FRANCE – Sanofi and Blackstone Life Sciences have announced a risk-sharing agreement in which Blackstone Life Sciences will contribute up to €300 million (US$330 million) to fund the development of a subcutaneous formulation of Sarclisa (isatuximab) to treat multiple myeloma.

“The collaboration…will accelerate our ability to offer patients a subcutaneous anti-CD38 antibody therapy that we believe will be innovative and more convenient,” commented John Reed, global head of R&D for Sanofi.

Sanofi signed a deal with Enable Injections in 2019 to focus on the latter’s enFuse on-body drug delivery platform, stating at the time that it covered “multiple molecule development programs” but providing no further details.

If the Sarclisa program is successful, Blackstone will be eligible for royalties on future subcutaneous sales, though Sanofi will continue to fully manage the clinical program and retain full product rights.

The pivotal study of the new formulation is set to begin in the second half of 2022. The collaboration’s other terms were not disclosed.

Sarclisa is already approved for intravenous administration in combination with other drugs for certain previously treated patients with relapsed multiple myeloma in the United States and the European Union.

According to Sanofi, the drug is also being tested in a number of Phase III trials in combination with current standard treatments across the continuum for multiple myeloma, as well as in other hematologic malignancies and solid tumors.

Sarclisa is taking on Johnson & Johnson’s market-leading CD38 drug Darzalex (daratumumab), which was first introduced as an IV therapy for multiple myeloma in 2015, with a subcutaneous version – Darzalex Faspro –reaching the market in 2020.

Blackstone’s investment track record

As a private investment firm, Blackstone has a long history of assisting companies and their pipeline development programs.

Earlier this month, Blackstone led a US$200 million financing round for DNAnexus, Inc., based in California, to accelerate the global adoption of its cloud-based biomedical data analysis software.

Autolus Therapeutics received US$250 million in funding from Blackstone last year to support the development of obecabtagene autoleucel (obe-cel), a CD19 CAR T cell investigational therapy product candidate.

Last year, Blackstone and Abingworth took a similar approach, investing US$150 million in a trial of Nektar’s IL-2 drug bempegaldesleukin in combination with Merck & Co’s cancer immunotherapy Keytruda (pembrolizumab) in head and neck cancer through their joint venture company SFJ Pharma.

That may not prove to be a good investment, given the news this week that bempeg failed a phase 3 trial in melanoma as a combination therapy with Bristol-Myers Squibb’s Opdivo (nivolumab).

While Blackstone has provided some financing to support the studies, Sanofi stated that it is collaborating on the subcutaneous formulation with drug delivery technology specialist Enable Injections in order to provide a “unique patient-centric treatment experience.”

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