Sarclisa (isatuximab) is a monoclonal antibody that targets a specific epitope on the CD38 receptor on MM cells. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutics such as Sarclisa.
To date, Sarclisa has received regulatory approval for intravenous administration to treat certain patients with relapsed MM and is also under investigation across the MM treatment continuum of care for other hematologic malignancies and solid tumors.
The funds from Blackstone Life Sciences will accelerate the clinical development program and see global pivotal studies for the subcutaneous formulation begin in the second half of 2022.
If successful, Blackstone will be eligible to receive royalties on future subcutaneous sales. Sanofi will retain the full rights and control of Sarclisa and continue to manage the clinical program.
For subcutaneous formulation delivery, Sanofi has partnered with drug delivery tech company Enable Injections.
John Reed, MD, Ph.D., global head of research and development for Sanofi, said: “The collaboration with Blackstone will accelerate our ability to offer patients a subcutaneous anti-CD38 antibody therapy that we believe will be innovative and more convenient. We are committed to building an industry-leading, sustainable pipeline with a steady stream of new therapies that have the potential to transform the practice of medicine”.