GlycoNex, Inc.

GlycoNex plans to initiate Phase 3 clinical program of SPD8 in osteoporosis, targeting a multibillion USD global market opportunity NEW TAIPEI CITY, Taiwan, Aug. 19, 2024 /PRNewswire/ -- GlycoNex (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer therapies, today announced the successful completion of a Phase 1 clinical trial of its denosumab biosimilar, SPD8, developed in collaboration with Mitsubishi Gas Chemical Company, Inc. (MGC). The results enable the company to advance to Phase 3 clinical trials with the aim of offering a cost-effective alternative to the currently available denosumab treatment for osteoporosis. The Phase 1 study, conducted in healthy postmenopausal women, demonstrated that GlycoNex's denosumab biosimilar met the primary endpoint of clinical pharmacokinetic equivalence. The trial confirmed the biosimilar's pharmacokinetic profile, safety, and pharmacodynamics were comparable to the reference biologic, denosumab. With these positive results, GlycoNex is in the final stages of planning for its Phase 3 clinical program for SPD8, which is expected to commence in Q4 2024. This program will further assess the efficacy, safety, and immunogenicity of SPD8 in a larger patient population with osteoporosis. GlycoNex is working closely with regulatory authorities to ensure the trial design meets all necessary requirements for a comprehensive evaluation of the biosimilar's clinical performance. "The successful completion of the SPD8 Phase 1 study is an important milestone in the ongoing development of a denosumab biosimilar for the treatment of osteoporosis and GlycoNex's overarching mission to make advanced biologic therapies more accessible and affordable," said Mei-Chun Yang, CEO of GlycoNex. "As we move forward to Phase 3, we remain committed to delivering a safe and effective, high-quality denosumab biosimilar that offers the potential to improve patient outcomes, while reducing the financial burden on osteoporosis patients and healthcare systems around the world." Global sales of two denosumab-containing drugs amounted to 4 billion USD and 2.1 billion USD respectively in 2023. With the increasing elderly population and growing awareness of osteoporosis risks, the market for denosumab continues to expand. In addition to the Japanese market, GlycoNex is actively pursuing global development plans, aiming to provide improved treatment options to people with osteoporosis worldwide. GlycoNex, in collaboration with Mitsubishi Gas Chemical (MGC), is advancing the development and production of SPD8. Recently, MGC and GlycoNex successfully completed the Phase 1 clinical trial of SPD8 in Japan, marking a significant milestone in its development. Ms. Yang concluded: "We are energized by the opportunity to advance SPD8 and potentially add an additional revenue stream to GlycoNex's business, while showcasing our expertise in engineering monoclonal antibodies (mAbs) for a host of disease indications. This includes the continued development of our GNX102 antibody-drug conjugate (ADC) product, which combines a proprietary mAb and cytotoxic drug therapies for the treatment of multiple, high-incidence cancers." About GlycoNex Inc. GlycoNex Inc. is a clinical-stage biotechnology company focused on the development of glycan-directed cancer therapies that effectively inhibit tumor growth while minimizing side effects. GlycoNex possesses a robust pipeline led by GNX102, a humanized monoclonal antibody (mAb) designed to target abnormal sugar molecules in cancer cells. GNX102 has successfully completed Phase 1 clinical trials with data demonstrating excellent safety and promising efficacy. GlycoNex is also advancing a portfolio of antibody-drug conjugates (ADCs) that precisely attack cancer cells while sparing healthy tissue. GlycoNex is headquartered in New Taipei City, Taiwan. For more information, visit . Contact s for GlycoNex, Inc. Investor Relations Tiberend Strategic Advisors, Inc.   David Irish [email protected] Media Relations  Eric Reiss [email protected]   SOURCE GlycoNex, Inc.

