South Korean biotherapeutics firm SillaJen and Hong Kong-based biopharmaceutical company Lee's Pharmaceutical Holdings have secured approval from the China Food and Drug Administration (CFDA) for a Phase III clinical trial (PHOCUS) of Pexa-Vec in patients with liver cancer.

Based on SillaJen's Selective oncolytic vaccinia engineering (SOLVE) platform, Pexa-Vec’s backbone features a vaccinia strain that naturally targets cancer cells.

The product candidate is designed to delete thymidine kinase (TK) gene of the cancer cells and express GM-CSF immunogenic protein, resulting in tumour death, tumour vasculature blockade and sustained anti-tumoural immune attack.

The Phase III trial will be performed across North America, Asia, Australia, Europe and China in patients who were not previously treated with a systemic therapy.

Subjects will be administered with Pexa-Vec and then sorafenib or a monotherapy of sorafenib alone.

"This is exciting progress and a very important milestone for our Pexa-Vec programme."

SillaJen CEO Dr Eun Sang Moon said: "This is exciting progress and a very important milestone for our Pexa-Vec programme.

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"We are keenly aware of the high unmet needs in liver cancer in China, and it is our sincere hope that we will be able to offer Pexa-Vec to these patients in the years ahead."

The trial’s primary objective is overall survival with Pexa-Vec, followed by sorafenib, when compared to sorafenib monotherapy.

Lee's Pharmaceutical CEO Dr Benjamin Li said: "We are glad that the CDE of China CFDA has approved our phase III IND application, and we look forward to enrolling the PHOCUS trial in China.

“This is an important milestone for Pexa-Vec development, and is a result of our tremendous team work with SillaJen.”

Pexa-Vec is also being studied by SillaJen's regional partner Transgene in a clinical-stage programme for liver cancer.