A cancer vaccine to boost body’s natural defences to fight chordoma and head and neck cancer: MaxONCO

Programme(s): H2020-EU.3. - PRIORITY 'Societal challenges
H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs
H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies

Topic(s): EIC-SMEInst-2018-2020 - SME instrument

Call for proposal: H2020-SMEInst-2018-2020-2

Funding Scheme: SME-2 - SME instrument phase 2

Grant agreement ID: 880194

Project description:

Experimental vaccine for the treatment of Chordoma and head and neck cancer
The head and neck group of cancers includes diseases involving the head and neck, including mouth, throat and salivary glands, with 650 000 new cases annually. Chordoma is a rare cancer of the skull base and the spine. Currently, there are no approved drugs for chordoma treatment. Biotech company MaxiVAX developed a cancer vaccine comprising an immune boost agent released in situ by an engineered cell line and cancer autologous cells providing antigens. A Phase I trial with 25 patients with an advanced stage of cancer showed encouraging efficacy data and safety profile of the treatment. The current EU-funded MaxONCO project Phase II clinical trial will evaluate this vaccine in 45 patients with head and neck cancer and in chordoma patients. The chordoma trial will be conducted in the EU and USA as an Investigational New Drug programme that allows fast-track marketing of the drug in case of successful trial results.

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.