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June 1, 2018

Syndax and Nektar to conduct NKTR-214 and entinostat Phase lb/ll trial

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.

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.

“We believe this important preclinical finding could translate to improved tumour responses in patients who have become refractory to checkpoint inhibitors.”

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.

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