Immunic Receives Notice of Allowance for Composition-of-Matter Patent in the US for Small Molecule Modulator Targeting Restoration of Intestinal Barrier Function & Regeneration of Bowel Epithelium

Immunic, Inc. recently announced it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for patent application 16/646130 titled Compound Having Cyclic Structure. The patent covers composition-of-matter of IMU-856 and related pharmaceutical compositions and is expected to provide protection into at least 2038, without accounting for potential Patent Term Extension (PTE).

The patent application was originally filed by Daiichi Sankyo Co., Ltd. (Daiichi Sankyo), which discovered IMU-856. In 2018, Immunic and Daiichi Sankyo entered into a global option and license agreement, granting Immunic the exclusive right to license IMU-856, which was subsequently exercised by Immunic in 2020. The license included exclusivity on the composition-of-matter patent.

“Allowance of this composition-of-matter patent significantly strengthens our intellectual property estate and is key to the clinical development of IMU-856, which we believe to be a highly potent small molecule oral epigenetic regulator. In particular, IMU-856 appears to influence the tightly regulated network of genes and proteins associated with intestinal epithelial cell interaction and adhesion, which could present an entirely new and innovative approach to the treatment of a significant number of gastrointestinal diseases,” stated Daniel Vitt, PhD, Chief Executive Officer and President of Immunic. “In May 2022, we reached an important milestone with the initiation of part C of our phase 1 clinical trial of IMU-856 in patients with celiac disease, to confirm the drug’s ability to restore intestinal barrier function without affecting the immune system. We also look forward to reporting unblinded safety data from the single and multiple ascending dose parts of the phase 1 clinical trial in healthy human subjects in the third quarter of this year.”

IMU-856, which Immunic believes to be novel, is an orally available small molecule modulator that targets a protein, which serves as a transcriptional regulator of intestinal barrier function and regeneration of bowel epithelium. Based on preclinical data, the compound may represent a new treatment approach, as the mechanism of action targets the restoration of the intestinal barrier function and bowel wall architecture in patients suffering from gastrointestinal diseases such as celiac disease, inflammatory bowel disease, irritable bowel syndrome with diarrhea and other intestinal barrier function associated diseases. Immunic believes that, because IMU-856 has been shown in preclinical investigations to avoid suppression of immune cells, it may therefore maintain immune surveillance for patients during therapy, an important advantage versus chronic treatment with potentially immunosuppressive medications. IMU-856 is an investigational drug product that has not been approved in any jurisdiction.

IMU-856 was discovered by Daiichi Sankyo Co., Ltd. (Daiichi Sankyo). In November 2018, Immunic and Daiichi Sankyo entered into a global option and license agreement, granting Immunic the exclusive right to license IMU-856. The license also includes exclusivity on a patent application filed by Daiichi Sankyo, covering IMU-856’s composition of matter. Immunic exercised the option in January 2020.

Immunic, Inc. is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, vidofludimus calcium (IMU-838), a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect, is currently being developed as a treatment option for multiple sclerosis, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor RORγ/RORγt, is targeted for development in psoriasis, and castration-resistant prostate cancer. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction. For more information, visit www.imux.com.