Inventera Inc. announced on the 6th that it has decided to outsource the manufacturing of the API for the clinical development and commercial use of INV-003 to LGCHEM,LTD.
LGCHEM,LTD plans to manufacture the active pharmaceutical ingredients at its Onsan production facility in Ulsan and supply them to Inventera Inc. The specific contract value and supply volume were not disclosed.
This agreement expands the API production partnership—which was established last January for “INV-002,” a contrast agent specialized for magnetic resonance arthrography (MRA), and “INV-001,” a contrast agent specialized for magnetic resonance lymphangiography (MRL)—to include INV-003. As a result, the two companies have established a collaborative framework for the production of active pharmaceutical ingredients (APIs) for Inventera Inc.’s three key nano-MRI contrast agent pipeline products.
This agreement covers not only API production for clinical trials but also production required for commercialization following future marketing approval. Inventera Inc. plans to secure the APIs necessary for clinical development and prepare for commercialization by leveraging LGCHEM,LTD’s manufacturing facilities and quality control capabilities.
Previously, in mid-last month, Inventera Inc. received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for INV-003. INV-003 is an iron oxide-based oral MRI contrast agent developed using Inventera Inc.’s proprietary nanomedicine platform, “Invinity.”
INV-003 is designed to enhance image clarity by suppressing bright background signals from the stomach and duodenum that interfere with the visualization of the bile ducts and pancreatic ducts during magnetic resonance cholangiopancreatography (MRCP) examinations. The U.S. Phase 1 clinical trial will evaluate safety and tolerability and verify the drug’s ability to suppress background signals and improve image quality.
Inventera Inc. is also advancing the clinical development of its other key pipeline candidates. INV-002 has completed a Phase 3 clinical trial in Korea and is preparing to submit a marketing authorization application. INV-001 is currently undergoing a Phase 2a clinical trial in Korea, with the goal of completing it by the end of this year. All three key pipeline candidates have secured IND approval for clinical trials in the U.S.
Shin Tae-hyun, CEO of Inventera Inc., stated, “This agreement is significant in that it establishes a supply base for active pharmaceutical ingredients—from clinical development to commercial use—in time for INV-003’s entry into U.S. clinical trials.” He added, “We will expand our collaboration with LGCHEM,LTD to include our three key pipeline candidates and strengthen the production infrastructure necessary for clinical development and commercialization.”
