OUR MISSION
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.
TECHNOLOGY
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
REFERENCES / PUBLICATIONS delNS
The original paper Influenza A virus lacking the NS1 gene replicates in interferon-deficient systems (Virology 252,324) has accumulated 1248 citations in peer – reviewed journals (Google Scholar, December 2021).
The immunogenic properties and safety of delNS-based viruses have been widely published in top journals. A selection of corresponding papers is provided below:
- PLoS ONE 16(11): e0260155 / Elimination of equine sarcoids (4773 downloads)
- Scientific Reports 11, 22164 /Antiviral properties through interference (5095 downloads)
- J Virol 74,6203 / activation of PKR (4979 downloads)
- J Virol 76,1617 / induction of apoptosis (5577 downloads)
- J Infect Dis 201,354 / B-cell mediated local and systemic response (5408 downloads)
- Med Microbiol Immunol 199,93 / activation of NK cells (5212 downloads)
- Vaccine 37,3722 / B-cell mediated response (4823 downloads)
- PLoS One 10(9) e0138722 / T-cell mediated response against E6E7 (5672 downloads)
- Nature 424,324 / activation dentritic cells and induction IFN (4979 downloads)
PIPELINE
CANCER
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.
INFECTIOUS DISEASES
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.
OUR TEAM
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 –
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
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ADVISORY BOARD
Rüdiger Herrmann
– Squire Patton Boggs –
Noel Barrett
– CEO Affiris –
Josef Poandl
– Investor –
NEWS & EVENTS
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.
Equine sarcoids: visible sucess with delNS-based immunotherapy
Cancer therapy has reached a new milestone: BlueSky Immunotherapies has achieved to completely and permanently eliminate sarcoids in horses with its viral vector platform delNS and also the papillomvirus that causes this aggressive form of skin cancer.
Patent protection for innovative technology-platform
BlueSky Immunotherapies has secured its patents that cover a recombinant influenza virus vector comprising an NS gene encoding a truncated NS1 protein.
FUNDING
