Next generation immunotherapy against cancer & infections

BLUESKY IMMUNOTHERAPIES

NEXT GENERATION IMMUNOTHERAPY AGAINST CANCER AND INFECTIOUS DISEASES

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

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.

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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.

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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.

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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:

PIPELINE OVERVIEW

The pipeline spans HPV-induced indications already in clinical development, as well as rapidly advancing preclinical programs targeting breast and prostate cancers.

PIPELINE DESCRIPTION

1. HPV-Related Diseases (Clinical Stage)

HPV-Induced Cervical Lesions (<CIN3)

Vector: delNS/E6E7
Status: Phase 1 systemic routes (s.c., i.d., i.m.) completed, intralesionsal ongoing. Phase 2 planned
Completed Phase 1 study demonstrated an excellent safety profile and >80% elimination of precancerous lesions, along with clearance of human papillomavirus (HPV)—confirming the platform’s unique dual mechanism in humans.

Cervical Cancer (HPV-driven)

Vector: delNS/E6E7
Status: Advancing to Phase 2
Building on early efficacy, upcoming trials will assess tumor regression, durability, and HPV eradication in higher-grade cervical disease.

HPV-Positive Head and Neck Cancer (OPSCC)

Vector: delNS/E6E7
Status: Phase 1 ongoing
Interim neoadjuvant data demonstrate strong infiltration of CD8⁺, CD4⁺ T cells and macrophages, and PD-L1 upregulation, confirming potent tumoral immune activation. These results support combination strategies with PD-1/PD-L1 inhibitors.

2. Cross-Species Mechanistic Validation

Equine Sarcoids (Papillomavirus-Induced Tumors)

Vector: delNS/E6E7
Status: Ongoing clinical program
BlueSky has shown complete elimination of aggressive and otherwise incurable papillomavirus-induced tumors in horses, offering compelling cross-species mechanistic validation and demonstrating broad applicability to papillomavirus-driven disease.

3. Expanded Oncology Programs (Preclinical)

Breast Cancer

Vector: delNS expressing breast tumor antigens
Status: Preclinical
Building on the platform’s validated mechanism, BlueSky is advancing antigen constructs targeting breast cancer–associated epitopes.

Prostate Cancer

Vector: delNS expressing prostate tumor antigens
Status: Preclinical
The program focuses on antigens relevant to aggressive and castration-resistant prostate cancer, leveraging the delNS platform’s ability to reshape the tumor microenvironment via strong interferon induction.

Summary

The delNS platform is now backed by strong human clinical validation, demonstrating lesion elimination, HPV clearance, and tumor immune activation. These findings support BlueSky’s strategy to expand beyond HPV-related disease toward solid tumors including breast and prostate cancer, while also advancing combination immunotherapy strategies.

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 Immunotherapy Announces Successful Completion of Phase 1 Trial Demonstrating High Efficacy in HPV-Induced Precancerous Cervical Lesions

BlueSky Immunotherapy’s Phase 1 trial of its delNS vector for HPV-induced cervical lesions showed excellent safety and >80% lesion regression with HPV clearance after subcutaneous administration. The therapy differentiates itself by combining strong type I interferon induction with HPV E6/E7 antigen expression. These results support expansion into Phase 2 and broader oncology applications, including HPV-positive head and neck cancers.

BlueSky Immunotherapies Reaches Milestone with delNS Viral Vector for OPSCC Treatment

BlueSky Immunotherapies, a leader in innovative cancer immunotherapy, has announced a major breakthrough in the treatment of HPV-induced Oropharyngeal Squamous Cell Carcinoma (OPSCC) with its pioneering delNS viral vector technology. This milestone marks the successful treatment of the first patient in a clinical trial against OPSCC utilizing the delNS viral vector platform, demonstrating both a strong safety profile and indications of efficacy.

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.

CONTACT US

Thank you for visiting us. Please keep an eye on our site as we will add new content very soon. In the meantime, let’s stay in touch. If you have any question, query or idea, please send us an email.

We are looking forward to connecting with our business partners.

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OUR MISSION

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

Breakthrough Research at BlueSky Immunotherapies

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:

PIPELINE OVERVIEW

The pipeline spans HPV-induced indications already in clinical development, as well as rapidly advancing preclinical programs targeting breast and prostate cancers.

