U.S. FDA Clears IND for First-in-Class Anti-B7H7 Antibody, Announces Harbour BioMed

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  • HBM1020, the first fully human monoclonal anti-B7H7 antibody in the world class, is available now.
  • HBM1020, the first monoclonal anti-B7H7 antibody ever cleared for clinical trials by the regulatory agency, is the world’s first.
  • HBM1020 could be a new anti-tumor therapy that complements PD(L)1 therapies, particularly for PDL1-negative/refractory cancer patients.

Harbour BioMed, HKEX 02142 (the “Company”) announced that the U.S. Food and Drug Administration has approved the application for an investigational new drug to begin clinical trials in the U.S. of its first-in class fully human monoclonal antibodies HBM1020 against B7H7. This multicenter, open-label study will evaluate HBM1020’s safety, tolerability and pharmacokinetics as well as its anti-tumor effect in patients with advanced solid tumours. HBM1020 was also the first monoclonal B7H7 antibody to be cleared for clinical trials by the regulatory agency.

HBM1020, a fully human monoclonal anti-B7H7 antibody is the first of its kind. It was generated using the Harbour Mice (r) H2L2 platform. The antibody is able to enhance anti-tumor immune response by blocking the novel target of immune checkpoint. Preclinical studies demonstrated that the antibody’s immune activation and antitumor functions were functional.

B7H7 belongs to the B7 family of immune modulatory molecules. These pathways are very attractive for cancer immunotherapy because the B7 family plays a central role in regulating T-cell responses. The majority of immune-oncology targets that have been validated so far, such as PD-(L), and CTLA-4, are part of the B7 family. Therapies against B7 targets have already changed the paradigm of cancer treatment with impressive clinical benefits. B7H7 is a recently discovered member of B7 family. Its expression does not overlap with PDL1 in many tumor types. This indicates that there are other immune evasion pathways besides PD(L)1. In PDL1-negative/refractory cancer patients, B7H7 may play a greater role in the tumor cells, allowing them to escape immune surveillance. This is expected to lead to next-generation immuno-oncology therapies.

HBM1020, with its novel biology mechanisms, may offer a new anti-tumor therapy that is complementary to PD(L)1 therapies, particularly for PDL1-negative/refractory cancer patients.

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