The Phase Ib trial will investigate naptumomab plus Imfinzi for treating advanced or metastatic solid tumours. Credit: Dr. Cecil Fox, National Cancer Institute, National Institutes of Health.

NeoTX Therapeutics has dosed the first patient in a Phase Ib clinical trial of a naptumomab estafenatox and Imfinzi (durvalumab) combination for the treatment of solid tumours.

Designed as immunotherapy, naptumomab stimulates the immune system to identify and kill tumour cells. The drug triggers certain T cells outside the tumour microenvironment and redirects the immune cells to attack the tumours.

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In preclinical studies involving different tumour models, naptumomab demonstrated the potential for a synergistic effect with checkpoint inhibitors.

NeoTX Therapeutics licensed the drug from Active Biotech in 2016. As part of the licence agreement, NeoTX has to carry out the development and commercialisation of the drug in oncology indications.

Imfinzi is a checkpoint inhibitor developed by AstraZeneca. It is a human monoclonal antibody that inhibits the PD-L1 interaction with PD-1 and CD80.

Imfinzi has approvals for the treatment of unresectable, stage III non-small cell lung cancer (NSCLC) and advanced bladder cancer. The drug is also being developed for various other solid tumours.

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The open-label, multi-centre, dose-finding Phase Ib trial will investigate the safety and tolerability of naptumomab plus Imfinzi for treating advanced or metastatic tumours in around 45 patients who received prior therapies.

NeoTX Therapeutics CEO Asher Nathan said: “The dosing of the first patient in our Phase Ib trial is a significant milestone for NeoTX, as it is our first clinical-stage molecule developed with our Selective T Cell Redirection (STR) platform.

“Previous clinical studies have shown Nap to be well-tolerated, and preclinical work conducted by the NeoTX team supports its broad potential in treating advanced and metastatic tumours, especially in combination with checkpoint inhibitors.”

During the Phase Ib trial, NeoTX intends to establish the maximum tolerated dose before initiating a Phase II cohort expansion study.

The trial will also monitor the incidence of adverse events and determine the recommended Phase II dose.