BlueSky Immunotherapies Reaches Milestone with delNS Viral Vector for OPSCC Treatment

Vienna, March 1st – Innovative Approach Shows Promise in Neoadjuvant Setting Vienna, February 25, 2025 – 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.

HPV-positive OPSCC is one of the fastest-rising cancers in the Western world, making the need for innovative treatment approaches more urgent than ever. BlueSky’s delNS viral vector is designed to induce interferon production while expressing the tumor-specific E6 and E7 antigens derived from HPV, effectively overcoming the immunosuppressive environment associated with OPSCC. By stimulating the immune system to recognize and attack cancer cells, this novel approach has the potential to revolutionize treatment for HPV-associated cancers.

In a neoadjuvant setting, where therapy is administered before surgery, the first treated patient experienced no safety concerns, marking a crucial milestone in clinical development. Furthermore, indications of strong immunogenicity such as massive infiltration of T-cells and macrophages into the tumor environment were observed, suggesting that the treatment successfully activated an anti-tumor immune response.

“Following the successful completion of a trial demonstrating safety and efficacy against cervical neoplastic lesions, this achievement represents another significant step forward in our mission to develop next-generation immunotherapies for cancer,” said Dr. Thomas Muster, Chief Executive Officer at BlueSky Immunotherapies. “We are highly encouraged by these results and remain dedicated to advancing this technology to offer new hope to patients with OPSCC and beyond.”

BlueSky Immunotherapy continues to collaborate with leading oncology centers to further evaluate the potential of its delNS viral vector platform. The company plans to expand clinical trials to validate these promising early findings and accelerate the development of this innovative therapy.

For more information about BlueSky Immunotherapy and its groundbreaking work in cancer immunotherapy, please visit www.bluesky-itx.com.

About BlueSky Immunotherapies

BlueSky Immunotherapy is a biotechnology company dedicated to developing novel immunotherapies for cancer treatment. Leveraging cutting-edge delNS viral vector technology, the company aims to transform cancer care by harnessing the immune system to target and eliminate cancer cells.

Forward-Looking Statements
This press release may contain forward-looking statements subject to applicable European Union regulations and Austrian financial disclosure laws. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. BlueSky Immunotherapy assumes no obligation to update these statements except as required by law.