mRNA-4157
- Generic Name
- mRNA-4157
Cancer Vaccines Emerge as Promising Frontier in Oncology with Multiple Approaches Showing Clinical Success
• Cancer vaccines are gaining momentum across multiple tumor types, with FDA-approved options like BCG, sipuleucel-T, and talimogene laherparepvec demonstrating clinical utility in bladder cancer, prostate cancer, and melanoma respectively.
• Novel vaccine approaches including mRNA-based mRNA-4157, KRAS-targeted ELI-002, and viral vector-based aglatimagene besadenovec are showing promising results in clinical trials, with significant improvements in survival outcomes across various cancers.
• Experts believe cancer vaccines hold particular promise in early-stage and high-risk disease settings by targeting micrometastatic disease, potentially increasing cure rates and transforming treatment paradigms when combined with existing immunotherapies.
NHS Expands Cancer Vaccine Launch Pad to Include Promising Melanoma Treatment
• The NHS Cancer Vaccine Launch Pad program is expanding to include trials of a new melanoma vaccine, aiming to improve treatment outcomes for patients with advanced skin cancer.
• The iSCIB1+ (Immunobody) vaccine works by helping the immune system recognize and attack cancer cells, potentially boosting the effectiveness of existing immunotherapy treatments.
• With melanoma cases projected to increase by 33% by 2040, the needle-free vaccine will be available at seven initial hospital sites across England, with first patient referrals expected in May 2025.
Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development
• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development.
• FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer.
• Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.
BioNTech, Moderna Lead the Race in Personalized Cancer Vaccine Development with Promising Clinical Results
• Personalized cancer vaccines are emerging as a transformative approach in oncology, with BioNTech, Moderna, and myNEO Therapeutics leading development using mRNA technology refined during the COVID-19 pandemic.
• The KEYNOTE-942 study demonstrated significant clinical benefit when combining Moderna's mRNA-4157 with Keytruda in melanoma patients, achieving a 74.8% recurrence-free survival rate at 2.5 years versus 55.6% for Keytruda alone.
• Despite promising results, manufacturing challenges persist with production costs exceeding $100,000 per patient, though advancements in automation and AI-driven technologies are expected to reduce costs and increase accessibility.
FDA Clears Everest Medicines' IND Application for Novel mRNA Cancer Vaccine EVM14
• EVM14, Everest Medicines' first internally developed mRNA therapeutic vaccine, has received FDA clearance for its IND application, marking a significant milestone in the company's oncology innovation strategy.
• Preclinical studies demonstrated EVM14's ability to induce antigen-specific immune responses, inhibit tumor growth in multiple models, and prevent tumor recurrence, offering potential for long-term cancer-free survival.
• The off-the-shelf mRNA vaccine targets multiple tumor-associated antigens and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer, with plans for NMPA submission in China.
Circulating DNA/RNA Market Set to Triple to $16.4 Billion by 2032, Driven by Patent Innovations
• The global circulating DNA/RNA market is projected to grow from $5.32 billion in 2023 to $16.4 billion by 2032, advancing at a CAGR of 13.29% according to a new patent landscape report.
• Key industry players Nantomics, Genentech, and Novartis are leading innovation in the sector, with the United States dominating patent activity with over 600 patents, followed by Europe and Asia.
• The oncology segment leads patent filings, with technological advancements in non-invasive diagnostics and personalized medicine driving market expansion and creating new opportunities in genomic medicine.
Moderna-Merck's Personalized Cancer Vaccine Shows Strong Promise in Advanced Melanoma Trial
• Moderna and Merck's personalized cancer vaccine mRNA-4157, combined with Keytruda, demonstrated a 65% reduction in risk of distant metastasis or death in high-risk melanoma patients.
• The Phase 2b KEYNOTE-942 trial showed significant improvement in recurrence-free survival, with 79% of combination therapy patients versus 62% on Keytruda alone remaining disease-free at 18 months.
• Based on these promising results, the companies are advancing to Phase 3 trials later this year, with the treatment already receiving FDA breakthrough designation and EMA PRIME status.
DelveInsight Report: Over 50 Pipeline Drugs in Development for Urothelial Carcinoma Treatment
• DelveInsight's latest pipeline analysis reveals 40+ pharmaceutical companies actively developing 50+ therapeutic candidates for urothelial carcinoma treatment, indicating robust research activity in this space.
• Major pharmaceutical companies including AstraZeneca, Seagen, and Janssen are advancing promising therapies, with notable candidates like disitamab vedotin and cetrelimab in late-stage development.
• Recent clinical trials include Seagen's Phase 2 study of disitamab vedotin with pembrolizumab, and Roche's Phase 1b/II umbrella study investigating multiple combination therapies for advanced urothelial carcinoma.
