Viralytics and MSD collaborate on combination cancer trial

Sydney-based immunotherapy developer Viralytics (ASX:VLA) has entered into a clinical trial collaboration agreement with subsidiaries of global healthcare company MSD. The trial will evaluate the combination of Viralytics’ investigational cancer immunotherapy, CAVATAK, with MSD’s KEYTRUDA, an anti-PD-1 (programmed death receptor-1) therapy.

Both CAVATAK and KEYTRUDA are designed to enhance the body’s defences in fighting cancer. CAVATAK is an investigational agent based on a bioselected common cold virus that preferentially infects and attacks cancer cells. KEYTRUDA is a humanised monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumour cells and healthy cells.

Planned to begin in 2016, the clinical trial will evaluate the safety and efficacy of the novel immunotherapy combination in patients with either advanced stage non-small cell lung cancer (NSCLC) or metastatic bladder cancer. According to Viralytics CEO and Managing Director Dr Malcolm McColl, it will be the first trial “to explore the combination of an intravenously delivered oncolytic virotherapy with a checkpoint inhibitor such as KEYTRUDA in non-small cell lung and metastatic bladder cancer”.

The phase 1b combination trial will be the second stage of Viralytics’ ongoing STORM clinical trial. The first stage of the study is focusing on assessing the intravenous administration of CAVATAK as a monotherapy in late-stage solid cancer patients. Initial results indicate that multiple intravenous infusions of CAVATAK have been well tolerated and have produced potential tumour viral replication in some advanced cancer patients, with antitumour activity seen in some individual lesions.

The second stage of the trial has been redesigned to assess the intravenous delivery of CAVATAK in combination with KEYTRUDA in cancer patients. The aim of the study is to establish a recommended dose regimen for the CAVATAK/KEYTRUDA combination and to evaluate anticancer activity and patient tolerability.

Viralytics will provide CAVATAK and sponsor the study, while MSD will provide KEYTRUDA and conduct biomarker analysis. The parties may extend the collaboration to include a potential Phase 3 clinical trial.

Viralytics (ASX:VLA) shares were trading 14.53% higher at $0.67 as of around 3.30 pm on Friday.