Biropepimut-S (GL-0817) is an investigational cancer vaccine being developed by Gliknik for the treatment of head and neck squamous cell carcinoma and to prevent the recurrence of high-risk squamous cell carcinoma of the oral cavity.

How Biropepimut-S works

Biropepimut-S is composed of engineered peptides (small parts of proteins) derived from the human melanoma antigen A3 (MAGE-A3), which is a tumor-associated antigen present in significantly greater amounts in a variety of cancer cells and associated with a poor prognosis.

The engineered Biropepimut-S peptides were designed to enter cells more effectively, travel through them without being degraded, and then be cleaved to intact antigen epitopes (or part of an antigen that is recognized by the immune system), therefore, generating a stronger immune response against cancer cells expressing MAGE-A3.

Biropepimut-S in clinical trials

Biropepimut-S was first tested in a small Phase 1 dose escalation study (NCT00257738) to evaluate its safety and ability to trigger an immune response in six patients with MAGE-A3 positive recurrent or metastatic squamous cell carcinoma of the head and neck.

The results of the study, published in the scientific journal Cancer Immunology, Immunotherapy, showed that four of the six patients (67 percent) developed antigen-specific cell and antibody responses to the vaccine. The vaccine was well tolerated and no dose-limiting toxicity was reached.

Gliknik is currently assessing the safety and efficacy of Biropepimut-S in a randomized, double-blind, placebo-controlled Phase 2 trial (NCT02873819) to prevent the recurrence of squamous cell carcinoma of the oral cavity.

Following standard post-operative chemoradiotherapy for high-risk disease, participants will be treated with either Biropepimut-S and low-dose cyclophosphamide (Cytoxan) or placebo with the vaccine adjuvants (or helper drugs) Leukine and Hiltonol for 10 vaccinations over a two-year period.

The trial is still recruiting participants at 45 sites across the U.S., Germany, Hungary, Poland, Serbia, Spain, and Ukraine, and is expected to be completed in March 2020.

Other details

The most common adverse effects associated with the use of Biropepimut-S include redness, pain, and itching at the injection site and headache, nausea, and chills when used at the highest dose.


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