Sillajen said Tuesday that it has started recruiting patients participating in phase 1b clinical trials for REGN2810 study, a Pexa-Vac and REGN2810 combo kidney cancer treatment.

REGN2810, co-developed by Regeneron Pharmaceuticals and Sanofi, is a monoclonal antibody that targets a protein called programmed cell death 1, or PD-1.

The phase 1b clinical trial will divide 89 patients into three treatment groups who had previously metastasized or unresectable kidney cancer. From April, the company will start enrolling patients in Korea, U.S and other countries awaiting clinical trial approval such as Australia and New Zealand.

Before its approval in Korea, the U.S. Food and Drug Administration (FDA) gave a green light on Sillajen’s investigational new drug (IND) application, which uses the same combo treatment, in November of last year.

“The two companies plan to recruit 89 patients, which is quite a large number for phase 1b clinical trials, is evidence that they both want to see objective data from the clinical trial,” the company said in a statement.

To verify dose escalation the company plans to administer Pexa-Vec via IV infusion at a dose of 3x10^8 pfu once per week for four treatments. Based on the occurrence of dose-limiting toxicities, the company may subsequently enroll patients to receive Pexa-Vec on the same schedule at a dose of 1x10^9 pfu. The patients will also receive REGN2810 through an IV infusion every three weeks.

Courtesy of Clinicaltrials.gov

The company also plans to conduct three clinical trials to confirm the safety, overall response rate, maximum tolerated dose, maximum feasible dose, progression-free survival and disease control rate of the combination treatment.

“Various researches have proved that Pexa-Vec can reverse the immunosuppressive environment of tumor cells by inducing the penetration of other immune cells into T-cells in the tumor microenvironment,” a company official said. “This company expects strong synergy with REFN 2810 as Pexa-Vec mechanism will amplify the response of the tumor cells to the PD-1 inhibitor.”

corea022@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>