GlycoNex previously received U.S. composition of matter patent for GNX102, a humanized monoclonal antibody (mAb) designed to target tumor-associated carbohydrate antigens (TACAs) NEW TAIPEI CITY, Taiwan, June 24, 2024 /PRNewswire/ -- GlycoNex (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer therapies, today announced that multiple global patents have been issued for GNX102 in Japan, South Korea, Russia and Taiwan. These patents follow the previous granting by the United States Patent and Trademark Office (USPTO) of U.S. Patent No. 1440967 to GlycoNex for composition of matter claims for GNX102. GNX102 is a humanized monoclonal antibody (mAb) designed to target novel tumor-associated glycans to inhibit tumor growth. GNX102 has successfully completed Phase 1 clinical trials with data demonstrating strong safety and promising efficacy. "As GNX102 continues to advance in the clinic, the confirmation of additional patents in multiple countries, following the previous receipt of a U.S. composition of matter patent, validates the unique chemical structure and distinct properties of this novel humanized mAb designed to bind to abnormal sugar molecules in cancer cells," commented Dr. Mei-Chun Yang, CEO of GlycoNex. "Data produced thus far in Phase 1 clinical trials of GNX102 suggest the compound could have potential in multiple, high-incidence cancer indications, including stomach, bladder, pancreatic, and lung cancers. We look forward to reporting additional results from the GNX102 clinical program in anticipation of advancing our GNX102 antibody drug conjugate (ADC) product to later stage trials." GNX102 ADC combines proprietary mAb and cytotoxic drug therapies to elicit cellular cytotoxicity to target cancer cells with high specificity. This approach binds antibodies to cancer cell antigens, initiating apoptotic cell death while directly delivering cytotoxic drugs to the tumor. About GlycoNex Inc. GlycoNex Inc. is a clinical-stage biotechnology company focused on the development of glycan-directed cancer therapies that effectively inhibit tumor growth while minimizing side effects. GlycoNex possesses a robust pipeline led by GNX102, a humanized monoclonal antibody (mAb) designed to target abnormal sugar molecules in cancer cells. GNX102 has successfully completed Phase 1 clinical trials with data demonstrating excellent safety and promising efficacy. GlycoNex is also advancing a portfolio of antibody-drug conjugates (ADCs) that precisely attack cancer cells while sparing healthy tissue. GlycoNex is headquartered in New Taipei City, Taiwan. For more information, visit . Contact s for GlycoNex, Inc. Investor Relations Tiberend Strategic Advisors, Inc. Daniel Kontoh-Boateng [email protected] Media Relations Eric Reiss [email protected] SOURCE GlycoNex, Inc.

NEW TAIPEI CITY, Taiwan, May 30, 2024 /PRNewswire/ -- GlycoNex, Inc. (4168, hereinafter referred to as GNX), a clinical stage biotechnology company focused on the development of glycan-directed cancer immunotherapies, today announced its participation in this year's BIO International Convention, which is being held in San Diego, CA, June 3-6, 2024. "We are excited to engage with potential partners at BIO to showcase our differentiated clinical stage targeted cancer treatments that focus on sugar molecules. GNX102, our lead antibody-drug conjugate (ADC) candidate, has demonstrated promise for difficult-to-treat cancers such as gastric and bladder cancer. Since our inception, partnering has been a cornerstone of our strategy and business model, and we look forward to exploring new opportunities to advance our mission at BIO," commented Dr. Mei-Chun Yang, CEO of GlycoNex. During the conference, Dr. Yang will conduct one-on-one meetings with pharmaceutical executives to explore partnering and strategic opportunities for the Company's robust anti-cancer pipeline, specifically GNX102, its lead asset. About GlycoNex Inc. GlycoNex Inc. is a clinical-stage biotechnology company focused on the development of glycan-directed cancer immunotherapies that effectively inhibit tumor growth while minimizing side effects. GlycoNex possesses a robust pipeline led by GNX102, a humanized monoclonal antibody (mAB) designed to target abnormal sugar molecules in cancer cells. GNX-102 has successfully completed Phase 1 clinical trials with data demonstrating excellent safety and promising efficacy. GlycoNex is also advancing a portfolio of antibody-drug conjugates (ADCs) that precisely attack cancer cells while sparing healthy tissue. GlycoNex is headquartered in New Taipei City, Taiwan. For more information, visit . Contacts for GlycoNex, Inc. Investor Relations Tiberend Strategic Advisors, Inc.   Daniel Kontoh-Boateng  [email protected] Media Relations Eric Reiss [email protected] SOURCE GlycoNex, Inc.