Clinical Trials

Date: 2018-09-25

Type of information: Initiation of the trial

phase: 2

Announcement: initiation of the trial

Company: Maxivax (Switzerland)

Product: MVX-ONCO-1

Action mechanism:

  • immunotherapy product. MVX-ONCO-1 is a biological product made up of two components. The first consists of complete tumor cells taken from each individual patient and represents the best repertoire of antigens, i.e., cancer-specific targets against which a coordinated immune response can be directed. The cancer cells are lethally irradiated before being implanted subcutaneously in the patient.
  • The second component consists of the adjuvant, or booster. Adding a strong adjuvant is essential for triggering an efficient immune response. The release of the potent adjuvant GM-CSF, a white blood cell growth factor, is obtained by the implantation of a biocompatible capsule that contains a cell line genetically modified to produce the strong adjuvant. The encapsulation of the GM-CSF-producing cells allows the continuous, in-situ delivery of the immune boosting agent over seven days at the site of immunization. This is a critical parameter for the successful and sustained immunization against the cancer cells.
  • A recently completed Phase 1 clinical trial demonstrated that MVX-ONCO-1 was safe and well tolerated.

Disease: head and neck squamous cell carcinoma (HNSCC)

Therapeutic area: Cancer - Oncology

Country: Switzerland

Trial details:

  • The purpose of this trial is to determine the efficacy of the immunotherapy with MVX-ONCO-1 in patients with advanced head and neck squamous cell carcinoma. The whole treatment takes 9 weeks. At weeks 1, 2, 3, 4, 6 and 8, the tumor cells are injected underneath the skin and two capsules are implanted for a week. At weeks 2, 3, 4, 5, 7 and 9 the capsules are removed again. The patients are then followed-up for 5 years. The trial will include 40-45 patients. The primary endpoint is overall survival at 26 weeks.  Other endpoints include progression-free survival, adverse and serious events .(NCT02999646)

Latest news:

  • • On September 25, 2018, MaxiVAX , 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 across different sites in Switzerland 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.
  • The company received the 2017 CTI Swiss Medtech Award for its ground-breaking work with MVX-ONCO-1. In 2018, the FD accepted the company’s Investigational New Drug (IND) Application to conduct clinical trials.
  • 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.
  • 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.

Is general: Yes