BlueSky Immunotherapies GmbH (Ltd.): Phase 1 clinical trial for delNS HPV 16

BlueSky's delNS technology makes tumours vulnerable to the immune system. A pioneering innovation for eliminating tumours

VIENNA, Austria I March 19, 2021 I 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. In order to eliminate existing infections with human papillomavirus type 16 (HPV 16) and prevent resulting tumours in humans, a phase 1 clinical trial for treating subjects infected with HPV 16 is currently being conducted. 

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.

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.

According to WHO, five percent of all cancers worldwide are induced by human papillomaviruses (HPVs). The number of new cases 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 this cancer are limited and include surgery and chemoradiation which are ineffective and do not treat the underlying HPV infection. The aim of the innovative immunotherapy developed by BlueSky Immunotherapies is to eliminate these existing HPV infections.

Advantages of the delNS vector

  • Strong proof of concept/confirmation of hypothesis – fist-sized incurable tumours caused by papillomaviruses in horses could be eliminated.
  • The technology has already been tested in several clinical trials and is safe and tolerable in humans.
  • The platform can be used for all types of cancer.
  • Low production costs are a salient feature of delNS vector manufacturing.

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.).

Scientific approach and technology

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

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

About BlueSky Immunotherapies GmbH (Ltd.)

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 therapies against cancer and infectious diseases.

SOURCE: BlueSky Immunotherapies

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