Harbour BioMed (HBM), a global, clinical-stage, innovative biopharmaceutical company announced approval of two Investigational New Drug (IND) applications by the China National Medical Products Administration (NMPA) of its next-generation fully human anti-CTLA-4 antibody (HBM4003). These approvals for mono- and combination therapy with toripalimab (TUOYI?, PD-1, Junshi Biosciences) for the treatment of patients with advanced solid tumors, closely follow HBM's ongoing Ph. 1 trial in Australia (Nov 2019), and U.S. Food and Drug Administration (FDA) approval its IND application.

CTLA-4 is one of the major negative regulators of T cell immune activation. First-generation anti-CTLA-4 antibodies are immune checkpoint inhibitors that enhance T cell activity, improving anti-tumor immune response. Despite demonstrated efficacy of anti-CTLA 4 antibodies in cancer immunotherapy, their safety profiles have always hindered their potential applications as mono- or combination therapies.

HBM4003 is the first of several fully human mAbs generated using its proprietary heavy chain only antibody (HCAb) technology. It targets CTLA-4 and enhances the elimination of tumor infiltrating regulatory T cells (Treg) by enhancing the antibody dependent cellular cytotoxicity (ADCC), consequently improving the body's immune response against tumor cells to treat multiple refractory or recurrent tumors. Improved anti-tumor efficacy, tolerance of HBM4003 and synergistic efficacy with combination of anti-PD-1 antibody were demonstrated in a series of preclinical animal efficacy and toxicology studies, which showed the great potential of HBM4003 as both mono- and combination therapy with other immune-oncology drugs in clinic.

Junshi Biosciences' toripalimab (TUOYI?) is the first commercialized domestically-developed anti-PD-1 mAb approved for unresectable or metastatic melanoma for those who have previously failed systemic treatments. So far, more than 30 clinical studies of toripalimab covering more than ten indications have been carried out in China, the United States and other countries. Recently, toripalimab has achieved Breakthrough Therapy designation (BTD) and 3 Orphan Drug designations (ODD) from the US FDA.

HBM will evaluate the safety, tolerability, pharmacokinetic characteristics, and anti-tumor activity in patients with advanced solid tumors, in both mono- and combination therapy setting in melanoma and other solid tumors in China and around the world to establish HBM4003 as the leading next-generation IO therapy.

"This is a significant milestone for HBM and our growing portfolio of innovative molecules starting with HBM4003, which is the first of our HCAb molecules to be tested in the clinics. The preclinical and clinical results so far have been encouraging and with these approvals, we aim to expand the use of HBM4003 in Chinese patients and in combination therapy." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "These studies are part of our global development program, where we believe HBM4003 will potentially provide better treatment opportunities for patients suffering from malignant tumors across the world." he added.

About Harbour BioMed

Harbour BioMed is a global, clinical development stage, biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology, immunologic diseases, and COVID-19.  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?) for generating both fully human monoclonal antibodies, heavy chain only antibodies (HCAb) and HBICE? immune cell engager technology 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. 

About Junshi Biosciences:

Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 26 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurologic, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for PD-1 monoclonal antibody in China and clinical trial application approval for anti PCSK9 monoclonal antibody from NMPA. The world's first in human anti-BTLA antibody for solid tumors was officially approved for clinical trials by the FDA and NMPA. From this year onwards, Junshi Biosciences pooled its efforts with Chinese science institutions to co-develop JS016, China's first neutralizing human monoclonal antibodies against SARS-Cov-2, that has entered clinical trial, part of our continuous innovation for disease control and prevention in China and beyond. We have about 2,000 employees in San Francisco and across Maryland in the United States, as well as Shanghai, Suzhou, Beijing, and Guangzhou, China.