The Phase 1/2 trial evaluating an immunotherapy, MG1-MAGEA3, in combination with Keytruda (pembrolizumab) in non-small cell lung cancer patients who fail to respond to chemotherapy has dosed its first patient, the therapy’s developer, Turnstone Biologics, announced.
Named the Sandpiper Trial (NCT02879760), this is the second clinical trial evaluating Turnstone’s lead product and is recruiting participant. The first trial, which is still ongoing, is assessing MG1-MAGEA3 as a monotherapy in NSCLC and in breast and esophageal cancer patients.
“Initiation of the Sandpiper Trial represents an important milestone for Turnstone. We are excited to evaluate our technology in combination with pembrolizumab as a potential treatment for lung cancer, and about the promise it may hold for patients,” Sammy Farah, the company’s CEO, said in a press release. “Preclinical evidence strongly suggests that our product can sensitize cancers to the activity of checkpoint inhibitors and provide enhanced benefits to a larger segment of lung cancer patients compared to either therapy alone.”
MG1-MAGEA3 is a cancer vaccine. It consists of the attenuated, oncolytic form of the Maraba virus, MG1, which has been engineered to express the MAGE-A3 gene. Once administrated to cancer patients, the virus is designed to only replicate inside cancer cells, killing them while leaving healthy cells unharmed.
In addition, the expression of the MAGE-A3 protein stimulates the patient’s immune system to mount an effective response against tumor cells expressing this protein. MAGE-A3 is a tumor-associated antigen that is commonly found in a number of cancer cell types, including lung cancer.
Combining MG1-MAGEA3 with immune checkpoint inhibitors has shown promise in preclinical studies. This led the company to design the Sandpiper Trial, a multi-center, open-label, dose escalation trial for patients with metastatic NSCLC who have completed a first treatment course with platinum-based chemotherapy.
The trial will enroll 55 participants who express the MAGE-A3 protein in their cancer cells. Two sites in Canada are currently recruiting participants — The Ottawa Hospital and Juravinski Cancer Centre in Hamilton — and additional cancer centers will begin enrolling within the next year.
“I am treating people today with pembrolizumab alone and seeing some impressive outcomes,” said Dr. Rosalyn Juergens, oncologist and site lead investigator at the Juravinski center, and an associate professor of oncology at McMaster University. “Combining it with Turnstone’s oncolytic viral immunotherapy could be a way for more people to benefit from this emerging class of immunotherapies. Many experts in the field think that these combination approaches could truly harness the power of the body’s immune system to selectively target and destroy cancer, and keep it at bay.”
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