US-based biopharmaceutical firm Gliknik has commenced patient dosing in a Phase II clinical trial of immunomodulatory therapeutic biropepimut-S (GL-0817) to prevent recurrence of oral cavity squamous cell cancer.
Biropepimut-S is an engineered peptide cancer vaccine currently being developed to train the body’s immune system against various peptides present in MAGE-A3 protein that is expressed in different cancers.
To enhance the potential for immune response, the investigational therapeutic is being developed to have increased penetration into immune system cells by avoiding protein degradation pathways.
The randomised, double-blind, placebo-controlled Phase II trial will assess the safety and efficacy of biropepimut-S with low-dose cyclophosphamide vaccination, compared to placebo controls with vaccine adjuvants Leukine and Hiltonol for ten vaccinations over two years.
Planned to be conducted at 45 centres across the US, Germany, Hungary, Poland, Serbia, Spain, and Ukraine, the trial will involve HLA-A2 positive patients who are a high risk of disease recurrence following surgery, chemotherapy and radiation.
Gliknik CEO David Block said: “With recurrent oral cavity cancer being so difficult to treat, now is an opportune time to assess how useful and safe biropepimut-S may be in protecting individuals from recurrence of high-risk oral cavity cancer.
“The goal of the study is to see if we can activate the individual’s immune system to eliminate residual cancer cells that cannot be seen by current imaging methods, thereby avoiding clinical recurrence.”
The US Food and Drug Administration (FDA) has previously granted orphan drug designation to biropepimut-S, which demonstrated epitope-specific T-cell responses in the majority of subjects during prior trials.