April 20, 2024
Bio
Genexine, MSD get approval to test DNA vaccine for cancer
[THE INVESTOR] Korean vaccine maker Genexine said on June 19 it has received regulatory approval to conduct clinical trials for its DNA vaccine in combination with MSD's cancer immunotherapy Keytruda in patients with cervical cancer.
Following the approval, Genexine will start the triala on 46 patients here to evaluate safety and efficacy of its GX-188E, a first-in-class DNA therapeutic vaccine for the treatment of cervical intraepithelial neoplasia and cancers caused due to human papilloma virus, or HPV, with Keytruda.
“The two companies believe that this study will prove synergies between an immunosuppressive drug and an immunotherapy vaccine and will be a meaningful collaborative study that will overcome the limitations of both treatments,” said a Genexine official.
This is a follow-up to a collaboration agreement signed by the two firms in November last year.
Through the drug combo, the pharma companies seek to boost the immuno-oncology drug’s low objective response rate, the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. In patients with advanced cervical squamous cell cancer, treatment with Keytruda resulted in an objective response rate of 12.5 percent.
GX-188E is a therapeutic DNA vaccine encoding the fusion protein of human papillomavirus subtypes 16 and 18 with an immune-enhancer. This fusion protein induces T-cells to recognize and kill HPV-positive tumor cells.
Keytruda blocks the interaction between programmed death-1, a co-receptor that is expressed predominantly by T cells, and its ligands, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Blocking this interaction is reported to enable T-cell activation and potentiates antitumor activity.
Preclinical data for the combination treatment suggested the induced disease-specific T-cells could work synergistically with anti-PD1 antibodies.
The clinical trials of the combination seek to reproduce these proof-of-concept studies in humans to increase T-cell specific immunotherapy.
By Park Han-na (hnpark@heraldcorp.com)
Following the approval, Genexine will start the triala on 46 patients here to evaluate safety and efficacy of its GX-188E, a first-in-class DNA therapeutic vaccine for the treatment of cervical intraepithelial neoplasia and cancers caused due to human papilloma virus, or HPV, with Keytruda.
“The two companies believe that this study will prove synergies between an immunosuppressive drug and an immunotherapy vaccine and will be a meaningful collaborative study that will overcome the limitations of both treatments,” said a Genexine official.
This is a follow-up to a collaboration agreement signed by the two firms in November last year.
Through the drug combo, the pharma companies seek to boost the immuno-oncology drug’s low objective response rate, the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period. In patients with advanced cervical squamous cell cancer, treatment with Keytruda resulted in an objective response rate of 12.5 percent.
GX-188E is a therapeutic DNA vaccine encoding the fusion protein of human papillomavirus subtypes 16 and 18 with an immune-enhancer. This fusion protein induces T-cells to recognize and kill HPV-positive tumor cells.
Keytruda blocks the interaction between programmed death-1, a co-receptor that is expressed predominantly by T cells, and its ligands, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Blocking this interaction is reported to enable T-cell activation and potentiates antitumor activity.
Preclinical data for the combination treatment suggested the induced disease-specific T-cells could work synergistically with anti-PD1 antibodies.
The clinical trials of the combination seek to reproduce these proof-of-concept studies in humans to increase T-cell specific immunotherapy.
By Park Han-na (hnpark@heraldcorp.com)
