Sydney-based Viralytics (ASX: VLA) has entered into a clinical trial collaboration agreement through subsidiaries of US-based Merck & Co (known as MSD in Australia) to evaluate the combination of its investigational cancer immunotherapy CAVATAK with MSD’s PBS-listed KEYTRUDA, an anti-PD-1 therapy.
The Phase 1b clinical trial will evaluate the safety and efficacy of this novel immunotherapy combination in patients with either advanced stage non-small cell lung cancer (NSCLC) or metastatic bladder cancer.
Viralytics, in collaboration with MSD, will be the sponsor of the study, which is planned to begin in 2016. MSD will provide KEYTRUDA and conduct biomarker analysis. The agreement includes a provision where the parties may extend the collaboration to include a potential Phase 3 clinical trial.
KEYTRUDA is currently reimbursed in Australia for advanced melanoma. MSD is already progressing an extended listing to treat NSCLC. The therapy is also being trialled in dozens of studies to treat a range of other cancers.
As members of a new class of cancer treatments known as immunotherapies, both CAVATAK and KEYTRUDA are designed to enhance the body’s own defences in fighting cancer.
CAVATAK is an investigational agent based on a proprietary bioselected common cold virus that has been shown to preferentially infect and attack 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.
KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumour cells and healthy cells.
“We are excited to collaborate with MSD on this clinical trial, which is the first 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 cancers,” said Dr Malcolm McColl, CEO and Managing Director of Viralytics.
“We are pleased to have this opportunity to work with a leader in the immuno-oncology field to evaluate the potential synergy of these two novel immunotherapies in these very common cancer types.”
“We believe that there may be potential benefit in combining CAVATAK with our anti-PD-1 therapy, KEYTRUDA – which have different, yet complementary approaches to engaging the immune system to fight cancer –and look forward to seeing results from this study.” said Dr Eric Rubin, vice president and therapeutic area head, oncology early-stage development, MSD Research Laboratories.
Viralytics also announced positive data from two clinical studies of CAVATAK at the 30th Annual Meeting of the Society for the Immunotherapy of Cancer in the US. The data included updated results from the Phase 1 STORM clinical trial of intravenous CAVATAK in advanced cancers and from the Phase 1 CANON clinical trial of intravesicular CAVATAK in nonmuscle invasive bladder cancer.
In the ongoing Phase 1 STORM clinical trial, multiple intravenous doses of CAVATAK are being administered to patients with late-stage non-small cell lung cancer, hormone refractory prostate cancer, metastatic bladder cancer, and late stage melanoma.
The company said initial results from the dose escalation phase in the first 12 patients, including six patients in the third cohort who have been administered the highest dose of CAVATAK, show that multiple infusions of CAVATAK are generally well tolerated with no Grade 3 or higher CAVATAK-related adverse events.
In the Phase 1 CANON trial, which is assessing the administration of CAVATAK via catheter directly into the bladder in patients with non-muscle invasive bladder cancer, initial results demonstrate that CAVATAK has been generally well tolerated with no Grade 2 or higher CAVATAK-related adverse events.