GlycoMimetics (GLYC) Advances GMI-1359 Program With Patent Issuance, FDA Designations

GlycoMimetics, Inc. (Nasdaq: GLYC) today announced several achievements for its GMI-1359 development program, including the issuance of a new patent and key designations granted by the U.S. Food and Drug Administration (FDA) that may provide future development support and marketing protections. GMI-1359 is the Company’s novel drug candidate designed to simultaneously inhibit both E-selectin and CXCR4, two adhesion molecules involved in tumor trafficking and metastatic spread. Duke University investigators recently dosed the first patient in a proof-of-concept Phase 1b study to evaluate GMI-1359 drug candidate in patients with advanced breast cancer with bone metastases.

New Patent

GlycoMimetics today said that the United States Patent and Trademark Office has issued a patent for GMI-1359, covering composition of matter as well as pharmaceutical formulations, and will provide protection through 2035, excluding any patent term adjustments or extensions.

“The new patent for GMI-1359 will help protect the composition of matter of this innovative approach in oncology. GMI-1359 may have a role in treating rare pediatric cancers, such as osteosarcoma, as well as breast cancer and other solid tumors that metastasize to bone,” stated Rachel King, Chief Executive Officer of GlycoMimetics. “This intellectual property, as well as that previously granted in Europe, will play a key role as the company advances the drug candidate, especially with the new orphan and rare pediatric disease designations granted by the FDA.”

New FDA Designations

In parallel, GlycoMimetics today announced that the FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to GMI-1359 for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States. These designations will aid in the development of this drug candidate, including making it eligible for the FDA’s Pediatric Priority Review Voucher.

“It’s encouraging for us as well as for patients and providers that the FDA recognizes the urgent need for new, more effective treatments for this devastating pediatric disease,” stated Ms. King.

In addition to its clinical work in breast cancer, GlycoMimetics has conducted preclinical studies that have demonstrated strong support for the potential use of GMI-1359 in osteosarcoma. At the 2018 American Association of Cancer Research Annual Meeting, GlycoMimetics presented data establishing the biologic rationale for the use of a dual e-selectin/CXCR-4 inhibitor in pediatric and young adult patients with osteosarcoma. In that study, GMI-1359 was shown to inhibit tumor progression in an orthopedic model of osteosarcoma as well as inhibit the development of pulmonary metastases from primary osteosarcoma lesions. (https://glycomimetics.com/wp-content/uploads/2018/11/Osteosarcoma-GMI1359-AACR-2018-V4.pdf)

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