Today, a brief rundown of news from Merck & Co. and Roche, as well as updates from Arcus Biosciences and Ray Therapeutics that you may have missed.
Merck & Co. is the latest pharmaceutical giant to dig deeper into artificial intelligence, announcing Wednesday a broad partnership with Google Cloud to boost its "digital backbone as an AI-enabled enterprise." Merck will make a multiyear investment worth up to $1 billion in the deal, through which it will apply AI tools to everything from research and development to manufacturing, commercial and corporate functions. The partnership comes amid a broader adoption of AI by large pharmaceutical companies, which are using one-off deals and grander alliances to help accelerate drug development. — Ben Fidler
Merck has also won Food and Drug Administration clearance to begin selling a new, two-drug combination for HIV. Called Idvynso, it was approved on Tuesday as a replacement therapy for adults whose HIV-1 levels are currently suppressed by another drug regimen. Idvynso combines Merck's previously approved medication Pifeltro with the newer agent islatravir in a single tablet. The drug has had a winding development journey, with studies once halted due to safety concerns. But it's now earned the first of what could be two FDA nods, as the agency may afterward allow use in "treatment-naive" patients as well. The latter decision is the "key inflection point" for Idvynso, though it's unlikely the drug will "materially disrupt" the dominant position of Gilead Sciences' Biktarvy, wrote RBC Capital Markets analyst Trung Huynh. A once-monthly, oral preventive therapy Merck is working on has higher upside, he added. — Ben Fidler
Roche presented detailed results from a pair of studies it's hoping will support approvals of fenebrutinib, an experimental pill for multiple sclerosis. Study data unveiled at the American Academy of Neurology meeting show that, when compared to Sanofi's Aubagio over 96 weeks, fenebrutinib led to a 51.1% reduction in annual relapse rates in one trial and a 58.5% reduction in another study. That performance equates to patients having one relapse every 17 years, Roche said. Some analysts have been skeptical of fenebrutinib's approval chances, given an imbalance in patient deaths in the studies and the presence of the kind of liver-related side effects that led U.S. regulators to reject a similar medicine. Roche noted, however, that the rates of liver enzyme spikes between patients who got Aubagio and fenebrutinib in its two trials were "comparable." — Ben Fidler
Arcus Biosciences and Gilead Sciences halted, for futility, a Phase 3 trial testing two Arcus immunotherapies and chemotherapy against Merck's Keytruda and chemo in non-small cell lung cancer. Arcus also announced in a Monday regulatory filing that the partners are ending a longstanding, cancer-focused research collaboration that began in 2020. The study stoppage followed a previous failure in gastroesophageal cancers that led Arcus to pivot away towards a different medicine it's advancing for kidney tumors. The deal's end is "an opportunity for the company to pursue broader business development strategies" with that drug, casdatifan, as well as other pipeline candidates, wrote Leerink Partners' Daina Graybosch. — Ben Fidler
Ray Therapeutics has raised another $125 million to advance gene therapies meant to restore vision in people with blinding eye conditions. The financing announced Tuesday comes from nearly a dozen backers, including Janus Henderson Investors, Adage Capital Management, Deerfield Management and Novo Holdings. The funds will support late-stage development of its lead program in retinitis pigmentosa, and earlier testing of a therapy for Stargardt disease and geographic atrophy. Ray secured a $100 million Series A round upon launching in 2023. It’s making “optogenetic” therapies that deliver light-sensitive proteins into retinal cells, an approach researchers hope will help patients regain sight regardless of the genetic mutation underlying their disease. — Gwendolyn Wu
