Could we see Sanofi give up on cancer? Not according to Paul Hudson, although the CEO admitted that after some struggles with its headline candidates, the French pharma might seek solace earlier in its pipeline.
“We have to concede that maybe our efforts are naturally moving towards an earlier oncology positioning,” Hudson said on a fourth-quarter earnings call this morning. “We're doing some very interesting things, setting a very high bar—but it is earlier. So it consumes a little less investment [and] it allows us to allocate more towards the areas where we're having a really important effect.”
Hudson referenced “the setback with amcenestrant,” an oral selective estrogen receptor degrader (SERD) that Sanofi decided to drop in August after getting a look at a phase 3 interim analysis. Another of the Big Pharma’s cancer bets, an IL-2 molecule dubbed SAR444245, has been pushed back from phase 2 to a phase 1/2 trial after posting lower-than-expected efficacy data.
“With our IL-2 retreating to phase 1/2 on the dose interval, we may yet still come back and say something very meaningful with the interval reduction, what that means in efficacy,” he explained on the call. “The ability to reduce the interval was one of the reasons why we took the decision to invest in it in the first place.”
Sanofi won’t keep a foot in the oncology space solely for historic reasons, the CEO said, pointing to the company’s decision to walk away from diabetes R&D. Instead, the Big Pharma will take a “pragmatic” approach to cancer development. “So we may go back to the magic a bit earlier in oncology,” he added.
The company’s cancer pipeline is already heavily weighted to early-stage. Its phase 3 oncology programs all center around new indications for approved immunotherapy Sarclisa or a phase 3 trial for the antibody-drug conjugate tusamitamab ravtansine. An interim analysis of the tusamitamab trial in non-small cell lung cancer is due in the second half of the year.
In contrast, Sanofi lists 11 different candidates in phase 1 development for cancer indications, including an mRNA therapy in partnership with BioNTech and SAR446309, a HER2 T-cell engager brought on board as part of the $1 billion acquisition of Amunix.
One area where Sanofi does remain “very excited”—in the words of Sanofi’s R&D head John Reed—is natural killer (NK) cell engagers. Sanofi, which bought allogeneic or "off-the-shelf" NK cell platform developer Kiadis for $358 million back in 2020, recently went back for a second helping of its NK cell engager collaboration with Innate Pharma.
Despite Senti Bio and Fate Therapeutics culling some NK programs in recent weeks, Reed remained upbeat about Sanofi’s offering. “It's early days…and we hope to have a lot more to say about it as we approach the end of this year,” Reed added.