Immunic, Inc Announces the Execution of an In-License Agreement with the University Medical Center
September 22, 2021 at 06:30 am EDT
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Immunic, Inc. announced the execution of an in-license agreement with the University Medical Center Goettingen, Germany, covering the combination of DHODH inhibitors and nucleoside analogues to treat viral infections (COVID-19 and Influenza). Terms of the agreement were not disclosed. Preclinical research recently completed by the parties and their collaborators has shown that certain DHODH inhibitors, including Immunic's lead asset, IMU-838, strongly synergize with selected nucleoside analogues to inhibit SARS-CoV-2 replication in vitro. For instance, in an in vitro test system, IMU-838 alone showed an up to 99.9% reduction in viral RNA at concentrations of 5 µM, which is well within the exposure levels seen in prior clinical trials. Likewise, N4-hydroxycytidine (NHC), the active metabolite of molnupiravir[2], alone, was associated with an up to 99% reduction in viral RNA at concentrations of 100 nM. Compared to single agent activity, the combination of IMU-838 and NHC achieved an extra-ordinary reduction in viral RNA, down to the limit of detection, reducing SARS-CoV-2 RNA by up to seven log units (corresponding to 0.00001% viral RNA remaining). This powerful reduction of virus replication in vitro was demonstrated across multiple SARS-CoV-2 variants, including alpha, beta and delta, highlighting the independence of this approach to mutant virus forms. In addition to molnupiravir, Immunic is exploring alternate nucleoside analogues, some of which have shown very promising antiviral activity in vitro. The company plans to present detailed data at an upcoming scientific conference. The company re-iterates its prior guidance that phase 2 top-line data of IMU-838 in ulcerative colitis is expected to be available in the second quarter of 2022, and that regarding IMU-935, data from the multiple ascending dose part of the ongoing phase 1 trial is expected in the fourth quarter of 2021, with initial clinical data in psoriasis expected in the second quarter of 2022. The phase 1 trial of IMU-935 in metastatic castration-resistant prostate cancer is expected to commence in the fourth quarter of 2021. Moreover, the company continues to expect enrollment of the first patient in the phase 2 CALLIPER trial of IMU-838 in progressive multiple sclerosis later this month, and first patient in the phase 3 ENSURE program of IMU-838 in relapsing-remitting multiple sclerosis in the fourth quarter of 2021.
Immunic, Inc. is a biotechnology company. The Company is focused on developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The Companyâs s lead development program, vidofludimus calcium (IMU-838), is in phase III and phase II clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in phase II clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and moderate-to-severe ulcerative colitis. IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease. IMU-381 is in preclinical testing, a next generation molecule being developed to specifically address the needs of gastrointestinal diseases.