IN8bio (NASDAQ:INAB) Inc shares slid 16% to $2.51 in early Tuesday trading after the biopharmaceutical company announced that it has received orphan drug designation from the US Food and Drug Administration (FDA) for the company’s INB-400 and INB-410.
The drug candidates cover a wide range of malignant glioma treatments including newly diagnosed Glioblastoma multiforme (GBM), considered the most common form of primary malignant brain tumor.
IN8bio (NASDAQ:INAB) said the milestone marks the first genetically modified gamma-delta T cell therapy to receive this designation, which offers potential incentives such as seven-year market exclusivity.
“Our novel approach combines engineered, chemo-resistant gamma-delta T cells with standard-of-care treatments to amplify immune signals, maximize tumor killing, and eliminate more cancer cells,” IN8bio (NASDAQ:INAB) CEO William Ho said in a statement.
“We eagerly anticipate enrolling our first Phase 2 patients for INB-400 later this year,” he added.
In December 2022, the FDA cleared IN8bio's investigational new drug application (IND) for a Phase 2 clinical trial in newly diagnosed GBM for INB-400.
Treatment options for GBM, which is considered to be a highly aggressive and difficult-to-treat brain cancer, have remained largely unchanged for more than 18 years, with a median progression-free survival of 6-7 months and overall survival of 14-16 months, according to the company.
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