SurVaxM (SVN53-67/M57-KLH) is an investigational immunotherapy being developed to treat a type of brain cancer called glioblastoma as well as multiple myeloma. The therapy was initially developed at Roswell Park Cancer Institute in Buffalo, New York, and is now being advanced by Roswell Park’s spin-off company, MimiVax.
How SurVaxM works
SurVaxM is a type of immunotherapy called a cancer vaccine, which acts to educate the immune system to identify and target cells producing proteins that are associated with cancer.
The immune system recognizes antigens, substances associated with a disease that are not normally produced by the body. Specific immune cells called antigen presenting cells (APCs) identify and process these antigens. They then activate another type of immune cell called T-cells to recognize and kill the cells producing the antigen.
Around 95 percent of glioblastomas produce a protein called survivin, which is rarely present in the body. SurVaxM consists of a peptide, part of the survivin protein, that can be recognized as an antigen by the immune system. The peptide is attached to a metalloprotein called keyhole limpet hemocyanin (KLH), which can boost the immune response against the peptide.
When SurVaxM is injected into the patient, the immune system stimulates the production of T-cells that target the survivin-producing tumor cells, reducing the tumor size or preventing tumor growth.
SurVaxM is administered in combination with the adjuvant or “helper drug” Leukine (sargramostim), which acts to boost the numbers and activity of immune cells such as APCs.
SurVaxM in clinical trials
The safety and tolerability of SurVaxM were initially assessed in an open-label Phase 1 clinical trial (NCT01250470) carried out at the Roswell Park Cancer Institute. It investigated SurVaxM in combination with Leukine in nine patients with several types of brain cancer.
The results, published in the scientific journal Cancer Immunology, Immunotherapy, reported that the therapy was well tolerated. The most common adverse events were injection site reactions, fatigue, and muscle pain. Six of the eight evaluable patients had a confirmed immune response to the vaccine.
On average, patients whose cancer recurred appeared to have a longer life expectancy, at 12 to 20 or more months, compared to patients receiving only standard-of-care, which is around seven months. Two of the eight patients were still progression-free at the time of last follow-up.
Following these positive results, an open-label Phase 2 study (NCT02455557) was initiated. The trial aims to assess the safety and efficacy of SurVaxM in combination with the chemotherapy Temodal (temozolomide). The trial is recruiting patients with glioblastoma at five sites in the U.S.
SurVaxM is being tested in combination with Revlimid (lenalidomide) as a maintenance therapy for multiple myeloma in a Phase 1 trial (NCT02334865). The trial is being conducted in collaboration with Celgene and aims to enroll an estimated 18 patients at the Roswell Park Cancer Institute.
On Aug. 3, 2017, SurVaxM was granted orphan drug status by the U.S. Food and Drug Administration for the treatment of glioblastoma.
MimiVax also aims to investigate SurVaxM as an auto-immune disease therapy in the future, based on positive results in preclinical trials of the vaccine showing that it improves symptoms of myasthenia gravis in a mouse model.
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