MaxONCO SIGNED

Project "MaxONCO" data sheet

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 Project objective

MaxiVAX a private Swiss clinical-stage biotech company with a novel cancer immunotherapy product in development (MaxONCO) will perform two Phase 2 clinical trials in two indications (Head & Neck, and Chordoma) and prepare the commercialization of MaxONCO, its first immuno-therapy product. The objective of the Phase II clinical trials is to demonstrate efficacy and safety of MaxONCO in the patients treated and compare the results to the current standard of care. MaxONCO is a biological product acting as a cancer vaccine and composed of (i) an immune boost agent released in situ by a genetically modified cell line and (ii) cancer autologous cells, which are the source of antigens. A Phase 1 trial in 25 patients with a range of cancer types at an advanced stage showed encouraging efficacy data and a benign safety profile of the treatment. Head and Neck cancer is a group of cancers that develops in the areas of the head and neck which include the mouth, throat and salivary glands; accounting for 650,000 new cases in 2018 diagnosed globally. With the approval of Swissmedic, MaxiVAX has initiated the Phase 2 clinical trial to evaluate MaxONCO in 40-45 patients with Head & Neck cancer. The study will be conducted across 4-6 different sites in Switzerland. Encouraging clinical results show that among 4 initial Head & Neck patients treated with MaxONCO all survived beyond the 6-month time point (primary efficacy end point). Chordoma is a rare type of cancer that occurs in the skull base and anywhere along the spine. Besides surgery and radiotherapy that are showing only limited success, there are currently no approved drugs to treat Chordoma. In the Phase 1 clinical trial, MaxONCO, has shown promising effects on chordoma patients. A phase 2 Chordoma clinical trial will be conducted in the EU and USA, under an FDA investigational new drug application (IND). A positive overall response rate in Chordoma would allow MaxONCO to benefit from the breakthrough therapy designation as fast-track market opportunity, Chordoma being an orphan indication. Currently accounting for 8 employees, the company plans to grow up to 25 employees by the end of the SME phase 2 project, creating up to 30 indirect jobs.