When Paul Hudson became Sanofi’s leader in 2019, one of his main goals was to make the group an oncology player. That dream actually seems very far away now, as the company is battling various fires in its pipeline.
The news that the group had discontinued its oral Serd amcenestrant wasn’t all that surprising given the project’s previous major failures, but Sanofi’s shares fell 5% this morning nonetheless. If the company is deprioritizing oncology, as this move and other recent moves suggest, this could be a Hudson decision, given that he was the architect of Sanofi’s oncology push. What does that mean for his tenure?
In March, amcenestrant failed the Ameera-3 trial in ER-positive, Her2-negative breast cancer, but this and other oral Serd failures focused on all patients, not those with ESR1 mutations. It was the result of guessing.
One question, therefore, is why Sanofi chose to abandon amcenestrant altogether, rather than conduct an ESR1 mutant-enhanced trial.
This isn’t the only recent indication that Sanofi may be lukewarm in oncology. Sanofi recently returned the rights to Libtayo to her Regeneron. Just a year later, he argued, PD-1 laggards could challenge Merck & Co’s her Keytruda with a first-line non-miniature drug. cell lung cancer.
Indeed, some of Sanofi’s many recent deals have been in oncology, but the biggest of these, the $2.5 billion acquisition of Synthorx, is the “non-alpha” IL-2 project SAR444245. After initial data of disappointment, we are in a precarious situation.
Sanofi has maintained confidence in the ‘245 so far, but it doesn’t seem as bullish on the asset as it was a few months ago. In the first quarter results, Hudson talks about the ‘245’s “best-in-class potential,” highlighting some intermediate-stage research he’s started reading this year. However, Sanofi’s slide his deck in Q2 only said a Phase 3 decision on ‘245 is due by the end of his 2022.
Sanofi’s late-stage pipeline is conspicuously absent of oncology. The only notable project without amcenestrant is the anti-Ceacam5 antibody drug conjugate tusamitamab ravtansine, which Sanofi hopes to file next year for second/tertiary treatment of NSCLC.
Bolt Biotherapeutics recently discontinued its preclinical Ceacam5-targeting immunostimulatory antibody conjugate, BDC-2034, after a death in a non-human primate study. However, Bolt has accused his BDC-2034 of binding to other members of his Ceacam family.
Expectations for tsamitamab ravtansine, at least Drug evaluationsell-side consensus forecasts are not particularly high.
Apart from the aforementioned ‘245, Sanofi’s medium-term oncology relies on the anti-Icos MAb, aromfilimab, and the Shp2 inhibitor SAR442720.
“Highlights” of the pipeline
The rest of Sanofi’s late-stage pipeline outside of oncology is also unremarkable. There are big questions about tolebrutinib and rilzabrutinib, oral BTK inhibitors from Sanofi’s $3.7 billion acquisition of Principia, universal hemophilia candidate fitusiran, and itepekimab in his COPD project. .
In fact, the only bright spots are the ultra-long-acting factor VIII therapy efanesoctocog alfa and the respiratory syncytial virus antibody nircevimab. These look likely to be approved, but there are still questions about how big they will get.
Sanofi also has a Zantac lawsuit to address, but today the first lawsuit against GSK was dismissed, a sign that concerns about this may have been overstated.
With news like that, Sanofi should have been up today. The fact that it wasn’t shows how bad things happened to the company.