Welcome to the latest edition of our weekly EuroBiotech Report. We start this week with Sanofi, which embarked on a new phase in its history with the $2.5 billion takeover of Synthorx and data on sutimlimab. Elsewhere, Roche shared data suggesting its bispecific works in patients failed by CAR-T therapies. Leo Pharma revealed its rival to Dupixent met all the endpoints in a pivotal program. The FDA hit Ipsen's palovarotene with a clinical hold. And more. — Nick Taylor
1. Sanofi inks $2.5B Synthorx takeover to gain IL-2 cancer drug
Sanofi has struck a deal to buy Synthorx for $2.5 billion (€2.3 billion). The takeover, the first of Paul Hudson’s time as CEO, will give Sanofi control of an IL-2 drug it thinks can become a foundation of future immuno-oncology combinations.
2. ASH: Sanofi eyes FDA filing as orphan blood drug hits late-phase goal
A phase 3 trial of Sanofi’s rare blood disease drug sutimlimab has met its primary endpoint. More than half of the participants met the primary endpoint, teeing Sanofi up to file for FDA approval of the complement C1s inhibitor.
3. ASH: Roche bispecific delivers for hard-to-treat lymphoma patients failed by CAR-Ts
Roche rolled out new data this weekend showing mosunetuzumab can trigger complete responses in a tough group—lymphoma patients failed by CAR-Ts and other drugs. The phase 1/2b linked the bispecific antibody to durable responses in a significant minority of hard-to-treat non-Hodgkin lymphoma patients.
4. Leo's Dupixent rival hits all endpoints in pivotal program
Leo Pharma’s tralokinumab has hit all the primary and secondary endpoints in its three pivotal trials. The data position Leo to file for approval of the Dupixent rival in atopic dermatitis next year, but the lack of numbers shared publicly make it impossible to gauge whether tralokinumab is a threat to Sanofi and Regeneron’s blockbuster incumbent.
5. FDA hits Ipsen's $1B drug with clinical hold over safety signal
The FDA has placed two trials of palovarotene on partial clinical hold eight months after Ipsen gained the drug in its $1 billion (€900 million) takeover of Clementia Pharmaceuticals. FDA staff took the action in response to cases of early growth plate closure in children on the retinoic acid receptor gamma agonist.
And more articles of note>>