Immunotherapie clinical trial

Slide Immunotherapy: Phase 1 clinical trial for delNS HPV 16 A pioneering innovation for cancer therapy

BlueSky delNS therapy makes tumours vulnerable to the immune system: Scientists of the Viennese biotech company BlueSky Immunotherapies currently conduct a phase 1 clinical trial for treating subjects infected with Human Papillomavirus type 16, in short HPV 16, to eliminate existing infections and prevent resulting cervical cancer and other tumour types in humans. Find out here what pioneering milestone was achieved regarding the next-generation cancer therapy.

Immunotherapy to activate the immunological defense reaction against cancer

The focus of the biotech company BlueSky Immunotherapies is on utilising its proprietary delNS technology platform for viral vectors which activate antiviral and antitumoural reactions:

  • activate natural killer cells (NK)
  • activate cytotoxic T cells (CTL)
  • activates dendritic cells (DC)
  • inhibit immunosuppressive regulatory T cells (Treg)

These properties are being used in the development of next-generation immunotherapy against infectious diseases and cancer.

Cancer immunotherapy: advantages of the delNS vector

As tumours suppress the activation of an immune response directed against them, they remain virtually invisible to the body’s immune system. Treatment with delNS/E6E7 abolishes this immunosuppression. Hence, the immune system can recognise and fight the tumours.

Further advantages of the delNS vector are:

  • Strong proof of concept: The scientific hypothesis was confirmed. Fist-sized incurable tumours caused by papillomaviruses in horses could be elimintated.
  • Safety clinically tested: The technology has already been tested in several clinical trials and is safe and tolerable in humans.
  • Comprehensive, antitumour effect: The platform can be used for all types of cancer.
  • Affordable cancer therapy: Low production costs are a salient feature of delNS vector manufacturing.

Phase 1 clinical trial for the treatment of women with a persistant HPV 16 infection

According to WHO, five percent of all cancers worldwide are induced by human papillomaviruses (HPVs). The number of new cases caused by HP viruses is around 760,000 per year. In addition, there are millions of cases of precancerous lesions, i.e. tissue changes that might become malignant. Treatment options for the invasive form of cancer are limited and include surgery and chemoradiation which are ineffective and do not treat the underlying HPV infection.

The innovative immunotherapy with delNS technology from BlueSky Immunotherapies aims to eliminate this high-risk HPV type in the future and prevent resulting tumours in humans. A phase 1 clinical trial is currently being conducted.

Important innovation for eliminating tumours

The trial’s primary endpoint is to evaluate safety and to determine the dosage for the subsequent phase 2. First results obtained in the clinical trial have now confirmed the tolerability of the delNS-based vector delNS/E6E7 after subcutaneous administration. In the course of the study, secondary endpoints such as the removal of the HPV 16 infection and the elimination of already existing tumours and tumour cells will also be assessed.

It is important to note that the delNS technology platform can also be used for expressing other tumour antigens and thus has an enormous potential for the treatment of other solid tumours.

 “The elimination of HPV 16 infections mediated by the delNS vector delNS/E6E7 could prevent millions of conisations of precancerous lesions and up to 150,000 deaths due to cervical cancer annually. HPV 16 infection is highly prevalent and persistent, and no early-stage treatment is available. We want to change this,”

explains Thomas Muster, CEO of BlueSky Immunotherapies GmbH (Ltd.).

Company Contact Details

BlueSky Immunotherapies GmbH (Ltd.)
Univ.Doz. Dr. DI Thomas Muster, CEO

Mariahilfer Straße 101/1/21
1060 Wien
+43 6641888028


Press & Enquiries

Isolde M. Bergmann
+43 699 12278607

BlueSky Immunotherapies