- Long-time partners Sanofi and Regeneron will narrow their research collaboration in immuno-oncology, reworking a 2015 discovery and development deal to focus on two bispecific cancer therapies while moving apart elsewhere.
- Sanofi will pay Regeneron the remaining balance under the original partnership, which was set to end in mid-2020, along with up to $120 million for Regeneron's continued development of the two bispecific antibodies. After that money runs out, or when proof-of-concept is demonstrated, Sanofi can opt-in to either program, under terms announced Sunday on the eve of the J.P. Morgan Healthcare Conference.
- The companies' partnership has already yielded an approved cancer immunotherapy in Libtayo, which will be unaffected by the restructuring. Sanofi, though, indicated it aims to develop its early-stage immuno-oncology pipeline more independently, excepting the two bispecific therapies selected.
As with most pharma companies, Sanofi aims to accelerate its efforts in oncology, particularly with regards to immunotherapies.
The partnership with Regeneron has been a backbone of that push, giving the French pharma a PD-1 inhibitor which both companies hope can serve as a vehicle for expansion in the competitive field.
Now, the companies look to be pulling apart to a degree, while retaining their collaboration around Libtayo (cempilimab) and the selected bispecific therapies. (A separate antibody partnership that led to several approved drugs outside of cancer wound down at the end of 2017.)
That Sanofi and Regeneron will continue to work together on cancer bispecifics is notable, given the accelerating progress in that field. Last month, at the annual meeting of the American Society of Hematology, bispecifics from Amgen, Roche and Regeneron drew attention for early clinical results in several blood cancers.
Under the reworked deal, Regeneron will continue to develop a bispecific targeting BCMA, an antigen of particular interest to drugmakers for the treatment of multiple myeloma, and a protein commonly found on the surface of T cells.
Once proof-of-concept is demonstrated, or the $70 million earmarked for that program's development dries up, Sanofi can opt-in to lead development and commercialization. If approved, the companies would split global profits.
The other bispecific in play targets MUC16 and CD3 and is aimed at mucin 16-expressing cancers such as ovarian. Terms are slightly different here, with Regeneron taking the lead for development and U.S. commercialization post-Sanofi opt-in. Profits would be shared equally.
Regeneron, meanwhile, keeps full rights to its other earlier-stage immuno-oncology assets, which include a LAG3 targeted antibody.
"Though investors may ask 'what’s wrong?' with the remaining I/O assets and development platform shunned by Sanofi, we believe the company is more likely walking away for financial reasons after the PD-1 development commitment was upsized by $1 [billion] and Sanofi tracked internal, wholly-owned oncology assets in phase I that will not be associated with favorable terms for Regeneron," noted Leerink analyst Geoffrey Porges in a Jan. 7 note to investors.
While immuno-oncology remains a priority, both companies trail in the space, where Merck & Co., Bristol-Myers Squibb and others have staked leading positions.