Everest Medicines Announces FDA Clearance of IND Application for Tumor-Associated Antigen Vaccine EVM14

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• EVM14 received U.S. FDA clearance for its IND application, becoming Everest's first internally discovered program, and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development.
• Preclinical highlights：
  • EVM14 induced a dose-dependent, antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models.
  • As a therapeutic vaccine, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence.
  • In combination with immune checkpoint inhibitors (ICIs), EVM14 significantly enhanced anti-tumor activity, supporting exploration of combination therapies in clinical trials.
• EVM14, EVM16 and in-vivo CAR-T programs are the core pillars of Everest's oncology and autoimmune disease innovation strategy.

SHANGHAI, March 23, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its  Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) vaccine. EVM14 is Everest's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company's efforts to develop innovative mRNA therapeutics in oncology.

EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple TAAs and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. It utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens. These antigens are then processed and presented by major histocompatibility complex (MHC) molecules to T cells, triggering an antigen-specific immune response. The activated T cells migrate to tumor tissues, recognize and kill the cancer cells expressing the target antigens.

In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. EVM14 promoted T cell infiltration into tumor tissues, increased T cell activation and cytotoxic function, decreased the Treg population and cytotoxic T lymphocyte (CTL) exhaustion - all well correlated with its anti-tumor activity. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with ICIs greatly enhanced the anti-tumor activity, supporting clinical exploration of combination therapies.

"With FDA IND approval, EVM14 has become the Everest's first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development. This marks a critical breakthrough, advancing our mRNA technology from early-stage research to global clinical trials and highlighting our growing capabilities in mRNA technology. It also represents a new chapter in our 'dual-engine' strategy, evolving from a license-in model to a balanced integration of both license-in and in-house R&D innovation." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Through our clinically validated and fully-integrated mRNA platform, we have realized synergies with our 'AI-powered' pipeline, underscoring Everest's leadership position in advancing innovation in oncology and immunology. EVM14, along with EVM16, which is a personalized cancer vaccine in clinical development and in-vivo CAR-T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases. Everest is at the forefront of China's mRNA and AI-powered therapeutic development, having advanced mRNA cancer therapeutic vaccines to the clinical trials. Over the past four years, Everest has utilized its AI- and big data-powered mRNA platform to accelerate target identification, sequence design, and delivery optimization. Our proprietary algorithm for mRNA design, now in its third generation, has significantly improved target protein expression and continues to evolve through big data-driven modeling."

Luo added: "This approach has enabled key breakthroughs in mRNA technology, expanded our global pipeline, and unlocked potential new opportunities for international collaboration. We look forward to advancing EVM14 into clinical trials and providing new treatment options for cancer patients. Additionally, we will submit the IND application for EVM14 to the China National Medical Products Administration (NMPA) in the near future."

According to Globocan 2022 statistics, nearly 20 million new cancer cases were diagnosed worldwide, with approximately 9.7million cancer-related deaths¹. Lung cancer remains the most prevalent cancer globally, responsible for almost 2.5 million new cases.  Lung cancer was also the leading cause of cancer death, with an estimated 1.8 million deaths. Non-small cell lung cancer (NSCLC) accounts for 85%–90% of all lung cancers², with squamous NSCLC (sq-NSCLC) comprising 25%–30%³. However, targetable genetic alterations, such as EGFR mutations, ALK, and ROS1 rearrangements occur in fewer than 10% of sq-NSCLC cases⁴, underscoring the urgent need for new treatment options.

Additionally, Global Cancer Statistics 2022 reports that head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer, accounting for an estimated 890,000 new cases and 450,000 deaths annually⁵.  more than 50% of patients with locally advanced HNSCC who have completed definitive treatment ultimately experience recurrence or metastasis⁶, leading to poor prognosis, high mortality rates, and diminished quality of life.

Neither immunotherapy nor targeted therapy can offer long term benefits to cancer patients. EVM14's unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and delaying disease recurrence, aligning with current trends in oncology drug development.

Everest has built end-to-end capabilities within its proprietary mRNA platform. The Company is advancing multiple mRNA therapies targeting cancer and autoimmune diseases, including personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) cancer vaccines, immunomodulatory cancer vaccines, and in vivo CAR-T therapies. Additionally, the Company is working on next-generation LNP delivery systems to further boost cell-mediated immune responses. The Company's first internally developed personalized mRNA cancer vaccine, EVM16, has completed its first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025.

Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China, is designed to comply with global cGMP standards and to produce at clinical- and commercial-scale.

About EVM14

EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with mRNA solution encoding multiple tumor-associated antigens (TAAs), encapsulated in a lipid nanoparticle system. After intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs) and translated into target antigens. These antigens are processed, presented to T cells by major histocompatibility complex (MHC) molecules and activated antigen-specific T cells. The activated T cells can migrate to tumor tissues, recognize, and kill the tumor cells expressing the target antigens.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at www.everestmedicines.com.

Forward-Looking Statements

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

Reference:

1.    Globocan统计数据：https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf.

2.    Duma, N., R. Santana-Davila, and J.R. Molina, Non–Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment. Mayo Clinic Proceedings, 2019. 94(8): p. 1623-1640

3.    Socinski, M.A., et al., Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer. Journal of Thoracic Oncology, 2018. 13(2): p. 165-183

4.    Zhou, C., et al., A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004). Cancer Cell, 2024. 42(2): p. 198-208.e3

5.    Bray, F., Laversanne, M., Sung, H., et al. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 1-35.

6.    Haddad, R.I., et al., Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651. J Clin Oncol, 2023. 41(12): p. 2166-2180

SOURCE Everest Medicines