Policy & Regulation
Jubilant Therapeutics' JBI-778 IND application receives US FDA approval to treat solid tumours with brain metastases and primary brain tumours
4 August 2022 -

Jubilant Therapeutics Inc., a US-based biopharmaceutical company, announced on Wednesday that it has received approval from United States Food and Drug Administration (US FDA) for the Investigational New Drug application (IND) for JBI-778, an oral, brain penetrant and selective protein arginine methyl transferase 5 (PRMT5) inhibitor, intended to treat solid tumours with brain metastases and primary brain tumours including high-grade glioma.

The Phase I/II trial is an open-label, two-part dose escalation and expansion study, aimed at defining the product's safety profile, pharmacokinetics, optimal dosing and preliminary activity. The participants in the dose escalation phase will include patients with stable brain metastasis whose disease has failed prior standard therapy. Expansion cohorts are to include patients with active brain metastases and high-grade gliomas.

Hari S Bhartia, Jubilant Therapeutics Inc chairman, said, 'JBI-778 will be our second, highly selective oral drug candidate to enter clinical development following JBI-802. These two programs, along with several others partnered or in preclinical development, highlight Jubilant Therapeutics' proven discovery engine and structure-based drug discovery expertise.'