerable resources into as a complement to its lucrative metabolic disease business. Lilly acquired Loxo Oncology in 2019 and, since then, has used deals to buy into other areas of precision oncology such as radiopharmaceuticals and antibody-drug conjugates.Verzenio, which Lilly discovered and developed internally, has become the top-selling drug of its class, though much of Lillys revenue is derived from its diabetes and weight loss treatments. Lilly also has in its pipeline an internally developed PI3Ka inhibitor thats in Phase 1 testing.Lillys deal with Scorpion adds to an upward trend in private biotech M&A. The increase has coincided with a weakening market for initial public offerings, which as forced many mature startups to explore strategic options.Scorpion was co-founded in 2020 by Gary Glick, who helped the company raise nearly $300 million in venture funding before departingin 2021. Prior to Scorpion, Glick led Lycera, which inked a 2015 deal with Celgene, and IFM Therapeutics, which has spun off multiple companies that were acquired by Bristol Myers Squibb and Novartis.Glicks latest company, Odyssey Therapeutics, is developing treatments for inflammatory diseases. '