Genexine Co., Ltd. (CEO Neil Womar, Woojung Won 095700) is a cancer treatment DNA vaccine GX-188E, GX-I7 (ingredient name: epineptakine alfa), which is being developed as an immunotherapy, and Keytruda, an immunotherapy drug of Merck (MSD), USA. (Ingredient name: pembrolizumab) announced on the 1st that it has received IND approval from the Ministry of Food and Drug Safety for the researcher-led phase 2 clinical trial.
In this clinical trial, GX-188E, GX-I7, and Keytruda were combined as adjuvant therapy before surgery in 11 patients with a total of 11 HPV (human papillomavirus)-16 or HPV-18 positive resectable locally advanced head and neck cancer (LA HNSCC) patients. This is a clinical study to explore the efficacy and safety of administration and it is led by Professor Hye-ryun Kim, Department of Oncology, Yonsei Cancer Hospital.
The primary treatment method before surgery is an anti-cancer therapy that precedes the removal of cancer cells through surgery. In particular, head and neck cancer mainly occurs in the face, nose, neck, mouth, larynx, pharynx, salivary glands and thyroid gland below the brain and above the chest. Therefore, the attention of this clinical trial is noteworthy.
Squamous cell carcinoma of the head and neck (HNSCC) is a cancer that arises from squamous cells of the head and neck, including the oral cavity, pharynx, and larynx, and is often accompanied by loss of function, poor prognosis, and high mortality. In particular, the loss of functions such as the oral cavity, nasopharynx, oropharynx, such as chewing, swallowing, vocalization, breathing, taste, and smell, as well as the occurrence of cancer in aesthetically important positions such as appearance, It is a cancer that greatly affects the quality of life and causes a lot of physical and mental pain that patients experience during the treatment process.
In the case of Opdivo combination therapy, for which Genexine received IND approval on March 7, 2022, it was a systemic therapy in which three drugs were administered in combination for relapsed/metastatic patients who could not be operated on. After administering Keytruda, GX-188E, and GX-I7 as a prior therapy for patients with is intended for
Professor Hyeryun Kim of Yonsei University, who led this phase 2 clinical trial, said, “Currently, there is no treatment strategy using HPV-specific immunological properties of HPV-positive LA HNSCC patients.” “We expect this clinical study to be an effective treatment strategy for patients with intractable HPV-positive head and neck cancer as adjuvant therapy before surgery.” said.
Genexine CEO Woo Woo-Won said, “In this clinical trial, GX-188E, which has already significantly increased the therapeutic effect with Keytruda in the cervical cancer clinical trial, is expected to induce cancer cell-specific T cells well in HPV-16/18-induced head and neck cancer. Expect. Here, through synergy with Keytruda, which amplifies T cells through GX-I7 and blocks the immune-suppressive function of cancer cells against T cells, the immuno-oncology drug developed by Genexine has the potential to extend the scalability to preoperative patient therapy. It will be an opportunity to confirm.”
