BIO Asia–Taiwan 2025 亞洲生技大會

BIO Asia–Taiwan 2025 亞洲生技大會

TEACHER

Vu Truong

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Session A-5 – CMC Program Design: Pioneering Biologics Development Excellence

Date:24 July 
Time13:30– 13:50  (GMT+8)

Vu Truong

Chief executive officer
Aridis Pharmaceuticals



Vu L. Truong, Ph.D.
CEO & CSO
Dr. Truong is currently CEO and CSO of Aridis Pharmaceuticals. He has over 25 years of experience in biopharmaceutical drug development, focusing on the discovery and development of human monoclonal antibodies and vaccines. His product development experience includes FluMist™, Synagis™ mAb, and a number of other monoclonal antibody-based therapeutics. Dr. Truong is the principal architect of the Aridis technologies, which includes a range of biologics and small molecule anti-infective products, APEXTM human mAb discovery and production platform technology, and pharmaceutical processing technologies. He received his Ph.D. in Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine.

Speech title & Synopsis

Development and Manufacturing of Human Monoclonal Antibodies In Infectious Diseases

Aridis is developing anti-infective immunotherapies for patients with serious respiratory infections. The company has a diverse pipeline of therapeutic monoclonal antibodies (mAb) and novel anti-infectives designed to expand the current standards of care. Aridis also has a platform technology to rapidly identify human-derived monoclonal antibodies and create production cell lines using gene editing. The company’s lead asset is a mAb ‘AR-301’ that neutralizes S. aureus alpha-toxin, leading to protection against toxin mediated destruction of host immune response.  AR-301 is being developed for the treatment of acute pneumonia, with the first of two Phase 3 studies conducted during the COVID-19 pandemic. Despite a limited study sample size, the available data showed patients treated with AR-301 exhibited superior clinical improvement compared to SOC antibiotics alone, especially in the older adults >65 yrs. The company is currently seeking funding to complete the final Phase 3 study.  The company is also developing its biomanufacturing strategy for the Phase 3 trial and subsequent commercial implementation.  The presentation will highlight the company’s programs and its biomanufacturing strategy.

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