Country: South Korea

Genecraft Inc. is a biopharmaceutical company that was founded based upon the 20-year research achievements of the Korean government’s Cancer Defense Mechanism Research foundation. Our adeno-associated virus (AAV)-gene therapy, RX001, targeted at KRAS mutant non-small cell lung cancer, exhibits remarkable cancer-killing capabilities for all types of KRAS (PAN-KRAS) mutations through a unique mechanism of action that activates the body’s inherent cancer defense mechanisms. Additionally, the combination of the safe AAV and human genes demonstrates both high-level of safety and selective cancer-killing capabilities. RX001 has completed GLP-preclinical validation, GMP manufacturing and IND application preparations, and is expected to enter a combined Phase 1/2 clinical trial in 2025 to simultaneously verify its safety and efficacy. | GeneCraft Incorporated is an AAV-based gene therapy company focused on developing highly efficient and scalable therapeutics by leveraging its proprietary platform technologies. Based in Cheongju, South Korea, GeneCraft is committed to solving the key bottlenecks in gene therapy development and manufacturing by enhancing vector productivity, stability, and delivery efficiency. GeneCraft is committed to expanding the therapeutic scope of adeno-associated virus (AAV) gene therapy beyond rare diseases to tackle more complex and prevalent conditions such as cancer and metabolic disorders. To achieve this, we have developed SuperITR™, a proprietary and versatile AAV platform technology that enhances vector productivity across a wide range of transgenes and capsids. SuperITR™ is based on a structural innovation of the inverted terminal repeat (ITR)—a critical component in AAV genome replication and packaging. This breakthrough has enabled significantly improved manufacturing yields and genome stability, making it suitable not only for rare monogenic diseases but also for indications requiring higher dosing, broader tissue distribution, or scalable production. Demonstrating the platform’s clinical relevance, GeneCraft received IND approval from the Korean MFDS for our lead program RX001, a first-in-class pan-KRAS gene therapy for non-small cell lung cancer (NSCLC). RX001 represents the first clinical-stage AAV therapy in Korea targeting a solid tumor with high unmet need, enabled by the productivity and stability of SuperITR™. At the heart of our approach lies our SuperITR™ platform, a novel genetic element designed to dramatically improve AAV productivity, genome integrity, and transgene expression. This platform has shown significant advantages in both small- and large-scale production settings, enabling more robust and cost-effective development of gene therapy candidates. GeneCraft’s pipeline is designed to address high-burden diseases with large patient populations, starting with oncology and expanding into inflammatory and degenerative conditions. Our lead program targets pan-KRAS mutations in non-small cell lung cancer (NSCLC), and we are actively expanding indications to include pancreatic, colorectal, and gastric cancers, as well as degenerative joint diseases such as osteoarthritis. Each of our programs is carefully selected based on clinical unmet need, biological tractability, and platform fit—areas where our SuperITR™-based vectors offer a tangible advantage in manufacturability, systemic delivery, and transgene expression. By combining robust platform performance with clear therapeutic rationale, we aim to advance gene therapies that are not only innovative but also scalable and clinically impactful. In parallel, we are pursuing strategic collaborations and licensing opportunities with partners seeking to integrate our platform technologies into their own therapeutic pipelines. Our strength lies in our people. GeneCraft is composed of experts with deep domain knowledge and proven track records across clinical development, molecular research, intellectual property strategy, and Quality by Design (QbD). This multidisciplinary team enables integrated decision-making from early discovery to translational development and regulatory readiness. By combining scientific rigor with industrial experience, we are equipped to execute with both speed and precision. GeneCraft aims to become the enabling force behind the next wave of AAV gene therapies—not just through its own pipeline, but also by supporting global biotech and pharmaceutical partners with technology that allows safer, more potent, and more scalable therapies. Our business model blends in-house product development with strategic technology licensing. Situated in Cheongju, South Korea, GeneCraft is part of the Bio-Regenerative Innovation Zone, providing proximity to leading academic institutions, manufacturing networks, and regulatory resources. This strategic location supports both rapid R&D progress and seamless integration into global supply chains.