[Edaily Reporter KIM SUNG-JIN ] OSCOTEC Inc.(039200)OSCOTEC Inc. is aiming for a technology export deal led by “OCT-648,” a candidate drug for the treatment of fibrosis in chronic kidney disease. Having already successfully commercialized Lazertinib (known in Korea as Lecraza) and secured three consecutive technology export deals, OSCOTEC Inc. plans to strengthen its position as a new drug developer through this next technology export. OSCOTEC Inc. is currently in discussions with major global pharmaceutical companies regarding the technology transfer of OCT-648.

Kwak Young-shin, Director of OSCOTEC Inc.’s Research Institute, stated in a recent interview with Pharm e-Daily, “Among OSCOTEC Inc.’s pipeline, OCT-648 is the project closest to a technology transfer,” adding, “Our goal is to complete the technology transfer next year.” He specified that discussions are limited to the top 10 global pharmaceutical companies. Director Kwak explained, “We will first discuss with the top-tier companies, and if that doesn’t work out, we will move on to the next stage.”

The company also plans to pace its technology transfers. Following last year’s export of “ADEL-Y01,” a new drug candidate for Alzheimer’s disease, to Sanofi, OSCOTEC Inc. successfully transferred the rights to “Sebidoplenib,” a candidate drug for autoimmune diseases that had once been on the verge of being discontinued, to Azios Pharmaceuticals (Azios) in June of this year. The fact that a domestic biotech company has succeeded in three major technology transfers is considered a rare achievement in the industry.

Regarding this, Director Kwak explained, “Technology transfer is a process that takes several years—from the science involved in raising the quality of the compound prior to the contract, through contract negotiations, to the technical handover of data after the contract is signed,” adding, “There is a world of difference between a company that has done this before and one that hasn’t.”

“Targets and blocks NUAK1 specifically…”“Safety, Not Efficacy, Is the Competitive Edge”

OCT-648, considered a next-generation technology transfer candidate at OSCOTEC Inc., aims to directly block renal fibrosis. Director Kwak stated, “Currently, hypertension and diabetes medications are being approved and used as treatments for chronic kidney disease. However, these drugs address the underlying causes of chronic kidney disease, and there are currently no treatments that actually prevent renal fibrosis.”

Treatments for chronic kidney disease are a key focus of the global pharmaceutical industry. This is because, as the population ages and the number of patients with diabetes and hypertension increases, so does the number of patients experiencing kidney function decline. Although the causes vary, the condition ultimately progresses from fibrosis—the hardening of kidney tissue—to chronic kidney failure; consequently, the global pharmaceutical and biotech industries are conducting research and development to prevent this fibrosis.

Director Kwak explained, “The key pathway in fibrosis is TGF-beta (β). When tissue is damaged, TGF-β is secreted to initiate a ‘patching’ process for repair; however, if this process becomes excessive, it leads to fibrotic disease.” TGF-β activates a protein called YAP, and YAP enters the cell nucleus to produce large quantities of proteins necessary for fibrosis.

He said, “The industry has been developing TGF-β antibodies but has hit a wall. Because TGF-β performs both beneficial and harmful functions in the body, side effects have emerged alongside the therapeutic effects.” He continued, “The kinase NUAK1 has emerged as an alternative. Over the past five to six years, a series of studies have shown that NUAK1 is involved in the TGF-β–YAP signaling pathway, prompting big pharma companies to jump into the development of NUAK1 inhibitors.”

The problem is that targeting both NUAK1 and NUAK2 simultaneously can lead to serious side effects. It is necessary to selectively target NUAK1 alone, but it is reported that some big pharma companies have abandoned their R&D efforts due to the high technical difficulty involved. OCT-648, currently under development by OSCOTEC Inc., is a therapeutic candidate that targets NUAK1.

Reactions from the industry are also reportedly positive. Director Kwak emphasized that when he introduced OCT-648 at this year’s Bio USA, meeting requests poured in. “One company told us that they understood better than anyone else what kind of profile we (OSCOTEC Inc.) should aim for in developing a treatment for chronic kidney disease, and asked us to contact them first—and no one else—once we reach a certain stage,” Director Kwak said.

