Today, a brief rundown of news from Moderna and Roche, as well as updates from Summit Therapeutics and Eli Lilly that you may have missed.
Moderna has licensed out rights to an experimental treatment it’s been developing for a rare metabolic disorder. Per terms of a deal announced Thursday, Italian pharmaceutical company Recordati will receive global commercialization rights to a therapy called mRNA-3927 and in late-stage clinical testing for propionic acidemia, which disrupts the body’s ability to process certain proteins and fats. Moderna will receive $50 million upfront and possibly $110 million more in milestones, as well as royalties on sales. The numbers amount to a “garage sale” for Moderna, wrote Leerink Partners analyst Mani Foroohar, who wrote in a note that the “modest” terms suggest “tepid demand” for the company’s rare disease drugs. Shares, which have climbed by nearly 50% this month, ticked down slightly in early trading. — Delilah Alvarado
Moderna separately announced two changes to its leadership team. Chief Medical Officer Jacqueline Miller, who helped develop the company’s COVID-19 vaccine Spikevax, will step down effective March 2. On that same day, David Berman will become the company’s new chief development officer. Berman has years of experience developing cancer immunotherapies at Immunocore, AstraZeneca and Bristol Myers Squibb. Miller will serve as a consultant to Moderna to assist with the transition. — Delilah Alvarado
On an earnings call with analysts this week, Roche executives defended the company’s prized, experimental weight loss shot CT-388, arguing that a different protocol in Phase 3 testing might alleviate some of the side effects reported in a mid-stage trial. The late-stage study will include three dosing regimens that could lower the rate of adverse events that led nearly 6% of the Phase 2 participants who received Roche’s therapy to drop out, said Teresa Graham, Roche’s CEO for pharmaceuticals. Study discontinuations led to a sizable, 5-percentage-point gap in placebo-adjusted weight loss totals between drug recipients who completed the trial or didn’t. Graham said that difference is typical of what’s been seen in obesity drug trials. — Jonathan Gardner
The Food and Drug Administration has begun reviewing what could become the first marketed cancer immunotherapy in the U.S. that simultaneously targets the proteins PD-1 and VEGF. Summit Therapeutics, which holds most rights to the therapy, known as ivonescimab, said Thursday that the agency accepted its application and could clear it for patients with EGFR-mutated lung cancer by Nov. 14. Some analysts have been skeptical of ivonescimab’s approval chances, given the lack of a clear survival benefit in the late-stage study underlying its application. A clearance is “highly unlikely,” wrote Leerink Partners’ Mani Foroohar, in December, though he did acknowledge that Summit could benefit from “political pressure.” — Ben Fidler
Eli Lilly on Thursday announced plans to team up with Flagship Pioneering startup Repertoire Immune Medicines to make “tolerizing therapies” for autoimmune conditions. Repertoire will receive $85 million upfront, and could get up to $1.84 billion more if drugs in the deal hit certain development and commercial goals. The Flagship-backed startup already has collaborations in place with Roche and Bristol Myers Squibb to develop other immune disease prospects. Repertoire has a variety or programs in development, from its autoimmune medicines to bispecific drugs and vaccines for cancer. — Gwendolyn Wu
