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

Subcutaneous Administration Achieves >80% Lesion Regression and HPV Clearance; Results Support Unique Mechanism and Strong Differentiation from Competitive Approaches

Vienna, November 29, 2025 – BlueSky Immunotherapy today announced the successful completion of its Phase 1 clinical trial evaluating the company’s delNS viral vector immunotherapy for the treatment of HPV-induced cervical lesions (<CIN3). The therapy demonstrated an excellent safety profile across multiple routes of administration and showed particularly high efficacy following subcutaneous (SC) delivery, with more than 80% of precancerous lesions regressing and the causative agent—human papillomavirus (HPV)—being eliminated.

These results strongly differentiate BlueSky’s platform from current competitive approaches, reinforcing the therapeutic potential of combining potent type I interferon induction with expression of HPV-derived tumor antigens E6 and E7 within the delNS viral vector.

“This is the strongest clinical validation to date of our mechanistic hypothesis,” said Dr. Thomas Muster, Chief Executive Officer at BlueSky Immunotherapy. “By simultaneously inducing a powerful local interferon response and presenting HPV antigens, our delNS vector directly clears both the precancerous lesion and the underlying viral infection. The high rate of lesion regression and HPV elimination—especially with subcutaneous administration—exceeds what has been reported with competing immunotherapies.”

The cervical lesion data build on prior preclinical and translational experience, including successful elimination of papillomavirus-driven sarcoid tumors in horses, further demonstrating broad activity of the platform across species, tissue types, and papillomavirus variants.

“These Phase 1 results give us strong confidence as we advance our ongoing neoadjuvant trial in HPV-positive head and neck cancer (OPSCC),” said Michael Tscheppe, CFO of BlueSky Immunotherapy. “The ability to clear both tumor and virus in early disease suggests that our approach may have meaningful impact in advanced cancers as well. We are now evaluating opportunities to extend this concept to other tumors.”

BlueSky Immunotherapy will advance the program into Phase 2 to further evaluate durability of lesion clearance, HPV eradication, and clinical benefit, while continuing to explore broader oncology applications enabled by the delNS platform.

About BlueSky Immunotherapy

BlueSky Immunotherapy is a biotechnology company developing next-generation, interferon-inducing delNS viral vector immunotherapies for cancer and infectious disease. The company’s platform is designed to activate strong innate and adaptive immune responses against tumors and virally driven lesions, with multiple clinical programs underway.

Media Inquiries

For media inquiries, please contact:
Michael Tscheppe at m.tscheppe@bluesky-itx.com.