This is a Phase IB/IIA clinical study of BAT6026 in patients with AD. The subjects were adults with moderate to severe atopic dermatitis (AD) whose disease was not adequately controlled by prior topical medications or for which topical medications were not appropriate. The first phase was the phase IB study, which was double-blind controlled by placebo in the group and consisted of 3 dose groups. After completing the dose escalation study, the phase IIA study was entered. The Phase IIA study was a randomized, double-blind, controlled, multicentering clinical trial with different dose groups and placebo groups. The primary endpoint was to explore the efficacy and safety of BAT6026 in patients with eczema area and severity index (EASI) of at least 75% lower than the baseline at week 16 after 4 treatment cycles. To provide the optimal dose for the phase III regimen.

Start Date09 Nov 2023

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

NCT05109650

/ TerminatedPhase 1

A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6026 as Monotherapy and in Combination With BAT1308 in Patients With Advanced Solid Tumours

This is a multicenter, open-label, Phase 1 dose-escalation study of BAT6026, an OX40 monoclonal antibody, combined with the anti-PD-1 IgG4 monoclonal antibody BAT1308 in subjects with advanced solid tumours. After a screening period of up to 28 days, qualified subjects will be enrolled to receive their assigned dose regimen until disease progression or intolerable toxicity, withdrawal of consent, per Investigator decision, or end of study, whichever occurs first. The maximum treatment duration is 1 year. Subjects who remain on treatment in the absence of disease progression for more than 1 year may continue to receive study drug for the next cycle at the maximum of 2 years.

Start Date28 Feb 2022

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

NCT05105971

/ CompletedPhase 1

A Phase 1, Multi-Center, Open-Label Dose Escalation Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6026 in Patients With Advanced Solid Tumors

the main purpose:
* Evaluate the safety and resistance of BAT6026 injection as a single agent in the treatment of patients with locally advanced or metastatic solid tumors Acceptability
* Explore maximum tolerated dose (MTD) or maximum administered dose (MAD) and be phase II or follow-up clinical The study provides recommended doses and reasonable dosing schedules.
Secondary purpose:
* Evaluate the single dose and multiple doses of BAT6026 injection in patients with locally advanced or metastatic solid tumors Pharmacokinetic (PK) characteristics of the drug;
* Evaluate the immunogenicity of BAT6026 injection;
* Evaluate the pharmacodynamic properties of BAT6026 injection;
* Preliminary evaluation of the anti-tumor efficacy of BAT6026 injection.

Start Date23 Dec 2021

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

100 Clinical Results associated with Vedastotug

100 Translational Medicine associated with Vedastotug

100 Patents (Medical) associated with Vedastotug

Literatures (Medical) associated with Vedastotug

01 Jun 2025·iScience

Anti-OX40 antibody BAT6026 in patients with advanced solid tumors: A multi-center phase I study

Article

Author: Zhang, Li ; Tang, Long ; Zhou, Huaqiang ; Yuan, Gang ; Fu, Ziyi ; Li, Yongsheng ; Zhao, Hongyun ; Yu, Jin-Chen ; Guo, Yubiao ; Ma, Yuxiang

BAT6026 is a fully human IgG1 OX40 monoclonal antibody. This was a multicenter, open-label, dose escalation, and dose expansion phase I study of BAT6026 conducted in patients with advanced solid tumors who failed standard treatment. Patients received BAT6026 injections ranging from 0.01-10 mg/kg on day 1 of every 3 weeks (Q3W) in dose escalation. In dose expansion phase, 6 patients received 10 mg/kg BAT6026 (Q3W). Thirty patients were enrolled, with 24 in the dose escalation phase and 6 in the dose expansion phase. BAT6026 was generally well tolerated and demonstrated an adequate safety profile at doses ranging from 0.01 mg/kg and 10 mg/kg. 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.

Frontiers in oncology

BAT6026, a novel anti-OX40 antibody with enhanced antibody dependent cellular cytotoxicity effect for cancer immunotherapy

Article

Author: Zheng, Dandan ; Yu, Jin-Chen ; Liu, Cuihua ; Liu, Xiong ; Liang, Shizhong ; Li, Shengfeng ; Mei, Xiong ; Xiao, Cuizhen ; Yue, Haitao ; Qin, Chao ; Lin, Jian ; Zhou, Congcong

