BSI-038 / Biosion, Sino Biopharm - LARVOL DELTA

A first-in-human phase 1 study of TQB2916, a novel CD40 agonist antibody for advanced malignancies (AACR 2024) - P1 | "Pharmacodynamics analysis suggested that TQB2916 treatment achieved CD40 occupancy and immune activation with the changes in cytokines. Considering the safety profile and efficacy, 200 mg was determined as the preliminary expansion dose as it was well tolerated. Studies of TQB2916 in combination with immune checkpoint inhibitors and/or other anti-cancer therapies are ongoing."

First-in-human • Metastases • P1 data • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • CD40 • TNFA

A Clinical Study on the First-line Treatment of Metastatic Pancreatic Cancer With TQB2916 Injection Combined With Gemcitabine Hydrochloride for Injection and Paclitaxel for Injection (Albumin-bound Type) (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

Phase II clinical trial of TQB2916 injection combined with gemcitabine injection and albumin paclitaxel injection in the treatment of pancreatic cancer subjects (ChiCTR) - P2 | N=50 | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P2 trial • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

TQB2916 Injection Combined With Chemotherapy or Penpulimab Injection in the Treatment of Solid Tumors (clinicaltrials.gov) - P2 | N=54 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P2 trial • Melanoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Biosion Presents Discovery and Development Data at PEGS for its Anti-CD40 Agonistic Antibody (PRNewswire) - "Biosion USA...announced the upcoming presentation of discovery and development data for BSI-038, an anti-CD40 agonistic antibody at the PEGS Boston conference to be held from May 15 to 19, 2023....It exhibited potent and dose-dependent anti-tumor activity in animal models. It was well tolerated in pre-clinical studies with the highest non-severely toxic dose (HNSTD) established at 150 mg/kg in non-human primates."

Preclinical • Oncology