MaxiVAX announces promising results from its phase 1 anti-cancer clinical trial

MVX-ONCO-1 is a unique product combining a vaccine against the complete tumor cell with an immune system boosting agent provided in a sustained manner. The objective of this 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 that 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. 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.

Dr Nicolas Mach MD, Chief Scientific Officer, said: “We are delighted with these promising results which validate the safety and tolerability of this potentially novel therapy for treating cancer patients who to date faced a bleak prognosis. The vast majority of individuals suffering from cancer with local infiltration or metastasis will die from their malignancy within three years despite the currently available therapies.” He continued: “MVX-ONCO-1 is the first personalized cell-based cancer immunotherapy using encapsulation cell technology. This reprograms and boosts the patient’s own immune system to fight cancer. Therapy is individualized and can be applied to any cancer type.”

Dimitrios Goundis PhD, Chief Executive Officer, commented: “These encouraging results underlie our confidence in taking MVX-ONCO-1 into a number of cancer indications, of which the first will be a phase-2 trial in head and neck cancer in Switzerland, starting later this year. Moreover the benign safety profile of MVX-ONCO-1 makes it an ideal candidate for combination therapies with other anti-tumor agents such as checkpoint inhibitors.”

The results will be presented at the Swiss Biotech Day to be held in Basel on 12 April 2016.

About MVX-ONCO-1
MaxiVAX’s novel Immuno-Oncology therapeutic vaccination 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 has been classified as an Advanced Therapeutic Medicinal Product by the European Medicines Agency (EMA).

MVX-ONCO-1 contains two distinct biological entities: the Vaccine, WHICH IS administered by sub-cutaneous injection, using the patient’s own irradiated cancer cells as vaccine antigens and an Immune boosting agent, GM-CSF (granulocyte macrophage- colony stimulating factor). Which are delivered at the site of vaccination in a sustained manner, via genetically reprogrammed cells, encapsulated in a small biocompatible capsule. 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.

About MaxiVAX
MaxiVAX is a Swiss-based clinical stage biotech company with a totally novel, patient-specific and personalized active immunotherapy product for cancer vaccination. The field of Immuno-Oncology has recently seen successes of first generation cancer immunotherapies which are paving the way for MaxiVAX’ s novel and competitive approach. The company’s mission is to develop novel therapeutic vaccines that are more effective, personalized, and enable the patient’s immune system to fight his/her own disease. The company is managed by a world class team of scientists and business professionals. It is financed by private investors together with grants from public and private institutions.

(Press release)