First clinical data for Regenelead’s personalized cancer vaccine RGL-270 deliver a perfect double: 100% 18-month recurrence-free survival rate, 100% immune response
At the 2026 ASCO Annual Meeting, the world’s premier oncology conference, Professor Xianjun Yu’s team from Fudan University Shanghai Cancer Center presented new results for RGL-270 Injection as adjuvant therapy for pancreatic cancer. RGL-270 is a personalized neoantigen mRNA cancer vaccine discovered and developed in-house by Shanghai Regenelead Therapies Co., Ltd (“Regenelead”). The investigator-initiated study enrolled 16 patients. At a median follow-up of 18 months, no patient had experienced recurrence, and all 16 patients developed an immune response. RGL-270 is China’s first personalized neoantigen mRNA cancer vaccine to receive IND clearance, and its first-in-human data now show two 100% results.
•Durable efficacy: At a median follow-up of 18 months, the 18-month recurrence-free survival (RFS) rate was 100%. By comparison, more than 50% of patients with pancreatic cancer relapse within 12 months of surgery with standard care.
•Strong immunogenicity: Immune responses were rapid, with a 100% response rate.
•Favorable safety: The vaccine was safe and well tolerated, with no severe adverse events.
Pancreatic cancer’s grim odds meet mRNA’s moment: Regenelead’s proprietary “AI + Delivery” dual-engine platform powers RGL-270
Pancreatic cancer has long been known as the “king of cancers”. More than half of patients relapse within one year of surgery, making it one of the most stubborn challenges in oncology worldwide. mRNA cancer vaccines are among the most promising ways to change that. Regenelead’s “AI + Delivery” platform has two components: AI pinpoints the neoantigen epitopes unique to each patient’s tumor, and the company’s proprietary mRNA delivery system and construct design then deliver the vaccine efficiently. For patients at high risk of postoperative recurrence, this approach offers a shift from reactive treatment to proactive defense, moving cancer care away from one-size-fits-all regimens toward truly tailored precision medicine.
Dr. Cheng Liao | Chairman of Regenelead
“As China’s first personalized neoantigen mRNA cancer vaccine to receive IND clearance, RGL-270 has produced data that validate the clinical translatability of our platform and lay a solid foundation for registrational development and indication expansion. Going forward, we will stay patient-centric and partner with leading oncologists in China and around the world to explore combinations of neoantigen vaccines with CAR-T, bispecific antibodies, and other therapies, with the goal of extending these benefits to a broader range of tumor types and disease stages.”
About Regenelead
Founded in August 2021, Regenelead is an innovative biopharmaceutical company focused on cell and gene therapy (CGT). The company has developed a proprietary, AI-powered R&D platform built on three core technologies: AAV, mRNA, and cell therapy. This platform is supported by end-to-end process development, manufacturing, and quality control capabilities for plasmids, viral vectors, mRNA, and cell therapies, delivering high yield, recovery, quality at low cost to accelerate drug development. Regenelead’s pipeline targets therapeutic areas with significant unmet medical needs and strong market potential, including neurology, ophthalmology, metabolic diseases, and oncology. Guided by its mission to safeguard human health, Regenelead continues to strengthen its core capabilities and pursue pioneering innovation, with the goal of enabling better, healthier lives for patients worldwide.