바이오스펙테이터

바이오스펙테이터 Sungmin Kim 기자

DMC, accepting ‘recommendation of study termination’ .. ‘Pexa-Vec + Nexavar combination did not improve the survival time compared to the control group’ .. “Will be promoting license-out from data of

Sillajen early-terminate the PHOCUS Phase 3 clinical trial with oncolytic virus therapy candidate ‘Pexa-Vec’ for hepatocellular carcinoma patients and focus on clinical trials with Pexa-Vec and immunotherapy combo. It means they accepted the recommendation of the Independent Data Monitoring Cmmittee, DMC, to terminate clinical trials.

Moon Eun-Sang, CEO of Sillajen, told a press conference held in Yeouido, Seoul on the 4th that “From the interim analysis of DMC for phase 3 of PHOCUS, sequential administration of Pexa-Vec as a primary treatment for liver cancer and Nexavar as a target treatment did not improve the survival period compared to Nexavar monotherapy” and he explained, “The reason of this early termination of phase 3 clinical trial is not because of Pexa-Vec itself, but because we have not found the therapeutic significance of the combination therapy of anticancer virus and target anticancer drug”.

Moon said, “Sillajen has confirmed the possibility from initial results in combination of Pexa-Vec and immunotherapy, and will concentrate on combination clinical trials in the future. And we will actively pursue licensing out once the data is secured with our further development direction.”

He also said that “We are planning to license out as soon as the ongoing clinical data is secured. Because of the varying rates of response of the same drug by indications in immunocancer drugs, regardless of the outcome as liver cancer treatment option, if the efficacy data is excellent as a combination therapy, it can be licensed out with different indications.”

Sillajen showed a part of clinical data on the combination of Pexa-Vec with Regeneron in public on that day. Sillajen is conducting the clinical trial of Pexa-Vec and Libtayo combination therapy for kidney cancer patients who do not respond to the target treatment; “Libtayo” is a PD-1 antibody of Regeneron. The company announced that, in a clinical trial determining the dose, one patient had a complete response (CR), 1 partial response (PR), 1 stable lesion, and 2 progressive disease among 5 patients. Also, they mentioned the clinical trial on combination of Opdivo with Pexa-Vec confirmed the complete response (CR).

On the other hand, on the 2nd of August, Sillajen announced that the Independent Data Monitoring Committee (DMC) recommended termination of the phase 3 trial of PHOCUS from the results of mid assessment for hepatocellular carcinoma patients. The price of Sillajen shares fell to 30% (price limit band) on that day.

▲press conference held in Yeouido, Seoul on the 4th