BlueSky Immunotherapies Commences Phase 1 Trial for Oropharyngeal Cancer Treatment

Vienna, March 7th – BlueSky Immunotherapies, a clinical stage biotech company in the field of innovative cancer therapeutics based on its interferon-inducing delNS- vector platform, is proud to announce the initiation of Study BS03, marking the commencement of Phase 1 clinical trials for its potentially groundbreaking treatment targeting HPV16-positive oropharyngeal cancer. The trial is being conducted at the Department of Clinical Pharmacology, Medical University Vienna.

The primary objective of Study BS03 is to assess the safety and tolerability of delNS/E6E7, administered both intratumourally and intramuscularly, in patients diagnosed with HPV16-positive oropharyngeal cancer, in a peri-adjuvant setting in conjunction with the current standard therapy. This innovative approach is designed to tackle locoregionally advanced disease.

Employing an open-label, proof-of-concept methodology, the study enrolls a cohort of 12 patients aged between 18 and 65. These individuals exhibit newly diagnosed, histologically confirmed HPV16-positive oropharyngeal squamous cell carcinoma featuring locoregionally advanced disease.

The primary endpoints of the study are centered on evaluating the occurrence of local and systemic adverse events following each administration of the investigational medication. Additionally, several secondary endpoints are being investigated throughout the study period, including the incidence of adverse events over the entire duration of the study, overall survival, progression-free survival, immunogenicity, and HPV infection status.

“Our encouraging interim data from the currently ongoing clinical trial targeting cervical lesions revealed clearance of the HPV16 infection and elimination of neoplastic cervical lesions in a substantial number of patients. These observations indicate the potential of delNS/E6E7 to reduce recurrences observed in standard oropharyngeal cancer therapy,”

said Thomas Muster, Chief Executive Officer at BlueSky Immunotherapies.

BlueSky Immunotherapies is committed to advancing the field of cancer treatment through innovative approaches and rigorous clinical research. Study BS03 represents a significant milestone in the pursuit of safer and more effective therapies for patients with oropharyngeal cancer.

 

About BlueSky Immunotherapies

BlueSky Immunotherapies is a biopharmaceutical company dedicated to developing transformative cancer therapies that harness the power of the immune system. With a focus on innovative approaches, we strive to improve outcomes for patients facing challenging diagnoses.

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