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 (15268 downloads)
- Scientific Reports 11, 22164 /Antiviral properties through interference (16581 downloads)
- J Virol 74,6203 / activation of PKR (14936 downloads)
- J Virol 76,1617 / induction of apoptosis (15558 downloads)
- J Infect Dis 201,354 / B-cell mediated local and systemic response (16005 downloads)
- Med Microbiol Immunol 199,93 / activation of NK cells (16177 downloads)
- Vaccine 37,3722 / B-cell mediated response (15783 downloads)
- PLoS One 10(9) e0138722 / T-cell mediated response against E6E7 (16455 downloads)
- Nature 424,324 / activation dentritic cells and induction IFN (15817 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
●
●
●
ADVISORY BOARD
Noel Barrett, Ph.D.
– Board Member –
- 40+ years in Pharma/Biotech: Extensive management experience in R&D for innovative products
- Former Global VP R&D at Baxter Healthcare: Led the vaccines division
- Former CEO of abiotech start-up specialized in developing immunotherapies for neurodegenerative and cardiovascular diseases
Katherine Cohen, Ph.D.
– Board Member –
- 25+ years in Biotech industry: strategic advisor, venture capital investor, biotech entrepreneur and executive
- Former venture partner at Panacea Venture, former CEO at Hookipa Biotech (Hookipa Pharma) and former SVP at Intercell (Valneva)
- European Patent Attorney and Honorary Professor – University of Applied Sciences Austria
Rüdiger Herrmann, Ph.D.
– Board Member –
- Experienced international lawyer specialized in M&A and licensing, experienced in life science matters in Europe, China, and Taiwan
- Partner at SquirePatton LLP – specialized in biotechnology and pharmaceutical sectors
- Highly Ranked Attorney – recognized in directories such as JUVE, Chambers Europe, and Legal 500
Josef Poandl
– Board Member –
- Experienced business angel in diverse industry, 30+ years senior roles in local and global companies
- Co-founding and leading AmRest Serbia., co-founder and investor in Ecko, BlueSky Immunotherapies GmbH, Nuvonis Technologies GmbH
- Property development and management: Managing partner at ProFood Invest GmbH since 2007 and involved with STELLAR Immobilienverwaltung GmbH since 2000
NEWS & EVENTS
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.
FUNDING
