SK Biopharmaceuticals Aims to Become a Global RPT Leader by 2027

New Oncology Drug IND Submission Planned for Next Year

[photo=SK Biopharmaceuticals]

SK Biopharmaceuticals has set an ambitious goal to emerge as a global player in the radiopharmaceutical(RPT) sector within the next three years. The company plans to strengthen its capabilities through both external pipeline acquisitions and in-house development.

On the 30th, during a conference call, SK Biopharmaceuticals unveiled a detailed roadmap for its RPT business, which it has identified as the next key modality, and announced its plan to become a global leader in the field by 2027. In its mid- to long-term strategy revealed last year, the company highlighted targeted protein degradation (TPD), RPT, and cell and gene therapy (CGT) as its three next-generation modalities.

RPT is an emerging cancer treatment technology that involves binding radioactive isotopes to targeting molecules and administering them into the body to kill cancer cells. This area has seen increased investment from global pharmaceutical companies since last year. According to SK Biopharmaceuticals, the RPT market, valued at $6 billion in 2021, is expected to grow at an annual rate of 19%, reaching $35 billion by 2031. However, the field has high entry barriers due to the short half-life of the isotopes and the challenges associated with handling them. To overcome these challenges, SK Biopharmaceuticals plans to secure market leadership through both external pipeline acquisitions and internal development.

In July, the company acquired 'SKL35501' from Hong Kong-based PulivTech. SKL35501 is an RPT candidate designed to selectively bind to 'NTSR1', a protein overexpressed in various cancers, including colorectal, prostate, and pancreatic cancers, and deliver a radioactive substance. SK Biopharmaceuticals expects to develop SKL35501 as a versatile oncology treatment with multiple indications, aiming for it to be a 'Best-in-Class' drug. In preclinical trials, a single dose of the drug was shown to reduce tumors by 93-99%.

Choi Yoon-jung, Head of Business Development at SK Biopharmaceuticals, stated, "We plan to develop therapeutic agents based on Actinium-225 (a radioactive isotope) and also develop diagnostic agents in parallel. We aim to submit the IND for clinical trials in the second half of next year." She further explained, "Part A of the Phase 1 clinical trial will be conducted in Korea, while Part B will take place simultaneously in the U.S. and Korea." The company targets entering Phase 2 trials by 2030, with a goal of obtaining U.S. FDA approval by 2034.

To support this, SK Biopharmaceuticals recently signed a supply agreement for Actinium-225 with TerraPower. The radioactive isotope is difficult to source, but this contract ensures sufficient quantities to support up to Phase 2 clinical trials.

The Actinium-225 supplied by TerraPower is a high-purity, high-quality isotope. Compared to Lutetium-177, the isotope used in existing radiopharmaceutical treatments like Novartis' Lutathera and Pluvicto, Actinium-225 has a longer half-life and a smaller exposure range, making it more effective at targeting cancer cells, according to the company.

However, as the clinical trials progress, the demand for isotopes will increase, and certified GMP (Good Manufacturing Practice) raw materials will become necessary. Therefore, SK Biopharmaceuticals plans to secure additional production contracts beyond TerraPower to establish a global manufacturing and production network.

Additionally, the company plans to bolster its internal R&D capabilities while also acquiring more candidate substances. Choi added, "We aim to enter the preclinical stage with our internal R&D projects by 2025 and establish our proprietary patent platform by 2026. Along with this, we plan to strengthen our capabilities by acquiring two additional early-stage clinical substances during the preclinical phase to elevate our RPT business to a global level by 2027."

SK Biopharmaceuticals President Lee Dong-hoon stated, "As we set and execute our RPT strategy, we will proceed steadily and methodically, like a bull walking forward, without getting distracted by short-term successes or setbacks. We will lay the foundation for becoming a major pharmaceutical and biotech company in the U.S. market."

천옥현 기자 (okhi@kormedi.com)