MedPath

Sotigalimab

Generic Name
Sotigalimab
Drug Type
Biotech
CAS Number
2305607-45-6
Unique Ingredient Identifier
JEA93WJ5DG
Background

Sotigalimab is under investigation in clinical trial NCT03123783 (CD40 Agonistic Antibody APX005M in Combination With Nivolumab).

Pipeline Progress: Over 25 New Therapies in Development for Metastatic Liver Cancer

• DelveInsight's latest report reveals a robust pipeline with over 20 companies developing 25+ therapies for metastatic liver cancer, offering new hope for patients with limited treatment options. • Several promising clinical trials are underway in 2025, including studies evaluating novel combinations such as AK104 plus lenvatinib, tislelizumab with lenvatinib, and triplet therapy of nivolumab, relatlimab and bevacizumab. • Key emerging therapies include exoASO-STAT6 targeting tumor-associated macrophages, STP705 dual TGF-ß1/COX-2 inhibitor, and ONCR-177, an oncolytic viral immunotherapy expressing five transgenes to fight tumors through multiple mechanisms.

Gastrointestinal Cancer Symposium 2025: Key Advances in Treatment Strategies

• Nivolumab plus ipilimumab demonstrates superior progression-free survival compared to nivolumab alone in MSI-H/dMMR metastatic colorectal cancer. • Encorafenib combined with cetuximab and chemotherapy shows significant improvement in overall response rate for BRAF V600E-mutated metastatic colorectal cancer. • TACE plus camrelizumab and rivoceranib extends progression-free survival in patients with unresectable hepatocellular carcinoma, offering a manageable safety profile.

Esophageal Cancer Treatment Landscape Evolves with Novel Therapies and Approvals

• The esophageal cancer market is expected to grow significantly, driven by increasing prevalence and the introduction of novel therapies. • In 2023, approximately 77,000 new cases of esophageal cancer were reported across seven major markets, with Japan having the highest number. • Recent FDA approval of TEVIMBRA (tislelizumab) as a monotherapy marks a significant advancement in treating unresectable or metastatic ESCC. • Emerging therapies like zanidatamab and bemarituzumab are expected to revolutionize the esophageal cancer market dynamics during the forecast period.

Sotigalimab Plus Chemoradiotherapy Shows Promise in Rectal Cancer

• The phase 2 INNATE trial evaluated sotigalimab in combination with chemoradiotherapy for rectal cancer, showing a safe and feasible profile. • Patients receiving sotigalimab had a pathological complete response (pCR) rate of 22.2% compared to 14.3% in the control arm. • Grade 3/4 adverse events were lower in the sotigalimab arm (26%) compared to the control arm (45%). • The trial demonstrated a clear pharmacodynamic impact and evidence of adaptive immunity with sotigalimab addition.

Combination Immunotherapies Show Promise in Pancreatic Cancer Treatment

• Combining anti-PD-(L)1 antibodies with hyaluronidase enhances tumor growth inhibition by remodeling the stroma and improving drug delivery in pancreatic cancer models. • Blocking IL-6 in combination with anti-PD-L1 antibodies inhibits tumor volume and increases survival in preclinical pancreatic cancer models, warranting clinical verification. • Combining CD40 agonists with PD-L1 blockade improves overall survival and promotes anti-tumor immunity in orthotopic pancreatic cancer mouse models. • Inhibiting the CXCL12/CXCR4 pathway alongside anti-PD-(L)1 therapy modulates immunosuppression and demonstrates synergistic effects in treating pancreatic cancer.
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