BlueSky Immunotherapies Announces Approval of a Phase 1 Clinical Trial for its cancer immunotherapy delNS/E6E7

BlueSky Immunotherapies, a company developing next generation immunotherapies using its own proprietary novel interferon-inducing viral vector technology platform (delNS1) against cancer and infectious diseases, today announced the start of a Phase 1 clinical trial (BS-01) of delNS/E6E7, a novel immunotherapy for the treatment of Human Papillomavirus associated infections, lesions and cancers.

delNS/E6E7 is an influenza-based immunotherapy that induces a high level of interferon. By expressing the tumour antigens E6 and E7 in an immunologically activated environment, a TH1-type immune response activating both innate and adaptive immunity within the tumour bed is generated. In preclinical studies, treatment of tumours in the mouse model showed strong reduction and elimination of tumours. Moreover, striking proof of concept was obtained in a clinical trial in horses showing that even aggressively growing untreatable papillomavirus-induced sarcoid tumours could be effectively eliminated.

Thomas Muster, CEO of BlueSky commented “We are very excited to begin our clinical testing using delNS1 for treating HPV-associated tumours. Based on our excellent data against aggressive noncurable tumours in horses, we believe that we can generate an attractive treatment option for a variety of HPV induced tumours. This study will pave the way to fully unlock the features of delNS1 in therapy of cancer.”

About the Clinical Trial

The clinical trial is a randomised, double-blind, placebo-controlled phase 1 dose-escalation study of delNS/E6E7 in up to 20 women. It is designed to assess the safety, tolerability, immunogenicity and efficacy after three subcutaneous administrations of two dose levels of delNS/E6E7.

About BlueSky

BlueSky Immunotherapies GmbH (formerly BlueSky Vaccines) is a biotech company in Vienna, Austria. BlueSky was founded as a limited partnership (GmbH) in Vienna/Austria in September 2016. Its headquarters are located at Mariahilfer Strasse 101/1/21, 1060 Vienna, the laboratories are located at the University of Veterinary Medicine, Vienna.

The company’s focus is on its own proprietary, novel technology platform for interferon (IFN)- inducing viral vectors (delNS). IFNs can activate a wide variety of antiviral and immunostimulating mechanisms. Hence, the delNS-based therapies developed by BlueSky can be used to fight infectious diseases and cancer.

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