GlycoNex Completes Phase 1 Study of SPD8, a Denosumab Biosimilar

NEW TAIPEI CITY, Taiwan, Aug. 19, 2024 -- GlycoNex (4168, hereinafter referred to as GNX), a clinical-stage biotechnology company specializing in glycan-directed cancer therapies, has announced the successful completion of a Phase 1 clinical trial for its denosumab biosimilar, SPD8. This trial, developed in partnership with Mitsubishi Gas Chemical Company, Inc. (MGC), paves the way for the company to advance to Phase 3 clinical trials. The objective is to provide a cost-effective alternative to the existing denosumab treatment for osteoporosis.

The Phase 1 study was conducted on healthy postmenopausal women and demonstrated that GlycoNex's denosumab biosimilar achieved the primary endpoint of clinical pharmacokinetic equivalence. The trial results indicated that the biosimilar's pharmacokinetic profile, safety, and pharmacodynamics were comparable to those of the reference biologic, denosumab.

Buoyed by these positive outcomes, GlycoNex is finalizing plans for its Phase 3 clinical program for SPD8, which is expected to launch in Q4 2024. This phase will further assess the efficacy, safety, and immunogenicity of SPD8 in a larger patient population suffering from osteoporosis. The company is collaborating closely with regulatory authorities to ensure that the trial design meets all necessary requirements for a thorough evaluation of the biosimilar's clinical performance.

"The successful completion of the SPD8 Phase 1 study marks a significant milestone in the development of a denosumab biosimilar for osteoporosis treatment, aligning with GlycoNex's mission to make advanced biologic therapies more accessible and affordable," said Mei-Chun Yang, CEO of GlycoNex. "As we transition to Phase 3, our commitment remains to deliver a high-quality denosumab biosimilar that is both safe and effective. We aim to enhance patient outcomes while alleviating the financial burden on osteoporosis patients and healthcare systems worldwide."

In 2023, global sales of two denosumab-based drugs reached 4 billion USD and 2.1 billion USD, respectively. With an aging population and increasing awareness of osteoporosis risks, the market for denosumab is expanding. Besides focusing on the Japanese market, GlycoNex is pursuing global development plans to offer improved treatment options to osteoporosis patients worldwide.

GlycoNex, in collaboration with MGC, is progressing in the development and production of SPD8. Recently, both companies successfully completed the Phase 1 clinical trial of SPD8 in Japan, marking a crucial milestone in its development.

Ms. Yang concluded: "We are excited about the opportunity to advance SPD8, potentially adding a new revenue stream to GlycoNex's business, while showcasing our expertise in engineering monoclonal antibodies (mAbs) for various disease indications. This includes the continued development of our GNX102 antibody-drug conjugate (ADC) product, which combines a proprietary mAb with cytotoxic drug therapies for the treatment of multiple high-incidence cancers."

GlycoNex Inc., headquartered in New Taipei City, Taiwan, is a clinical-stage biotechnology firm focusing on developing glycan-directed cancer therapies that inhibit tumor growth while minimizing side effects. Their pipeline is led by GNX102, a humanized monoclonal antibody designed to target abnormal sugar molecules in cancer cells. GNX102 has completed Phase 1 clinical trials with data showing excellent safety and promising efficacy. GlycoNex is also advancing a range of antibody-drug conjugates (ADCs) that precisely target cancer cells, sparing healthy tissue.

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