On May 30, 2024 MimiVax Inc, a clinical-stage biotechnology company developing immunotherapeutics for cancer and autoimmune diseases, reported that the United States Food and Drug Administration (FDA) has awarded a supplemental orphan drug designation to MimiVax’s SurVaxM vaccine to now include malignant glioma (Press release, MimiVax, MAY 30, 2024, View Source;utm_medium=rss&utm_campaign=us-fda-awards-supplemental-orphan-drug-designation-to-survaxm-to-now-include-treatment-of-malignant-glioma [SID1234643861]). Currently, SurVaxM vaccine is being studied as a treatment for newly diagnosed glioblastoma (nGBM) in a phase 2b randomized clinical study (the SURVIVE trial) which will assess the efficacy of SurVaxM in a large patient population with nGBM. This supplemental orphan drug designation greatly expands the potential for SurVaxM’s use in other forms of pediatric and adult malignant gliomas. An orphan drug designation plays a critical role in encouraging the development of treatments for rare diseases, ultimately improving the lives of patients who might otherwise have few or no treatment options.
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Gliomas are brain tumors that are initiated from glial cells that and support nerve cells in the brain and spinal cord. Gliomas comprise about 80% of all malignant primary brain tumors and include such tumors as astrocytomas, oligodendrogliomas and ependymomas.
"Receiving orphan drug designations for SurVaxM emphasizes the critical demand for novel and enhanced therapeutic options for people living with malignant gliomas," said Michael Ciesielski, Ph.D., CEO of MimiVax. "We hope that this designation may help to advance SurVaxM’s application for important indications beyond adult GBM including for pediatric brain cancers."
Orphan designation is granted by the FDA to advance the evaluation and development of new therapies intended to treat a rare disease or condition that generally affects fewer than 200,000 individuals each year in the United States. Under the Orphan Drug Act, regulatory agencies may offer certain benefits to expedite the approval process for orphan drugs, recognizing the urgent need for treatments for rare diseases. This can include accelerated review timelines and flexibility in clinical trial design, tax credits for qualified clinical trials, FDA user-fee benefits, and seven years of market exclusivity in the United States after new drug approval.