A study across different sites in Switzerland will evaluate the first personalized cell-based cancer immunotherapy using encapsulation cell technology. All enrolled patients will have failed standard therapy.
MaxiVAX SA, a private Swiss clinical-stage biotech company developing novel anti-cancer vaccines, announced the start of an open label Phase 2 study to evaluate its MVX-ONCO-1 product in 40-45 patients with Head & Neck cancer. The study is being conducted in collaboration with SAKK, the Swiss Group for Clinical Cancer Research. All enrolled patients will have a confirmed diagnosis of Head and Neck Squamous Carcinoma (HNSCC), stage III/IV in recurrent or metastatic stage and will have failed standard therapy. The primary endpoint is overall survival at 26 weeks.
Successful Phase I study
The company received the 2017 CTI Swiss Medtech Award for its ground-breaking work with MVX-ONCO-1. In 2018, the US Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) Application to conduct clinical trials. The start of the Phase 2 clinical trial follows the successful completion of a Phase 1 trial in 25 patients with a range of cancer types at an advanced stage, when no serious adverse events were reported in the study drug.
Dr Nicolas Mach MD, Chief Scientific Officer of MaxiVAX, commented: “I am proud that we have started this really important Phase 2 clinical trial for patients who have not responded to traditional therapy for Head & Neck tumors. There is a clear medical need for these patients.”
He continued: “MVX-ONCO-1 is the first personalized cell-based cancer immunotherapy using encapsulation cell technology. Crucially, it benefits those patients whose immune system is still functioning at a certain base level. Therapy is individualized and can be applied to any cancer type.”
Dr Peter Brauchli, CEO of SAKK, the Swiss Group for Cancer Research, said: “We are delighted to be working with MaxiVAX and be involved in the clinical development of MVX-ONCO-1. With the full engagement of our network of hospital sites, we will ensure timely completion of this important study for these patients who clearly need more effective therapies.”
The Phase 2 Head and Neck study has been made possible in part thanks to grants made to Dr Nicolas Mach MD, Geneva University Hospital. In addition to his function as Deputy Head of the hospital’s Oncology Division, Dr Nicolas Mach is Chief Scientific Officer of MaxiVAX and founder of its novel immunotherapy technology. A grant of CHF 240,000 was made available by the Swiss Cancer League, and another grant of CHF 300,000 was awarded by SAKK/RTFCCR/Gateway Research.
(Press release)
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