Bio-Thera Solutions Starts Phase I Trial for ADCC-Enhanced CD20 Monoclonal Antibody

Dec 11, 2018 | Non-Hodgkin Lymphoma, Oncology

Antibody Therapy

Bio-Thera Solutions, a China-based clinical-stage biopharmaceutical venture announced that patient dosing has initiated for a Phase I clinical study of BAT43606F in relapsed/refractory CD20-positive B-cell non-Hodgkin’s lymphoma patients. BAT4306F is an ADCC-CD20 monoclonal antibody that has demonstrated enhanced potency in preclinical studies with potential to be a “best-in-class” therapeutic.

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.

Who is Bio-Thera Solutions?  Bio-Thera Solutions Ltd, purports to be 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.  Formed in 2003, they have an estimated 50 to 100 employees.

Shengeng Li founded Bio-Thera. Prior to founding Bio-Thera, he was a founder and founding Chief Scientific Officer of California-based Abmaxis, Inc. which was acquired by Merck.  Before Abmaxis Mr. Li worked at Cor Therapeutics which merged with Millennium.  Dr. Li clearly has had some good fortune with biotech M&A results.  He received his PhD in Microbiology in 1991 from the University of Georgia.


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