Two novel drug candidates for immune diseases that AprilBio has out-licensed are being assessed as having entered a new development phase. Based on its secured cash assets, AprilBio is moving swiftly to strengthen communication with shareholders and partners while preparing medium- to long-term growth drivers.
AprilBio said Wednesday that it plans to introduce multiple new pipelines applying its 'REMAP' platform at 'BIO Europe 2026,' the largest-scale bio-pharmaceutical partnering event in Europe, held in Cologne, Germany starting on the 9th, and discuss possibilities for joint development including technology transfer.
Additionally, on the 9th when BIO Europe begins, the company will host an 'R&D Day' event at Seoul Yeouido, inviting fund managers, analysts, and others to disclose topics such as △the background of large-scale fundraising from TKG Group, IMM Investment, and others △the clinical development status of partners △development directions for next-generation pipelines △and medium- to long-term business development strategies.
AprilBio is an antibody drug development specialist company that listed on the KOSDAQ in 2022. It holds an 'antibody library' (HuDVFab) for discovering antibodies and a platform called 'SAFA' that extends the half-life of drugs in the body and accurately delivers them to disease sites. REMAP is a multi-antibody platform expanded from SAFA, which focuses on single targets, and was developed to simultaneously bind to up to four different targets.
Based on its understanding and technological capabilities regarding autoimmune and inflammatory diseases, AprilBio achieved results by out-licensing the CD40L-targeting therapeutic 'APB-A1' to Denmark's Lundbeck in 2021 and the IL-18-targeting therapeutic 'EVO301' (APB-R3) to the U.S.-based Evomune in 2024, with a total deal value of up to $923 million (approximately 1.2 trillion won at the time).
Although Lundbeck halted the Phase 1b clinical trial of APB-A1 for thyroid eye disease (TED) last August due to below-expected efficacy, resulting in a temporary hit to the stock price, assessments maintain that the possibility of continuing development targeting other indications remains intact, given that safety and tolerability were evaluated as favorable.
Researcher Kim Sun-a at Hana Securities recently said in a report, noting Amgen's success in Phase 3 clinical trials for Sjögren's syndrome with a CD40L-targeting therapeutic last September, stating, "The CD40/CD40L target itself is considered clinically validated in autoimmune diseases."
Another partner, Evomune, has declared that it will halt research on existing development materials and focus on the development of EVO301, expanding its scope to include subcutaneous (SC) formulation application and ulcerative colitis. EVO301 is a therapeutic that broadly inhibits IL-18 related to inflammatory responses; Evomune has completed Phase 2a clinical trials in patients with moderate-to-severe atopic dermatitis and aims to enter Phase 2b clinical trials by mid-next year.
Based on approximately 400 billion won in funds secured through investments from TKG Taekwang and IMM Investment, AprilBio plans to accelerate research and development (R&D) for dual-target autoimmune disease therapeutics based on SAFA and REMAP, bispecific antibody ADCs, and others.
Additionally, the company intends to secure options and joint development priority rights for an siRNA (small interfering RNA) platform through strategic investment in RNA drug developer Curigen, and promote the development of next-generation antibody-oligonucleotide conjugates (AOCs) combining platform technology with Curigen's dual-target siRNA technology.
Since immune diseases involve complex immune responses, it is important to precisely set targets and optimize dosing frequency and dosage. Both out-licensed substances apply the SAFA platform, and efficacy validation through clinical trials and securing marketability are expected to serve as indicators for additional technology transactions.
Kim said, "Next year, we can expect changes from APB-A1's TED to new indications, entry into Phase 2b clinical trials for APB-R3 in atopic dermatitis and clinical trials for ulcerative colitis, and technology transfer of the REMAP platform," diagnosing that new opportunities may open up for AprilBio.
An official from AprilBio said, "Uncertainties regarding APB-A1 and APB-R3 are gradually being resolved," adding, "We will strive to increase the speed of new pipeline development to achieve results such as technology transfer as early as possible."
in THEBIO
