Syndax Pharmaceuticals has signed a non-exclusive, clinical collaboration agreement with Nektar Therapeutics to conduct a Phase lb/ll trial to examine the safety and efficacy of NKTR-214 in combination with entinostat to treat patients with metastatic melanoma.
The trial will enrol metastatic melanoma patients who have previously progressed on treatment with an anti-programmed death receptor-1 (PD-1) agent.
The Phase lb portion of the trial intends to identify the safety and a recommended dose for the combination regimen.
It will be followed by a Phase ll portion that aims to evaluate the efficacy of the combined treatment, as defined by objective response rate and durability of response.
The Phase lb/ll trial will also evaluate progression-free survival and overall survival rate.
As part of the new agreement, Syndax will conduct the trial. The deal also includes a provision where the signatories may extend the collaboration to include a pivotal trial based on mutual interest.
Nektar Therapeutics senior vice-president and chief scientific officer Jonathan Zalevsky said: “The combination of NKTR-214 and entinostat demonstrated a unique synergy in our preclinical models, which warrants further study in the clinic.
“Importantly, we observed elevated levels of cytokine-positive tumour-infiltrating cytotoxic T-cells following treatment with the combination.
“We believe this important preclinical finding could translate to improved tumour responses in patients who have become refractory to checkpoint inhibitors.”
Nektar's NKTR-214 is an investigational therapy designed to stimulate cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells.
Entinostat is an oral, small molecule, Class 1 specific histone deacetylase inhibitor (HDAC) developed by Syndax.