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Details:
The Company will fund the ongoing clinical development of its three lead candidates, IMU-838 (vidofludimus calcium), a small molecule investigational drug in development as an oral next generation treatment option for patients with multiple sclerosis, IMU-856 and IMU-381.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Neurology Product Name: IMU-838
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BVF Partners
Deal Size: $240.0 million Upfront Cash: $80.0 million
Deal Type: Private Placement January 05, 2024
Details:
IMU-838 (vidofludimus calcium) is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Neurology Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 09, 2023
Details:
IMU-838 (vidofludimus calcium) is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Neurology Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2023
Details:
IMU-838 (vidofludimus calcium) inhibits dihydroorotate dehydrogenase (DHODH), a key enzyme for highly metabolically activated T and B immune cells experience metabolic stress, its inhibition results in less pro-inflammatory cytokines and thereby reduce the inflammation.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Gastroenterology Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2023
Details:
IMU-838 (vidofludimus calcium) is an investigational drug in development as an orally available, next-generation selective immune modulator that is designed to inhibit the intracellular metabolism of activated immune cells by blocking the enzyme DHODH.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Neurology Product Name: IMU-838
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
Details:
The Company intends to use net proceeds from the financing to fund the ongoing clinical development of its three lead product candidates, vidofludimus calcium (IMU-838), IMU-935 and IMU-856, and for other general corporate purposes.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Neurology Product Name: IMU-838
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Securities
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement October 10, 2022
Details:
IMU-838 (Vidofludimus calcium) is an investigational drug in development as an orally available, next-generation selective immune modulator that is designed to inhibit the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Neurology Product Name: IMU-838
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2022
Details:
The trial did not achieve the primary endpoint of clinical remission for the pooled 30 and 45 mg/day active dose groups of IMU-838 (vidofludimus calcium) versus placebo at week 10.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Gastroenterology Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
IMU-838 is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH) used in patients with progressive multiple sclerosis (PMS).
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Immunology Product Name: IMU-838
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Details:
Preclinical research recently completed by Immunic and collaborators has shown that certain DHODH inhibitors, including it's lead asset, IMU-838, strongly synergize with selected nucleoside analogues to inhibit SARS-CoV-2 replication in vitro.
Lead Product(s): Vidofludimus calcium anhydrous,Beta-D-N4-hydroxycytidine
Therapeutic Area: Infections and Infectious Diseases Product Name: IMU-838
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: University Medical Center Goettingen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 22, 2021
Details:
The Company intends to use the net proceeds of the offering to fund the ongoing clinical development of its three lead product candidates, IMU-838, IMU-935 and IMU-856, and for other general corporate purposes.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Immunology Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $45.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 19, 2021
Details:
The Company intends to use the net proceeds of the offering to fund the ongoing clinical development of its three lead product candidates, IMU-838, IMU-935 and IMU-856, and for other general corporate purposes.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Immunology Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $45.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 15, 2021
Details:
The acquisition of the royalties will enable Immunic to realize the full market potential of IMU-838, not only as a treatment for RRMS but also as a potential new therapeutic option for ulcerative colitis, Crohn’s disease, COVID-19, and primary sclerosing cholangitis.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Immunology Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Immunic Therapeutics
Deal Size: $17.2 million Upfront Cash: Undisclosed
Deal Type: Agreement March 31, 2021
Details:
Primary and key secondary endpoints were not evaluable due to very low rates of serious complications in the population of hospitalized patients with moderate covid-19. High-risk patients and patients aged >65 years experienced a more substantial treatment effect of imu-838.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Infections and Infectious Diseases Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 17, 2021
Details:
The aim of the CALVID-1 trial is to investigate IMU-838 as an oral treatment option for moderate COVID-19 and to support potential use of IMU-838 as a treatment for current and potential future viral pandemic threats.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Infections and Infectious Diseases Product Name: IMU-838
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
The venture loan is intended to support Immunic’s ongoing phase 2 CALVID-1 trial of its lead asset, IMU-838, in patients with moderate coronavirus disease 2019 (COVID-19).
Lead Product(s): Vidofludimus calcium anhydrous,Oseltamivir Phosphate
Therapeutic Area: Infections and Infectious Diseases Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: European Investment Bank
Deal Size: $28.6 million Upfront Cash: Undisclosed
Deal Type: Funding October 20, 2020
Details:
The net proceeds will support ongoing clinical development of Immunic's 3 lead product candidates, IMU-838, IMU-935 and IMU-856, including to investigate IMU-838 in a potential phase 3 program in relapsing-remitting multiple sclerosis, and for other general corporate purposes.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Neurology Product Name: IMU-838
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SVB Leerink
Deal Size: $90.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 04, 2020
Details:
The study achieved all primary and key secondary endpoints. study met its primary endpoint, demonstrating a statistically significant reduction in the cumulative number of combined unique active magnetic resonance imaging (MRI) lesions
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Neurology Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 02, 2020
Details:
The IONIC trial is a prospective, randomized, parallel-group, open-label phase 2b study, designed to evaluate efficacy & safety of IMU-838 in combination with the neuraminidase inhibitor, Oseltamivir, in approximately 120 adult COVID-19 patients.
Lead Product(s): Vidofludimus calcium anhydrous,Oseltamivir Phosphate
Therapeutic Area: Infections and Infectious Diseases Product Name: IMU-838
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
Details:
It is a prospective, multicenter, randomized, placebo-controlled, double-blind clinical trial in patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Immunic intends to use the proceeds from the offering to fund the ongoing clinical development of the Company's three small molecule products: IMU-838, IMU-935 and IMU-856, and for other general corporate purposes, including to investigate IMU-838.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Roth Capital Partners
Deal Size: $25.0 Million Upfront Cash: Undisclosed
Deal Type: Public Offering June 10, 2020
Details:
Immunic has received regulatory allowance from the U.S. Food and Drug Administration to initiate its phase 2, CALVID-1 clinical trial of IMU-838, the company’s selective oral DHODH inhibitor, in coronavirus disease 2019 (COVID-19) at centers in the United States.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2020
Details:
The CALVID-1 study is a prospective, multicenter, randomized, placebo-controlled, double-blind phase 2 clinical trial in approximately 230 patients with moderate COVID-19, designed to evaluate efficacy, safety and tolerability of IMU-838.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Immunic intends to use the proceeds to fund the ongoing clinical development of the Company's three small molecule products: IMU-838, IMU-935 and IMU-856.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Altium Capital
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Financing April 23, 2020
Details:
In cellular assays with SARS-COV-2 clinical isolates, IMU-838 shows ability to inhibit viral replication of SARS-COV-2.
Lead Product(s): Vidofludimus calcium anhydrous
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2020
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