WuXi Biologics a global leadingopen-access biologics technology platform company offering end-to-end solutions for biologicsdiscovery, development and manufacturing,
and its Chinese partner Harbin Gloria PharmaceuticalsCo Ltd , today announced that an exclusive license to the anti-PD-1 antibody GLS-010has been granted to Arcus Biosciences, a US-based biotechnology company focused on thediscovery and development of innovative cancer immunotherapies.
Gloria contracted WuXi Biologics to discover and develop GLS-010, a novel anti-PD-1 antibody,using Ligand’s transgenic rat platform OmniRat®. GLS-010 is currently being evaluated in cancerpatients in phase I clinical studies in China. Arcus has licensed the exclusive development andcommercialization rights of GLS-010 in North America, Europe, Japan and certain other territories.
Arcus plans on developing GLS-010 as a combination product with the other product candidates inits portfolio. Based on the terms of the agreement, Arcus will pay $18.5mm in upfront paymentsas well as development and regulatory milestones which could total up to $422.5mm for thedevelopment and approval of 11 products that include GLS-010 as a component. WuXi Biologicsand its partner Gloria, through an existing agreement will also receive commercial milestones ofup to $375mm which could result in aggregate payments from Arcus of $816mm. Arcus will paytiered royalties that range from the high single-digits to low double-digits on net sales of GLS-010.In addition, WuXi Biologics and Arcus intend to enter into an exclusive 3-year agreement for thedevelopment of Arcus’ biologics portfolio. WuXi Biologics also will be the exclusive manufacturerfor GLS-010 in the licensed territories for a specified period of time.
“We are pleased that our integrated platform has enabled companies such as Gloria to enter intobiologics with an exciting program. We are also excited to enter into this agreement to expeditebiologics development to treat patients globally,” commented Dr. Chris Chen, CEO and executivedirector of WuXi Biologics. “This new partnership continues to reinforce the value of our integratedservice platform, the global quality WuXi Biologics commits to, and the success of our ‘follow-themolecule’ strategy.
“We are thrilled to gain access to GLS-010 in our territories,” commented Dr. Tim Sullivan, VicePresident of Business Development at Arcus. “This molecule will enable us to fully exploit thepotential of our other immuno-oncology agents for the benefit of patients. Working with WuXiBiologics also ensures high-quality clinical supply of our biologics, an essential operationalcomponent of our strategy to develop a series of novel and best-in-class combination therapies forthe treatment of cancer.”
“Gloria has recently been focusing its R&D research on biologics, especially in the immunooncology area. We hope our efforts can bring more innovative medicines into the Chinese marketin order to fill unmet medical needs,” said Mr. Hongbing Yang, Chief Executive Officer of HarbinGloria Pharmaceuticals. “It is the first time that an antibody envisioned by Gloria has the potentialto reach patients worldwide. We are extremely pleased that, with our development in China andArcus’ exclusive license in many other countries in the world, each working with WuXi, that GLS-010 may become available in both China and worldwide.”
GLS-010, also referred to as WBP3055, is an investigational fully human monoclonal antibody thatbelongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It isdesigned to bind to PD-1, a cell surface receptor that plays an important role in the downregulationof the immune system by preventing the activation of T-cells. Other anti-PD-1 antibodies have beenapproved by the US FDA in multiple cancer settings. It is estimated that more than 500 clinical trialsare ongoing to continue to investigate this class of biologics for more than 20 different cancerindications.
About WuXi Biologics
WuXi Biologics is the only open-access biologics technology platform in the world offering end-toend solutions to empower organizations to discover, develop and manufacture biologics fromconcept to commercial manufacturing. Our company history and achievements demonstrate ourcommitment to providing a truly ONE-stop service offering and value proposition to our globalclients. For more information on WuXi Biologics, please visit: http://www.wuxibiologics.com.
About Harbin Gloria Pharmaceuticals Co., Ltd.
Gloria is a leading Chinese pharmaceutical company headquartered in Beijing. It is considered byanalysts “the fastest growing pharma company in China”. Gloria is also one of the most active dealmakers among all the pharmaceutical companies nationwide. Gloria Pharmaceutical focuses onthe following therapeutic areas: orthopaedics, cardiovascular and metabolic diseases, andoncology. For additional information, please visit www.gloria.cc.