[Edaily Reporter SONG YOUNG-DOO ] #Inventera Inc., a nanopharmaceutical platform company, is accelerating its efforts to secure approval for an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) and to commercialize its next-generation magnetic resonance cholangiopancreatography (MRCP) contrast agent, “INV-003,” on a global scale. This is because the company has secured a comprehensive support system covering the entire new drug development lifecycle—from regulatory compliance to clinical strategy and commercial viability verification—after being selected for consecutive support programs by the Korea Drug Development Fund (KDDF).

Inventera Inc. announced on the 1st that INV-003, its next-generation oral MRCP-specific contrast agent, has been selected for the KDDF’s Global Regulatory Affairs (RA) support program.

INV-003 is an iron (Fe)-based nano MRI contrast agent currently under development to selectively suppress high signals from the stomach and duodenum during MRCP examinations, thereby producing clearer images of the pancreatic and bile ducts. The company explained that, following its selection for a KDDF preclinical development project last year, it has now been consecutively selected for this global RA support program, the ACT program, and the drug value assessment support program, thereby gaining recognition for both its technological achievements and commercial viability.

In particular, the Global RA Support Program assists with establishing regulatory strategies, developing IND packages, and filing applications required for U.S. FDA IND approval. It is reported that only two companies among the KDDF-funded projects were selected for this program. Through this initiative, Inventera Inc. plans to begin full-scale preparations for the FDA IND submission with support from RA specialists QBest Bio and KCRN Research.

Selection for the ACT program also contributes to the development of a global clinical strategy. The company is collaborating with the clinical team at Asan Medical Center in Seoul to refine disease-specific clinical advice and clinical trial design. Based on this, the company’s strategy is to validate the clinical utility of INV-003 in pancreatic and biliary tract diseases, such as pancreatic cancer, pancreatitis, cholangiocarcinoma, and cholangitis.

Through the Drug Value Assessment Support Program, the company is working with specialized institutions to quantitatively analyze the clinical and economic value of INV-003. The plan is to use this analysis as objective supporting data in future negotiations regarding global technology transfer, joint development, and commercialization.

This selection is also linked to Inventera Inc.’s track record of successfully completing previous KDDF projects. After its lead pipeline, “INV-002,” was selected for KDDF support in 2023, the company received a total of 6.4 billion won in R&D funding over approximately two years to complete the project, which was designated an “outstanding project” at the end of last year. Building on this success, its follow-up pipeline, INV-003, has also been consecutively selected for national support programs, maintaining momentum in its development.

Inventera Inc. has currently completed the domestic Phase 3 clinical trial for INV-002 and is accelerating the expansion of its nano-MRI contrast agent platform while preparing for the global clinical trial of its follow-up pipeline, INV-003.

An Inventera Inc. official stated, “INV-003 has been recognized for its technological capabilities and global commercialization potential, having been selected consecutively for the KDDF preclinical development project, the Global RA Support Program, the ACT Program, and the Drug Value Assessment Support Program,” adding, “Based on the completion of our preclinical package and a full-cycle support system, we will actively pursue U.S. FDA IND approval, global clinical trials, and license-outs.”