What Is SurVaxM?
SurVaxM is an investigational drug being studied for its potential to treat various types of cancer. It is a synthetic peptide conjugate designed to stimulate the body's immune system. Specifically, SurVaxM works by targeting the survivin molecule, which is often found in cancer cells and helps them survive. By producing an immune response against survivin, SurVaxM aims to help the body identify and kill these cancer cells. The drug consists of multiple copies of a specific peptide (SVN53-67/M57) conjugated to Keyhole Limpet Hemocyanin (KLH), forming the molecule SVN53-67/M57-KLH. This immunotherapy approach is currently being evaluated in clinical trials for its safety and effectiveness in patients with certain brain and spinal cord tumors.
Uses and Conditions Under Study
SurVaxM is currently under investigation in clinical trials for several types of aggressive brain and spinal cord cancers. These conditions include various forms of glioma and other central nervous system tumors, all of which are being studied in one trial each.
- Glioblastoma and Newly Diagnosed Glioblastoma: Glioblastoma multiforme is a fast-growing, aggressive type of brain tumor. SurVaxM is being studied for its ability to stimulate an immune response against cancer cells in these patients.
- Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, and High-grade Astrocytoma NOS: These are also aggressive brain tumors. SurVaxM aims to target cancer cells that express the survivin molecule, potentially offering a new treatment approach.
- Anaplastic Ependymoma and Ependymoma: Ependymomas are tumors that can occur in the brain or spinal cord. SurVaxM's immune-stimulating properties are being explored to fight these tumors.
- Medulloblastoma: This is a common malignant brain tumor, often affecting children. SurVaxM is being investigated for its potential to elicit an immune response against medulloblastoma cells.
- Diffuse Intrinsic Pontine Glioma (DIPG): DIPG is a highly aggressive and difficult-to-treat brain tumor primarily affecting children. SurVaxM is being studied as a potential treatment option for patients with non-relapsed DIPG after radiation therapy.
In total, SurVaxM has been studied across four clinical trials involving 323 participants, with the first trial starting in 2019.
Dosing
SurVaxM is administered as an emulsion, typically given by injection. The specific dosing regimen can vary depending on the study and the patient's age and condition.
One studied dose involves 500 mcg (1 mL) of SurVaxM emulsion, often combined with Montanide ISA 51. In some trials, sargramostim is also co-administered, with doses of 3.33 mcg/kg/dose for patients weighing less than 30 kg, and 100 mcg for patients weighing 30 kg or more.
A common treatment schedule involves an initial "prime-boost" phase where participants receive four doses of SurVaxM spaced two weeks apart, completing this phase in six weeks. Following this, maintenance doses of SurVaxM are administered every three months for up to two years.
SurVaxM has been studied in various pediatric populations, including:
- Patients aged 10 to 21 years with relapsed or progressive medulloblastoma, high-grade glioma, or ependymoma.
- Patients aged 1 to less than 10 years with relapsed or progressive medulloblastoma, high-grade glioma, or ependymoma.
- Patients aged 1 to 21 years with non-relapsed Diffuse Intrinsic Pontine Glioma (DIPG) after radiation therapy.
Another dosage mentioned in trials is 200 mg IV every three weeks, though the specific context for this dose with SurVaxM is not fully detailed.
Side Effects
In a clinical trial (NCT04013672) evaluating SurVaxM in combination with Pembrolizumab for glioblastoma at first recurrence, the safety and tolerability of the treatment were assessed. This study included participants who had not previously received immunotherapy.
The trial recorded various adverse events to measure safety. While a number of events were observed across participants, the specific types of these events (e.g., headache, fatigue, nausea) and their individual frequencies are not detailed in the provided data. Therefore, a list of specific side effects and their rates cannot be presented here. The data available indicates a total count of events, but without their classification, a patient-friendly summary of common side effects is not possible.
Since this data comes from a single treatment arm, direct comparisons of side effect rates against a placebo group or another treatment are not available from this specific trial information.
Clinical Trial Results
Glioblastoma
The efficacy of SurVaxM when combined with Pembrolizumab was investigated in a clinical trial (NCT04013672) for patients with glioblastoma at first recurrence. This study specifically focused on participants who had not received prior immunotherapy.
One key outcome measured in this trial was Progression-Free Survival (PFS). PFS refers to the length of time during and after treatment that a patient lives with the disease without it getting worse. In the arm of the study consisting of participants who had not previously received immunotherapy, 34.5% of patients experienced progression-free survival.
This result indicates that over one-third of the participants in this specific group maintained their disease without progression for the duration of the PFS measurement period in this trial. The study aimed to assess the potential benefit of adding SurVaxM to Pembrolizumab for this challenging condition.
Currently Recruiting Trials
Currently, there are no clinical trials actively recruiting participants for SurVaxM based on the available data. Clinical trials are essential for studying new treatments, and their availability can change as research progresses.
Where to Participate
At this time, there are no specific locations listed for participating in SurVaxM clinical trials, as no trials are currently recruiting. When trials become available, specific sites, cities, and states will be provided.
General eligibility criteria for past or future SurVaxM studies indicate that healthy volunteers are typically not included. While age is not specified, children are generally excluded from participation. Studies are open to all genders.
Development Timeline
The journey of SurVaxM in clinical development began on July 10, 2019, with its first recorded trial. Since then, a total of four clinical trials have been initiated, enrolling 323 participants to date, with the latest trial starting on December 20, 2021.
Early development saw SurVaxM being investigated for conditions such as IBS-C and hyperphosphatemia. However, the focus of the research quickly expanded, indicating a strategic shift towards oncology. The pipeline grew to include a range of serious brain cancers and related conditions, demonstrating the drug's potential in this area.
The development has progressed through different phases, with one trial in Phase 1, two trials in Phase 2, and one trial with an unspecified phase. This progression from early-stage to mid-stage trials is a key milestone in drug development. Several organizations have sponsored these studies, including Children's Oncology Group, David Peereboom, MimiVax, LLC, and Roswell Park Cancer Institute, highlighting a collaborative effort in advancing SurVaxM.
The conditions under investigation now include:
- Anaplastic Oligodendroglioma
- Diffuse Intrinsic Pontine Glioma
- Ependymoma
- Glioblastoma
- Glioblastoma Multiforme
- High-grade Astrocytoma NOS
- Medulloblastoma
- Newly Diagnosed Glioblastoma
- Recurrent Glioblastoma