BA1106 / Luye Group, Shandong Boan Biotechnology - LARVOL DELTA

Shandong Boan Biotechnology announced that China’s Center for Drug Evaluation has accepted its application for a Phase II clinical trial of its anti-CD25 antibody BA1106 combined with PD-1 inhibitor BA1104 as first- or second-line therapy for driver gene-negative non-small cell lung cancer. (TipRanks) - "The multicenter, single-arm, open-label study will assess efficacy, safety, and pharmacokinetics in a patient population with limited options after developing resistance to existing immune checkpoint inhibitors."

New P2 trial • Non Small Cell Lung Cancer

Preliminary safety and efficacy results of an anti-CD25 monoclonal antibody (BA1106) in patients with advanced solid tumors: The first-in-human study (AACR 2025) - P1 | "BA1106 was well-tolerated and showed preliminary anti-tumor activity in solid tumors. Simultaneously, a clear decrease of Treg cells and increased Teff/Treg ratio were observed, what show the potential to combined with PD-1 inhibitors.This trial was registered in clinicaltrial.gov, NCT05650242."

Clinical • First-in-human • Metastases • P1 data • Colorectal Cancer • Endocrine Cancer • Hepatocellular Cancer • Malignant Pleural Mesothelioma • Mesothelioma • Neuroendocrine Carcinoma • Oncology • Pleural Mesothelioma • Small Intestinal Carcinoma • Solid Tumor • CD4 • CD8 • IL2 • MB

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=177 | Recruiting | Sponsor: Shandong Boan Biotechnology Co., Ltd | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Dec 2025

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Anxin International: The performance of Boan Biological (06955) is expected to be greatly improved due to the heavy volume of various products and the imminent listing [Google translation] (Investing.com) - "BA2101 (long-acting IL4R monoclonal antibody) has entered Phase 1 clinical trials in China and is expected to complete Phase 1 clinical trials for SAD by the end of 2023; BA1106 (non-IL-2 blocking anti-CD25 monoclonal antibody) has entered Phase 1 clinical trials in China. It is expected to complete the Phase 1 SAD clinical trial in 2024; BA1105 (ADCC enhanced Claudin 18.2 monoclonal antibody) has entered the Phase 1 clinical trial in China, and is expected to complete the Phase 1 SAD clinical trial by the end of 2023; BA1301 (Claudin 18.2 ADC) has obtained IND approval is expected to start phase 1 clinical trial in the second quarter of 2023; BA1202 (CEA/CD3 double antibody) is expected to receive IND approval in the first half of 2023."

IND • New P1 trial • Gastrointestinal Cancer • Immunology • Oncology • Solid Tumor

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=177 | Recruiting | Sponsor: Shandong Boan Biotechnology Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Boan Biotech’s Investigational Anti-CD25 Antibody BA1106 Administered for First Patient in Phase I Clinical Trial (PRNewswire-Asia) - "Luye Pharma Group today announced that BA1106, an investigational non-IL-2 blocking anti-CD25 antibody developed by its subsidiary Boan Biotech, has been administered for the first patient in a Phase I clinical trial. This trial is designed to evaluate the safety, pharmacokinetics and preliminary efficacy of BA1106 in patients with advanced solid tumors. BA1106 is the first investigational anti-CD25 antibody to start clinical trials in China for treating solid tumors."

Trial status • Oncology • Solid Tumor

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=177 | Not yet recruiting | Sponsor: Shandong Boan Biotechnology Co., Ltd

New P1 trial • Oncology • Solid Tumor

Application Proof of Shandong Boan Biotechnology Co., Ltd (HKEXnews) - "'We were conducting the pre-clinical process research of BA1202 as of the Latest Practicable Date, and we plan to submit the IND application in the first half of 2023...BA1106 is an innovative CD25 fully human monoclonal antibody independently developed by us...CD25 antibody is a broad-spectrum immuno-oncology drug, with potential indications for cervical cancer, renal cancer, ovarian cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, gastric cancer and breast cancer...We were conducting non-clinical studies of BA1106 as of the Latest Practicable Date, and we plan to submit the IND application in the third quarter of 2022'."

IND • Preclinical • Oncology • Solid Tumor

Luye Pharma : Boan Biotech's Investigational Anti-CD25 Antibody BA1106 Approved for the First Clinical Trial on Treating Solid Tumors in China (Market Screener) - "Luye Pharma Group announced today that BA1106, a human anti-CD25 monoclonal antibody developed by its subsidiary Boan Biotech, has been approved for clinical trials by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA)."

New trial • Oncology • Solid Tumor

Two novel human anti-CD25 antibodies with antitumor activity inversely related to their affinity and in vitro activity. (PubMed, Sci Rep) - "Structural analysis by cryo-EM revealed that BT942 recognizes an epitope on opposite side of the CD25-IL-2 binding site, consistent with no IL-2 signaling blockade in vitro. BT942 appears to be an excellent candidate for cancer immunotherapy."

Journal • Preclinical • Oncology • CD4 • CD8