US not-for-profit clinical research centre City of Hope has launched two Phase Ib clinical trials to evaluate a combination of cytokine and immunotherapy to treat advanced cancers.
The trials will be backed by biopharmaceutical firm Brooklyn ImmunoTherapeutics, which will also supply the experimental cytokine therapy IRX-2.
IRX-2 is an allogeneic, reproducible, cell-derived biologic with multiple active human cytokines that act on different parts of the immune system to boost immune response.
One of the Phase Ib trials will assess IRX-2 in combination with Bristol-Myers Squibb’s nivolumab for the treatment of patients with advanced hepatocellular cancer.
The second trial will involve IRX-2 plus Merck’s pembrolizumab in advanced gastric and gastroesophageal junction adenocarcinoma patients.
The trials are designed to investigate the safety and efficacy of the combinations, and will each enrol approximately 20 patients who did not experience adequate response to other cancer treatments.
City of Hope Medical Oncology & Therapeutics Research department assistant clinical professor Daneng Li said: “We’re trying to turn potentially cold tumours, those with strong fortresses nearly impenetrable to the immune system, into hot tumours that have walls equipped with ladders for immune T cells so that more patients can derive benefit from treatment with immunotherapy.”
In case the initial group of subjects do not experience significant side effects, the trials will be transitioned into the expansion part.
City of Hope affiliate Translational Genomics Research Institute (TGen) will conduct DNA, RNA and protein sequencing of tumour tissue from the participants to identify any biomarkers that could enable targeted therapy.
City of Hope Medical Oncology & Therapeutics Research department assistant clinical professor Joseph Chao added: “This combination therapy attempts to turbo boost the immune system so that it can attack cancer. We are releasing the brakes and adding gas.”