[Edaily Reporter KIM SAE-MI ] “Inventera Inc. is a company specializing in nanopharmaceuticals that develops diagnostic tools and therapeutics based on platform technologies that overcome the limitations of immune cell phagocytosis and accumulation in the body—this is Inventera Inc.’s identity.”
‘Infinity,’ a Platform to Surpass the Limits of Nanopharmaceuticals… Targeting Precision Diagnostics and TherapyShin Tae-hyun, CEO of #Inventera Inc., recently met with E-Daily’s pharmaceutical and biotech premium content service, Pharm E-Daily, and defined his company not merely as a contrast agent manufacturer but as a specialized nanopharmaceutical company developing new drugs for precision
diagnostics and therapyusing its proprietary platform technology. A key turning point is expected to be the final clinical study report (CSR) for “INV-002,” a contrast agent specialized for musculoskeletal disorders, scheduled for release in the third quarter of this year.
Although Inventera Inc. is currently widely perceived in the market as a contrast agent manufacturer, the company’s origins lie in nanopharmaceuticals. CEO Shin explained that nanotechnology is not merely a technique for making materials smaller, but rather a technology that alters a material’s size and atomic arrangement to realize new physical properties that cannot be observed in its bulk form. Inventera Inc.’s entry into contrast agent development is an attempt to apply these characteristics of nanomaterials to the life sciences field.
CEO Shin cited the similar size to biomolecules and multifunctionality as the reasons why nanotechnology is bound to intersect with medicine. “Proteins, genes (DNA), and viruses fall within the 1–100 nanometer (nm) range that nanotechnology deals with,” he said. “Nanoparticles of this size are well-suited to interact with cells in terms of scale.”
He continued, “A single nanoparticle can be endowed with multiple functions,” explaining, “It has the advantage of being able to simultaneously incorporate various functions—such as target ligands, drugs, and coatings—onto a single platform.”
Nanomedicines refer to pharmaceuticals that utilize nanometer-scale materials—designed and synthesized—for the diagnosis and treatment of diseases. Since the world’s first nanomedicine, “Doksil,” was launched in 1996, dozens of nanomedicines have been commercialized to date. Nanomedicines are considered a core technology for precision diagnosis and precision therapy because they are similar in size to biomolecules and can incorporate multiple functions simultaneously onto a single platform.
However, there are limitations: after administration, immune cells recognize the nanoparticles as foreign substances and engulf them through phagocytosis, and the nanoparticles tend to accumulate in organs such as the liver and spleen. CEO Shin stated, “In reality, when nanomedicines are injected into the body, less than 1% actually reach the site of the lesion,” adding, “The reality is that the rest are being engulfed by immune cells.”
Inventera Inc. has proposed its proprietary nanomedicine platform, Invinity, as an alternative. Invinity is a platform designed to prevent protein corona formation and enhance dispersion stability, enabling nanoparticles to circulate stably within the body. The key objective is to extend circulation time and increase selectivity for the target lesion, while ensuring that the nanoparticles are excreted through urine—rather than accumulating in the liver or spleen—once they have fulfilled their function.
CEO Shin cited Invinity’s versatility—its ability to carry various payloads—as one of its key strengths. Invinity allows for the attachment of various types of payloads, such as metal compounds, peptides, small-molecule drugs, and antibodies, to the surface of spherical nanoparticles. Depending on the payload attached, it can be implemented as a nano-MRI contrast agent, drug conjugates, or Invinity-antibody-drug conjugates (Invinity-ADCs).
In the medium to long term, the company plans to expand Invinity into the therapeutic and ADC fields. Inventera Inc. is conducting research on drug conjugates—which utilize Invinity’s dispersion stability to reliably deliver hydrophobic payloads—and on Invinity-ADCs, which can achieve a higher drug-to-antibody ratio (DAR) compared to existing ADCs. Inventera Inc.’s medium- to long-term strategy is to first gain experience in human validation and commercialization with contrast agents and then use that foundation to expand into precision drug delivery systems and next-generation ADCs.
