On December 6, 2024 UP Oncolytics, Inc’s reported that program to develop Zika Virus strains to treat glioblastoma has achieved two major milestones (Press release, UP Oncolytics, DEC 6, 2024, View Source [SID1234648856]).
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SBIR Fast Track Grant from the NINDS
Orphan Drug Designation from the FDA
"In the nearly 40 years I have been caring for glioblastoma patients, prognosis hasn’t changed. By using multiple resistance mechanisms, including the blood brain barrier, glioblastoma can defeat traditional chemotherapy, radiation, targeted therapy, and immunotherapy. Something needed to change," commented Richard A Rovin, MD, CEO and co-founder of UP Oncolytics. That change comes in the form of an oncolytic virus–a naturally occurring or genetically modified virus that can preferentially enter and kill cancer cells.
According to Parvez Akhtar, PhD, CSO and co-founder, "The Zika Virus strains we are testing have the unique combination of safety, efficacy, and the ability to cross the blood brain barrier."
The SBIR award and Orphan Drug Designation come after years of extensive pre-clinical testing led by Dr Akhtar. "Both of these validate the scientific work we have done and the company we have built," observed Dr Akhtar.
Dr Rovin: "I think the SBIR and Orphan Designation show that the NINDS and FDA understand the urgent and unmet need to develop novel, effective treatments for GBM. Parvez and I are humbled and excited to bring Zika Virus treatment to clinical trial."
About the SBIR Fast Track Grant
The Small Business Innovation Research (SBIR) program through the NIH provides seed funding to early-stage small businesses so that they can bring their innovation from "bench to bedside". The Fast-Track process allows companies to submit both Phase I and Phase II in one application for review. The Fast-Track mechanism minimizes the funding gap between phases but requires a fully developed Phase II application/plan at the time of submission. In 2023, fewer than 20% of applicants received funding.
About Orphan Drug Designation
The FDA Office of Orphan Products Development (OOPD) "supports and advances the development and evaluation of new treatments for rare diseases." A rare disease affects fewer than 200,000 people in the United States. The OOPD can grant Orphan Status to a drug or biologic for the treatment of a rare disease. An Orphan Drug Designation provides benefits to the sponsor including tax benefits, waiver of fees, and seven-year market exclusivity after approval.
About Gliomas
Gliomas are considered primary tumors as they originate in the brain. They account for 23% of all primary brain tumors and 81% of malignant primary brain tumors. Glioblastoma (GBM), the most aggressive brain cancer, accounts for 61% of gliomas. (Price et al., 2024a)
There are approximately 13,000 new cases of GBM each year (Price et al., 2024b) and about 25,000 people in the United States are living with GBM. (Neff et al., 2023)
In the United States, the median survival for patients with GBM is 9 months and the 5-year survival rate is 7.1%. (Price et al., 2024a)