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 (14513 downloads)
- Scientific Reports 11, 22164 /Antiviral properties through interference (15810 downloads)
- J Virol 74,6203 / activation of PKR (14270 downloads)
- J Virol 76,1617 / induction of apoptosis (14814 downloads)
- J Infect Dis 201,354 / B-cell mediated local and systemic response (15249 downloads)
- Med Microbiol Immunol 199,93 / activation of NK cells (15354 downloads)
- Vaccine 37,3722 / B-cell mediated response (14927 downloads)
- PLoS One 10(9) e0138722 / T-cell mediated response against E6E7 (15715 downloads)
- Nature 424,324 / activation dentritic cells and induction IFN (14976 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 –
Michael Tscheppe
– CFO –
Christina Nicolodi
– Chief Regulatory Officer –
Markus Wolschek
– CSO –
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