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Genexine scores FDA nod for trials of GX-I7 combination therapy

Lee Han-soo  Published 2020.07.22  17:43  Updated 2020.07.22 17:43

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Genexine has received U.S. Food and Drug Administration’s approval to conduct a phase 2 clinical trial of a combination treatment of GX-I7, an immunotherapeutic drug candidate, and Bristol Myers Squibb’s Opdivo, to treat various cancers.

Genexine has won the FDA approval to conduct a phase 2 clinical trial of the combined therapy of its GX-I7 and Bristol Myers Squibb’s Opdivo to treat metastatic gastric and gastro-esophageal junctional cancer, and esophageal adenocarcinoma. (Genexine)

During the trial, the company plans to use the combination therapy in treating metastatic gastric and gastro-esophageal junctional cancer, and esophageal adenocarcinoma, Genexine said in a press release Wednesday.

“We expect a good synergy between GX-I7, which enhances T cells, and Opdivo, which reactivates T cells that have lost activity,” the company said.

With the addition of the new trial, Genexine is now conducting several studies to demonstrate the efficacy of GX-I7 as immunotherapy.

Trials conducted by the company include a phase 2 clinical trial of glioblastoma with I-MAB, a combination phase 1b and 2 clinical trials of high-risk skin cancer with Roche’s Tecentriq, and a combination phase 1b and 2 clinical trials of triple-negative breast cancer with MSD’s Keytruda.

“Just as GX-I7 has shown therapeutic effects in combination with Keytruda in end-stage breast cancer patients, the company expects that the combination therapy with Opdivo will be a new treatment option in patients with metastatic gastric cancer and esophageal cancer,” Genexine CEO Sung Young-chul said.

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