Genexine, a Korean biopharmaceutical company dedicated to the production of life-saving treatments, has announced the publication of their groundbreaking phase 2 clinical trial data in the ASCO (American Society of Clinical Oncology).
The revolutionary therapy combined the DNA vaccine GX-188E (tirvalimogene teraplasmid) and the lymphopenia-correcting immune-oncology drug GX-I7 (efineptakin alfa) with the industry-leading immune checkpoint inhibitor Keytruda® (pembrolizumab) to provide a promising triple combination neoadjuvant therapy for the treatment of HNSCC (head and neck squamous cell carcinoma). This advances the possibility of a much needed cure for the disease, and positions Genexine as a leader in the field of cutting-edge biopharmaceutical treatments.
Professor Hye-Ryun Kim of the Division of Medical Oncology at Yonsei University Severance Hospital and Professor Yoon Woo Koh of theDepartment of Otolaryngology have united to conduct a groundbreaking phase 2 investigator-initiated clinical trial (IIT) in South Korea.
11 patients with HPV-positive cervical cancer have enrolled in the trial and are scheduled to undergo surgery following the administration of Keytruda 200mg on day 1 and 22, as well as Genexine’s GX-188E DNA vaccine 2mg and GX-I7 on days 1, 8, 22.
The primary endpoint of the trial examines the major pathological response (MPR) of patients; while other evaluation criteria such as safety, recurrence rate and survival rate will also be evaluated.
Eleven patients took part in the trial and underwent surgery as planned after neoadjuvant therapy with no complications. Of the seven individuals who experienced a major pathological response, four saw a full recovery after the combination therapy.
Comparative analysis of pre- and post-intervention tissue showed a marked increase in the presence of follicular helper T cells (CD4+) and reactivation of killer T cells (CD8+), demonstrating the therapy’s effectiveness. Altogether, the results demonstrate the promise of this novel approach to treating cancer.
AI-based analysis technology has uncovered a remarkable triple combination therapy that can effectively transform previously immune-deficient tumors into inflamed ones! This treatment increases the density of tumor-infiltrating lymphocytes (TIL) which can have a potentially profound impact in the field of cancer treatment.
Clinical trial leader Professor Hye-Ryun Kim expressed her excitement over the success of the triple combination therapy in treating human papillomavirus (HPV)-positive head and neck Squamous Cell Cancer (HNSCC). She believes that the therapy has the potential to become a reliable and effective option for HPV positive HNSCC patients in the future.
Genexine is thrilled by the initial results of its latest clinical trial for its combination therapy for head and neck cancer, a serious unmet medical need. This is the first time this particular treatment has been used, giving new hope to those with HNSCC. With its promising data, Genexine believes there is potential to expand the label for GX-188E beyond cervical cancer to include HNSCC.
Smoking and high-risk HPV infection have been associated with the development of Head and Neck Squamous Cell Carcinoma (HNSCC). In the past, surgery, radiation therapy and chemotherapy have been used to treat the tumor, though these treatments aren’t without potential for stark effects on patient’s quality of life.
With the development of immune checkpoint inhibitors, however, immunotherapy has become an increasingly attractive alternative for treating HNSCC. The results of these exciting developments will be presented at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2-6. Make your mark and join the conversation!
About Genexine
Genexine, a publicly traded clinical-stage biotechnology company, is striving to revolutionize and improve the quality of life for patients worldwide. By utilizing cutting-edge technology platforms such as therapeutic DNA vaccine technology and hyFcR fusion technology, the Company has multiple products advancing through clinical development, including several undergoing Phase 3 registration trials.
With an impressive pipeline of products, ranging from GX-188 (tirvalimogene teraplasmid) for cervical cancer, to GX-E4 for CKD-induced anemia, Genexine has forged strategic partnerships with global companies to enable rapid product development and ensure success in the global healthcare market. Don’t miss out on the leader in biotechnology – Genexine, listed on the Korean exchange (KOSDAQ: 095700) and headquartered in Seoul, Korea.