Abogen Biosciences Announces FDA and NMPA IND Approvals for ABO2102, a First-in-Class Multi-KRAS Mutant mRNA Cancer Vaccine

8Month4Day,AbogenAnnounced according to the Center for Drug Evaluation of the National Medical Products Administration(CDE)Official website announcement, its independently developed newmRNATumor VaccineABO2102New Drug Clinical Trials(IND)Application(Application Number:CXSL2500388)Has obtained clinical tacit permission.

ABO2102As of this year5Month receives approval from the U.S. National Drug Administration（FDA）Clinical Trial Approval. This approval in China marksABO2102Achieving the Important Milestone of Dual Filing and Dual Approval in China and the US。

AboutABO2102

According to the press release from Abogen,ABO2102It is the first in China targeting multipleKRASTherapeutic tumor vaccines for mutations,ABO2102Suitable for carryingKRAS 5Common Mutations(Such asG12C、G12D、G12Vetc.)Patients with solid tumors harboring any mutations.

KRASMutation is one of the most common oncogenic mutations in solid tumors, often associated with malignant cancers:KRASThe mutation occurs in pancreatic cancer at a rate as high as approximately85%, in colorectal cancer approximately40%, in non-small cell lung cancer approximately30%。ButKRASBecause its protein surface is relatively smooth and lacks drug-binding“Pocket”Due to its special properties, it has long been regarded as“Undruggable”Target. Traditional targeted drugs(Such asEGFRInhibitor)CorrectKRASLimited Efficacy of Mutations, Immune Checkpoint Inhibitors(Such asPD-1/PD-L1）The single-drug response rate is also low.

ABO2102It is based on the independent innovation of Abogen.mRNATechnology Platform DevelopmentABO2102Therapeutic tumor vaccine. It adopts a multi-target antigen design and simultaneously encodes5Common SpeciesKRASMutant AntigenmRNAMolecules, compared to only targetingG12CSmall molecule inhibitors of mutations,ABO2102Can cover a wider range ofKRASMutation type.

In addition,ABO2102Can induce specificityTCells continue to expand, establishing long-term immune memory and breaking through traditional methods.KRAS G12CInhibitors develop resistance due to a single target and the inability to cope with the adaptive evolution of the tumor microenvironment.Preclinical data shows,ABO2102Vaccine-ActivatedTCells can be precisely identifiedKRASThe new antigens on the surface of mutated cells effectively kill tumor cells. This endogenous immune response not only avoids the common off-target toxicity of targeted drugs but also continuously suppresses tumor recurrence through immune memory mechanisms. Additionally, studies in mouse models have shown,ABO2102UnitedPD-1Monoclonal antibodies have a synergistic effect, further enhancing anti-tumor efficacy.

Abogen stated,ABO2102Is expected toKRASThe paradigm of targeted therapy has shifted from "passive inhibition" to "active immune clearance," demonstrating breakthrough clinical value. With off-the-shelf（off-the-shelf）Advantages,ABO2102It can be used for salvage treatment in advanced patients and also as an adjuvant treatment method in the early postoperative period.

Market Prospects

KRASMutation RateInLung Cancer（25-30%）、Colorectal Cancer（40%）、Pancreatic Cancer（80-90%）Very high in cancers such as, More than X new cases of related cancers occur globally each year200Ten thousand cases. Existing targeted drugs only coverG12C, and a few other subtypes.ABO2102Broad-spectrum(Coverage5Common mutation)Can cover approximately70%ofKRASMutant patients.mRNAVaccines can be custom-designed to address the limitation of existing drugs that target only a single mutation, reducing the risk of recurrence and metastasis.

Expected2030Year GlobalmRNAThe market size of tumor vaccines has reached145Billion US dollars,ABO2102As an innovative product, it is expected to occupy10-15%Share(Approximately14-22(Billion USD)The domestic market benefits from the growth in the scale of anti-tumor drugs.（2025Year Exceeded6500(Billion Yuan), butABO2102Need to break through technical validation(Safety, Delivery System), challenges such as competitive pressure and pricing accessibility. If clinical data is positive, it is expected to reshapeKRASMutation Tumor Treatment Landscape.

mRNATumorVaccineTrack,ModernaThemRNA-5671(CoverageG12C/G12D/G12Vetc.)AndBioNTechSimilar products are in Phase I clinical trials.ABO2102Is the world's first to enter clinical trials, covering multipleKRASMutatedmRNAVaccine.Currently, there is no global solution for multipleKRASMutatedmRNAVaccine Approved,ABO2102If successfully launched, it may become the first drug of its kind, seizing the market advantage.

1. Official WeChat Account of Abogen