• Successful completion of Phase 2 monotherapy trial paves way for Phase 3 trials in China in early 2020

Cambridge, MA, Rotterdam, NL, Shanghai, CN – October 11^th, 2019

Harbour BioMed (HBM) today announced completion of Phase 2 study of HBM9036 (tanfanercept), a new investigational TNF receptor-1 fragment, in adult patients with moderate-to-severe Dry-Eye-Disease (DED) in China. The study results combined with previous results from HBM’s partner HanAll’s clinical trials position the product to begin phase 3 studies in China in early 2020. The study was designed to compare the safety & efficacy of tanfanercept to a previously conducted Phase 2 study (VELOS-1) in the US by HanAll, and results of which were presented at The Association for Research in Vision and Ophthalmology (ARVO) 2019. In the HBM study, 100 patients were randomized to receive 0.25% HBM9036 or vehicle control, administered as eye drops, to moderate-to-severe DED patients, twice a day for 8 weeks. The study, conducted at Qingdao Eye Hospital of Shandong Eye Institute, was led by Prof. Lixin Xie, a prominent ophthalmologist in the field of ophthalmic diseases and member of the Chinese Academy of Engineering in China. The study results were consistent with the previous Phase 2 trial (VELOS-1) that showed significant improvements in signs as measured by Corneal Staining Score, a measure of corneal damage. HBM9036 was generally safe and well tolerated with similar comfort level as vehicle control. More detailed results will be presented at upcoming international medical meetings.

“Dry eye disease is a complex and often underdiagnosed disease that has a significant impact on patient lives. Recent studies have indicated an increase in the incidence of this condition fueled by a global increase in aging population, increased use of smartphones, and higher levels of micro-dust in the environment. Artificial tears, the most commonly used treatment in China, only provide symptomatic relief. Blocking inflammation with TNFR1 directly in the eye may provide a novel approach for this serious condition,” said Prof. Xie. “The learnings from this study will enable us to design a robust Phase 3 study and bring much needed relief to Chinese patients with DED”. 

“HBM9036 is the first and most advanced biologic approach for DED in China that address the underlying inflammation responsible for the progression of the disease. The robust improvement in signs accompanied by a favorable safety profile further paves the way for Phase 3 clinical trial in China which we anticipate beginning in early 2020” said Dr. Jingsong Wang, M.D., Ph.D., Chairman and CEO of HBM. “With increasing burden and impact of DED on our society, we are excited to work with the Chinese medical community to develop this novel therapy addressing unmet patients’ needs.” 

About Dry Eye Disease

More than 300 million people experience dry eye disease worldwide, but only one-fifth of those receive medical care, owing to the undiagnosed and/or under-diagnosed patient population. DED is more prevalent in Asia and over 100 million people in China are estimated to be affected by DED. In contrast, fewer options for Chinese patients are available with the most commonly used drugs being artificial teas only to provide temporary relief on symptoms. Over the next decade, the incidence and severity is expected to grow exponentially, aided by better tools to effectively diagnose DED, and fueled by a growing aging population worldwide, excessive use of smartphones and environmental changes including micro-dust. 

About HBM9036 (tanfanercept)

HBM9036 for the treatment of DED is a biopharmaceutical drug developed by our global partner HanAll BioPharma Co., Ltd. Tanfanercept is a molecularly engineered TNF receptor 1 fragment, as a therapy for relief of the signs and symptoms of dry eye. HL036 was specifically developed for ophthalmic topical use with tissue distribution, stability, and potency optimized for treatment of dry eye disease. HBM licensed the rights to develop, manufacture and commercialize tanfanercept as HBM9036 in Greater China. Tanfanercept is concurrently being studied in a global Phase 3 trial (VELOS-2) by HanAll. HBM9036 is the first global innovative biologic in clinical development for the treatment of DED in China.  

About Harbour BioMed

 
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on oncology and immunology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.

 
The Company’s proprietary antibody technology platforms Harbour Mice^® generate fully human monoclonal antibodies in two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building upon the HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) are capable of delivering tumor killing effects unachievable by traditional combination therapies. Integrating Harbour Mice^® with single B cell cloning platform, our antibody discovery engine is highly unique and efficient for development of next generation therapeutic antibodies. 

For further information, please refer to www.harbourbiomed.com

Media and Investor Relations Contact:

Atul Deshpande, Ph.D., MBA

Chief Strategy Officer and Head, US Ops.

Phone: +1-908-210-3347

E-mail: atul.deshpande@harbourbiomed.com