By recruiting three highly skilled experts, Jonny Østensen (Project Leader Manganese-enhanced MRI in Heart Failure), Miriam Balstad, (Senior Regulatory Affairs Manager) and Christina Abrahamsberg (Chief Scientific Officer) the company is well prepared to drive its main projects. The three experts bring extensive expertise and a strong background in research, clinical development, manufacturing and life cycle management of contrast agents to the company. “The new team members will be vital to IC Targets to reach the next milestones and position the company for future growth”, said Håkon Sæterøy, Chairman of IC Targets AS.
Update on company projects
Cardiac project – preclinical study initiated
For the cardiac indication the development project “Mangafodipir-enhanced MRI for myocardial characterization in Heart Failure” is 70 % funded by the Research Council of Norway (RCN). The main objective of the cardiac project is to validate a MRI procedure which will enable characterization of calcium handling at a cellular level. This is expected to represent a major improvement over conventional contrast enhanced imaging.
As one milestone in this RCN-funded project, the preclinical study was successfully initiated during H1/2022. The study is done in collaboration with the Intervention Center at Oslo University Hospital (OUH) and will be finalized by the end of 2022. Results of this preclinical study will make a basis for the initiation of the cardiac clinical development program.
The clinical trial will focus on Heart Failure with preserved Ejection Fraction (HFpEF) patients. The complex pathophysiology of HFpEF makes it a diagnostic and therapeutic challenge. Only recently, specific drug treatment options for this patient group have become available. Novartis’ Entresto® was FDA approved as the first drug for treatment of HFpEF in February 2021, followed by Jardiance® (Boehringer Ingelheim) in February 2022. Additional drug approvals can be expected, as Farxiga® (AstraZeneca) met the primary endpoint in a Phase III trial showing improved symptom burden and health-related quality of life in patients with mildly reduced or preserved ejection fraction. These FDA approvals open an enormous demand for diagnostic methods translating the better understanding of the pathophysiology in subgroups of HFpEF into clinically applicable strategies.
The novel IC Targets procedure may provide a tool for improved selection of therapy and monitoring of treatment efficacy in patients with heart diseases where calcium handling is altered, such as ischemic heart disease, dilated and hypertrophic cardiomyopathies and heart failure. Our long-term goal is to get approval for mangafodipir-enhanced MRI (MEMRI) in all common heart diseases where calcium handling may be altered.
MRI of lesions of the liver and pancreas
In parallel with the cardiac innovation project, IC Targets aims to relaunch the product on a global basis for the previously marketed indications for the detection of lesions in the liver and pancreas.
Active Pharmaceutical Ingredient (API) synthesis development work and technical batch production were successfully achieved during 2022. Manufacturing of the API GMP batches is currently ongoing and will be finalized by December 2022. These API batches will be used for manufacturing of the Finished Dosage Forms (FDF) of mangafodipir trisodium injection in 2023. The chemical and pharmaceutical development work on the mangafodipir product is carried out for the benefit of both of the two company projects.
In parallel with the development work, the regulatory pre-submission activities for the original indications, including preparation of the dossier, will be carried out during 2023. The objective is to submit for a marketing authorisation in the EU in Q1/2024.
IC Targets sees a significant potential for the product in the previously marketed indications. The commercial strategy will initially focus on the European and North American markets.
Patents – PCT application for cardiac application filed
Our patent portfolio has been strengthened in June 2022 by filing a PCT application for “Mangafodipir-enhanced MRI for myocardial characterization in heart failure”. Upon grant, the new patent will further improve the value proposition of mangafodipir trisodium and extend the patent protection rights until 2041. National patent filings in strategic markets will be carried out until the end of 2023.
