The oral therapy works by targeting a faulty protein signaling pathway that can lead to cancer. In addition to liver tumors, bozitinib suppressed lung, gastric and pancreatic tumors in the lab, he company said. The pre-clinical trial study also indicated the therapy was safe, researchers said.
CBT presented the results of the study in a poster session at the American Association for Cancer Research 2017 Annual Meeting in Washington, April 1-5. The session was titled “Bozitinib, a highly selective inhibitor of cMet, demonstrates robust activity in gastric, lung, hepatic and pancreatic in vivo models.”
Bozitinib targets the epithelial to mesenchymal transition (EMT) pathway that helps cancer cells migrate elsewhere in the body. It does this by inhibiting a faulty version of the c-Met protein receptor.
When normal, that receptor facilitates human growth and development. It functions abnormally in some cancers, however.
Bozitinib inhibited the activation of faulty versions of the c-MET receptor in a range of cancers, researchers found. In fact, it suppressed tumor growth in lab models of liver, lung, gastric, and pancreatic cancer better than other selective c-MET inhibitors, they said.
“These preclinical data support our commitment to advancing the clinical development of bozitinib as a targeted therapy for c-MET dysregulated tumors,” Sanjeev Redkar, PhD, president and chief executive officer of CBT Pharmaceuticals, said in a press release. “Based on these promising findings, we plan to submit an Investigational New Drug Application [to the U.S. Federal Drug Administration] soon and initiate a Phase 1 dose escalation and dose and disease expansion study in 2017.”
The drug was developed by Crown Bioscience. CBT has the worldwide rights to it in every country but China, where it belongs to Beijing Pearl Biotechnology.
The China Food and Drug Administration has accepted an investigational new drug application for bozitinib. CBT is evaluating it there in two Phase 1 clinical trials. One trial (NCT02896231) involves patients with non-small cell lung cancer (NSCLC). The other (NCT02978261) involves patients with high grade gliomas with a PTPRZ1-MET fusion gene.
The company plans a Phase 1 clinical trial in the United States later.