BAT6026 / Bio-Thera Solutions - LARVOL DELTA

Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Completed

Trial completion • Solid Tumor

Anti-OX40 antibody BAT6026 in patients with advanced solid tumors: A multi-center phase I study. (PubMed, iScience) - "In 26 patients who were efficacy evaluable, 10 of them achieved stable disease and the disease control rate (DCR) is 38.5%. Further studies including combined with other immunotherapies and some new drug delivery modality and regimen need to be investigated."

Journal • P1 data • Oncology • Solid Tumor

Evaluate the Safety, Tolerability of BAT6026 (clinicaltrials.gov) - P1/2 | N=33 | Recruiting | Sponsor: Bio-Thera Solutions | N=126 ➔ 33

Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2024 ➔ Nov 2023

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

Bio-Thera Solutions Announces Initiation of Phase IB / IIA Clinical Trial for BAT6026, a Monoclonal Antibody Targeting OX40, in Patients with Moderate to Severe Atopic Dermatitis (PRNewswire) - "Bio-Thera Solutions...today announced that dosing has begun in Phase IA/IIB clinical trial to study efficacy and safety of BAT6026 in patients with moderate to severe atopic dermatitis....The Phase IA/IIB, multicenter clinical trial of BAT6026 is designed to assess the efficacy and safety of BAT6026 in patients with moderate to severe atopic dermatitis. Key objectives in the study include determining safety, tolerability, pharmacokinetics, and preliminary anti-inflammatory activity."

Trial status • Atopic Dermatitis • Dermatitis • Immunology • Inflammation

Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Bio-Thera Solutions | N=51 ➔ 30 | Trial primary completion date: Dec 2023 ➔ Jun 2024

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

Evaluate the Safety, Tolerability of BAT6026 (clinicaltrials.gov) - P1/2 | N=126 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluate the Safety, Tolerability of BAT6026 (clinicaltrials.gov) - P1/2 | N=126 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

BAT6026, a novel anti-OX40 antibody with enhanced antibody dependent cellular cytotoxicity effect for cancer immunotherapy. (PubMed, Front Oncol) - "Several OX40 agonistic antibodies are in the clinical stage for cancer treatment, among which PF-04518600 is the leader and currently in phase II trial. Preclinical safety assessment in non-human primates demonstrated a good safety profile for BAT6026. Together these data warrant further development of BAT6026 into clinical trials for patients with cancer."

Journal • Oncology • CD8 • IL2

BAT6026, a novel anti-OX40 antibody with enhanced antibody dependent cellular cytotoxicity effect for cancer immunotherapy (Front Oncol) - "...BAT6026 activated T cells more effectively when clustered by FcγRs engagement and stimulated SEB-pretreated PBMCs to secrete IL-2 cytokines in vitro....BAT6026 also showed a significantly synergistic effect on tumor inhibition when combined treatment with PD-1 antibody. Analysis of tumor-infiltrating T cells revealed that BAT6026 treatment significantly reduced Treg cells and increased CD8+ T cells in tumor."

Preclinical • Oncology

Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumour Patients (clinicaltrials.gov) - P1 | N=13 | Terminated | Sponsor: Bio-Thera Solutions | N=29 ➔ 13 | Trial completion date: Dec 2024 ➔ Mar 2023 | Not yet recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Mar 2023; Considering that the high budget will affect the subsequent development, it is decided to terminate the test voluntarily

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Bio-Thera Solutions Announces First Patient Dosed in a Phase 1 Study in Australia Evaluating BAT6026, an Anti-OX40 Antibody with Enhanced ADCC Effect, in Combination with BAT1308, an Anti-PD-1 Antibody (Businesswire) - "Bio-Thera Solutions, Ltd...announced that dosing has begun in Phase 1 clinical study to evaluate the pharmacokinetics, safety, and preliminary anti-tumor activity of BAT6026, a highly differentiated monoclonal antibody targeting OX40 with enhanced ADCC functions, in combination with BAT1308, a proprietary anti-PD-1 antibody currently in early-stage clinical trials...This Phase 1, multicenter, open-label, dose-escalation clinical trial is designed to assess the safety and tolerability of the combination of BAT6026 and BAT1308 in advanced solid tumor patients."

Trial status • Oncology • Solid Tumor

Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China (clinicaltrials.gov) - P1; N=51; Recruiting; Sponsor: Bio-Thera Solutions; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor

Bio-Thera Solutions Announces Initiation of Phase I Clinical Trials for BAT6026, a Monoclonal Antibody Targeting OX40 (Businesswire) - "Bio-Thera Solutions...announced that dosing has begun in Phase I clinical study to compare the pharmacokinetics and safety of BAT6026, an agonist monoclonal antibody targeting OX40 in cancer patient volunteers. BAT6026 was discovered using Bio-Thera’s proprietary IDEAL (Intelligent Design and Engineered Antibody Libraries) platform."

Trial status • Oncology • Solid Tumor