Three Drug Candidates from Sanofi, Novartis, and Compass Therapeutics Advance in Clinical Development

According to announcements from various companies, the CDE official website, and the China Drug Clinical Trial Registration and Information Disclosure Platform, three drugs have made new clinical progress! They are Sanofi's Class 1 new drug RIPK1 inhibitor SAR443820, Compass Therapeutics' VEGF/DLL4 bispecific antibody ES104 (CTX-009), and Novartis' BAFF-R inhibitor ianalumab (VAY736).

Sanofi Submits Clinical Application for First-in-Class New Drug RIPK1 Inhibitor in China

According to the public information on the CDE official website, Sanofi has submitted a clinical trial application in China for SAR443820, a novel Class 1 drug. Public data indicates that this is a CNS-penetrant RIPK1 small molecule inhibitor (also known as DNL788). Sanofi has recently initiated overseas Phase 2 clinical trials to evaluate the efficacy and safety of this product in treating Amyotrophic Lateral Sclerosis (ALS).

Receptor-interacting serine/threonine-protein kinase 1 (RIPK1) is a key signaling protein in the tumor necrosis factor (TNF) receptor signaling pathway, which regulates inflammation and cell death in tissues throughout the body. In preclinical models of amyotrophic lateral sclerosis and multiple sclerosis, inhibiting RIPK1 activity can slow disease progression. Public data shows that SAR443820 is a novel CNS-penetrant small molecule RIPK1 inhibitor with the potential to cross the blood-brain barrier.

Currently, SAR443820 is being evaluated in a Phase 2, randomized, double-blind study in patients with amyotrophic lateral sclerosis. Meanwhile, the product is also planned to enter Phase 2 clinical trials for multiple sclerosis.

Compass Therapeutics: VEGF/DLL4 Bispecific Antibody Phase 2 Clinical Trial Yields Positive Interim Results

Elpiscience Biopharma Announces Positive Interim Results from Phase 2 Clinical Study of ES104 (CTX-009) in Combination with Paclitaxel for the Treatment of Biliary Tract Cancer Reported by its Partner Compass Therapeutics. ES104 is a bispecific antibody that simultaneously blocks VEGF/DLL4, and Elpiscience Biopharma holds the exclusive rights to the drug in Greater China.

ES104 is a bispecific antibody that simultaneously blocks the VEGF and DLL4 signaling pathways, which play important roles in angiogenesis and tumor vascularization.

This time, Compass Company announced the interim results of a Phase 2 clinical study on ES104 combined with paclitaxel for the treatment of biliary tract cancer. The trial data showed that ES104 demonstrated anti-tumor activity in patients who had received prior treatment. Among the 24 enrolled patients, 22 achieved either partial response (PR) or stable disease (SD), with a clinical benefit rate of 92%; 10 patients achieved PR, resulting in an overall response rate (ORR) of 42%, of which 9 PRs were confirmed according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), with one pending confirmation. Additionally, the drug was well-tolerated, showing preliminary safety profiles consistent with previous study results.

Novartis BAFF-R Inhibitor Initiates Phase 3 Clinical Trial in China

China Drug Clinical Trial Registration and Information Disclosure Platform recently disclosed that Novartis has initiated a Phase 3 clinical trial in China for the BAFF-R inhibitor ianalumab (VAY736) in the treatment of lupus nephritis. According to the disclosed information, this study is the Chinese segment of the international multicenter Phase 3 clinical trial for ianalumab, and its results will support the drug's registration application for the lupus nephritis indication.

B-cell activating factor (BAFF) is a type II transmembrane protein that mediates B-cell survival and maturation, and regulates the proliferation, development, and differentiation of B cells by binding to the B-cell activating factor receptor (BAFF-R) expressed on B cells. The overexpression of BAFF is a significant cause of various B lymphocyte-related autoimmune diseases such as systemic lupus erythematosus. According to publicly available information from Novartis, ianalumab is a fully human monoclonal antibody against BAFF-R, specifically designed for antibody-dependent cell-mediated cytotoxicity (ADCC)-induced B-cell depletion, thus possessing a dual mode of action involving BAFF-R inhibition and B-cell depletion.

The SIRIUS-LN study launched by Novartis in China is a randomized, double-blind, parallel-group, placebo-controlled, international multicenter Phase 3 trial designed to compare the safety, efficacy, and tolerability of ianalumab + standard of care (SoC) versus placebo + SoC in adult subjects with active lupus nephritis (ISN/RPS Class III, IV active glomerulonephritis, with or without coexisting Class V features, or pure Class V membranous lupus nephritis).

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