Genexine Gets Green Light For Stem Cell Cancer Trial
This article was originally published in PharmAsia News
Executive Summary
South Korean biotech firm Genexine’s R&D pipeline is progressing, with most of its therapies currently in Phase II clinical trials at home and abroad, and a new green light from domestic authorities to conduct a trial with a novel anticancer stem cell and gene therapy.
SEOUL – South Korea’s Genexine has received approval from the Ministry of Food and Drug Safety to initiate domestic Phase IIa clinical trials for GX-051, its genetically modified mesenchymal stem cell therapy for head and neck cancers.
GX-051 is a novel-concept anticancer therapy that uses mesenchymal stem cells, which tend to move toward tumor tissues, and a natural killer cell promoting gene called IL-12M to find and attack cancer and tumor tissues.
It is the first fusion anticancer immunotherapy to be developed in South Korea and the second anticancer gene therapy in the world to receive approval for clinical trials after the U.S. City of Hope Medical Center's neural stem cell cancer treatment, which is undergoing clinical trials in the U.S.
The company expects the therapy to have fewer side-effects and to be more effective in treating cancer compared with existing anticancer therapies.
“During the latest clinical trials, we plan to administer GX-051 along with chemotherapy to progressive head and neck cancer patients to evaluate the safety and efficacy of the drug. We also plan to look into the possibility of increasing its indications to other cancer types,” said the company.
Head and neck squamous cell cancer (HNSCC) is the fifth most common cancer worldwide, with limited treatment options for patients. Recurrent/metastatic HNSCC has a median overall survival of 10 months in the first-line setting, with patients generally receiving chemotherapy or the EGFR inhibitor Erbitux (cetuximab).
Genexine’s therapy has proven its safety during a Phase I study which was conducted at Seoul St. Mary's Hospital in recurrent and metastatic cancer patients who had ceased treatment after showing no reaction to surgery, radiotherapy and chemotherapy. The company received approval for the Phase I study in February 2014.
GX-051 was selected as a key research project by the Ministry of Health and Welfare in 2009. The company has been jointly developing GX-051 with stem cell company POCASTEM, which is a joint venture between Genexine, Pohang University of Technology and Science as well as Catholic University.
Potential Rivals
Some other firms are also progressing with therapies for head and neck cancers.
Kite Pharma Inc. and bluebird bio Inc. in the U.S. have said they are joining forces to develop second-generation candidates that should be more selective and potent than those currently in clinical development for cancer immunotherapy.
They will apply bluebird’s gene-editing and lentiviral vector delivery platforms to Kite’s Phase I HPV-16 E6 TCR candidate, which is being investigated in cervical and head and neck cancers (Also see "Bluebird Brings Gene Editing Tech To Kite’s TCR Candidates" - Pink Sheet, 22 Jun, 2015.).
Merck & Co. Inc. is also moving forward aggressively with the development of Keytruda (pembrolizumab) in head and neck squamous cell cancer, based on the results of a Phase Ib trial, KEYNOTE-012, in 132 patients with recurrent or metastatic head and neck cancer (Also see "Merck Marches Keytruda Into Next Wave Of Indications" - Pink Sheet, 2 Jun, 2015.).
Genexine is a clinical stage biopharmaceutical company that focuses on development and commercialization of novel therapeutic vaccines and next-generation Fc fusion protein drugs for treatment of incurable diseases.
SK Securities expects Genexine to be able to clinch small-scale license out deals from the latter half of this year and possibly a large-scale license out deal in the latter half of next year.
Its core new drug pipeline includes GX-188E, a therapy for cervical intraepithelial neoplasia, GX-F7, a therapy for hemophilia, GX-P2 for autoimmune diseases, and GX-H9, a growth hormone treatment. Currently, the company is conducting Phase II studies at home and abroad for most of its research projects.
The brokerage noted that the DNA vaccine GX-188E has shown high effectiveness, with a full recovery rate of 78% during clinical testing. At present, there is no specific therapy for cervical intraepithelial neoplasia.