Bio-Thera Solutions Initiates Phase I Clinical Trial for BAT4306F, an ADCC-enhanced CD20 monoclonal antibody
GUANGZHOU, China--(BUSINESS WIRE)--Dec 7, 2018--Bio-Thera Solutions, a clinical-stage pharmaceutical company, today announced that patient dosing has begun in a Phase I clinical study of BAT4306F in relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma patients. BAT4306F is an ADCC-enhanced CD20 monoclonal antibody that has demonstrated enhanced potency in preclinical studies with potential to be a “best-in-class” therapeutic.
“Initiating our Phase I clinical trial for BAT4306F represents a major milestone for Bio-Thera Solutions as BAT4306F is our first clinical candidate developed for the treatment of hematologic malignancies,” said Shengfeng Li, CEO, Bio-Thera Solutions. “While the BAT4306F development plan will be initially focused on CD20-positive B-cell non-Hodgkin’s lymphoma we believe BAT4306F also has great potential as a treatment for other hematologic malignancies.”
The Phase 1, multicenter, open-label, dose-escalation clinical trial of BAT4306F is designed to assess the safety and tolerability of BAT4306F as a single agent. The study will enroll subjects with relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma. Key objectives in the study include determining maximum tolerated dose, dose-limiting toxicity, pharmacokinetics and recommended doses for phase II clinical studies.
More information on the trial is available at http://www.chinadrugtrials.org.cn/ (CTR20181568).
BAT4306F is an investigational ADCC-enhanced CD20 monoclonal antibody that has the potential to be a “best-in-class” therapeutic. BAT4306F is currently being evaluated in relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma. CD20 is a naturally occurring receptor that is overexpressed in many types of hematologic malignancies. BAT4306F is being developed for use as a single agent and in combination with other agents for a variety of hematologic malignancies.
About Bio-Thera Solutions
Bio-Thera Solutions Ltd, a leading global biotechnology company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. A leader in next generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials and has applied for marketing authorization for one candidate. In addition, the company has multiple promising candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter ( @bio_thera_sol ) and wechat (Bio-Thera).
View source version on businesswire.com:https://www.businesswire.com/news/home/20181207005096/en/
CONTACT: Bio-Thera Solutions, Ltd:
Bert E. Thomas IV +1.410.627.1734
KEYWORD: ASIA PACIFIC CHINA
INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CLINICAL TRIALS PHARMACEUTICAL RESEARCH SCIENCE
SOURCE: Bio-Thera Solutions
Copyright Business Wire 2018.
PUB: 12/07/2018 08:08 AM/DISC: 12/07/2018 08:08 AM