New anticancer drug clinical trial plan submitted next year… “Expected to be the best drug in the series”
input 2024.08.30 14:28
input 2024.08.30 14:28
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SK35501 Development Plan [사진=SK바이오팜 컨퍼런스콜 자료]
SK Biopharmaceuticals has expressed its ambition to become a global player in the radiopharmaceutical (RPT) field within three years. The plan is to strengthen its capabilities through the introduction of external pipelines and in-house development.
SK Biopharmaceuticals announced a detailed roadmap for its RPT business, a new next-generation modality (modality, a method of showing drug efficacy), through a conference call on the 30th, and revealed its plan to become a global leading player by 2027. When the company announced its mid- to long-term strategy last year, it presented targeted protein degrading therapy (TPD), RPT, and cell therapy (CGT) as the three next-generation modalities.
RPT is a new cancer treatment technology that combines cell-killing radioactive isotopes with target substances and administers them into the body. It is an area in which global pharmaceutical companies have been increasing their investment since last year. According to SK Biopharmaceuticals, this market, which was worth $6 billion in 2021, is expected to grow by an average of 19% per year to $35 billion in 2031. However, the entry barrier is high due to the short half-life and difficulty in handling. Accordingly, SK Biopharmaceuticals plans to preempt the market by introducing external pipelines and developing them in-house.
First, the company introduced ‘SKL35501’ from Hong Kong Full Life Technologies in July. SKL35501 is an RPT candidate designed to selectively bind to ‘NTSR1’, a protein that is overexpressed in cancer, and deliver radioactive substances. Since NTSR1 is overexpressed in solid cancers such as colon cancer, prostate cancer, and pancreatic cancer, the company expects that SKL35501 can be developed as an anticancer drug with various indications and a ‘best-in-class drug’. In particular, in preclinical tests, it was confirmed that the tumor was reduced by 93-99% with a single administration.
Eun-Jung Choi, head of the business development division, said, “We will develop a treatment based on actinium-225 (radioactive isotope) and also develop a diagnostic system,” and added, “We plan to submit an investigational new drug (IND) application in the second half of next year.” She continued, “Part A of the clinical trial phase 1 will be conducted in Korea, and Part B will be conducted simultaneously in the U.S. and Korea.” The goal is to enter phase 2 clinical trials in 2030 and obtain approval from the U.S. Food and Drug Administration (FDA) after 2034.
To this end, SK Biopharm recently signed a contract with Terrapower to supply actinium, a radioactive isotope. It is difficult to secure the raw materials for radioactive isotopes, but this contract has secured enough material to be used up to phase 2 clinical trials.
The ‘Ac-225 (Actinium-225)’ supplied by Terrapower is a high-purity, high-quality actinium. The company explained that it is better at targeting cancer cells because it has a longer half-life and a smaller radiation exposure range than the radioisotope ‘lutetium (lutetium-177)’ that is included in existing radiopharmaceutical treatments, Novartis’ Lurathera and Fluvicto.
However, as the clinical stage increases, the amount of isotopes required will increase, and raw materials that have received Good Manufacturing Practice (GMP) certification may be required. Accordingly, SK Biopharmaceuticals added that in addition to Terrapower, it will sign supply contracts with additional manufacturers to build a global manufacturing and production network.
In addition, the company plans to introduce additional candidate substances while securing internal R&D capabilities. CEO Choi said, “Regarding internal R&D projects, we will enter the preclinical stage in 2025 and establish our own patent platform in 2026.” He added, “In addition, we will strengthen our capabilities by introducing two additional substances from the preclinical to early clinical stage, thereby growing the RPT business to a global level by 2027.”
SK Biopharmaceuticals CEO Lee Dong-hoon said, “We will set up and implement the RPT strategy without being overly excited or depressed, but rather proceed slowly and step by step like a trotting ox,” adding, “We will lay the foundation for a leap forward as a major pharmaceutical and biotechnology company in the U.S. market.”
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