Genexine, a Korean biopharmaceutical firm, said GX-188E, a DNA vaccine candidate for cervical cancer, in combination with MSD’s immunotherapy Keytruda showed a 35 percent overall response rate in phase 2 clinical trials.
GX-188E induces an immune response against cancer-causing proteins generated in human papillomavirus (HPV) subtypes 16 and 18. It is called a therapeutic vaccine because it treats cancer just like a vaccine by activating the body’s immune response.
The phase 2 study was conducted on 65 patients with HPV 16- and/or HPV 18- positive recurrent or metastatic advanced cervical cancer who had received the standard therapy.
According to the study results, 60 patients available for efficacy evaluation showed a 35 percent objective response rate (ORR), meaning that 21 patients experienced either a 30 percent reduction in tumor size or complete remission, the company said.
Genexine emphasized that it would present the latest data at various meetings during the J.P. Morgan Healthcare conference, to be held in San Francisco from Monday through Thursday this week.
“We are pleased to be able to offer much-needed hope to patients showing an impressive response rate regardless of PD-L1 expression and extended survival of 16.7 months in advanced cervical cancer patients,” said Neil Warma, President and CEO of Genexine, in a statement.
Based on these study results, Genexine plans to seek conditional approval for GX-188E to the Ministry of Food and Drug Safety, news reports said.
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