PIPELINE DESCRIPTION

1. HPV-Related Diseases (Clinical Stage)

HPV-Induced Cervical Lesions (<CIN3)

Cervical Cancer (HPV-driven)

Vector: delNS/E6E7 Status: Advancing to Phase 2 Building on early efficacy, upcoming trials will assess tumor regression, durability, and HPV eradication in higher-grade cervical disease.

HPV-Positive Head and Neck Cancer (OPSCC)

Vector: delNS/E6E7 Status: Phase 1 ongoing Interim neoadjuvant data demonstrate strong infiltration of CD8⁺, CD4⁺ T cells and macrophages, and PD-L1 upregulation, confirming potent tumoral immune activation. These results support combination strategies with PD-1/PD-L1 inhibitors.

2. Cross-Species Mechanistic Validation

Equine Sarcoids (Papillomavirus-Induced Tumors)

Vector: delNS/E6E7 Status: Ongoing clinical program BlueSky has shown complete elimination of aggressive and otherwise incurable papillomavirus-induced tumors in horses, offering compelling cross-species mechanistic validation and demonstrating broad applicability to papillomavirus-driven disease.

3. Expanded Oncology Programs (Preclinical)

Breast Cancer

Vector: delNS expressing breast tumor antigens Status: Preclinical Building on the platform’s validated mechanism, BlueSky is advancing antigen constructs targeting breast cancer–associated epitopes.

Prostate Cancer

Vector: delNS expressing prostate tumor antigens Status: Preclinical The program focuses on antigens relevant to aggressive and castration-resistant prostate cancer, leveraging the delNS platform’s ability to reshape the tumor microenvironment via strong interferon induction.

Summary

OUR TEAM

Thomas Muster

– CEO –

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

Michael Tscheppe

– CFO –

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

Christina Nicolodi

– Chief Regulatory Officer –

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

Markus Wolschek

– CSO –

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

ADVISORY BOARD

Noel Barrett, Ph.D.

– Board Member –

Katherine Cohen, Ph.D.

– Board Member –

Rüdiger Herrmann, Ph.D.

– Board Member –

Josef Poandl

– Board Member –

NEWS & EVENTS

BlueSky Immunotherapy Announces Successful Completion of Phase 1 Trial Demonstrating High Efficacy in HPV-Induced Precancerous Cervical Lesions

BlueSky Immunotherapies Reaches Milestone with delNS Viral Vector for OPSCC Treatment

BlueSky Immunotherapies Commences Phase 1 Trial for Oropharyngeal Cancer Treatment

FUNDING

CONTACT US

Thank you for visiting us. Please keep an eye on our site as we will add new content very soon. In the meantime, let’s stay in touch. If you have any question, query or idea, please send us an email.

Name*

E-Mail*

Message*

We are looking forward to connecting with our business partners.

BlueSky Immunotherapies

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inhibits ***Immunosuppressive* *Regulatory T-Cells***

Vector: delNS/E6E7
Status: Advancing to Phase 2
Building on early efficacy, upcoming trials will assess tumor regression, durability, and HPV eradication in higher-grade cervical disease.

Vector: delNS/E6E7
Status: Phase 1 ongoing
Interim neoadjuvant data demonstrate strong infiltration of CD8⁺, CD4⁺ T cells and macrophages, and PD-L1 upregulation, confirming potent tumoral immune activation. These results support combination strategies with PD-1/PD-L1 inhibitors.

Vector: delNS/E6E7
Status: Ongoing clinical program
BlueSky has shown complete elimination of aggressive and otherwise incurable papillomavirus-induced tumors in horses, offering compelling cross-species mechanistic validation and demonstrating broad applicability to papillomavirus-driven disease.

Vector: delNS expressing breast tumor antigens
Status: Preclinical
Building on the platform’s validated mechanism, BlueSky is advancing antigen constructs targeting breast cancer–associated epitopes.

Vector: delNS expressing prostate tumor antigens
Status: Preclinical
The program focuses on antigens relevant to aggressive and castration-resistant prostate cancer, leveraging the delNS platform’s ability to reshape the tumor microenvironment via strong interferon induction.