Sanofi Submits Clinical Trial Application in China for Subcutaneous Formulation of Anti-CD38 Antibody Isatuximab

Source | Pharma Observer

On June 17, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Sanofi had submitted a clinical trial application for isatuximab injection (subcutaneous injection). Public information shows that isatuximab is an anti-CD38 monoclonal antibody, which has been previously approved by regulatory agencies in multiple countries and regions for intravenous administration to treat certain patients with relapsed multiple myeloma (MM).

In March 2022, Sanofi and Blackstone Life Sciences announced a strategic collaboration, under which the latter will contribute up to 300 million euros to accelerate global pivotal research and clinical development programs aimed at evaluating the subcutaneous formulation of isatuximab for the treatment of patients with MM. Sanofi stated in a press release that this pivotal study is expected to begin in the second half of 2022.

Screenshot source: CDE official website

Isatuximab is a monoclonal antibody that specifically binds to the CD38 receptor expressed on multiple myeloma cells. It acts through multiple mechanisms of action, including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of multiple myeloma cells, making it a potential target for therapeutic antibodies.

In the development of the subcutaneous formulation of isatuximab, Sanofi has previously collaborated with Enable Injections, a company specializing in innovative drug delivery technologies, to advance the development of subcutaneous administration for this product. The goal is to provide a unique, patient-centered therapeutic experience. Compared to intravenous infusion, subcutaneous injection can significantly reduce administration time. According to the ClinicalTrials website, a phase 3 clinical trial of the subcutaneous formulation of isatuximab is currently being conducted in patients with relapsed/refractory multiple myeloma.

Previously, the intravenous formulation of isatuximab has been approved overseas (with the brand name Sarclisa). In March 2020, it received approval from the U.S. FDA for use in combination with pomalidomide and dexamethasone (pom-dex) to treat adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. In April 2021, the drug was again approved by the FDA, this time for use in combination with carfilzomib and dexamethasone (Kd) as a standard treatment for patients with relapsed/refractory multiple myeloma who have undergone 1-3 prior lines of therapy.

In the Phase 3 clinical trial named ICARIA-MM, the combination of isatuximab with the pom-dex regimen reduced the risk of disease progression and death by 40% compared to the control group. The median progression-free survival (11.53 months vs. 6.47 months) and overall response rate (60.4% vs. 35.3%) were also significantly improved. In another randomized, double-blind, open-label Phase 3 clinical trial named IKEMA, the combination of isatuximab with the standard Kd treatment reduced the risk of disease progression or death by 45%, and extended the median progression-free survival (PFS) in patients.

Multiple Myeloma (MM) is a blood cancer caused by the malignant transformation of plasma cells in the bone marrow. Abnormal plasma cells accumulate in the bone marrow, forming tumors in multiple skeletal sites throughout the body. Not only do these cells fail to perform normal functions, but the antibodies they produce also prevent the bone marrow from generating healthy blood cells. The cancerous plasma cells disrupt the production of normal blood cells, leading to decreased blood cell counts, bone destruction, and kidney damage. Despite significant advances in MM treatment in recent years, most MM patients still face issues of relapse or drug resistance, which threaten their lives.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Jun 17, 2022. From https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Sanofi announces €300 million collaboration with Blackstone Life Sciences to advance an innovative treatment for multiple myeloma. Retrieved March 15, 2022, from https://www.sanofi.com/en/media-room/press-releases/2022/2022-03-15-07-00-00-2403030

[3] FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma. Retrieved March 31, 2021, from https://www.globenewswire.com/news-release/2021/03/31/2202919/0/en/FDA-approves-Sarclisa-isatuximab-in-combination-with-carfilzomib-and-dexamethasone-for-patients-with-relapsed-or-refractory-multiple-myeloma.html

[4] FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma. Retrieved March 31, 2021, from https://www.globenewswire.com/news-release/2021/03/31/2202919/0/en/FDA-approves-Sarclisa-isatuximab-in-combination-with-carfilzomib-and-dexamethasone-for-patients-with-relapsed-or-refractory-multiple-myeloma.html

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