Aridis Pharmaceuticals has created a joint venture with Shenzhen Hepalink Pharmaceutical Group (Hepalink) to develop and gain regulatory approval for Aridis’ fully human monoclonal antibody (mAb) therapies for the greater China market. 

The jointly owned subsidiary company will be named Shenzhen Arimab Biopharmaceuticals, and headquartered in China’s largest technology hub, Shenzhen.  The company will be launched with significant capital commitment to advance two of Aridis’ clinical candidates, AR-301 and AR-101, through potential China Food and Drug Administration (CFDA) approvals in acute pneumonia caused by Gram-positive Staphylococcus aureus and Gram-negative Pseudomonas aeruginosa infection, respectively.  Aridis and Hepalink are actively collaborating on clinical and regulatory strategies to include major hospital centers in China as part of global pivotal trials for these two assets.

“We are very pleased to collaborate with one of China’s largest and most respected pharmaceutical companies, which has a strong track record of product development and commercialization of innovative biopharmaceuticals,” stated Vu Truong, Ph.D., founder and chief executive officer of Aridis.  “We believe our AR-301 and AR-101 mAbs, two of the world’s most advanced immunotherapies addressing severe bacterial infections, may serve as major technological advancement for treating life-threatening infections such as bacterial pneumonia.”

AR-301 is a fully human IgG1 mAb that specifically targets S. aureus alpha-toxin and protects host cells from toxin-dependent destruction by repressing functional toxin pore formation. In a completed Phase 2a clinical trial of AR-301 as an adjunct therapy to standard-of-care antibiotics in patients with severe hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) caused by S. aureus, patients experienced no related serious adverse events at any AR-301 dose level and compared to antibiotic treatment alone, patients treated with AR-301 at all dose levels spent a shorter time under mechanical ventilation.  

AR-101 is a highly specific mAb targeted against P. aeruginosa lipopolysaccharide serotype O11, which accounts for ~20% of all P. aeruginosa hospital-acquired infections worldwide and higher incidence in China. It is intended to be a first-line adjunctive therapy for patients with severe P. aeruginosa pneumonia being treated in intensive care units and has Orphan Drug designation from the U.S. FDA and Europe’s EMA regulatory agencies. Aridis successfully completed Phase 2a clinical testing of AR-101 in P. aeruginosa HAP and VAP patients, demonstrating a strong safety profile and efficacy trends, including improvement in mortality, shorter time to clinical cure of pneumonia, shorter time on mechanical ventilation, and fewer days in the ICU as compared to standard of care antibiotics-alone.