IN8bio’s INB-400 and INB-410 are indicated to treat newly diagnosed glioblastoma multiforme. Credit: Nephron/ commons.wikimedia.org.

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM).

This marks the first-ever designation for genetically modified gamma-delta T cell therapies.

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INB-400, an autologous, genetically engineered gamma-delta T cell therapy, is the company’s DeltEx chemotherapy-resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology.

It will expand the application of DRI gamma-delta T cells into other solid tumour types by developing allogeneic or “off-the-shelf” DeltEx DRI technology.

The regulator cleared the company’s investigational new drug (IND) application to commence a Phase II clinical trial of INB-400 in newly diagnosed GBM in December 2022.

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The trial has been designed to evaluate the tolerability, efficacy and safety of genetically modified DeltEx DRI cells at medical centres across the US.

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Participant enrolment is anticipated to commence in the second half of 2023.

The Institutional Review Board’s (IRB) review and site initiation are ongoing.

IN8bio CEO and co-founder William Ho stated: “Our goal is to achieve our ‘mission of cancer zero’ by eradicating cancer cells and improving patient outcomes.

“Our novel approach combines engineered, chemo-resistant, gamma-delta T cells with standard-of-care treatments to amplify immune signals, maximise tumour killing and eliminate more cancer cells. We eagerly anticipate enrolling our first Phase II patients for INB-400 later this year.”