Next-Generation Anticancer Drug Development Accelerates with Consecutive Clinical Trials and Candidate Substance Announcements

Targeted and Immuno-Oncology Drugs
to Be Unveiled at the American Association for Cancer Research Next Month

Next-generation anticancer pipeline development by domestic pharmaceutical and biotech companies is gaining momentum. Next month, they will unveil new drug candidates at the American Association for Cancer Research (AACR) and present preclinical results of antibody-drug conjugate (ADC) candidates, demonstrating rapid progress in next-generation anticancer drug development. ADC is an anticancer drug that precisely targets cancer cells at desired sites by linking an antibody and an anticancer agent (payload) with a linker. It is called the 'guided missile' of anticancer drugs because it improves not only treatment accuracy but also side effects.

According to the pharmaceutical and biotech industry on the 31st, Daewoong Pharmaceutical will unveil three anticancer drug new pipelines?'DWP216,' 'DWP217,' and 'DWP223'?for the first time at the American Association for Cancer Research meeting held in Chicago, USA, from the 25th to the 30th of next month. All three aim to be First-in-Class drugs. In particular, DWP216 is a targeted anticancer drug that precisely targets only the TEAD1 protein to treat NF2 gene mutation cancers. TEAD proteins regulate the cell life cycle. When mutations occur in this protein, excessive cell proliferation causes various diseases, including cancer. Daewoong Pharmaceutical's ADC candidate DWP217 acts on this TEAD protein to selectively inhibit mutations in the tumor suppressor gene 'NF2.' While existing ADC candidates inhibit all types of TEAD (1 to 4), Daewoong Pharmaceutical's candidate selectively inhibits only TEAD1, minimizing the risk of kidney damage while showing strong anticancer effects. It was selected last year as a national new drug development project.

Ligakem Biosciences will also reveal preclinical research results for a total of five candidates, including the STING agonist 'LCB39' under development as an immuno-oncology drug and ADC platform technology transfers, at the American Association for Cancer Research next month. LCB39 is a next-generation immuno-oncology drug candidate independently developed by Ligakem Biosciences. It targets the 'STING protein,' which plays a crucial role in regulating immune responses, and induces activation of innate immune cells. STING agonists have attracted attention as a drug mechanism that can overcome the limitations of existing immuno-oncology drugs. Although many global pharmaceutical companies have attempted development, most have abandoned it due to insufficient efficacy and side effect issues. Ligakem Biosciences' LCB39 features reduced cell permeability and increased penetration and exposure duration within tumor tissues compared to competing STING agonist drugs, leveraging Ligakem's proprietary technology. Ligakem plans to enter clinical trials early next year for a total of five ADC substances, including the immuno-oncology candidate 'LCB39.'

Celltrion plans to start clinical trials for three ADC candidates this year, and Aptis, a subsidiary of Dong-A ST, plans to begin clinical trials for ADC candidates from next year. Celltrion will initiate Phase 1 clinical trials for 'CT-P70' this year and begin patient administration. CT-P70 targets cell growth factor receptors activated in cancer cells that promote tumor growth, with indications including non-small cell lung cancer and colorectal cancer. Celltrion is also sequentially preparing Investigational New Drug (IND) applications for bladder cancer drug candidates CT-P71, CT-P72, and CT-P73, which are solid tumor treatments. Aptis plans to accelerate clinical trials for ADC new drug candidates starting next year. Aptis has completed preclinical studies for the claudin18.2 ADC candidate 'DA-3501,' targeting stomach and pancreatic cancers, and is conducting toxicity evaluations for Phase 1 clinical trials. Aptis possesses its own third-generation linker platform called 'AppClick.' This technology selectively introduces drugs at desired locations and uses antibodies without modification, ensuring uniform production quality.

Researcher Kwon Hae-soon of Eugene Investment & Securities stated in a report, "The position of ADCs in the anticancer drug market is strengthening because they show high efficacy by replacing chemotherapy treatments with high systemic toxicity as targeted anticancer drugs," adding, "Interest from big pharma in domestic ADC pipelines is also increasing."

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