Glioblastoma (GBM) is the most common and aggressive form of adult brain cancer, carrying a historically poor prognosis. Standard treatment involves surgery, radiation, and chemotherapy, but recurrence is common, and average overall survival remains short, typically 15 to 18 months. SurVaxM is a novel, peptide-based immunotherapy designed as a therapeutic vaccine candidate to improve outcomes for patients with newly diagnosed GBM. It harnesses the body’s own immune system to specifically recognize and target cancer cells.
Targeting Survivin: The Mechanism of Action
SurVaxM targets survivin, a protein highly expressed in over 95% of glioblastoma tumors. Survivin inhibits apoptosis (programmed cell death), allowing cancer cells to evade the body’s natural self-destruction mechanisms. Because survivin is minimally expressed in healthy adult tissues, it serves as an ideal molecular target.
The vaccine is a synthetic peptide conjugate, mimicking a specific segment of survivin. It consists of a 15-amino acid peptide epitope bound to the immune-stimulating molecule keyhole limpet hemocyanin (KLH). This structure trains the patient’s immune system to recognize the survivin mimic as foreign.
Once administered, SurVaxM prompts a targeted immune response, stimulating the production of survivin-specific cytotoxic T-cells (CD8+ T-cells) and anti-survivin antibodies. These activated components circulate, locating and destroying tumor cells that display the survivin protein on their surface.
Administration Protocol and Safety Profile
The SurVaxM vaccine is administered via subcutaneous injection. The treatment protocol involves a priming phase followed by a maintenance phase. Patients first receive four priming doses over a short period, such as every two weeks.
The vaccine is delivered in an emulsion with an adjuvant, such as Montanide ISA 51, and often combined with a second immune-stimulating agent like sargramostim. These components enhance the immune response generated by the survivin peptide. Following the initial priming series, patients receive maintenance booster doses, usually every 12 weeks, alongside standard of care chemotherapy.
SurVaxM has demonstrated a favorable safety and tolerability profile compared to traditional cancer treatments across multiple clinical trials. No serious adverse events have been reported. Common side effects are mild and include temporary injection site reactions (redness or swelling), mild fatigue, and occasionally a low-grade fever or myalgia.
Clinical Trial Progress and Efficacy Results
SurVaxM has progressed through clinical trials. A multi-center Phase IIa single-arm trial evaluated the vaccine in 63 newly diagnosed glioblastoma patients who received SurVaxM alongside standard treatment (radiation and Temozolomide, or TMZ). The primary endpoint was achieving a 70% progression-free survival rate at six months from diagnosis.
The trial successfully met this endpoint, with 95.2% of evaluable patients remaining progression-free at six months. Measured from the first immunization, the median progression-free survival (mPFS) was 11.4 months for the group. The median overall survival (mOS) was 25.9 months, which compares favorably to the historical average of 15 to 18 months.
This benefit was observed across different molecular subtypes of GBM, including those with unmethylated MGMT genes, which are typically associated with a poorer prognosis. For patients with the most favorable prognostic factor (MGMT methylated), the median overall survival reached 41.4 months. These positive outcomes led to the launch of the randomized, placebo-controlled Phase IIb SURVIVE trial to further evaluate the vaccine’s efficacy.