US FDA Awards Supplemental Orphan Drug Designation to SurVaxM to Now Include Treatment of Malignant Glioma

MimiVax Inc., a clinical-stage biotechnology company developing immunotherapeutics for cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration has awarded a supplemental orphan drug designation to SurVaxM to now include malignant glioma. SurVaxM is currently being studied as a treatment for newly diagnosed glioblastoma in the Phase 2b SURVIVE trial, and this designation expands its potential use to other forms of pediatric and adult malignant glioma.

Gliomas are brain tumors that originate from glial cells, which support nerve cells in the brain and spinal cord. They comprise about 80% of all malignant primary brain tumors and include astrocytomas, oligodendrogliomas and ependymomas.

“Receiving orphan drug designations for SurVaxM emphasizes the critical demand for novel treatment options,” said Michael J. Ciesielski, PhD, Chief Executive Officer.

Orphan drug designation is granted by the FDA to advance the development of therapies for rare diseases generally affecting fewer than 200,000 people in the United States each year. It can include accelerated review timelines, flexibility in trial design, tax credits for qualified trials, FDA user-fee benefits, and seven years of U.S. market exclusivity after approval.

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About SurVaxM: SurVaxM is an experimental cancer vaccine targeting survivin, a protein found in many cancer cell types. Delivered subcutaneously, it stimulates a patient’s immune response against tumor cells to help prevent disease recurrence.

About MimiVax: MimiVax, Inc. is a Delaware-incorporated, clinical-stage biopharmaceutical company developing immunotherapies for cancer treatment, with clinical trials evaluating SurVaxM in glioblastoma, multiple myeloma, neuroendocrine tumors, and pediatric relapsed high-grade glioma, medulloblastoma, ependymoma and diffuse intrinsic pontine glioma (DIPG).