Immunity Boosting Combination Therapy for Myelodysplastic Syndrome (pre-Leukemia) Treatment: A Milestone Collaboration Between ABVC and OncoX, ABVC Eligible to Receive Aggregate Income of $13.75M and Royalties of up to $12.50M

​​US FDA-IND 131300 (ABV-1702) FREMONT, CA – (NewMediaWire) – May 24, 2024 –  ABVC BioPharma, Inc. (NASDAQ: ABVC) (“Company”), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and Oncology/Hematology, announced today a significant step in the fight against Myelodysplastic Syndrome (pre-Leukemia). The Company and its subsidiary BioLite, Inc. had entered into a definitive agreement with OncoX BioPharma, Inc., a private company registered in the British Virgin Islands, to collaborate on a combination therapy. We believe this therapy holds the potential to revolutionize Myelodysplastic Syndrome treatment and significantly improve patient outcomes. ABVC and its subsidiary are eligible to receive an aggregate license fee of $12,500,000 in the form of cash or shares of OncoX securities within 30 days of executing the agreement, with an additional aggregate milestone payment of $1,250,000 in cash after OncoX’s next round of fundraising, of which there can be no guarantee. OncoX may remit partial cash payments of at least $100,000 to the licensing fees, which would be deductible from the second milestone payment.   ABVC and its subsidiary are also entitled to receive royalties of 5% of net sales, up to $12,500,000, after the launch of the licensed product, which remains uncertain. There is no guarantee that ABVC or its subsidiary will receive any of the fees listed.  The United States Food & Drug Administration (US FDA) has granted its approval to four INDs, a testament to the safety and efficacy of our investigational new drugs. These include ABV-1501 (IND 129575) for Triple Negative Breast Cancer (TNBC), ABV-1519 (IND 161602) for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 (IND 131300) for Myelodysplastic Syndrome (MDS), and ABV-1703 (IND 136309) for Pancreatic Cancer Therapy. The Investigational New Drug (IND) application for ABV-1702 proposed the clinical investigation of BLEX 404 as a Combination Therapy Drug with Chemotherapy to prevent the recurrence of MDS or pre-leukemia. The active ingredient of BLEX 404 is the β-glucan extracted from Grifola frondosa (maitake mushrooms), an edible fungus with high medical and commercial values in Japan; 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.[1] Myelodysplastic Syndromes (pre-leukemia), a group of diverse bone marrow disorders characterized by ineffective blood cell production, have posed substantial challenges to conventional treatment methodologies.[2] MDS and its treatments can significantly impact patients’ quality of life due to symptoms such as fatigue, anemia, and infection risk. It may lead to leukemia if not well treated. More effective supportive care strategies and symptom management approaches are needed to enhance patients’ well-being and functional status.[3] In vitro results have proven that β-glucan of MD-fraction, a key ingredient of BLEX 404, enhances bone marrow colony formation and reduces chemotherapy toxicity.[4] “This landmark collaboration aims to revolutionize MDS treatment by developing a novel combination therapy. We expect this innovative combination therapy, the result of extensive research and development efforts, to significantly improve patient outcomes by addressing the underlying mechanisms of MDS more comprehensively than current treatments allow. By leveraging synergistic effects between multiple therapeutic agents, this approach aims to enhance efficacy while minimizing adverse effects, offering new hope to patients and healthcare professionals alike,” said Dr. Uttam Patil, ABVC’s Chief Executive Officer. He added, “Through this collaboration, we aim to redefine the standard of care for MDS patients, empowering them with more effective and personalized treatment options.””We are thrilled to announce this definitive agreement with ABVC, which marks a pivotal moment in our ongoing commitment to advancing the field of oncology and … 

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