Korean-based SillaJen has entered a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), US, to develop a new combination therapy for colorectal cancer (CRC).

SillaJen is a clinical-stage biotherapeutics company that focuses on the development of oncolytic immunotherapy products for the treatment of cancer.

Under the agreement, SillaJen will work in collaboration with NCI Center for Cancer Research Thoracic and Gastrointestinal Oncology Branch senior investigator Dr Tim Greten to study the combination of the company’s lead clinical candidate, pexastimogene devacirepvec (Pexa-Vec), with anti-PDL1 and anti-CTLA4 antibodies.

The evaluation will be carried out in an early phase clinical trial in patients with advanced-stage CRC.

SillaJen chief medical officer Dr James Burke said: “Treatment options for advanced CRC 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.

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“Therefore, investigation of the potential for Pexa-Vec to ‘prime’ or sensitise 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."

“We believe this trial, being conducted in collaboration with Dr Greten and the NCI, will provide an excellent opportunity to assess this potential.”

As part of the project, Dr Greten will recruit and treat patients at the NCI on the jointly developed protocol, while the cancer institute will handle the management of the trial.

In addition, an in-depth evaluation of tumour biopsies and other collected patient samples will be carried out to study the immune modulating potential of Pexa-Vec administered together with checkpoint inhibitor therapy.

The current deal will provide the biotherapeutics company with access to NCI's scientific and clinical expertise to enable the development of Pexa-Vec.


Image: Invasive adenocarcinoma, the most common type of colorectal cancer. Photo: courtesy of Nephron.