Genome and Company and Merck (MSD) have signed a clinical trial collaboration and supply agreement to analyse GEN-001 plus Keytruda (pembrolizumab) in a Phase II clinical trial to treat biliary tract cancer.

An oral immuno-oncology microbiome therapeutic candidate of Genome, GEN-001 contains single-strain bacteria, Lactococcus lactis, obtained from a healthy human. 

It was developed to possess immune-modulating activities that lead to possible combination with immune checkpoint inhibitors. Keytruda is an anti-programmed death-1 (PD-1) therapy of MSD.

Following the signing of the deal, Genome will carry out the Phase II trial which will analyse the safety and efficacy of the combination treatment for biliary tract cancer.

As per the agreement, the trial will be sponsored by Genome with MSD supplying Keytruda.

Genome and Company CEO Dr Jisoo Pae said: “Genome and Company has established clinical trial collaborations to evaluate ‘GEN-001’ with both anti-PD-L1 and anti-PD-1 therapies through agreements with MSD, Merck KGaA, Darmstadt, Germany and Pfizer, which shows that the company is being recognised for its innovative technology by global immuno-oncology companies.” 

“Through this clinical trial collaboration, we look forward to evaluating the potential additive benefit of ‘GEN-001’ in combination with Keytruda as treatment for patients with biliary tract cancer.”

GEN-001 demonstrated a favourable safety margin as well as synergistic effects with immune checkpoint inhibitors in preclinical studies. 

It worked by boosting the effect of suppressing the growth of immune checkpoint inhibitor sensitive and resistant tumour models. 

The Phase I/Ib trial of GEN-001 is currently underway in the US and Korea.

In October last year, the Korean Ministry of Food and Drug Safety granted approval to an Investigational New Drug (IND) application for the Phase II trial of the microbiome therapeutic candidate.

In January 2020, Genome, Merck and Pfizer entered a clinical trial collaboration and supply agreement to assess GEN-001 for oncology indications in a Phase I/Ib trial.