SIBP-03 / Sinopharm - LARVOL DELTA

HER3 upregulation reduces DS-8201 sensitivity in HER2-positive tumor cells by ATR/CHK1/FoxO1 signaling cascade. (PubMed, Acta Pharmacol Sin) - "Based on this finding, we showed that combining DS-8201 with either a HER3-targeting antibody (SIBP-03) or an ATR inhibitor (BAY1895344) resulted in significant synergistic antitumor efficacy without substantial toxicity in vitro or in vivo. Overall, this study revealed that the ATR/FoxO1/HER3 pathway plays a critical role in modulating the efficacy of DS-8201, suggesting that combining DS-8201 with ATR or HER3 inhibition represents a promising therapeutic strategy for HER2-positive cancers."

Journal • Oncology • CHEK1 • ERBB3 • HER-2

Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=81 | Recruiting | Sponsor: Shanghai Institute Of Biological Products | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=81 | Not yet recruiting | Sponsor: Shanghai Institute Of Biological Products | Trial completion date: May 2025 ➔ Jul 2026 | Initiation date: Dec 2023 ➔ Aug 2024 | Trial primary completion date: May 2025 ➔ Jul 2026

Metastases • Trial completion date • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Shanghai Institute of Biological Products Co., Ltd.'s application for implied clinical trial approval has been accepted [Google translation] (Stockstar) - "On June 21, according to the official website of CDE, Shanghai Institute of Biological Products Co., Ltd. jointly applied for the drug 'Recombinant anti-HER3 humanized monoclonal antibody injection' and obtained implicit approval for clinical trials, acceptance number CXSL2400232....This product combined with cetuximab is suitable for the treatment of patients with recurrent/metastatic advanced head and neck squamous cell carcinoma (HNSCC) who have progressed or are intolerant after previous anti-PD-1/anti-PD-L1 immunotherapy and platinum-containing treatment and have no indications for radical local treatment."

New trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

SIBP-03, a novel anti-HER3 antibody, exerts antitumor effects and synergizes with EGFR- and HER2-targeted drugs. (PubMed, Acta Pharmacol Sin) - "Importantly, SIBP-03 enhanced the antitumor activity of EGFR- or HER2-targeted drugs (cetuximab or trastuzumab) in vitro and in vivo. The mechanisms underlying this synergy involve increased inhibition of HER3-mediated downstream signaling. Collectively, these results demonstrated that SIBP-03, which is currently undergoing a Phase I clinical trial in China, may offer a new treatment option for patients with cancers harboring activated HER3, particularly as part of a combinational therapeutic strategy."

Journal • Oncology • EGFR • HER-2

Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=69 | Not yet recruiting | Sponsor: Shanghai Institute Of Biological Products

Metastases • New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase Ⅰa Clinical Study Exploring Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors. (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Shanghai Institute Of Biological Products | Recruiting ➔ Completed | N=68 ➔ 36

Enrollment change • Metastases • Trial completion • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • EGFR • ERBB3 • FAT1 • HER-2 • NOTCH1 • NOTCH2 • NOTCH4 • NRG1 • PIK3CA • TP53