OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424

OBI Pharma announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL). OBI-3424 is a first in class DNA alkylating cancer therapeutic agent targeting aldo-keto reductase 1C3 (AKR1C3) overexpressing cancers.

This is the second FDA orphan drug designation for OBI-3424. On July 9, 2018 OBI-3424 was granted orphan drug status for the Treatment of Hepatocellular Carcinoma (HCC). A Phase 1/2 study of OBI-3424 in patients with solid tumors, including HCC and castrate-resistant prostate cancer (CRPC), has commenced enrollment at the University of Texas M.D. Anderson Cancer Center.

"This additional orphan drug designation for OBI-3424 by the FDA is a significant step in the development of this drug candidate in ALL, including T-ALL, an unmet medical need disease with limited treatment options," Amy Huang, General Manager of OBI Pharma, said. "We are excited that the FDA has recognized the need to develop novel targeted therapeutic agents such as OBI-3424 in the fight against ALL."

Acute Lymphoblastic Leukemia (ALL), also known as Acute Lymphocytic Leukemia, is a rare blood cancer affecting the maturation of B-cell and T-cell lymphoblasts from progenitor cells. The current prevalence of ALL in the US is around 86,462 cases in 2018. The disease affects primarily children, with 60% of cases occurring at age <20 years. The remission rate for pediatric ALL is approximately 90%, with overall survival around 60-70% in recent years. Current treatments for ALL have been less successful in both infant and adult patients, as well as patients with recurrent disease, leading to an unmet medical need for new treatments.

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