BPB-101 / Betta Pharma - LARVOL DELTA

A phase I first-in-human study of BPB-101, a novel triple functional bispecific antibody targeting GARP/TGF-β complex and PD-L1, in patients with locally advanced or metastatic solid tumors (ESMO Asia 2025) - P1/2 | "BPB-101 showed a manageable safety profile in patients with advanced solid tumors. Based on safety and PK/PD results, 1200 or 1800 mg Q3W was determined as tentative RP2D."

Clinical • First-in-human • Metastases • P1 data • Breast Cancer • Cervical Cancer • Endometrial Cancer • Esophageal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TGFB1

Discovery and preclinical evaluation of BPB-101: a novel triple functional bispecific antibody targeting GARP-TGF-β complex/SLC, free TGF-β and PD-L1. (PubMed, Front Immunol) - "Furthermore, BPB-101 showed a favorable safety profile in nonhuman primate (NHP) toxicity studies. BPB-101 is a potentially promising therapeutic candidate that may address unmet clinical needs in cancer immunotherapy, thus, BPB-101 warrants further clinical investigation."

IO biomarker • Journal • Preclinical • Oncology • TGFB1

Tianfeng Securities: Give Betta Pharmaceuticals an overweight rating [Google translation] (Securities Star) - "On August 26, Beida Pharmaceutical Company released its 2023 semi-annual report...Ensartinib has been included in the medical insurance catalog for both first- and second-line treatment indications, resulting in a significant increase in product sales. In the first half of 2023, sales increased by 12.02% year-on-year....The clinical trial applications for BPI-460372, BPI-452080, BPB-101, and BPI-472372 projects have been approved by the National Medical Products Administration (NMPA) and can begin. The clinical trial of the BPI-460372 project has been approved by the NMPA and the US Food and Drug Administration (FDA)."

IND • New trial • Sales • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BPB-101 in Subjects With Metastatic or Locally Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=388 | Recruiting | Sponsor: Betta Pharmaceuticals Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Breast Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BPB-101 in Subjects With Metastatic or Locally Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=388 | Not yet recruiting | Sponsor: Betta Pharmaceuticals Co., Ltd.

Metastases • New P1/2 trial • Breast Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor