Orionis Biosciences has dosed the first subject in a Phase I clinical trial of immunotherapy ORB-011 to treat advanced solid tumours.
The open-label, dose-escalation trial is designed to analyse the pharmacokinetics, safety, and pharmacodynamics of ORB-011 monotherapy.
It will enrol subjects with various types of recurrent or refractory solid tumours such as HR+ or triple-negative breast cancer, colorectal cancer, pancreatic cancer and non-small cell lung cancer.
Patients with head and neck squamous cell carcinoma, bladder/urothelial, gastric cancers, metastatic melanoma, oesophageal, renal cell, hepatic and ovarian cancers will also be part of the trial.
The study will also identify a recommended dose of the immunotherapy for further trials.
Orionis Biosciences founder, president and CEO Nikolai Kley said: “The beginning of this clinical study represents a major milestone for Orionis and our A-Kine protein engineering platform, which combines a range of redesigned immune-modulatory cytokines with targeting modules aimed at cell types of therapeutic relevance.
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“ORB-011 has the potential to harness the therapeutic activity of interferon in a new way.”
An attenuated, cis-targeted interferon, ORB-011 precisely activates cDC1 dendritic immune cells. These cells are said to be tumour cell-destroying CD8+ T cell activators.
According to preclinical data, selectively activating cDC1s using conditionally active interferon molecules could offer antitumor activity.
Furthermore, targeted cDC1 activation was found to be well tolerated in studies in non-human primates.