RedHill Announces New Patent for Opaganib with Immune Checkpoint Inhibitors Valid Until 2040

RedHill Biopharma Ltd., a specialty biopharmaceutical company, has announced the issuance of a new Chinese patent notice of allowance for opaganib in combination with immune checkpoint inhibitors (ICIs) for inducing an anti-cancer immune response. This patent, which will be issued by the Chinese National Intellectual Property Administration (CNIPA), extends protection for this combination therapy until 2040. ICIs, such as Merck's Keytruda and BMS' Yervoy, are pivotal in cancer treatment, with the global market for these therapies expected to surpass $100 billion by 2028.

Opaganib is a broad-acting, oral small molecule that has shown a favorable safety and efficacy profile. It is currently in development for multiple oncology, viral, and inflammatory indications, including COVID-19, Ebola, and acute respiratory distress syndrome (ARDS). This new patent strengthens the potential use of opaganib in combination with a variety of approved and experimental ICIs across a range of cancer indications.

Guy Goldberg, RedHill’s Chief Business Officer, highlighted the significance of this patent, emphasizing the promising data from various in vivo experiments that demonstrate improved outcomes when opaganib is used in combination with specific ICIs. China’s proactive approach to ICI-based therapies makes this patent a crucial addition to RedHill’s robust intellectual property portfolio for opaganib.

Opaganib, also known as ABC294640, is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor. It has demonstrated anticancer, anti-inflammatory, and antiviral activities, targeting diseases such as prostate cancer, cholangiocarcinoma, gastrointestinal acute radiation syndrome (GI-ARS), and exposure to sulfur mustard. Its mechanism involves inhibiting multiple pathways, inducing autophagy and apoptosis, and disrupting viral replication by inhibiting three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1, and GCS).

Significantly, opaganib has been chosen for evaluation under two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome (ARS) and sulfur mustard exposure, both funded by the National Institutes of Health (NIH). These programs aim to develop opaganib as a potential treatment for these hazardous conditions.

The drug has also shown substantial antiviral activity against SARS-CoV-2, various variants, and other viruses like Influenza A and Ebola. In a U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Ebola virus study, opaganib significantly increased survival time, showcasing its potential as a host-directed molecule for Ebola treatment. Additionally, a U.S. Army-funded study demonstrated that opaganib, when combined with remdesivir (Veklury), significantly improved potency against the virus while maintaining cell viability.

Given its host-targeted mechanism, opaganib is expected to remain effective against emerging viral variants. In Phase 2/3 clinical data for hospitalized COVID-19 patients, the drug improved viral RNA clearance, expedited recovery, and reduced mortality in key patient subgroups compared to placebo. Opaganib has been tested in over 470 individuals in various clinical studies, establishing a solid safety and tolerability profile.

Opaganib has also been designated an Orphan Drug by the FDA for treating cholangiocarcinoma. It has undergone studies in advanced stages of this cancer and in prostate cancer. Furthermore, a Phase 1 chemoradiotherapy study protocol is ready for submission to the FDA.

RedHill Biopharma, based in Tel-Aviv, Israel, and Raleigh, North Carolina, focuses on gastrointestinal and infectious diseases. They promote drugs like Talicia for Helicobacter pylori infection and Aemcolo for traveler’s diarrhea. Their pipeline includes several late-stage development programs, such as RHB-107 for COVID-19 and RHB-204 for pulmonary nontuberculous mycobacteria disease.

This new patent fortifies RedHill’s position in developing opaganib as a versatile therapeutic agent across various critical health domains.