RedHill Biopharma Receives U.S. Patent Allowance Covering Opaganib and RHB-107 Combination

Notice of Allowance received for combination of RedHill’s novel orally-administered investigational drugs, opaganib and RHB-107, for treatment of solid tumor cancers; patent expected to extend IP protection until 2036

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Combination of opaganib and RHB-107 demonstrated potent antitumor effect and tumor regression in recent cholangiocarcinoma pre-clinical study

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RedHill plans to add third cohort evaluating this combination to its ongoing Phase 2a study of opaganib in advanced cholangiocarcinoma, subject to FDA discussions

TEL AVIV, Israel and RALEIGH, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent application related to the use of two of RedHill’s proprietary investigational compounds, opaganib (Yeliva, ABC294640) and RHB-107 (upamostat)¹, for the treatment of solid tumor cancers. The patent is expected to extend IP protection for the combination until 2036.

Findings from a recent pre-clinical study evaluating the antitumor effect of opaganib and RHB-107 on cholangiocarcinoma (also known as bile duct cancer) patient-derived xenografts demonstrated that treatment with opaganib and RHB-107, individually and in combination, resulted in tumor regression. Moreover, the combination of both drugs was found to be more potent and well tolerated in the animal models. These findings were presented at the American Association for Cancer Research (AACR) annual meeting earlier this year².

“It is becoming increasingly evident that cancers are dependent on a number of altered molecular pathways and can develop diverse mechanisms of resistance to therapy with single agents,” said Danielle T. Abramson, Ph.D., VP, Intellectual Property & Research at RedHill. “This application is part of a growing patent portfolio that expands patent protection for our oncology program through 2036. We are very pleased with the additional IP protection for the novel combination of opaganib and RHB-107, which follows promising findings on the potent synergistic antitumor activity of this combination.”