Date: 2017-08-16
Type of information: Development agreement
Compound: pexastimogene devacirepvec (Pexa-Vec) anti-PDL1 and anti-CTLA4 antibodies
Company: National Cancer Institute (NCI) (USA) Sillajen (Republic of Korea)
Therapeutic area: Cancer - Oncology
Type agreement: development
Action mechanism:
- oncolytic virus/gene therapy/oncolytic immunotherapy/monoclonal antibody/immune checkpoint inhibitor. Pexa-Vec (pexastimogene devacirepvec) is an oncolytic immunotherapy that utilizes the vaccinia poxvirus strain as its backbone. This strain has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic 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 is designed to attack cancer through three diverse mechanisms of action:
- 1) the lysis of cancer cells through viral replication,
- 2) the shutdown of the blood supply to tumors through vascular targeting and destruction, and
- 3) the stimulation of the body's immune response against cancer cells,(active immunotherapy).
Disease: advanced colorectal cancer
Details:
- • On August 16, 2017, SillaJen announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), for the development of a combination therapy for colorectal cancer (CRC). 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.
- 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.
- 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.
Financial terms:
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