VaxCell-Bio has completed a phase 2a clinical trial study of “Vax-NK,” a natural killer (NK) cell therapy for advanced hepatocellular carcinoma (HCC).
In a public notice issued on Wednesday, VaxCell-Bio unveiled the results of the phase 2a study today.
In the study, VaxCell-Bio evaluated the efficacy, safety, and immunologic response of Vax-NK in combination with hepatic artery infusion chemotherapy (HAIC) as a salvage therapy in patients with advanced HCC who have not responded to conventional therapy.
According to the disclosure, the phase 2a study was conducted at four institutions, including Chonnam National University Hwasun Hospital, and 16 patients were included in the outcome analysis. The objective response rate (ORR) for the primary endpoint, BICR, was 68.75 percent, meaning that 11 of the 16 patients had a complete response (CR) or partial response (PR)
Specifically, 18.75 percent (three patients) had a complete response (CR), and 50 percent (eight patients) had a partial response (PR). The 95 percent confidence interval ranged from 41.34 to 88.98, which, according to VaxCell-Bio, can be interpreted as a statistically significant result.
In a separate news release, VaxCell-Bio also emphasized that the remaining five patients (31.25 percent) had stable disease (SD), resulting in a disease control rate of 100 percent. According to the company, the time to progression (TTP) was 16.82 months, according to the investigator assessment, and the median BICR (blind independent committee review) assessment analysis has not yet been reached.
VaxCell-Bio said it plans to use the results of the phase 2a study to design a larger randomized clinical trial.
"Based on these results, we will consider the best way to commercialize the product by, for instance, applying for accelerated approval for conditional approval or advanced regenerative therapy approval under the New Drug Act," VaxCell-Bio CEO Lee Je-jung said. "We will also continue R&D to expand the indication beyond HCC to other cancers, including small cell lung cancer and pancreatic cancer."