Autotelic Bio, an innovative RNA-based antisense oligonucleotide (ASO) drug development company led by CEO Taehoon Kim, announced that it has received approval for the Phase 1 clinical trial protocol (IND) of its novel drug candidate ATB-320 from the Bellberry Human Research Ethics Committee (HREC) in Australia. The company also revealed that it has signed an agreement with Kiwoom Securities as the lead underwriter to move forward with its planned KOSDAQ listing next year.

Following the IND approval, Autotelic Bio will conduct an open-label, multicenter Phase 1 clinical trial at Sunshine Coast University Private Hospital in Australia to evaluate the safety and tolerability of ATB-320 in patients with advanced or metastatic solid tumors. ATB-320 is an ASO-based anticancer drug candidate with a dual mechanism of action that inhibits angiogenesis and activates immune responses. In non-clinical studies, the compound demonstrated strong anticancer efficacy and a favorable safety profile when administered in combination with a first-line pancreatic cancer treatment.

Through this Phase 1 study, Autotelic Bio plans to thoroughly assess the safety and pharmacological response of ATB-320 in humans and to secure critical data to support subsequent clinical development stages.

Meanwhile, the company has officially launched its IPO preparations by appointing Kiwoom Securities as its lead underwriter for its planned KOSDAQ listing. Autotelic Bio is currently conducting a Phase 3 clinical trial in Korea for ATB-101, the world’s first combination therapy for hypertension and diabetes. The company aims to complete the trial by the end of this year and, based on the results, proceed with regulatory approval and its public listing next year.

ATB-101 is an innovative combination therapy designed to simultaneously manage hypertension and diabetes. Beyond the domestic market, Autotelic Bio has signed an exclusive supply agreement with Chinoin to expand into the Mexican market and is actively pursuing global commercialization. In addition, the company was selected for the “Strategic Technology International Joint R&D Program” led by the Ministry of Trade, Industry and Energy, securing KRW 3 billion in research funding to support its entry into the U.S. market.

With the IND approval for ATB-320 and the expansion of its ASO pipeline targeting new molecular targets, Autotelic Bio expects to gain strong momentum toward its KOSDAQ listing through continued R&D and commercialization achievements.

An official from Autotelic Bio stated, “We are very pleased to receive IND approval for ATB-320 from the Bellberry HREC in Australia. We will do our utmost to successfully conduct this clinical trial and provide new treatment options for patients suffering from cancer.” The official added, “Through close cooperation with Kiwoom Securities, we aim to achieve a successful KOSDAQ listing and establish a sustainable foundation for continued growth in innovative drug development.”