The FDA has approved the investigational new drug application for HBM9027, a bispecific antibody.
An IND application for HBM9027 has been cleared by the FDA, allowing a first-in-human trial to evaluate the bispecific antibody in patients with advanced solid tumors to commence.1
"HBM9027, developed through our proprietary HBICE® platform, has demonstrated a promising safety profile and robust anti-tumor efficacy," said Jingsong Wang, MD, founder, chairman, and chief executive officer of Harbour BioMed, in a press release.1 "This achievement highlights the capability of our technology platform in developing novel solutions for advanced solid tumors. We firmly believe that our unweaving commitment to innovation will bring about meaningful advancements in cancer treatment."
HBM9027 is a novel PD-L1xCD40 bispecific antibody made through Harbour BioMed's proprietary, fully human HBICE® platform. The agent works to activate CD40, which needs PD-L1 crosslinking to show a promising safety profile.
According to the press release, PD-L1 is overexpressed on a variety of solid malignancies. In preclinical studies, HBM9027 has demonstrated crosslinking-dependent specificity on tumors and potent immune modulation activity. The crosslinking-dependent CD40 activation has shown that HBM9027 can overcome the liver and systemic toxicity of traditional anti-CD40 monoclonal antibodies.
HBM9027 has also been shown to mediate both the PD-1/PD-L1 inhibitory pathway and the CD40 agonistic pathway to reach synergistic antitumor immune responses.2 Further, potent in vivo antitumor efficacy and in vivo stability have been observed with the agent, as well as a long half-life.
Overall, these preclinical trials have shown HBM9027 to have a promising safety profile, a unique mechanism of action, and strong antitumor efficacy.
Now, a phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and antitumor activity of HBM9027 in patients with advanced solid tumors. The trial will take place in the United States.1