OX40 (CD134), a member of the TNF receptor superfamily, is a widely studied costimulatory immune checkpoint. 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. It has been recognized that one potential mode of action for anti-OX40 antibodies is the deletion of intratumoral Tregs. Thus, a novel human anti-OX40 antibody, BAT6026, was generated with enhanced antibody dependent cellular cytotoxicity (ADCC) via fucose deletion to strengthen its Treg depletion activity. This characteristic of BAT6026 differentiates it from other previously reported anti-OX40 antibodies in the field of tumor therapy. The affinity of BT6026 to OX40 was 0.28nM, approximately 8 times stronger than that of PF-04518600. BAT6026 effectively competed for the binding of ligand OX40L to OX40, whereas PF-04518600 only partially competed. Moreover, compared to PF-04518600, BAT6026 activated T cells more effectively when clustered by FcγRs engagement and stimulated SEB-pretreated PBMCs to secrete IL-2 cytokines in vitro. In addition, BAT6026 demonstrated stronger anti-tumor activity than PF-04518600 in an OX40-humanized mouse MC38 tumor model. 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 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.

News (Medical) associated with Vedastotug

01 Feb 2024

·www.prnewswire.com

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

GUANGZHOU, China, Feb. 1, 2024 /PRNewswire/ -- Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, 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. OX40 is an important autoimmune and inflammatory drug target, as OX40 is highly expressed by activated CD4+ and CD8+ T cells, which play an important role in many inflammatory diseases, such as atopic dermatitis (AD). BAT6026 not only blocks the OX40/OX40L interaction to prevent T cell activation and proliferation, but also specifically depletes activated OX40+ T cells through enhanced ADCC effect. Therefore, BAT6026 is expected to treat many inflammatory diseases, including those mediated by Th2 cells. BAT6026 has an exciting preclinical profile and was shown to be safe and well tolerated in a Phase 1 dose escalation clinical study. 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. About Bio-Thera Solutions Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including three approved products: QLETLI® in China, and TOFIDENCE ™/ BAT1806 and Avzivi®/Pobevcy® in the US and China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs. For more information, please visit follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera). Cautionary Note Regarding Forward-Looking Statements This news release contains certain forward-looking statements relating to BAT6026 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise. SOURCE Bio-Thera Solutions, Ltd

Phase 1

30 Mar 2022

·www.biospace.com

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

Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today 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. “BAT6026 has demonstrated highly potent anti-tumor activity as a single agent and in combination with BAT1308 in in vivo pharmacology studies.” said Dr. Shengfeng Li, CEO, Bio-Thera Solutions. To date, anti-OX40 antibodies as agonists have not delivered optimal clinical responses, and recent studies revealed that their activities correlate directly to antibody isotypes and Fc functions, suggesting that Treg depletion might be important in improving clinical outcomes. BAT6026 has demonstrated potent Treg depletion activity, while synergistically activating T effector cells. 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. Key objectives in the study include determining maximum tolerated dose and recommended Phase 2 dose (RP2D), pharmacokinetics and preliminary anti-tumor activity in combination therapy. Disease-specific expansion cohorts will be enrolled at the RP2D in Australia, China and other countries to further evaluate the safety and efficacy of BAT6026 in a variety of malignancies thereafter. In addition, BAT6026 has previously entered a monotherapy clinical study in China. Bio-Thera Solutions is developing several innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, CD47, TIGIT and IO bispecifics targeting synergistic targets like PD-L1/CD47. Bio-Thera recently disclosed its next generation Antibody-Drug Conjugate (ADC) platform that has generated clinical candidate for important and validated tumor target like Folate Receptor alpha.

VedastotugRecombinant humanized anti-PD-1 monoclonal antibody(Bio-Thera Solutions)OX40PD-1Solid tumorCollaborateAntibodyADC

100 Deals associated with Vedastotug

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Moderate Atopic Dermatitis	Phase 2	China	Bio-Thera Solutions, Ltd.	09 Nov 2023
Severe Atopic Dermatitis	Phase 2	China	Bio-Thera Solutions, Ltd.	09 Nov 2023
Solid tumor	Phase 1	Australia	Bio-Thera Solutions, Ltd.	30 Mar 2022
Advanced Malignant Solid Neoplasm	Phase 1	Australia	Bio-Thera Solutions, Ltd.	28 Feb 2022
Locally Advanced Malignant Solid Neoplasm	Phase 1	China	Bio-Thera Solutions, Ltd.	23 Dec 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05105971 (iScience \| Pubmed) Manual	Phase 1	Advanced Malignant Solid Neoplasm	30	BAT6026 (all doses)	romwqfcehv(rncpprajjb) = ncranhbopf ivqkpqdoye (iuvixrxnkp ) View more	Positive	20 Jun 2025

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