Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in autoimmune disease.
Summit Therapeutics snagged a $2 billion all-stock investment from AstraZeneca—likely enough to see the biotech through Phase 3 trials for the Akeso-partnered PD-1/VEGF bispecific ivonescimab. Summit shares popped more than 16% to $17.96 as the markets opened on Thursday. The deal comes as Summit awaits an FDA on the asset’s use in EGFR-mutated lung cancer, expected on or before Nov. 14.
Also on Tuesday, another popular biotech, uniQure, crashed nearly 40% after four-year data from the Phase 1/2 trial of its gene therapy for Huntington’s disease underwhelmed investors. The new data, which showed a 44% slowing of disease progression in 12 patients given the highest dose of the therapy, was a notable drop from the 75% slowing of progression seen at three years. However, company executives, as well as analysts, emphasized the importance of the three-year data—on which uniQure’s regulatory applications are based.
Speaking of the FDA, the agency has been on a roll with approvals recently, as AbbVie, Eli Lilly, Merck and Mirum Pharmaceuticals have all notched nods in the past week.
Meanwhile, CAR T therapies, whose use in autoimmune diseases has taken a hit recently, got some positive news last week as Kyverna Therapeutics’ mivocabtagene autoleucel (miv-cel) showed strong durability in patients with stiff person syndrome. The results could bolster Kyverna’s chances of scoring the first CAR T approval for an autoimmune indication. A rolling FDA submission on track for completion before the end of this year.
Finally, BioSpace’s Women in Leadership series continues as Senior Editor Gabrielle Masson spoke with Bicara cofounder and CEO Claire Mazumdar about how she built a culture around “no Sunday scaries” and how she knew it was time to hand the reigns to the company’s chief operating officer. You can check out that interview in BioPharma Executive this week.
