Tango Therapeutics has announced the first subject dosing in the open-label, multi-centre TNG456 Phase I/II trial in those with methylthioadenosine phosphorylase (MTAP)-deleted solid tumours, mainly focusing on glioblastoma (GBM).
Pharmacokinetics, safety, anti-tumour activity, and pharmacodynamics of the brain-penetrant, MTA-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor, TNG456 will be assessed in the trial.
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The Phase I segment involves a dose escalation study of the oral therapy, both as a standalone treatment and in conjunction with oral abemaciclib in this patient population.
The subsequent Phase II expansion portion will see six arms, each defined by confirmed tumour types, enrolling simultaneously at the recommended Phase II doses (RP2D) of the therapy alone and in combo.
Currently, the company is enrolling subjects to test the standalone treatment of the therapy in the dose escalation focusing on GBM.
Subjects who can tolerate the treatment can continue until disease progression is observed.
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By GlobalDataThe trial is being conducted at two locations within the US.
Tango Therapeutics Research and Development president Adam Crystal said: “Dosing the first patient in the TNG456 Phase I/II trial marks a significant step for us and for patients with MTAP-deleted GBM.
“People with GBM currently have few treatment options and a five-year survival rate below 10%. 45% of GBM is MTAP-deleted, thus a substantial number of patients have the potential to benefit from TNG456, where preclinical studies demonstrate potency, MTAP-selectivity and brain exposure that has the potential to be sufficient for meaningful efficacy in GBM.”
Tango Therapeutics is focused on developing precision medicine for cancer treatment.
Its strategy involves utilising synthetic lethality to identify and target essential pathways in cancer.
In January last year, Tango dosed the first subject in the Phase I/II trial of ubiquitin-specific protease 1 (USP1) inhibitor TNG348.
