ME Therapeutics Holdings Inc. has secured a significant intellectual property milestone with the receipt of U.S. Patent No. 12,421,308 for its lead G-CSF antibody candidate, marking continued progress toward clinical development of novel immuno-oncology therapeutics. The Vancouver-based biotechnology company announced the patent protection alongside advances across its broader pipeline of cancer-fighting drugs.
Patent Protection for Lead G-CSF Antibody
The U.S. Patent and Trademark Office granted patent protection for the amino acid sequence of ME Therapeutics' G-CSF antibody candidate and its therapeutic use for cancer treatment. The antibody candidate, designated H1B11-12, is a humanized biological drug designed to target and block granulocyte colony-stimulating factor (G-CSF), a glycoprotein cytokine that drives immune suppression in the tumor microenvironment.
"We are pleased with the business and scientific progress we have made across our pipeline as we work towards bringing novel immuno-oncology drugs to patients worldwide who today have limited treatment options," said Salim Dhanji, CEO of ME Therapeutics.
This represents the second international patent for the G-CSF antibody candidate, following patent approval from the China National Intellectual Property Administration in 2023.
Clinical Development Preparations
ME Therapeutics is advancing cell line development to meet Good Manufacturing Practices (GMP) standards in preparation for clinical trial regulatory meetings. Work conducted at a contract research organization has identified candidate cell lines demonstrating robust antibody production and stability. The company plans continued testing of antibody characteristics before selecting a lead clone for GMP master cell bank development.
The company has expanded its research capabilities with the addition of two new associate research scientists, positioning the organization to advance its lead antibody candidate toward clinical trials while accelerating progress across broader drug development programs.
Therapeutic mRNA Program Shows Promise
The company's therapeutic mRNA program is progressing through preclinical testing, with in vivo studies of the lead candidate showing immune cell recruitment into the tumor microenvironment. ME Therapeutics plans to initiate studies testing the lead mRNA candidate in a mouse colon cancer model, both as monotherapy and in combination with an immune checkpoint inhibitor.
A second therapeutic mRNA candidate has demonstrated strong T cell activation in vitro testing and will continue advancing through additional in vitro studies.
Next-Generation CAR Technology Development
ME Therapeutics is developing an in vivo CAR program that represents a next-generation approach to cancer immunotherapy. This technology delivers genetic instructions directly into a patient's body to reprogram cells within the tumor microenvironment. The company has confirmed in vitro activity of its tumor-targeted CARs and plans further in vitro testing before exploring in vivo studies.
Pipeline Focus on Tumor Microenvironment
The company's pipeline targets enhancing immune recognition of cancer cells and overcoming immune suppression in the tumor microenvironment. This approach addresses a critical challenge in cancer treatment, as immune suppression within tumors can limit the effectiveness of existing immunotherapies.
Dhanji noted that this quarter the company reached several key milestones for its lead G-CSF antibody candidate that maintain progress toward clinical development, including the U.S. patent and advancement of cell line development for GMP preparation.
