[2021/05/20] Genexine, inc. (KOSDAQ: 095700), a Korean biopharmaceutical company, announced that interim result of GX-188E and Keytruda®(Pembrolizumab) combination therapy’s clinical phase 2 study (KEYNOTE-567/GX-188E-005) was released on 19th at 5pm at ASCO 2021 webpage (https://conferences.asco.org).

The interim result shows 5 patients with complete remission and 10 patients with partial remission in which case size of target lesion decrease 30% from the conducted study averaged duration of 6.2 months, out of total 48 patients who are 16 or 18 type HPV induced recurrent/metastatic advanced cervical cancer.

The patient group with combination therapy with GX-188E and Keytruda® showed ORR of 31.3%, especially it showed ORR as high as 48% in case of the patient group with most common cervical cancer type which is PD-L1 positive, HPV type 16 and squamous cell carcinoma. Additionally, PFS was 4.1 months and OS was 16.7 months which is highly upgraded data when it is compared to the Keytruda®’s monotherapy.

In terms of safety, the company again evaluated high safeness of the DNA vaccine platform since 17 patients showed grade 1,2 light adverse events and only 2 patients with 3,4 adverse events out of 52 patients.

ASCO 2021 will be held online from 4th to 8th of June, Genexine will give oral presentation at 9 am June 4th with more advanced result than the released abstract contents.

GX-188E is currently in phase 2 clinical study for 60 patients in Korea, co-develop and support from Korea Drug Development Fund(KDDF) who aims to support for successful global new drug development.