Harbour BioMed Announces Dosing of First Patient in Tanfanercept Phase III Clinical Trial

Harbour BioMed today announced the dosing of the first patient in the Phase III clinical trial of its new global investigational tumor necrosis factor (TNF) receptor-1 fragment-based drug Tanfanercept (HBM9036) for adult patients with moderate-to-severe dry eye disease (DED) in China.

The purpose of this Phase III clinical trial is to evaluate the effectiveness and safety of Tanfanercept (HBM9036) eye drops (0.25%) compared with placebo in the treatment of moderate-to-severe DED patients in China. This clinical trial is led by Professor Zuguo Liu, Chairman of Asia Dry Eye Society (ADES) and Director of Eye Institute of Xiamen University.

"In China, DED has become a common health problem affecting people's work efficiency and quality of life, thereby rapidly growing the burden of disease. The current standard of care does not provide an effective and convenient solution to these patients. Targeted and safe treatments, like an anti-inflammatory treatment, is crucial." Prof. Liu said. "As an anti-TNF receptor-1 fragment-based drug, Tanfanercept eye drops directly targets an important inflammatory cytokine, resulting in significant reduction in the underlying inflammation. It is expected to be a novel approach for this serious condition and benefit DED patients."

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed said: "Owing to the changing lifestyle and aging population, the number of DED patients in China has been increasing significantly in recent years crossing 300 million in 2020. Following the initiation of Phase III clinical trial, we aim to further accelerate the commercialization of this novel therapeutic solution for DED to Chinese patients very soon."

About Tanfanercept (HBM9036)

Tanfanercept (HBM9036) is a modified 19 kDa TNF receptor 1 fragment. It is molecularly engineered as a therapy for relief of the signs and symptoms of DED and was specifically developed for ophthalmic topical use with good eye permeability, strong TNF-α neutralizing activity, high stability, and minor side effects. It is originally developed by HanAll Biopharma, based on a licensing agreement, Harbour BioMed owns the exclusive rights for development and commercialization of Tanfanercept in mainland China, Taiwan, China, Hong Kong, S.A.R., China, and Macau, S.A.R., China.  

About Dry Eye Disease (DED)

DED is a chronic, multifactorial ocular disease that can cause visual disturbance and long-term damage of the ocular surface, with a significant impact on quality of life. It currently affects 21%-30% Chinese people. The prevalence of this ocular disease is expected to grow significantly fueled by a growing aging population worldwide, excessive use of smartphones, and environmental changes. Artificial tears, which only provide temporary symptomatic relief, are still the most used treatment for DED in China, representing a large unmet need in the Chinese market.

About Harbour Biomed

Harbour BioMed (HKEX: 02142.HK) is a global, clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics in the areas of immunology and oncology diseases. The company is building its proprietary pipeline through internal R&D programs, collaborations with co-discovery and co-development partners and select acquisitions.

The company's internal discovery programs are centered around its two patented transgenic mouse platforms, Harbour Mice®, which generates fully human monoclonal antibodies in the classical two heavy and two light chain (H2L2) format, as well as heavy chain only (HCAb) format. Building on the HCAb antibodies, the company has also established HBICE™ (HCAb based immune cell engagers) platform for developing bispecific antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. 

The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou & Shanghai, China.