Sanofi is keeping an early pipeline of oncology projects even as it axed clinical-stage programs and reallocated resources to immunology, CEO Paul Hudson told reporters Thursday morning.
Hudson also said that the French pharma is not expecting a significant impact from the US legislation targeting Chinese service providers given the “grandfather nature” of existing relationships.
Sanofi, which is making moves to be an “immunology powerhouse,” has made clear over the past few months that it’s looking to narrow its oncology work after several bold platform plays didn’t work out the way it had hoped. Those changes took shape in recent weeks with the planned divestment of Amunix, shuttering of Kiadis and shrinking of a deal with IGM. It’s also led to job cuts.
“We’re doing the right thing,” Hudson said as he pointed to a recent Phase 3 immunology win. “We’re being respectful of our people and we’re trying to make sure we break new ground scientifically.”
It also means some pruning of the rest of its pipeline. In its first-quarter update, Sanofi disclosed that it’s ending a pair of Phase 2 studies in immunology and a Phase 3 trial in rare disease following disappointing results.
‘Hidden’ early work in oncology
After making “the sensible choice” of pulling back in areas of oncology where it doesn’t envision big success, what’s hidden is “a lot of early stuff” in NK cells, particularly with NK cell engagers, Hudson said. It’s also continuing to study in vivo CAR-T.
“I would say the excitement really is in the earlier stages of research,” he said. “With our industry, it’s better to go where you can differentiate, even if it’s early, and if we get some success we’ll be happy to invest to bring it forward.”
On the other hand, the CEO flagged a label expansion opportunity for its CD38 antibody Sarclisa, with a readout for a subcutaneous formulation expected later in 2024. Positive data could position the multiple myeloma treatment well against Darzalex from Johnson & Johnson and Genmab, the market leader “by some way” according to Hudson. In Q1, Sarclisa brought in just under $114 million for Sanofi, versus almost $2.7 billion for Darzalex.
“We think Sarclisa could go on to be a $2 billion medicine if the data reads out positively, so we’re enthusiastic about that,” he said.
Pipeline trims
Even while Sanofi ended a trio of trials for three programs, all are still being tested in other indications.
The Phase 3 venglustat study in GM2 gangliosidosis, a rare genetic disease, was axed “based on the absence of positive trends on clinical endpoints.” It’s the third time the company has crossed off an indication for this candidate, although the company maintains it has a favorable safety profile and will still be explored in other diseases.
Another high-profile compound, frexalimab, reached the end of the road in Sjögren’s syndrome due to subpar efficacy. But the CD40L antibody, which has been touted as a “pipeline-in-a-product,” continues to be developed in two different types of multiple sclerosis, type 1 diabetes as well as systemic lupus erythematosus.
The company also said it’s scrapping a Phase 2 study of oditrasertib in amyotrophic lateral sclerosis. The writing was on the wall when its partner Denali revealed in February that the study failed the primary endpoint of improvement based on a functional rating scale. But Sanofi, which had paid $125 million upfront to team up with Denali, will march on with a Phase 2 study in multiple sclerosis.
A higher bar for contracts
As for the impending Biosecure Act, which would bar certain Chinese service providers from doing business in the US, Hudson suggested that Sanofi is already doing the work to ensure it can adapt to changing policies and is “well ahead” in terms of preparation.
“Of course, it raises the bar on new contracts,” Hudson said. “I think it’s well understood in the public — because of the nature of the change in expectations from the US — that the grandfathering is important to keep continuity and to recognize it’s a shift,” he added.
The potential impact of the bill has been a persistent question in earnings calls. On Tuesday, Novartis said it is “actively” working on its existing partnerships with relationships likely to change “over time.” Meanwhile, Roche on Wednesday said it has “minor exposure” to Biosecure.