On April 6, 2022 Harbour BioMed ("HBM", "the Company", HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, reported a global out-license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) for CLDN18.2xCD3 bispecific antibody (HBM7022), a novel bispecific antibody generated from HBM’s HCAb Based Immune Cell Engagers (HBICE) Platform (Press release, Harbour BioMed, APR 6, 2022, View Source;301519595.html [SID1234611539]). This license agreement and recognition by an industry-leading global biopharmaceutical company marks a major milestone in HBM’s business development, validating the potential of the Company’s technology platform and innovation capabilities.

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HBM7022 is a bispecific antibody, currently in pre-clinical stage, that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (Claudin18.2) and CD3, and thus leads to potent T cell activation and tumor elimination.

Upon the execution of the license agreement and subject to terms and conditions thereof, AstraZeneca will be granted an exclusive global license for research, development, registration, manufacturing, and commercialization of HBM7022 and shall be solely responsible for all costs and activities associated with its further development and commercialization.

Pursuant to the license agreement and subject to the terms and conditions thereof, HBM shall receive an upfront payment of US$25 million with the potential for additional payments up to US$325 million pending achievement of certain development, regulatory and commercial milestones. HBM is also eligible to receive tiered royalties on net sales.

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, said, "HBM7022, one of our representative innovative bispecific antibodies generated from the HBICE platform, has significant potential value on a global basis. We are happy to reach this agreement with AstraZeneca, a leading innovator in oncology with a diverse portfolio and pipeline of life-changing medicines. We are very confident that AstraZeneca will maximize the value of HBM7022 to realize the potential of the molecule."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, "We are excited to enter into this agreement with Harbour BioMed for the development of the next-generation bispecific antibody HBM7022. This molecule is designed to harness the body’s immune system T cell response, with potential for strong efficacy across solid tumors including gastric and pancreatic cancers, both of which comprise large populations of patients with major unmet medical need."

About HBM7022

HBM7022 is a bispecific antibody that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (Claudin18.2) and CD3 and thus leads to potent T cell activation and tumor elimination. By using bivalent high affinity anti-Claudin18.2 and monovalent low affinity anti-CD3, HBM7022 has demonstrated potent cytotoxicity but low cytokine release syndrome risk. Preclinical studies have shown that it can treat not only wild type Claudin18.2 positive gastric cancer, but also pancreatic cancer and mutated Claudin18.2 gastric cancer. HBM7022 is one of the fully human bispecific antibodies developed from the HBICE Platform of the Company. Building on this unique platform technology, HBM7022 exhibits an encouraging safety profile, pharmacokinetics (PK) and potential for clinical development. With the unique HBICE molecule design and promising preclinical data, we believe that HBM7022 will lead the next generation of T cell engager therapy for solid tumors in future clinical trials.

About HBICE

Harbour HCAb platform can generate diverse and stable fully human Heavy Chain only Antibodies (HCAbs) and derived human VH single-domain moieties, enabling us to make novel multi-specific and multi-valent antibodies in simplified structures with relatively smaller molecule size and fewer number of polypeptide chains. On top of this, we have established proprietary HBICE (HCAb Based Immune Cell Engagers) platform to quickly develop multi-specific antibodies that redirect immune cells to the tumor microenvironment to eradicate tumors.

HBICE molecules recognize and bind both specific tumor-associated antigens on tumor cells and co-stimulatory molecules on immune cells such as T cells or NK cells, resulting in efficient and selective activation of immune cells specifically in the TME, thereby preventing non-specific or systemic activation of peripheral immune cells. Besides, HBICE technology provides the flexibility to generate molecules with different architectures and avidity profiles to achieve desired mechanisms of action that are usually unachievable by combo therapies.