Sillajen and its U.S. partner, Regeneron Pharmaceuticals, will expand the clinical design of their joint research into developing a combined treatment for kidney cancer in the United States, following a similar move in Korea.

The design is to administer the treatment intravenously on the patients who don’t respond to the immune checkpoint inhibitor, called the ICI refractory, Shillajen said.

So far, the trial has been targeting only patients who had no experience of treatment with ICI. The expanded design, however, will include patients who have failed to be cured with ICI medications, such as anti-PD-1 or anti-PD-L1.

The U.S. Food and Drug Administration has recently approved the two companies' additional investigation of new drug applications," the Korean company said. "We received similar approval from the Ministry of Food and Drug Safety in January this year."

According to Shillajen, researchers have been recruiting and screening patients for their expanded trials. If compliance criteria are met, they expect to enroll its first patient in the first quarter of this year.

“As a result of the new clinical design, a new treatment option could be expected for patients with kidney cancer who do not benefit from current immunotherapy inhibitor treatments," a company official said. "The company aims to make the combination therapy of Pexa-Vec and Libtayo to become the standard care in the kidney cancer drug market."

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