delNS-based immunotherapy against HPV 16: phase 1 clinical trial

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

BlueSky’s delNS vector makes tumours vulnerable to the immune system

Scientists of the Viennese biotech company BlueSky Immunotherapies GmbH (Ltd.) have accomplished yet another milestone with their proprietary innovative delNS technology for interferon-inducing viral vectors. Read more about the innovative cancer treatment of BlueSky Immunotherapies.

HPV 16 infection

Cohort with intradermal treatment successfully completed

In order to eliminate existing infections with human papillomavirus type 16 (HPV 16) and prevent resulting cancer tumours in humans, a phase 1 clinical test for treating women with cervical infections caused by HPV type 16 is currently being conducted.

The women are treated with a delNS-based vector expressing the HPV 16-derived tumour antigens E6 and E7 (delNS/E6E7) to eliminate cervical infections.

The treatment is safe, tolerable and shows preliminary anti-tumour activity.

Eliminating tumour cells that cause HPV 16 cancer

The trial’s primary endpoint is to evaluate safety and to determine the dosage and optimal route for the subsequent phase 2.

After successfully treating the first cohort by the subcutaneous route, BlueSky completed treatment of the second cohort, which received delNS/E6E7 by the intradermal route. Intradermal injection is a shallow injection into the dermis, which is located between the epidermis and the hypodermis. As this layer of the skin contains large numbers of immune cells, the intradermal route might be better suited to activate and direct the immune system to eliminate the tumour cells caused by HPV 16. Like subcutaneous administration, intradermal administration has been confirmed to be safe and well tolerated.

The follow-up observation period has already shown that the tumorigenic lesions of several responders have cleared or regressed. Moreover, in women responding to the HPV 16 therapy, clearance of HPV 16, which causes malignant transformation of normal cervical to tumour cells, was determined.

In addition to examining already treated patients in the follow-up observation period, recruitment is currently underway for the third and last cohort, which will be treated by the intramuscular route. Once HPV 16 treatment of this cohort has been completed, a phase 2 study with the optimal dose and route will be started.

 “These observations are very encouraging but need to be confirmed in larger phase 2 clinical trials. Many women would benefit from the elimination of HPV 16 infections and lesions mediated by delNS/E6E7. Worldwide, about 30 million women are persistently infected with HPV 16, leading to tumourigenic lesions in about 50%. Thus our cancer therapy could prevent millions of conisations of lesions and up to 150,000 deaths due to cervical cancer annually”,

explains Thomas Muster, CEO of BlueSky Immunotherapies.

Fighting cancer of the cervix: how our immunotherapy works

The high level of interferon induced by the delNS vector activates immunological defence reactions against cervical cancer, which

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

Our biotechnology company

The focus of BlueSky Immunotherapies GmbH (Ltd.) is on utilising its proprietary platform technologies which activate antiviral and antitumoural reactions. BlueSky’s unique mix of expertise and experience is geared to the success of new-generation immunotherapies against cancer and infectious diseases.

Company Contact Details

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

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


Press & Enquiries

Isolde M. Bergmann
+43 699 12278607

BlueSky Immunotherapies