Jennerex, a clinical-stage biotherapeutics company, has reported positive clinical data from its Phase II trial of JX594 in sorafenib-refractory hepatocellular carcinoma (liver cancer, HCC) patients.
The study demonstrated that JX594, a proprietary, engineered oncolytic immunotherapy, can be safely delivered through systemic route, and standard-of-care Sorafenib can be safely administered sequentially after JX594.
Jennerex R&D president, founder and chief medical officer Dr David Kirn said JX594 demonstrated its ability to selectively target and destroy tumours following intravenous infusion in the Phase II trial.
"This finding confirms the ability of JX594 to target both primary and metastatic, or distant, tumours which we believe is important in this HCC patient population and most cancers," Kirn said.
The primary objective of the study was the safety of JX594 followed by sorafenib in patients with advanced HCC, while secondary endpoints included the effect of the sequential treatment of JX594 followed by sorafenib on disease control and tumour response.
The sequential treatment regimen was well tolerated demonstrating JX594 side effects such as transient flu-like symptoms and transient leucopoenia. The sorafenib side effects observed were consistent with the expected toxicity profile of the product.
Evidence of antitumor activity was observed in both sorafenib-naïve and sorafenib-refractory patients, according to the study data.
Jennerex president and chief executive officer Dr Laurent Fischer said more than 160 patients were treated with JX594 to date, with active enrolment occuring in a multinational Phase IIb study in second line treatment of liver cancer patients, a Phase II all-IV trial in first line HCC patients and a Phase II study in colorectal cancer.
"We are excited with the progress we are making in our JX594 program and believe it has the potential to advance patient care across multiple types of cancer," Fischer said.
Image: Gross specimen of the liver showing hepatocellular carcinoma. Photo: Courtesy of Netha Hussain.