Jubilant Therapeutics has received the US Food and Drug Administration (FDA) clearance for the Investigational New Drug application (IND) to start a Phase I/II clinical trial of JBI-778 to treat solid tumours.
The therapy is intended for treating solid tumours with brain metastases and primary brain tumours including high-grade glioma.
The open-label, two-part dose escalation and expansion trial will analyse the safety profile, pharmacokinetics, optimal dosing and initial activity of JBI-778.
Subjects with stable brain metastasis whose disease did not respond to previous prior standard therapy will be part of the dose escalation phase.
Patients with active brain metastases and high-grade gliomas will be included in the expansion cohorts.
JBI-778 is an oral brain penetrant and selective inhibitor of protein arginine methyl transferase 5 (PRMT5).
As against current PRMT5 inhibitors, it has a mechanism of action by being substrate-competitive and S-adenosylmethoinine (SAM) cooperative.
This mechanism along with an improved brain exposure facilitates targeting of both primary brain tumours and CNS metastasis.
JBI-778 is said to be the second, highly selective oral drug candidate of the company to enter clinics.
Jubilant Therapeutics CEO Syed Kazmi said: “JBI-778 was engineered by our drug discovery team to be a PRMT5 substrate-competitive and brain penetrant drug candidate to address primary brain tumours and brain metastases which currently have limited treatment options.
“In addition to JBI-778, we are also advancing an oral brain penetrant PDL1 inhibitor, JBI 2174, which is on the IND-track to potentially treat primary CNS cancers among others.”
In April this year, the company dosed the first subject in a Phase I/II trial of JBI-802 in advanced solid tumour patients.