Immunic Receives Notice of Allowance for Composition-of-Matter Patents in the US & Europe for IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor

Immunic, Inc. recently announced the company received a Notice of Allowance from the USPTO for patent application 16/644581 titled IL-17 and IFN-gamma inhibition for the treatment of autoimmune diseases and chronic inflammation. The company also received notice of allowance of patent application EP18762111.5 in Europe, and notice of grant of patent application 2018330633 in Australia. All three patents cover composition-of-matter of IMU-935 and related formulations, and are expected to provide protection into at least 2038, without accounting for potential Patent Term Extension (PTE) in the United States or Supplementary Protection Certificates (SPC) in Europe, respectively.

“We believe IMU-935 is a highly potent and selective oral inhibitor of IL-17, which so far, has shown a remarkably differentiated safety and tolerability profile. Allowance of composition-of-matter patents for this molecule in the United States, Europe and Australia, each with significant lifespan, is incredibly important as we continue to advance IMU-935 through the clinic,” stated Daniel Vitt, PhD, Chief Executive Officer and President of Immunic. “This is especially true on the heels of our recently announced positive results from the single and multiple ascending dose parts of the phase 1 clinical trial of IMU-935, and the ongoing part C in moderate-to-severe psoriasis patients. Additionally, our ongoing phase 1 clinical trial of IMU-935 in patients with metastatic castration-resistant prostate cancer continues to enroll patients and we look forward to receiving initial clinical data from this indication as well.”

IMU-935 is a highly potent and selective inverse agonist of RORγ/RORγt (retinoic acid receptor-related orphan nuclear receptor gamma / truncated). The nuclear receptor RORγt is believed to be the main driver for the differentiation of Th17 cells and the release of cytokines involved in various inflammatory and autoimmune diseases. This target is believed to be an attractive alternative to approved antibodies for targets, such as IL-23, the IL-17 receptor and IL-17 itself. IMU-935 showed strong cytokine inhibition targeting both Th1 and Th17 responses in preclinical testing, as well as indications of activity in animal models for psoriasis, graft versus host disease, multiple sclerosis and inflammatory bowel disease. Preclinical experiments indicated that, while leading to a potent inhibition of Th17 differentiation and cytokine secretion, IMU-935 did not affect thymocyte maturation. IMU-935 is an investigational drug product that has not been approved in any jurisdiction.

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, ulcerative colitis, Crohn’s disease, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor RORγ/RORγt, is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barré syndrome. 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.