ABVC BioPharma provides update on development of combination therapy

ABVC BioPharma provided an update on its development of combination therapy for the treatment of cancer and immunity booster dietary supplements. The Company is currently marketing dietary supplements, as well as continuing to pursue clinical trials of pharmaceutical compounds; both of which are derived from the same source: Maitake Mushroom. The Company expects to initiate clinical trials at several prestigious medical institutes in the United States and Asia. Marketing and sales of dietary supplements in the US, Canada, and Asia have begun, and the Company expects revenue generation through its Fremont-based wholly-owned CDMO BioKey, Inc. The United States Food & Drug Administration has approved four INDs: ABV-1501 for Triple Negative Breast Cancer, ABV-1519 for Non-Small Cell Lung Cancer, ABV-1702 for Myelodysplastic Syndrome, and ABV-1703 for Pancreatic Cancer Therapy. The Investigational New Drug application proposed the clinical investigation of BLEX 404 as the primary active ingredient. The active ingredient of BLEX 404 is the beta-glucan extracted from Grifola frondosa, an edible fungus with high medical and commercial values in Asia; it contains various bioactive constituents such as polysaccharides, pyrrole alkaloids, ergosterol, etc., and has been widely served as functional foods for a long time in daily life. BioKey is a wholly-owned CDMO subsidiary of the Company based in Fremont, California, and has been working as the manufacturing unit for the Company’s projects. BLEX 404 is a combination therapy drug; the same combination of BLEX 404 has been formulated into dietary supplements in tablet and liquid forms by BioKey, Inc. Both the drug and dietary supplements are derived from the same source: Maitake Mushroom. The dietary supplements are already marketed in Asia through Define Biotech Co. Ltd. with a $3 million contract for three years. The Company and its subsidiary will work with Shogun for the US and Canadian markets. At the same time, the safety and efficacy of the Drug formulation will be studied in Phase II clinical trials as a combination therapy for oncology, which is being co-developed by BioKey and the Rgene Corporation. Utilizing the safety results from the previous study conducted by the ABVC team, including certain affiliates, which indicated that certain dose levels of BLEX 404 Oral Liquid, when combined with current cancer treatment medicines, showed promising results for patients. ABVC is now set to begin the first series of Phase II studies to determine the efficacy and safety of these combined drugs and the most effective dose level. Standard cancer treatments, while effective, often come with debilitating side effects that diminish patients’ quality of life. However, we believe our innovative immunotherapy product addresses this challenge by leveraging the body’s immune system to target cancer cells more precisely, minimizing collateral damage to healthy tissues and organs. As a result, patients experience fewer adverse effects such as nausea, hair loss, and fatigue, allowing them to tolerate treatment more effectively.