[Click eStock] "VaxCellBio Anticipates Midterm Results of Vax-NK Phase 2a Clinical Trial in Second Half"

Hana Financial Investment Report

[Asia Economy Reporter Minji Lee] Hana Financial Investment on the 22nd analyzed that the clinical trial of Vax-NK by Baxel Bio is progressing smoothly and emphasized the need to focus on the interim results of the Phase 2a trial in the second half of the year.

Baxel Bio published the results of the Phase 1 clinical trial targeting hepatocellular carcinoma with hepatic arterial infusion chemotherapy of Vax-NK in May this year in Frontiers in Immunology. The results showed a complete remission rate of 36.4%, an objective response rate of 63.6%, progression-free survival of 10.3 months, and overall survival of 41.6 months.

Currently, the clinical Phase 2a trial is underway with a modified regimen changing from 1 cycle (5 doses) to 2 cycles. As of May, the 10th patient was enrolled, confirming complete remission in the first patient. The interim results are scheduled to be announced in the second half of this year, and depending on the Phase 2a results, Baxel Bio plans to simultaneously proceed with entering Phase 2b, applying for conditional approval, and licensing out overseas.

Baxel Bio is continuously developing production technology related to NK cell therapeutics. In March this year, the Ministry of Food and Drug Safety approved changes to the manufacturing method related to the Vax-NK Phase 2a clinical trial. The revised manufacturing method allows for freezing and storing blood collected from patients.

Jae-kyung Park, a researcher at Hana Financial Investment, said, “Previously, manufacturing was only possible on the day of blood collection, but this limitation has been overcome, and production efficiency has been improved by utilizing cytokines,” adding, “In 2023, the goal is to further shorten the process period from the existing 14 days to 10 days and increase purity.”

Additionally, Baxel Bio signed a business agreement with the US-based Corea Therapeutics to develop Vax-ADC-NK and is collaborating with global companies to develop new NK cell therapeutics.

In February this year, Baxel Bio received approval to expand the research institutions for Boxlukin-15, an anticancer immunotherapy for companion dogs. Researcher Park explained, “We are making improvements through clinical design enhancements,” and added, “Depending on the results, commercialization could be possible as early as 2023.”