ABOR2014 (IPM511): World’s First mRNA Therapeutic Vaccine Encoding Nearly 20 Hepatocellular Carcinoma Antigens Enters First-in-Human Clinical Trial

Abogen Biosciences Co., Ltd. (hereinafter referred to as “Abogen Biosciences”) and Beijing Zhenzhi Medical Technology Co., Ltd. (hereinafter referred to as “Zhenzhi Medical”) jointly announced that the first patient has recently been enrolled in the clinical trial of ABOR2014 (IPM511), the first tumor antigen mRNA therapeutic vaccine co-developed by both parties, which was initiated at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (ABOR2014-MSA-202301; NCT05981066). This study aims to evaluate the safety, tolerability, and preliminary efficacy of the ABOR2014 (IPM511) mRNA therapeutic cancer vaccine, administered either as monotherapy or in combination with a PD-1 inhibitor, in patients with advanced hepatocellular carcinoma who have progressed after first-line standard therapy, and to determine the optimal biological dose (OBD) and the recommended dose for the expansion phase of ABOR2014 (IPM511).

ABOR2014 (IPM511) is based on Zhenzhi Medicine’s proprietary IMMURITHMS^®Tumor Antigen Epitope Computational Platform: Leveraging Abogen Biosciences’ proprietary mRNA technology platform, with its mature mRNA design capabilities and LNP delivery system, this platform has developed an mRNA-based therapeutic cancer vaccine encoding nearly 20 high-frequency antigenic epitopes of liver cancer. Upon intramuscular injection, the vaccine can reactivate the patient’s own immune system to restore anti-tumor immunity.

ABOR2014-MSA-202301 Principal Investigator: Professor Zhao Haitao, Chief Physician, Department of Liver Surgery, Peking Union Medical College Hospitalstated: “We are delighted that our team has completed the enrollment and dosing of the first patient in the ABOR2014-MSA-202301 study. ABOR2014 (IPM511) has demonstrated a favorable safety profile and clinical accessibility. Currently, mRNA-based therapeutic cancer vaccines combined with PD-1 inhibitors represent an exciting emerging therapy in oncology. mRNA therapeutic cancer vaccines can induce robust T-cell responses against tumor antigens, and their combination with PD-1 inhibitors further activates T cells. This novel therapeutic approach holds promise for addressing resistance issues associated with immunotherapy or combined targeted-immunotherapy in liver cancer.”

ABOR2014 (IPM511), a global first-in-class candidate, encodes nearly 20 liver cancer antigen epitopes, which have been confirmed to be highly expressed in patients with liver cancer. Leveraging these characteristics, the team has laid the foundation for launching this groundbreaking and challenging global clinical research program. This study will help us better explore whether emerging drug combinations can more effectively activate the immune system through multiple mechanisms, further elucidate the potential of mRNA tumor vaccines in the treatment of liver cancer, and identify potential beneficiary populations. Ultimately, it aims to provide patients with novel and accessible therapeutic options, with the promise of transforming current clinical practice and establishing a new paradigm in cancer immunotherapy.

Dr. Zhang Henghui, Founder and CEO of Zhenzhi Medicinestated: “Since its inception, Zhenzhi Medicine has pioneered a research model that leverages artificial intelligence/deep learning (AI/ML) algorithms in combination with the cross-feedback of ‘tumor immuno-multi-omics data + immunological biotechnologies,’ to develop IMMURITHMS.”^®Computing Platform. The company leverages this computing platform to establish antigen epitope libraries and T-cell receptor databases covering multiple solid tumors. ABOR2014 (IPM511) has demonstrated promising antigen-presenting capabilities in preclinical studies, presenting tumor antigens on both MHC class I and MHC class II molecules, with the ability to activate specific CD8+ and CD4+ T cells and exert anti-tumor activity. We eagerly anticipate the results of the exploratory clinical study ABOR2014-MSA-202301 to comprehensively evaluate its safety, immunodynamic profile, and preliminary efficacy.

Ms. Song Wenjie, Chief Medical Officer of Abogen BiosciencesAbogen Biosciences stated: “Since its inception, Abogen has been committed to establishing an mRNA technology platform and LNP delivery system with independent intellectual property rights, aiming to drive disruptive mRNA therapeutics to address disease challenges. During the COVID-19 pandemic, leveraging our mature mRNA platform capabilities, we efficiently iterated and developed a series of COVID-19 mRNA products, demonstrating the development efficiency and prowess of mRNA technology. We also look forward to applying our mRNA technology platform across a broader spectrum of diseases, providing novel therapeutic options for numerous unmet clinical needs. We believe that through collaboration, integrating diverse technological approaches and innovative capabilities—including AI and computational biology—we can better unlock the potential of our mRNA technology platform. Currently, several of Abogen’s mRNA oncology drug candidates have entered clinical trials. We look forward to working hand in hand with our partners to advance research progress in the safest and most scientific manner, accelerating the clinical application of mRNA therapeutics in oncology to serve a larger patient population.”

Abogen Biosciences (hereinafter referred to as “Abogen”) is an innovative biopharmaceutical company dedicated to the research and development of messenger RNA (mRNA) therapeutics. The company possesses industry-leading, independently owned mRNA and nanoparticle delivery technology platforms, making it one of the few mRNA drug developers in China with capabilities across the entire value chain, encompassing every stage from mRNA design and formulation development to large-scale manufacturing. Abogen has established a robust product pipeline covering multiple therapeutic areas, including infectious disease prevention and control (such as mRNA COVID-19 vaccines), tumor immunology, and protein replacement therapy. In September 2022, ARCoV, Abogen’s mRNA vaccine for SARS-CoV-2, received Emergency Use Authorization in Indonesia, becoming the first independently developed Chinese mRNA vaccine to obtain marketing approval overseas.

Zhenzhi Medicine is a biotechnology company dedicated to the development of tumor antigen-specific cell therapies and tumor antigen mRNA therapeutic vaccines. The company has pioneered the use of artificial intelligence/machine learning (AI/ML) algorithms combined with an interdisciplinary feedback research model integrating “tumor immunology multi-omics data + immunological biotechnologies,” thereby launching IMMURITHMS^®Computational platform to establish a tumor antigen epitope library and a T-cell receptor database.

The company boasts a 4,400 m² Advanced Therapeutic Technology Innovation Center, capable of high-throughput discovery and identification of tumor antigen epitopes and TCR sequences, preclinical evaluation of mRNA tumor vaccines and cell-based therapies, and operation of a clinical testing laboratory for tumor immunology. It features a Grade B+A cell therapy manufacturing facility compliant with the requirements of the EU EMA, US FDA, and China NMPA, meeting R&D needs across various stages, including early-stage development of mRNA tumor vaccines and cell-based therapies, exploratory clinical studies, and IND-enabling clinical trials.

Zhenzhi Medicine is a national high-tech enterprise, a Beijing “Specialized, Refined, Differential, and Innovative” (SRDI) small and medium-sized enterprise, and a Zhongguancun high-tech enterprise, with its headquarters located in Beijing, China. The core team has long been engaged in tumor immunology research and clinical studies on tumor vaccines and cell-based therapies, possessing forward-looking scientific insights into cancer immunotherapy. The company hosts a postdoctoral research station and serves as the “Beijing Engineering Research Center for Immune Cell Therapy,” approved by the Beijing Municipal Development and Reform Commission, as well as the Capital Stem Cell Public Platform.