Innova Therapeutics Receives Rare Pediatric Disease Designation from the Food and Drug Administration (FDA) for IVT-8086 for the Treatment of Osteosarcoma

ISLE OF PALMS, S.C., Sept. 24, 2020 /PRNewswire/ -- Innova Therapeutics Inc., a biopharmaceutical company committed to developing innovative cancer therapies for patients who have inadequate treatment options, today announced that the FDA has granted Rare Pediatric Disease (RPD) Designation for IVT-8086 for the treatment of Osteosarcoma (OS). IVT-8086 is a humanized monoclonal antibody (mAb) with high affinity to a novel anticancer target, secreted frizzled-related protein 2 (SFRP2).

"The FDA's Rare Pediatric Disease Designation of IVT-8086 for the treatment of osteosarcoma highlights the significant unmet medical needs for patients with this devastating and life-threatening disease. IVT-8086 has the potential to become the first FDA-approved therapy for individuals with osteosarcoma in over 30 years," said Robert Ryan, Ph.D., Chief Executive Officer of Innova Therapeutics.

This research was conducted in the laboratory at the Hollings Cancer Center at the Medical University of South Carolina (MUSC) by Nancy Klauber-DeMore, MD, who is a co-founder and Professor of Surgery and BMW Endowed Chair of Cancer Research.

Hollings Cancer Center Director Raymond N. DuBois, M.D., Ph.D. said, "This is very exciting for the cancer center. This is a new designation approved by the FDA for a terrible disease in children, osteosarcoma," DuBois said. "Hollings values these kinds of partnerships that help advance the great science happening here in our laboratories. Also, translating our basic science into the clinic is a major goal of Hollings, especially when there is such a great unmet need."

The FDA grants Rare Pediatric Disease Designation for serious and life-threatening diseases that primarily affect children ages 18 years or younger and fewer than 200,000 people in the U.S. If Innova's new drug application ("NDA") for osteosarcoma is approved, Innova may receive a priority review voucher from the FDA, which can be redeemed to obtain priority review for any subsequent marketing application or may be sold to another company for their programs.

About Osteosarcoma

Osteosarcoma is a malignant bone tumor with histological findings of osteoid or bone production. OS is a highly metastatic cancer that predominantly affects children, teenagers, and young adults. In the last 20 years, OS patients have not seen improvement in prognosis even with available treatments. The prevalence of OS is approximately 40,000 individuals in the US.

About IVT-8086

IVT-8086 has high affinity to SFRP2, which is a novel anticancer therapeutic target that is highly expressed in OS tumor cells. IVT-8086 has been shown to antagonize SFRP2 thereby blocking the non-canonical Wnt/Ca2+ pathway, resulting in decreasing tumor cell angiogenesis and cell migration, increasing tumor cell apoptosis, and rescuing T cell exhaustion.

About Innova Therapeutics

Innova Therapeutics is a Charleston, South Carolina based biotechnology company. The Company's most advanced investigational medicine, IVT-8086, is in late stage pre-IND development targeting SFRP2 which is highly expressed in various solid cancers, including OS. For more information visit

Forward Looking Statement

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release. Innova disclaims any intent or obligation to update these forward-looking statements.

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