EC grants orphan drug status for Genenta’s glioma therapy

he European Commission (EC) has issued orphan drug designation (ODD) for Genenta Science’s Temferon to treat glioma.

Temferon’s initial clinical indication is for treating glioblastoma multiforme (GBM), an aggressive type of diffuse glioma.

Temferon is a cell therapy that introduces immunomodulatory molecules to tumours to reprogramme the tumour microenvironment.

This product is being analysed in a Phase I/IIa clinical trial in individuals newly diagnosed with GBM who have an unmethylated MGMT [methylguanine methyltransferase] gene promoter.

Temferon has been shown to disrupt tumour-elicited tolerance, thereby aiding the immune system in detecting the tumour and generating a lasting immune response.

The EC grants ODD to therapies being developed for treating rare ailments that impact not more than five in 10,000 individuals in the European Union.

Genenta CEO Pierluigi Paracchi stated: “The European Medicine Agency’s committee reviewed Genenta’s ODD application for Temferon and agreed on the potential significant benefit that Temferon could contribute to patients suffering from GBM if approved.

“The ODD designation supports and facilitates the development of our cell therapy-based technology platform for solid tumours.

The company received ODD from the US Food and Drug Administration for Temferon to treat GBM in March 2023.

Earlier this year, Genenta entered a development and manufacturing service agreement with AGC Biologics to produce a cell therapy lentivirus-based product.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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