BlueSky Immunotherapies GmbH (Ltd.) is a clinical-stage biotech company. The company’s business is based on its own proprietary, novel technology platform for interferon-inducing viral vectors (delNS). Interferons have immunostimulatory and antiviral properties. BlueSky uses these delNS- mediated properties for therapies against cancer and viral infectious diseases.


The high level of interferon induced by the delNS vector activates immunological defence reactions against cancer. It also stimulates the production of antiviral molecules:

Immunostimulation / Immunomodulation

– NK –

activates Natural Killer Cells

– CTL –

activates Cytotoxic T-Cells

– DC –

activates Dendritic Cells

– Treg –

inhibits Immunosuppressive Regulatory T-Cells

– ΜΦ –

activates Macrophage

Antiviral molecules / Inhibition of viral replication

– ISG15 –

Interferon stimulated gene 15

– OAS –

Oligoadenylate synthetase

– PKR –

Protein Kinase R

– Mx –

Interferon-induced GTP binding protein

Revolutionizing Oropharyngeal Cancer Treatment

Breakthrough Research at BlueSky Immunotherapies

Dive into the forefront of cancer treatment with Study BS03, where pioneering techniques are combating HPV 16 oropharyngeal cancer. Led by BlueSky Immunotherapies, this Phase 1 trial marks a significant leap forward in addressing locoregionally advanced disease.

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

The Viennese biotechnology company BlueSky Immunotherapies announces three great news:

1. Superior interim efficacy data for elimination of HPV infection and associated cervical neoplastic lesions.

2. Application for clinical trial to treat HPV-positive oropharyngeal head and neck cancer submitted.

3. Last patient for intramuscular treatment of HPV infection and associated cervical neoplastic lesions recruited.

Visible success thanks to viral vector platform delNS in modern cancer therapy

The Viennese biotechnology company BlueSky Immunotherapies GmbH (Ltd.) has achieved visible success with its viral vector platform delNS for the therapy of equine sarcoids in horses in cooperation with the oncology team of the University of Veterinary Medicine Vienna. Those significant results show the further possibilities in the development of innovative and easy-on-the-body cancer therapies in humans. Read in our online article what that means for the future of immunotherapy against infectious diseases and cancer, and what other advantages delNS vectors offer in cancer therapy.




Preclinical studies have proven that the immunostimulatory properties of the delNS-vector “delNS/E6E7” destroy tumours. The vector’s potential for fighting metastases has also been demonstrated in animal models. Moreover, we have shown that delNS/E6E7 eliminates aggressive and incurable papilloma virus induced tumours in horses. Based on these promising results, BlueSky is currently conducting a phase I clinical trial with delNS/E6E7 for tumour elimination and prevention of cervical carcinoma in humans. Subsequently, its efficacy against cervical lesions, cervical cancer as well as head and neck cancer will be assessed in phase II trials.


Interferon also activates endogenous antiviral molecules such as the so-called protein kinase K (PKR). Based on this observation, we have developed “Pekarin”. As a first application, we have successfully tested Pekarin in animal models against influenza viruses. It was found that severity and duration of influenza were both significantly reduced. In principle, Pekarin can be used to fight all viruses. Accordingly, we recently demonstrated its efficacy in the mouse model against COVID-19.


Thomas Muster

– CEO –

Over 20 years biotech experience; more than 50 publications; 30 patents; has developed vaccines licensed to Baxter and Boehringer

● Vivaldi Biosciences
● AVIR Green Hills Biotechnology
● Mount Sinai School of Medicine

Michael Tscheppe

– CFO –

Over 20 years in finance, business administration & marketing; university lecturer

● Nuvonis Technologies
● AVIR Green Hills Biotechnology
● University of Applied Sciences
● Post AG

Christina Nicolodi

– Chief Regulatory Officer –

Christina Nicolodi
Senior regulatory affairs professional, global regulatory affairs, clinical development, clinical trial applications, marketing authorisations

● Takeda
● Shire
● Baxter

Markus Wolschek

– CSO –

Lead scientist; virology, genetic-engineering and product development expert, more than 30 publications and several patents

● AVIR Green Hills Biotechnology
● Medical University Vienna


Rüdiger Herrmann

– Squire Patton Boggs –

Noel Barrett

– CEO Affiris –

Josef Poandl

– Investor –


BlueSky Immunotherapies Commences Phase 1 Trial for Oropharyngeal Cancer Treatment

BlueSky Immunotherapies has initiated a Phase 1 trial named BS03 to test an innovative treatment for HPV16-positive oropharyngeal cancer. The study examines the safety and tolerability of the delNS/E6E7 drug in patients with advanced oropharyngeal cancer. The aim is to assess local and systemic adverse events and monitor patients’ survival and immune response. Preclinical results indicate the drug’s potential to reduce recurrences, marking a significant advancement in developing safer and more effective therapies for oropharyngeal cancer.

Landmark in HPV Treatment: Excellent Safety and Substantial Efficacy of Viral Vector delNS/E6E7 in Phase 1 Trial

BlueSky Immunotherapies is thrilled to share the remarkable success of its Phase 1 clinical trial. Patients with HPV16 infections and cervical lesions have experienced unprecedented safety and substantial efficacy with our revolutionary viral vector delNS/E6E7. Learn more about this groundbreaking advancement in healthcare and join us on the path to transforming the lives of those affected by HPV16-related cervical lesions. Read the full story now!

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

BlueSky Immunotherapies announced that its Clinical Trial Application for a phase 1 clinical trial of FLUBHPVE6E7, a delNS-based immunotherapy for the treatment of human papillomavirus-associated oropharyngeal cancer, has been formally accepted and is under review by the Austrian Agency for Health and Food Safety.



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