FDA Clears IND Application for HBM1020 for Advanced Solid Tumors
With the FDA clearing an investigational new drug application for HBM1020, the antibody can begin to be evaluated in clinical trials of patients with solid tumors.
The FDA has cleared an investigational new drug (IND) application to begin clinical trials of HBM1020 as a treatment option for patients with advanced solid tumors, according to Harbour BioMed.1
HBM1020 is a first-in-class fully human monoclonal antibody which targets B7H7. B7H7 is a newly discovered novel immunomodulatory molecule that belongs to the B7 family. This family works to regulate the T-cell response. Many validated targets in immuno-oncology, including PD-(L)1 and CTLA-4, are related to the B7 family.
In multiple tumor types, B7H7 expression can be found non-overlapping with PD-L1 expression. This indicates an alternative immune evasion pathway besides PD-(L)1.
For patients with PD-L1 negative or refractory disease, there is potential for B7H7 to have a more important role in tumor cells in order to escape immune surveillance. It is anticipated that this agent will be developed as next-generation immune-oncology therapeutic.
According to the press release, HBM1020 has the ability to enhance anti-tumor immunity by blocking the novel immune checkpoint target. In preclinical studies, HBM1020 demonstrated immune activation and anti-tumor functional activities.Also in humanized tumor models, the antibody demonstrated potent receptor blocking, excellent in vivo efficacy, and T-cell activation.2
Investigators are hopeful that treatment with HBM1020 may offer a novel anti-tumor therapeutic complementary to PD-(L)1 therapeutics for patients, including for those with PD-L1 negative/refractory disease.
The agent is also the first monoclonal antibody to target B7H7 that has been cleared by the FDA for clinical trials.
With this IND application, the FDA has granted clearance for HBM1020 clinical trials to be initiated. In these studies, investigators will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM1020 in patients with advanced solid tumors.
In addition to HBM1020, the company is working on multiple research programs which are developing other antibodies, such as HBM7008, HBM9378, HBM1022,, HBM7020, HBM7015, HBM1029, and HBM1007.
REFERENCES:
Harbour BioMed announces IND clearance for first-in-class anti-B7H7 antibody by the U.S. FDA. News release. Harbour Biomed. January 12, 2023. Accessed January 13, 2023. https://prn.to/3vYbRUG
Harbour BioMed reports 2021 interim results: product development breakthroughs continue to unlock value of integrated antibody discovery platform. News release. August 31, 2021. Accessed January 13, 2023. https://bit.ly/3XadVVI
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