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Immunotherapy Trial Shows Increased Brain Cancer Survival

Robert Fenstermaker and Michael Ciesielski

Robert Fenstermaker, left, and Michael Ciesielski (Roswell Park Comprehensive Cancer Center)

29 May 2018. Results from a clinical trial show an experimental treatment for an aggressive form of brain cancer that harnesses the immune system extends patients’ survival, when combined with standard cancer care. Researchers from Roswell Park Cancer Center in Buffalo, Cleveland Clinic in Ohio, and the company MimiVax LLC, also in Buffalo, plan to report the findings on Saturday, 2 June at the annual meeting of American Society of Clinical Oncology in Chicago.

The team is testing a synthetic antibody called SurVaxM as a therapy for glioblastoma, an aggressive brain cancer, which affects astrocyte or glial cells supporting neurons or nerve cells in the brain. Glioblastoma is often difficult to treat, where usually the best hope is to slow progression of the disease with radiation or chemotherapy. The cancer generally grows and spreads quickly, often resulting in death within 15 months of diagnosis. American Association of Neurological Surgeons estimates glioblastoma occurs in 2 to 3 out of 100,000 adults per year, and accounts for 52 percent of all primary brain tumors.

Researchers at Roswell Park who initially developed SurVaxM say the treatments target glioblastoma tumor cells in two ways. First, SurVaxM generates T-cells, white blood cells in the immune system, to attack cells that express a protein known as survivin, over-expressed on glioblastoma tumors, and is present in many other types of cancer. In addition, SurVaxM limits the survivin signaling pathway that supports tumor growth and recurrence.

Roswell Park licensed the intellectual property rights for SurVaxM to MimiVax, a spin-off company from the institute. MiMiVax was founded by institute researchers Robert Fenstermaker and Michael Ciesielski, co-inventors of the SurVaxM technology. Fenstermaker is neurosurgery chair at Roswell Park and chief medical officer at MimiVax. Ciesielski is the company’s chief scientist, as well as a professor of neurosurgery at Roswell Park.

The intermediate-stage clinical trial is recruiting 64 participants newly diagnosed with glioblastoma at Roswell Park, Cleveland Clinic, and three other cancer centers. Participants are asked to add SurVaxM to their standard chemotherapy temozolomide, with SurVaxM given in four doses every 2 weeks. The study team is looking particularly at 6-month progression-free survival rates among participants, as well as indicators of safety and tolerability and their overall survival. While the trial did not have a placebo or comparison group, the researchers compared response rates against historical averages for standard glioblastoma care.

Interim results show so far among the the 63 participants receiving both SurVaxM and temozolomide, 91 percent are still living 12 months after their first SurVaxM treatments, with 96 percent surviving without their cancer progressing for at least 6 months after their initial treatments. In comparison, 61 percent glioblastoma patients receiving standard cancer care historically survive 12 months, and 54 percent survive for 6 months without the cancer progressing. About 1 in 5 participants (13 of 63, or 21%) are living 12 months or more without their disease progressing. In addition, researchers say the treatments were well tolerated, with adverse effects considered mild, and no adverse effects attributed to SurVaxM.

Because many tumors are linked to the presence of survivin, the researchers believe SurVaxM has potential to treat a wider range of tumors. Ciesielski notes in an institute statement that “because survivin is present in a huge percentage of cancers in general, we expect that SurVaxM could have broad applicability in many cancers beyond glioblastoma.” MimiVax and Roswell Park are developing extensions of SurVaxM, including a highly targeted anti-survivn antibody and engineered T-cells expressing chimeric antigen receptor (CAR T-cell) anti-cancer proteins.

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