On May 9, 2025, Abogen Biosciences announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) approval for its novel KRAS mRNA cancer vaccine ABO2102, targeting five common KRAS mutations.

As China's first therapeutic cancer vaccine candidate targeting multiple KRAS mutations, ABO2102 represents a significant breakthrough in the highly challenging field of "undruggable" targets. This FDA IND approval positions Abogen at the forefront of global innovation in immuno-oncology, highlighting its growing international influence.

About KRAS Mutations

KRAS mutations are among the most common oncogenic mutations in solid tumors, occurring in approximately 85% of pancreatic cancers, 40% of colorectal cancers and 30% of non-small cell lung cancers. However, since its discovery in 1982, KRAS has long been considered "undruggable" due to its unique protein structure and therefore lack of natural small-molecule binding pockets.

Despite recent breakthroughs with KRAS G12C small-molecule inhibitors, their limited target patient population, inevitable resistance and modest survival benefits remain pressing challenges. There is still a significant unmet clinical need in the treatment of KRAS-mutant related tumors.

Epidemiology research shows that 75%-85% of KRAS-mutant patients in non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) carry these five most common mutations, underscoring the urgent need for pan-KRAS therapeutic strategies.

About ABO2102

ABO2102 is a therapeutic cancer vaccine developed on Abogen's proprietary mRNA technology platform. It has demonstrated exceptional anti-tumor activity and broad HLA (Human Leukocyte Antigen) subtype coverage through multifaceted technological innovations in preclinical studies. With strong clinical translation potential, it offers a novel solution for treating KRAS-mutant solid tumors.

1. Targeting Multiple Antigens in One Shot

ABO2102 encodes mRNA sequences for five common KRAS-mutant antigens. Upon intracellular translation, the resulting antigens are presented via MHC class I/II molecules and activate dual immune responses involving CD8⁺ cytotoxic T cells and CD4⁺ helper T cells, enabling precise recognition and targeting of KRAS mutations. Compared to small-molecule inhibitors targeting only the G12C mutation, ABO2102 is able to target a broad spectrum of KRAS mutation types.

2. Overcoming Resistance Challenges

Traditional KRAS G12C inhibitors have limited efficacy due to their single-target focus and inability to address the adaptive evolution of the tumor microenvironment, with a median progression-free survival (PFS) of only 6-9 months. In contrast, ABO2102 induces sustained proliferation of antigen-specific T cells and establishes long-term immune memory.

Preclinical data demonstrate that vaccine-activated T cells can precisely recognize and effectively eliminate KRAS-mutant tumor cells via neoantigen targeting. This endogenous immune response not only avoids the off-target toxicities often seen with targeted therapies but also sustains tumor suppression via immune memory mechanisms. Moreover, murine model studies revealed a synergistic effect between ABO2102 and PD-1 monoclonal antibodies, significantly enhancing antitumor potency.

3. Platform Powering Drug Development

The development of ABO2102 is powered by Abogen's advanced tumor vaccine platform. First, the vaccine leverages the LNP delivery system clinically validated at scale during the pandemic to ensure efficient and safe intracellular mRNA delivery. Moreover, the platform features modular antigen design, enabling flexible integration of diverse KRAS-mutant epitopes to rapidly address multiple mutation types. It also utilizes next-generation mRNA sequence optimization to significantly boost immunogenicity. Meanwhile, the platform employs AI-driven selection of high-coverage epitopes, validated through preclinical studies to exhibit broad HLA coverage potential.

4. Promising Clinical Translation Potential

ABO2102 represents a paradigm shift in KRAS-targeted therapy — from passive inhibition to active immune clearance, with potential outstanding clinical value. This multi-epitope vaccine precisely targets prevalent malignancies, and its modular technology platform further enables rapid expansion to other mutation-driven indications.

With its off-the-shelf advantage, ABO2102 can be used both as a salvage therapy for advanced-stage patients and as an adjuvant treatment in early-stage post-surgical settings. Additionally, its favorable safety profile allows combination with chemotherapy, radiotherapy, or immune checkpoint inhibitors, establishing a synergistic, multi-pronged anticancer strategy.

The FDA IND approval of ABO2102 marks a significant breakthrough in addressing traditionally undruggable cancer mutations, highlighting Abogen's innovation and competitiveness in mRNA therapeutics. ABO2102 is expected to offer a transformative treatment option for KRAS-mutant cancer patients and will reshape the landscape of immuno-oncology.