Genexine Designated as Fast-Track Drug for Cervical Cancer DNA Therapeutic Vaccine
GX-188E Secures Conditional Approval Application Eligibility
Clinical Trials Scheduled to Start This Year
[Asia Economy Reporter Myunghwan Lee] Genexine announced on the 19th that its cervical cancer DNA therapeutic vaccine 'GX-188E' (active ingredient Tivalimogene Therplasmid) has been designated as an expedited review target (FTD) advanced biopharmaceutical by the Ministry of Food and Drug Safety, marking the first DNA therapeutic vaccine to receive this designation. Accordingly, GX-188E has secured eligibility to apply for conditional approval.
According to Genexine, an evaluation of the full Phase 2 clinical trial data from the recently completed advanced cervical cancer trial confirmed that GX-188E met the criteria for designation as an expedited review target drug. Expedited review target drugs are granted based on non-clinical or clinical data for medicines intended to treat serious diseases. At the same time, they must demonstrate the potential to address unmet medical needs.
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Neil Warma, CEO of Genexine, stated, "We view the designation as an expedited review target very positively, as it can help shorten the clinical development period and deliver the drug to patients more quickly." He added, "We are currently in the process of designing the optimal Phase 3 clinical trial for GX-188E and plan to initiate that trial within this year."
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