mRNA Cancer Vaccine Data Exceeds Expectations; Everest MED (01952) Accelerates Domestic Personalized Cancer Vaccine Deployment

Stock News
01/21

On January 20th, the five-year follow-up data from the Phase 2 clinical trial of the mRNA cancer vaccine mRNA-4157 (intismeran autogene), jointly disclosed by Merck & Co. and Moderna in combination with Keytruda, injected a "strong stimulant" into the global field of cancer immunotherapy. Influenced by the news, Moderna's stock price rose 2.8% that day, and with the clinical progression of its mRNA product, its share price regained upward momentum, with the latest price approaching a one-year high. The study, code-named KEYNOTE-942/mRNA-4157-P201, demonstrated that in patients with high-risk stage III/IV melanoma after complete resection, the combination therapy of mRNA-4157 and the PD-1 inhibitor pembrolizumab (Keytruda) significantly reduced the risk of recurrence or death by 49% compared to Keytruda monotherapy. This data not only reflects significant efficacy but also highlights its durability. Previously, data from a two-year follow-up showed a 44% reduction in the risk of recurrence or death, which increased to 49% at the three-year mark; by the fifth-year follow-up, the risk reduction rate remained at the high level of 49%, strongly supporting the scientific hypothesis that the mechanism of mRNA cancer vaccines can induce a durable immune response. Although PD-1 inhibitors have become a cornerstone in the treatment of many cancers, the risk of recurrence still plagues a significant proportion of patients. Against this backdrop, the combination of "personalized vaccines + immune checkpoint inhibitors" is regarded as an important direction for cancer therapy to break through current treatment bottlenecks. As the world's first mRNA cancer vaccine to receive FDA Breakthrough Therapy designation, the core of mRNA-4157 lies in the innovative mechanism of individualized neoantigen therapy (INT): by sequencing and analyzing the unique mutational signature of a patient's tumor DNA, it designs a synthetic mRNA encoding up to 34 neoantigens. After the vaccine enters the body, through endogenous expression and antigen presentation mechanisms, it trains the patient's immune system to activate a T-cell response targeting tumor-specific mutations, thereby precisely identifying and attacking cancer cells for clearance. Moderna stated that these Phase 2 clinical results further validate the potential of mRNA technology in the field of oncology, and the company will continue to increase its investment in its oncology platform. Currently, the Phase 3 clinical trial for mRNA-4157 has completed enrollment; the trial scale far exceeds that of the Phase 2 trial, and the indication has expanded from stage III/IV melanoma to include stage IIb melanoma patients. Furthermore, the two companies are exploring the application of this combination therapy in various solid tumors, including non-small cell lung cancer (NSCLC), renal cell carcinoma, and bladder cancer. A total of eight clinical trials at different stages are currently underway, aiming to validate the potential of mRNA technology in a wide range of cancer treatments. While international players are achieving accelerated breakthroughs, domestic pharmaceutical companies are also speeding up their deployment in this promising field. Among them, Everest MED's (01952) personalized cancer vaccine, EVM16, is progressing notably and has become a key participant in this domestic race. Notably, the first patient was dosed with EVM16 at Peking University Cancer Hospital in March 2025, marking the successful entry of its self-developed mRNA technology platform and AI neoantigen screening system into the human validation stage. According to Everest MED's 2030 development strategy released in December 2025, EVM16 is being evaluated in an Investigator-Initiated Trial (IIT), and dose escalation has been completed. The company expects to read out complete Phase Ia clinical data within the next 6-12 months, followed by the initiation of a Phase Ib study. The development of EVM16 deeply integrates artificial intelligence (AI) with mRNA technology. Its core lies in utilizing the company's self-developed deep learning algorithm system, "EVER-NEO-1," to predict and screen tumor-specific neoantigens, thereby designing a highly personalized vaccine. Preclinical studies have shown that this algorithm demonstrates significant competitive advantages in predicting tumor neoantigens. In various mouse tumor models, EVM16 elicited strong neoantigen-specific T-cell immune responses and achieved significant tumor growth inhibition. More importantly, preclinical data also demonstrated synergistic anti-tumor effects when EVM16 was combined with a PD-1 antibody, providing a solid basis for its subsequent clinical development in combination with immune checkpoint inhibitors. Currently, Everest MED has built an end-to-end, full industrial chain platform covering antigen design, mRNA sequence optimization, LNP delivery, and industrial production, laying a foundation for the clinical advancement and future commercialization of mRNA vaccines like EVM16. The positive results from mRNA-4157 highlight the unmet needs in the field of cancer treatment, and the market potential of mRNA cancer vaccines is widely recognized by the industry. A research report from McGough Securities pointed out that mRNA cancer vaccines have the potential to become a new type of cancer immunotherapy that is pan-cancer, highly accessible, and兼具 off-the-shelf availability with personalization. Leveraging broad combination potential, they can enter the clinic as adjuvant therapy, gradually unlocking a market potential worth tens of billions of US dollars. As global R&D for mRNA cancer vaccines enters a period of results realization, the deployment of domestic companies in this field is accelerating. In the future, as clinical data for mRNA cancer vaccine products like Everest MED's EVM16 continue to be read out, the competitive landscape for domestic personalized cancer vaccines will enter a new phase.

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