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Sanofi will discontinue ongoing Phase 2 trials evaluating IL-2 compound from Synthorx

SOTIO Biotech

14/12/2022 | 2 minuty čtení

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After seeing BMS and Nektar Therapeutics give up on their candidate, Sanofi has reported “lower than projected” efficacy data on its prospect and rethought its plans for its IL-2 molecule. Sanofi entered the IL-2 space through its $2.5 billion takeover of Synthorx.

The deal gave Sanofi control of SAR444245, then known as THOR-707. Sanofi has initiated a clutch of midphase clinical trials to assess SAR444245 in various combinations and indications. The early signs from the trials were bad enough to prompt Sanofi to change course.

CLINICAL AND REGULATORY

Sanofi discontinues the ongoing clinical IL-2 platform from Synthorx

The decision was made to discontinue the ongoing phase 2 platform trials with the current every 3-week dose schedule as the efficacy observed in the early look of the data was lower than projected. The decision was not based on any safety-related issues. Sanofi booked a $1.6 billion impairment related to the candidate. The R&D team has decided to run a Phase 1/2 program focused on schedule intensification to solidify the foundation for a best-in-class target profile. The new R&D plan is based on emerging external and internal data about non-alpha IL2’s mechanism of action and therapeutic potential.

DEALS AND FINANCINGS

Incyte buys vitiligo company Villaris

Incyte will pay $70 million up front to acquire Villaris Therapeutics in a back-loaded deal that includes $310 million in developmental and regulatory milestones, plus nearly $1.1 billion in commercial milestones. Medicxi said that during its short lifespan, Villaris took an academic idea, that targeting IL-15 signaling could be a viable approach to create a durable treatment for vitiligo, and advanced the antibody auremolimab (VM6) to the late preclinical stage. Villaris founder John Harris saw in the clinic that lesions came back in the same space, suggesting a memory portion to this autoreactive disease. The use of an antibody targeting CD122 to reverse disease in mice with established vitiligo, a T cell-mediated autoimmune disorder that results in white patches on the skin. The molecule blocks IL-15 by binding the β subunit of CD122, a receptor shared by IL-2 and IL-15.

PureTech and Nektar rumored merger called off few days after the speculations appeared

Begininng of October, rumors spread that PureTech Health was preparing to merge with Nektar Therapeutics. But the deal, never officially announced, has been called off. When the rumors first broke, PureTech released a statement on Oct. 6 confirming the two companies were in negotiations, but that they were “non-binding” and “there can be no certainty that any firm offer will be made, nor as to the terms of any such offer.” Later, in a K-6 filing and release, PureTech announced the two companies had agreed to terminate discussions. Further, PureTech indicated the discussions had been very early, but under UK regulations, were required to be announced. PureTech shares took a hit, plunging 21%, while Nektar’s dropped 4.3%.

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