BioLineRx Secures Key Patent for GLIX1 Cancer Therapy Covering Over 90% of Cancer Types
核心洞察
BioLineRx received USPTO (搜索) Notice of Allowance for a key patent covering GLIX1 use in cancers where cytidine deaminase (搜索) is not over-expressed, representing over 90% of all cancers.
The patent strengthens GLIX1's intellectual property protection until 2040 with possible five-year extension, supporting expansion beyond initial glioblastoma (搜索) indication.
The company plans to initiate first-in-human GLIX1 trials in glioblastoma (搜索) patients in Q1 2026 while advancing preclinical studies in other cancer (搜索) models.
BioLineRx Ltd. has received a Notice of Allowance from the U.S. Patent and Trademark Office for a key patent covering its investigational cancer (搜索) therapy GLIX1, significantly expanding the drug's potential market reach to over 90% of cancer types. The patent, entitled "Deoxy-Cytidine or Uridine Derivatives for Use in Cancer Therapies," covers the use of GLIX1 for treating cancers in which cytidine deaminase (搜索) (CDA) is not over-expressed beyond a specific threshold.
Broad Cancer Coverage Potential
The newly allowed patent represents a critical milestone for GLIX1's development, as it is estimated that over 90% of all cancers do not overexpress CDA beyond the specific threshold covered by the patent. This broad applicability reflects the importance of the intellectual property as BioLineRx expands development of GLIX1 beyond glioblastoma (搜索), its initial indication, into other cancer (搜索) types once safety and dosing in glioblastoma are established.
"This Notice of Allowance from the USPTO (搜索) is a critical addition to GLIX1's intellectual property estate, as it protects our opportunity to evaluate this exciting molecule across the majority of cancers," stated Philip Serlin, Chief Executive Officer of BioLineRx.
Patent Protection and Clinical Timeline
The patent further broadens and strengthens GLIX1's patent protection for cancer (搜索) treatment until 2040, with a possible patent-term extension of up to five years. Corresponding patent applications are pending worldwide, providing potential global protection for the therapy.
BioLineRx is preparing to initiate a first-in-human study of GLIX1 in patients with glioblastoma (搜索) in the first quarter of 2026, while simultaneously advancing preclinical studies in other cancer (搜索) models. The company believes GLIX1's unique mechanism of action, which targets the DNA damage response (搜索) in cancer cells, has the potential to offer new hope to patients suffering from a broad range of difficult-to-treat cancers.
Comprehensive Patent Portfolio
GLIX1 is covered by a comprehensive portfolio of patents that are both issued and pending. The intellectual property protection includes:
- Patents for GLIX1 use in treating central nervous system cancers, such as glioblastoma, issued in the US, Europe and 13 other countries, valid until at least 2040 with possible five-year extension
- A pending international patent application covering GLIX1 in combination with PARP inhibitors for treating homologous recombination (HR) proficient cancers, which represent the majority of cancers, with potential validity until at least 2044
Development Strategy
The patent coverage supports BioLineRx's strategy to develop GLIX1 as both monotherapy and in combination with established anti-cancer (搜索) agents. The company has established a joint venture with Hemispherian AS (搜索) to develop GLIX1 as a first-in-class, oral, small molecule targeting DNA damage response (搜索) in glioblastoma (搜索) and other cancers.
BioLineRx is a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The company's first approved product, APHEXDA (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma (搜索) and is being commercialized by partners globally.