BlueSky Immunotherapies, a pioneering biopharmaceutical company specializing in innovative cancer therapeutics utilizing its advanced interferon-inducing delNS-vector platform, is thrilled to unveil the launch of Study BS03. This marks the beginning of Phase 1 clinical trials for its revolutionary treatment aimed at combating HPV 16 oropharyngeal cancer. Conducted at the Department of Clinical Pharmacology, Medical University Vienna, this trial signifies a significant advancement in the fight against oropharyngeal carcinoma.

What are the causes of oropharyngeal malignancy?

Oropharyngeal cancer, particularly when caused by HPV 16, can be attributed to a variety of factors. HPV, or human papillomavirus, is a sexually transmitted infection that plays a significant role in the development of pharyngeal cancer. HPV 16, a specific subtype of the virus, is strongly associated with the development of this type of cancer. However, HPV 16 is increasingly recognized as the primary cause in oropharyngeal cancer.

HPV positive oropharyngeal cancer: about the clinical trial

The main goal of Study BS03 is to thoroughly evaluate the safety and tolerance of delNS/E6E7, delivered both intratumorally and intramuscularly, in patients suffering with HPV P16 oropharyngeal cancer. This groundbreaking approach is meticulously crafted to address the complexities of locoregionally advanced disease, marking a significant leap forward in cancer treatment innovation.

Utilizing an open-label, proof-of-concept approach, the study selects a group of 12 patients aged 18 to 65. These individuals have been diagnosed with histologically confirmed p16 positive oropharyngeal squamous cell carcinoma, presenting with locoregionally advanced disease.

The main focus of the study revolves around assessing the occurrence of both local and systemic adverse events after each dose of the investigational medication. Furthermore, various secondary endpoints are under scrutiny during the study, including the overall incidence of adverse events, as well as assessing overall survival, progression-free survival, immunogenicity, and HPV infection status throughout the entire duration of the study.

“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.

About biotech company BlueSky Immunotherapies

BlueSky Immunotherapies is a biopharmaceutical company dedicated to developing transformative cancer therapies harnessing the immune system’s power. Through innovative approaches and meticulous clinical research, including Study BS03, BlueSky Immunotherapies strives to advance cancer treatment, particularly for individuals undergoing oropharyngeal cancer treatment, in pursuit of safer and more effective outcomes for patients facing challenging diagnoses.

In summary, Study BS03 represents a crucial step forward in our understanding and treatment of HPV 16 positive oropharyngeal cancer. By thoroughly evaluating the safety and effectiveness of delNS/E6E7 in addressing locoregionally advanced disease, this innovative study has the potential to significantly impact the lives of patients coping with this diagnosis. Through innovative approaches and meticulous research, we are dedicated to advancing the field of cancer treatment and improving outcomes for individuals with oropharyngeal cancer.