Key priorities going forward
Preparatory activities for the clinical Phase 2a trial of the cardiac project, including manufacturing of mangafodipir trisodium, are ongoing. The clinical trial application is planned for Q4/2023, patient recruitment will start in Q1/2024. Initiation of the clinical trial will be a major milestone within the RCN-funded cardiac project. Patients will be recruited within a period of approximately 12 months. Results of the clinical trial are anticipated for Q1/2025 and are then expected to make a basis for industrial partnering and sub-licensing agreements.
ICT is working to establish the supply chain for the product with manufacturing of the FDF as a major milestone during H1/2023. The objective is to submit a European marketing authorisation application for mangafodipir trisodiuminjection for the detection of focal lesions of the liver and the pancreas during Q1/2024.
Update on company development, project progress and timelinesThomas2022-11-16T14:54:51+00:00
On 11th June 2021 the Research Council of Norway announced that IC Targets AS is among the few selected companies out of 232 applicants whose grants were awarded under the call “Innovation Project for the Industrial Sector 2021”. This NOK 15,5 million non-dilutive grant is for the NOK 22 million R&D project “Mangafodipir-enhanced MRI for myocardial characterization in Heart Failure”. IC-T has already obtained use patents in the major markets for cardiac applications using manganese- based MRI agents including mangafodipir. To strengthen the IPR for cardiac applications in non-ischemic heart diseases on 7 June 2021 a new patent application was filed, with the title: “Mangafodipir-enhanced MRI for myocardial characterization in Heart Failure”. The main objective for the current project is to obtain clinical Proof of Concept within the cardiac field of use covered by the new patent application.
The primary objectives of this 2,5 years project will be to measure the two determinants of myocardial stiffness in patients with heart failure with preserved ejection fraction (HFpEF) using a novel, disruptive manganese-based MRI T1 mapping method. Success of this project will enable quantification of calcium channel activity at a cellular level with MRI, which represents a major improvement over conventional contrast enhanced imaging. Until recently, all drug therapies that are useful in patients with reduced contractility and ejection fraction have failed in more than 50% of heart failure patients with preserved ejection fraction. On 16 February 2021, Novartis’ drug Entresto® was approved by the FDA as the first drug for treatment of HFpEF. This FDA approval opens an enormous demand for diagnostic methods translating the better understanding of the pathophysiology in subgroups of HFpEF into clinically applicable strategies. No current non-invasive technique can measure the contribution of abnormal relaxation caused by abnormal cardiomyocyte calcium handling. Thus, the success of this innovative project would not only yield a novel contrast agent for Cardiac MRI, but also represent a paradigm shift for MRI, taking it from image contrast enhancement to quantification of cellular processes.
In parallel with the cardiac innovation project, ICT aims to relaunch the product on a global basis for the previously marketed indications for the detection of tumors in the liver and pancreas. The commercial strategy will initially focus on the European and North-American markets. ICT sees a significant potential for the product also in the previously marketed indications.
IC Targets AS is awarded a NOK 15,5 million grant: Cardiac project initiated, and new patent application filedThomas2022-08-18T12:58:56+00:00
Proceeds from the private placement of shares completed in August 2017 provided IC Targets AS with funding for entering into an exclusive worldwide license agreement with GE Healthcare (GEHC) for use of mangafodipir trisodium (“mangafodipir”) in vivo imaging. This agreement with GEHC is a key element of the revised business plan of IC Targets. With the agreement, the company has obtained access to the original contrast agent for use in clinical studies and subsequently also for commercialization of the patented proprietary cardiovascular indication.
Magnetic resonance imaging (MRI) is the fastest growing imaging modality, with more than 35 million procedures being performed in 2015 using Contrast Agents (CAs). All marketed MRI CAs contain the rare earth metal gadolinium (Gd). In recent years, regulatory health authorities have raised concerns about the use of Gd-based CAs (GBCAs). Thus, access to mangafodipir also provides IC Targets with a short-term business opportunity within the original indication liver and pancreas MRI. Presently, manufacturing and distribution agreements are being explored.
License agreement with GE HealthcareThomas2022-08-12T07:02:06+00:00