HLB said it would test a combination therapy using rivoceranib with Lonsurf for the treatment of metastatic colon cancer.

The company said it received approval for its investigational new drug (IND) application from the U.S. Food and Drug Administration to conduct the phase-1b/2 trial on rivoceranib. The drug is being developed by U.S. subsidiary LSK BioPharma, in combination with Lonsurf by Japan’s Taiho Pharmaceutical, to treat metastatic colon cancer.

The phase-1b will decide the optimal dose of rivoceranib and Lonsurf, and the phase-2 will divide about 100 patients into three groups to evaluate rivoceranib+Lonsurf, rivoceranib alone, and Lonsurf alone.

If the company confirms the efficacy of the combo treatment in the phase-1b/2 study, it will expand the trial to a global phase-3 one.

Rivoceranib is an oral cancer-fighting agent that not only suppresses neovascularization but also normalizes blood vessels in the tumor to induce activation of the immune system. Its common side effects include hypertension and hand-and-foot syndrome.

Lonsurf is an oral anticancer drug developed by Taiho Pharmaceutical by mixing trifluridine with tipiracil. Trifluridine is an antitumor nucleoside derivative that directly binds to cancer cell’s DNA to attack cancer cells. Tipiracil maintains the blood concentration of trifluridine by inhibiting the enzyme thymidine phosphorylase, which metabolizes trifluridine.

Lonsurf obtained the FDA’s approval in 2015 as a third-line of treatment for patients with metastatic colorectal cancer that are refractory or tolerant to standard chemotherapy.

“In the rivoceranib+Lonsurf combo therapy, Lonsurf directly kills cancer cells, and rivoceranib suppresses neovascularization and normalizes abnormal vascular structure of cancer to activate immune cells,” an official at HLB said. “Lonsurf and rivoceranib do not have overlapping side effects, and both are oral drugs, which are convenient to take. We expect the two will make the best combo therapy.”

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