SillaJen enters cooperative R&D agreement with NCI to develop combination therapy for colorectal cancer

Under the CRADA, SillaJen will collaborate with Tim Greten, M.D., to evaluate the combination of SillaJen's lead clinical candidate, pexastimogene devacirepvec (Pexa-Vec), with anti-PDL1 and anti-CTLA4 antibodies in an early phase clinical trial in patients with advanced stage CRC. 

"We welcome the opportunity to collaborate with Dr. Greten in the development of this promising combination therapy," said Eun Sang Moon, chief executive officer of SillaJen.

Dr. Greten is Senior Investigator in the Thoracic and Gastrointestinal Oncology Branch of NCI's Center for Cancer research and an expert in GI Oncology and tumor immunology.  Dr. Greten received his training in Medical Oncology, Gastroenterology and Hepatology in Germany and has been performing basic and translational research studies in tumor immunology for more than 20 years. He is currently studying novel immune based approaches to treat patients with primary hepatobiliary tumors and patients with tumors of the GI tract metastasizing into the liver.

"Treatment options for advanced colorectal cancer are a significant unmet medical need globally.  To date, there has been no approval for checkpoint inhibitor therapy for the vast majority of patients with CRC," stated James Burke, M.D, chief medical officer of SillaJen. "Therefore, investigation of the potential for Pexa-Vec to "prime" or sensitize CRC to check point inhibitor therapy is an exciting opportunity to further extend immunotherapy to this substantial number of patients without curative or immunotherapeutic options.  We believe this trial being conducted in collaboration with Dr. Greten and the NCI will provide an excellent opportunity to assess this potential."

Under the terms of CRADA, Dr. Greten will recruit and treat patients at the NCI on the jointly developed protocol, and NCI will handle the management of this trial. SillaJen will supply Pexa-Vec for the clinical trial while PD-L1 and CTLA-4 antibodies will be provided by a third party to NCI under a separate CRADA.  Further, in depth assessment of tumor biopsies and other collected patient samples will be conducted to assess the immune modulating potential of Pexa-Vec given concurrently with checkpoint inhibitor therapy. This CRADA will provide SillaJen access to NCI's scientific and clinical expertise to facilitate development of Pexa-Vec for the benefit of public health.

Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program, and over 300 cancer patients have been treated with Pexa-Vec to date. Pexa-Vec was engineered to target common genetic defects in cancer cells by deleting its thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack. Pexa-Vec has been shown to be effective when delivered both intratumorally and systemically by intravenous administration. Pexastimogene devacirepvec (Pexa-Vec) is currently being evaluated in a worldwide Phase 3 clinical trial for advanced primary liver cancer.

Sillajen enters cooperative, r&d agreement with nci, develop combination therapy, colorectal cancer