Biotechnology firm Genexine has secured approval from the South Korean Ministry of Food and Drug Safety (MFDS) to conduct a Phase Ib/II trial of GX-188E vaccine in combination with Keytruda (pembrolizumab) in patients with non-resectable cervical cancer induced by human papillomavirus (HPV).

GX-188E is an HPV therapeutic DNA vaccine currently being developed for cervical intraepithelial neoplasia (CIN) and HPV-induced cancers caused due to persistent infection of high-risk HPV types, while Keytruda is Merck’s anti-PD-1 therapy.

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Designed to enrol up to 46 patients, the Phase Ib/II trial will assess the safety and efficacy of the combination therapy, which is expected to induce an anti-tumour immune response in several ways.

According to data from previous clinical trials, the therapeutic DNA vaccine showed the ability to trigger a tumour-specific immune response and curative activity against high-grade CIN.

“According to data from previous clinical trials, the therapeutic DNA vaccine showed the ability to trigger a tumour-specific immune response and curative activity against high-grade CIN.”

Keytruda works by enhancing the immune system’s ability to detect and destroy tumour cells.

Genexine and Merck anticipate that the combination therapy has the potential synergistic effects to improve clinical response rates in patients who have undergone monotherapy with Keytruda for cervical cancer.

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With an option for expansion into a Phase III trial, the current agreement between the firms requires Genexine to conduct and fund the Phase Ib/II trial and Merck will supply Keytruda.

GX-188E’s Phase I trial demonstrated that when administered intramuscularly through electroporation, the HPV DNA vaccine triggers significant E6/E7 specific IFN-γ-producing T-cell responses in CIN3 patients.