Eisai and PIQUR Therapeutics are to conduct a Phase 1/2b clinical study to investigate PQR309 combined with Halaven (eribulin) in triple-negative breast cancer (TNBC) patients.

PQR309 is an oral, balanced pan-PI3K/mTOR inhibitor. As PIQUR’s lead compound, it has shown promising activity as a single agent in Phase 1 and 2 studies.

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Eribulin is believed to inhibit the growth phase of microtubule dynamics, which stops cell division.

The combination of a PI3K/mTOR inhibitor with eribulin could be an effective second-line therapy treatment for patients with locally advanced or metastatic TNBC.

“We believe that combining eribulin with PQR309 may provide new treatment options for patients with TNBC.”

The Phase 1/2b clinical study is slated to begin in early 2016.

Under the initial dose-escalation part of the study, PQR309’s safety and tolerability will be assessed when combined with eribulin in patients with locally advanced or metastatic HER2-negative and TNBC.

The Phase 2b expansion part of the study will see enrolment of patients with advanced or metastatic TNBC.

The aim of this part of the study is to assess the efficacy of the PQR309 in combination with eribulin.

Approximately 60 patients will be enroled in the Phase 1/2b study.

PIQUR will conduct the Phase 1/2b clinical trial. The firms may also carry out additional tests, including a Phase 3 clinical trial.

Eisai chief innovation officer and vice president Dr Takashi Owa said: “We are delighted to enter into this collaboration with PIQUR Therapeutics, which has rapidly established itself as one of the leading experts in the field of PI3K/mTOR inhibitors.

“Based on convincing pre-clinical data and on the promising results of PIQUR’s front runner compound PQR309 shown in Phase 1 study, we believe that combining eribulin with PQR309 may provide new treatment options for patients with TNBC.”

PIQUR Therapeutics chief business officer Hervé Girsault said: “We are very pleased to enter into this collaboration with Eisai, one of the worldwide leaders in oncology and to jointly explore new avenues to address an unmet need in breast cancer.”

Earlier this week, Eisai and Sysmex Corporation entered a collaboration agreement aimed at creating new diagnostics for dementia.