Cancer Treatment

Focuses on ‘Preventing

Resistance’… ‘OCT-598’ Aims for Top-Line Results in the First Half of Next Year

In the oncology field, OCT-598—a combination therapy candidate designed to prevent

resistance

to standard treatments—is the core pipeline. OSCOTEC Inc. acquired the compound from Kanaph Therapeutics Inc. in 2022 and has been continuing its research and development. Director Kwak stated, “The combination of Lazertinib and Amivantamab significantly increased overall survival because the two drugs work together to suppress the development of cancer resistance,” adding, “This gave us confidence in the resistance-suppressing mechanism.”

When cancer cells are attacked by anticancer drugs, they produce PGE2 to send survival signals to neighboring cancer cells. OCT-598 works by blocking the EP2 and EP4 receptors through which PGE2 exerts its effects. Existing approaches have relied on inhibiting COX-2, the enzyme that produces PGE2; however, this method has the clear drawback of also suppressing beneficial prostaglandins, and increasing the dose raises the risk of cardiovascular disease.

The core objective of OCT-598, currently under development by OSCOTEC Inc., is to target this mechanism of resistance formation to enhance the durability and efficacy of existing anticancer therapies. Data from a colorectal cancer model presented by OSCOTEC Inc. at an international oncology conference showed that while tumors regrew due to resistance approximately 30 days after monotherapy with Keytruda, the inhibitory effect persisted in the OCT-598 combination group.

OCT-598 is currently in a Phase 1 clinical trial in South Korea, with about 10 patients enrolled to confirm safety while gradually increasing the dose. A U.S. clinical trial is scheduled to begin soon. The Phase 1 trial is structured such that after determining the dose for monotherapy by cancer type, the study proceeds to combination therapy in Part B. Topline results were originally targeted for early next year, but the current goal is the first half of next year.

Director Kwak stated, “Rather than developing new, expensive anticancer drugs like Keytruda or CAR-T, extending the efficacy and duration of use of standard therapies benefits both patients and health insurance budgets.” He added, “If an anticancer drug developer secures a resistance inhibitor prior to approval, they can extend the drug’s protection period through approval for combination therapy, thereby increasing the likelihood of collaboration.”

AI Dramatically Reduces New Drug Development Time… Screening Platform “Rivendell”

OSCOTEC Inc. is also accelerating the development of platforms designed to reduce

the time

and cost involved in new drug

development

. “Rivendell,” developed by OSCOTEC Inc., is an AI-based screening platform for anti-resistance anticancer drugs that observes and analyzes the process by which resistance to existing anticancer drugs develops in real time at the single-cell level.

Director Kwak said, “We can reduce the initial target and candidate compound screening—which typically takes 3 to 4 years—to just one or two months,” adding, “Our goal is to create a success story in the development of resistance blockers through this.”

Simply put, Rivendell tracks the changes a drug induces within cells by observing changes in drug-treated cells through images and analyzing them with AI. The process involves staining various intracellular organelles individually, capturing large-scale image data showing changes before and after drug treatment, and then using AI to analyze this data to identify targets associated with specific drugs.

A key feature of this approach is the use of a library of compounds with known binding sites. By analyzing the changes that occur after treating cells with various compounds, researchers can reverse-engineer which targets the drugs are affecting.

Director Kwak emphasized, “To develop a new drug, you must first identify a target and then separately find a drug that inhibits that target; this process typically takes at least one year and costs 2 to 3 billion won,” adding, “We can accomplish this entire process with a single screening.”

In May of this year, OSCOTEC Inc. established a Core Technology Team within its research institute and began in earnest to build a platform for anti-drug-resistant anticancer agents. In particular, the company recruited Dr. Régis Grail, who served as the head of the Technology Platform at the Pasteur Institute of Korea for over 10 years.

Director Kwak emphasized, “While anyone can develop cell image screening, the technology Dr. Régis possesses—which involves coloring every organelle within a cell—is difficult for other companies to replicate.”

OSCOTEC Inc. is also pursuing collaborations with major domestic companies using the “Rivendel” platform. Director Kwak stated, “While I cannot disclose the company’s name, we will be announcing a collaboration with a major domestic company in the near future.”