Starting with Nano-MRI Contrast Agents… Simultaneously Pursuing Human Validation and CommercializationInventera Inc. aims to
simultaneouslyadvance the
humanvalidation and
commercializationof its nanopharmaceutical platform by targeting
nano-MRI contrast agentsas its first commercial product. He stated, “We were the first in the world to develop a nano-MRI contrast agent based on Invinity technology and have completed all validation up to Phase 3 clinical trials.” Through this, Inventera Inc. has confirmed the platform’s feasibility in humans; its strategy is to secure a revenue base through the commercialization of the contrast agent and then expand into the therapeutic drug sector.
Inventera Inc. chose to begin commercialization with contrast agents due to their development efficiency and market entry potential. The company explains that MRI contrast agents are drugs that improve the diagnostic accuracy of detecting microscopic lesions—which are difficult to identify with MRI equipment alone—and that there remains a diagnostic gap that existing contrast agents have not been able to address. Additionally, the company highlighted that contrast agents have the advantage of requiring smaller clinical trial scales and shorter durations compared to general new drugs, and that imaging quality and diagnostic accuracy can be verified quickly after administration.
CEO Shin stated, “The reason we are commercializing diagnostic nano-MRI contrast agents first is that we determined they are the optimal new drugs for establishing a stable foundation for growth through rapid platform validation and commercialization.” He added, “Inventera Inc.’s unique strength lies in rapidly commercializing products that can fill the diagnostic gaps in MRI contrast agents to generate stable revenue, and then expanding into therapeutics based on that foundation.”
Currently, Inventera Inc.’s nano-MRI contrast agent pipeline is centered on INV-002, INV-001, and INV-003. INV-002, an MR joint contrast agent specialized for musculoskeletal disorders, has completed Phase 3 clinical trials in Korea and received approval for an Investigational New Drug (IND) application for a U.S. Phase 2b trial. INV-001, an MR lymphatic contrast agent specialized for lymphatic system diseases, is currently undergoing a Phase 2a clinical trial in Korea and has secured approval for a U.S. Phase 2 IND. INV-003, an MRCP contrast agent specialized for pancreatic and biliary tract diseases, is scheduled to enter Phase 1 clinical trials within the year.
Q3 ‘INV-002’ CSR to Be a Turning Point… Revenue Expected to Materialize Next YearAmid recent stock price weakness, the INV-002 Phase 3 Clinical Study Report (CSR), scheduled for release in the third quarter of this year, is cited as the most significant event to watch. Since its KOSDAQ listing under the Technology Exemption Program on April 2, Inventera Inc.’s stock price had fallen to 7,770 won as of the 26th. This is 53.2% below the initial public offering price (16,600 won). This is believed to be due to external factors—such as geopolitical risks in the Middle East and a downturn in biotech investment sentiment—as well as concerns over a revenue gap prior to commercialization.
However, since INV-002—a contrast agent specialized for musculoskeletal disorders—met its primary endpoint in the interim analysis of its Phase 3 clinical trial, the release of the third-quarter CSR and the subsequent marketing authorization process are expected to be key factors in a potential turnaround of the stock price. CEO Shin stated, “INV-002 demonstrated exceptionally strong results, meeting all primary endpoints in the data cutoff analysis of 50 out of 85 patients,” adding, “It is a pipeline expected to progress successfully.”
Inventera Inc. plans to begin generating revenue in earnest starting next year with INV-002. To commercialize INV-002, Inventera Inc. has established a FIDDO (Fully Integrated Drug Development Organization) model that combines in-house efforts—from development to production and sales—with collaboration with partners.
He explained, “The hallmark of Inventera Inc.’s business model is that we independently carry out the entire new drug development process—from core technology to product approval—and, once the product is launched, generate stable revenue through collaboration with capable business partners,” adding, “We have completed all preparations for this.”
Inventera Inc. has finalized preparations for the commercial manufacturing, sales, and distribution of its new nano-MRI contrast agent in collaboration with partners, including #DongKook Life Science Co., Ltd., a leading domestic company in the contrast agent sector. Preparations for the commercial production of both active pharmaceutical ingredients (APIs) and finished dosage forms have been completed, and DongKook Life Science Co., Ltd. will participate as the marketing authorization holder and partner for sales, business development, marketing, and distribution.
Finally, CEO Shin emphasized, “Infinity is a versatile platform that can be expanded from contrast agents to therapeutics,” adding, “Inventera Inc. is a company with strong growth momentum, not only in disease diagnosis but also in the development of therapeutics through more precise drug delivery to target sites.”
