Harbour BioMed (HBM), a global, clinical-stage, bio-pharmaceutical company announced that the company will present the phase II clinical trial results of Tanfanercept (HBM9036) at the 25th Congress of Chinese Ophthalmological Society (CCOS) held in Xiamen from the 19th to 22nd November.

Tanfanercept (HBM9036) is a new investigational TNF receptor-1 fragment, in adult patients with moderate-to-severe DED. It is a molecularly engineered as a therapy for relief of the signs and symptoms of DED and was specifically developed for ophthalmic topical use with tissue distribution, stability, and potency optimized for treatment of DED.

In this proof-of-concept and comparability trial in China, Tanfanercept showed rapid onset of action, significant improvements in signs as measured by Corneal Staining Score, a measure of corneal damage. Tanfanercept was very well tolerated with similar comfort level as placebo. These results are consistent with previously reported Phase II clinical trial (VELOS-1) conducted by HanAll, HBM's partner, in the US. These favorable safety and efficacy results pave the way for Tanfanercept' s phase III clinical trial in China.

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 used treatment in China, only provides symptomatic relief. With increasing burden and impact of DED on our society, HBM anticipates bringing this novel therapy to address patients' needs soon.

Title: TNF-α inhibitor HBM9036 Ophthalmic Solution demonstrates efficacy in the treatment of moderate to severe dry eye disease (DED) - Results of phase 2 randomized, a double-blind controlled clinical study using Controlled Adverse Environment (CAE?)

About Tanfanercept

Tumor necrosis factor (TNF) is an important inflammatory cytokine that plays a central role in autoimmune and inflammatory diseases. In the pathogenesis of DED inflammation is one of the main causes of desiccating stress and high osmotic pressure, which result in cell damage and exacerbated ocular surface inflammation, reinforcing the cycle of this chronic episodic ocular disease. Tanfanercept is a modified 19 kDa TNF receptor 1 fragment originally developed by HanAll Biopharma as an ophthalmic solution with good eye permeability, strong TNF-α neutralizing activity, high stability, and minor side effects. 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 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 20-30% patients in China. 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 is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and inflammatory 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 discovery and development programs are centered around its two patented transgenic mouse platforms for generating fully human monoclonal antibodies. Harbour BioMed also licenses the platforms to companies and academic institutions. The company has operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Shanghai, China.