Neon Therapeutics has concluded patient enrolment in the Phase Ib clinical trial (NT-002) of its NEO-PV-01 in combination with Merck’s Keytruda (pembrolizumab) and chemotherapy to treat advanced or metastatic non-small cell lung cancer (NSCLC).

NEO-PV-01 is a neoantigen vaccine designed to induce an anti-tumour immune response that would stimulate patients’ T cells to target and kill cancer cells.

The vaccine will be custom-designed and produced for individual patients based on the neoantigens identified using the company’s RECON bioinformatics engine as the most therapeutically relevant.

In the Phase Ib trial, the safety, tolerability, and efficacy of the NEO-PV-01 vaccine will be evaluated.

Participants will undergo an initial tumour biopsy, followed by pembrolizumab and chemotherapy treatment for 12 weeks.

“Our NT-002 trial has the potential to demonstrate the effect that NEO-PV-01 may have in combination with pembrolizumab.”

At week 12, NEO-PV-01 will be administered and pembrolizumab will be continued throughout the trial.

The trial’s primary objective is safety. It will also monitor immune responses and clinical outcomes.

Neon Therapeutics Research and Development president Richard Gaynor said: “Our NT-002 trial has the potential to demonstrate the effect that NEO-PV-01, our personal neoantigen vaccine, may have in combination with pembrolizumab and chemotherapy, the current standard of care in first-line metastatic NSCLC.

“While the pembrolizumab-chemotherapy regimen has shown improved clinical outcomes in first-line NSCLC, we believe NEO-PV-01 could improve the therapeutic efficacy of this combination by directing T cells to target neoantigens expressed in each patient’s tumour.”

Announced in December 2017, the Phase Ib trial commenced dosing patients in May last year. Immune and clinical outcome results from the study are expected to be available next year.

The personal cancer vaccine has also been evaluated in combination with Bristol-Myers Squibb’s Opdivo (nivolumab) in metastatic melanoma, NSCLC and bladder cancer.