Date: 2016-04-07
Type of information: Results
phase: 1
Announcement: results
Company: Maxivax (Switzerland)
Product: MVX-ONCO-1
Action
mechanism: therapeutic vaccine/immunotherapy product. MVX-ONCO-1 is based on triggering the patient’s own natural immune response mechanism via an innovative and proprietary technology in order to eliminate cancer cells. MVX-ONCO-1 consists of a two-component system: The GM-CSF producing cells are themselves immuno-protected by a small hollow-fibre capsule, implanted under the skin. This innovative technology of protein delivery by encapsulated cells was pioneered by Prof. P. Aebischer, President of EPFL in Lausanne, who has been an advisor to Maxivax since its foundation.
1) Vaccine: administered by sub-cutaneous injection, using the patient’s own irradiated cancer cells as vaccine antigens, with a key benefit of using the entire set of tumour antigens from the patient’s own cells.
2) Immune boosting agent: an immune boosting agent (GM-CSF: granulocyte macrophagecolony stimulating factor) is delivered at the site of vaccination in a sustained manner, via genetically reprogrammed cells, encapsulated in a small hollow fibre capsule.
Disease: solid tumors
Therapeutic area: Cancer - Oncology
Country: Switzerland
Trial details:
Latest
news: * On April 7, 2016, Maxivax, a private Swiss biotech company, announced results from a ground-breaking clinical phase 1 trial at the Geneva University Hospital (HUG) with its proprietary cancer vaccination product, MVX-ONCO-1, in 15 patients suffering from various solid cancers at an advanced stage. Based on these results, the company will start a phase 2 trial in head and neck cancer in Switzerland in the second half of 2016 and is evaluating trials in other cancer types. The objective of the phase 1 study was to assess the safety and tolerability of MVX-ONCO-1, administered under the skin in 15 patients with advanced metastatic solid tumors in progression who were no longer amenable to standard therapy. Treatment duration was 8 weeks, with 6 vaccine injections and 6 subcutaneous implantations of the immune booster. The results demonstrate that MVX-ONCO-1 is safe and well tolerated. There were no adverse events related to the product itself, as assessed by the treating physician. Furthermore, encouraging efficacy results were observed particularly in those patients with a more robust immune system. The results will be presented at the Swiss Biotech Day to be held in Basel on 12 April 2016. * On November 13, 2014, MaxiVAX announced it is conducting a phase 1 trial at the Geneva University Hospitals with its proprietary cancer vaccination MVX-ONCO-1 in 15 patients suffering from various cancers at an advanced stage. The phase 1 trial in Geneva is due for completion in the middle of 2015. Assuming a successful outcome, the company plans to conduct multi-centre clinical phase IIa trials in Europe in 2015-2017. The goal is to establish the cancer-specific treatment efficacy and safety of MVX-ONCO-1 in larger lung, ovarian and pancreatic cancer patient populations. The company is conducting a new financing round with existing and new private investors to support these clinical programs.
This first phase I clinical trial of MVX-ONCO-1 is underway at the Geneva University Hospitals, under the auspices of SwissMedic. The therapeutic products are manufactured at the Centre of Cell Therapy, whereas patients are treated at the onco-haematology clinical research unit of the Dr. Henri Dubois-Ferriere Dinu Lipatti Foundation, at the Oncology Centre of the HUG. This clinical trial will evaluate the vaccine candidate’s safety and feasibility. Four patients out of a scheduled 15 patients, all with advanced stage tumors, have now received treatment with promising initial results. The feasibility of the treatment has been validated and all quality/safety endpoints have been met so far. No local or systemic side effects were detected in relation to the anti-tumor immunizations.
The decision to undertake this ground-breaking clinical trial in patients was based on extensive pre-clinical data by MaxiVAX which demonstrated the efficacy of this novel vaccination procedure in protecting mice against several types of cancers, leading to cure rates of over 80% compared to 100% mortality in untreated subjects.