Moderna Reports $3.2 Billion in 2024 Revenue, Submits Three mRNA Products for Regulatory Approval
• Moderna reported $3.2 billion in total revenue for fiscal year 2024, with a net loss of $3.6 billion as the company transitions from pandemic to seasonal COVID-19 vaccine market.
• The company has submitted three investigational mRNA products for regulatory approval, including a next-generation COVID vaccine, RSV vaccine for high-risk adults 18-59, and a flu/COVID combination vaccine.
• For 2025, Moderna projects revenue between $1.5-2.5 billion and plans to reduce costs by nearly $1 billion, with an expected year-end cash balance of approximately $6 billion.
mRNA Cancer Vaccines Show Promise in Clinical Trials, Aiming for Personalized Immunotherapy
• Over 60 mRNA cancer vaccine candidates are in clinical trials, signaling a transformative shift in cancer treatment.
• BioNTech's BNT111, targeting melanoma-associated antigens, shows positive Phase 2 data when combined with cemiplimab.
• Personalized mRNA vaccines, like Moderna's mRNA-4157, are being explored in combination with PD-1 therapies for various cancers.
• The first commercial mRNA cancer vaccine is expected by 2029, driven by technological advancements and increased investment.
Nanovaccines and mRNA Technology Spearhead New Era in Cancer Immunotherapy
• Nanovaccines leverage nanotechnology to enhance the delivery of cancer antigens to immune cells, potentially overcoming the limitations of traditional cancer vaccines.
• Clinical trials are underway to evaluate the safety and efficacy of nanovaccines, with early results showing promising immune responses and manageable side effects.
• mRNA-4157 (V940), a melanoma vaccine developed by Moderna and Merck, has demonstrated promising trial results and may receive FDA approval in 2025.
• Personalized mRNA vaccines, such as those being developed by BioNTech in collaboration with the NHS, are entering clinical trials targeting various cancers.
TIL Therapy and Novel Combinations Advance Melanoma Treatment
• Lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, received FDA accelerated approval for unresectable or metastatic melanoma after PD-1 inhibitor treatment.
• Studies show lifileucel, alone or with pembrolizumab, yields objective response rates of 31.5% to 65.2% in advanced melanoma, even after multiple prior therapies.
• IBI363, a PD-1, IL-2α bispecific antibody, demonstrates promising disease control and objective response rates in melanoma patients who have progressed on PD-1 inhibitors.
• Personalized cancer vaccine mRNA-4157 (V940) combined with pembrolizumab significantly reduces the risk of disease recurrence in resected stage IIIB to IV melanoma.
Landmark Clinical Trials of 2024: Advancements in Cancer, Metabolic Diseases, and Infectious Diseases
• Moderna and Merck's mRNA-4157 combined with pembrolizumab significantly reduced melanoma recurrence risk by 44% compared to pembrolizumab alone, marking a leap in personalized cancer treatment.
• Nivolumab combined with chemotherapy showed a 92% two-year progression-free survival rate in advanced Hodgkin lymphoma, offering a safer, more effective treatment option.
• Junshi Biosciences' toripalimab, combined with chemotherapy, significantly improved survival in extensive-stage small cell lung cancer, establishing a new first-line treatment.
• Eli Lilly's retatrutide demonstrated up to 82% liver fat reduction in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), showcasing potential in liver disease treatment.
Trial Investigating V940 and Pembrolizumab for Squamous Cell Skin Cancer Treatment
A global phase 2/3 trial is exploring the effectiveness of combining V940 and pembrolizumab with standard treatment for squamous cell skin cancer. The study aims to determine the best treatment approach, assess safety, side effects, and impact on quality of life.
Ensartinib Approved by FDA for First-Line ALK-Positive Non-Small Cell Lung Cancer
• The FDA has approved ensartinib (Ensacove) for first-line treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
• Ensartinib demonstrated statistically significant improvement in progression-free survival compared to crizotinib in the eXALT3 trial.
• Common adverse reactions to ensartinib include rash, musculoskeletal pain, constipation, cough, pruritus, nausea, edema, pyrexia, and fatigue.
• The recommended dose of ensartinib is 225 mg orally once daily until disease progression or unacceptable toxicity.
Merck and Moderna Launch Phase 3 Trial of mRNA-4157 plus Pembrolizumab in NSCLC
• Merck and Moderna have initiated a Phase 3 clinical trial (INTerpath-009) to assess mRNA-4157 in combination with pembrolizumab for NSCLC.
• The trial targets patients with resectable stage 2, 3A, or 3B (N2) NSCLC who did not achieve a pathological complete response after neoadjuvant therapy.
• The study will evaluate disease-free survival (DFS) and overall survival, with 680 participants randomized to receive either the combination therapy or placebo plus pembrolizumab.
• mRNA-4157 is an individualized neoantigen therapy designed based on the unique mutational signature of the patient’s tumor DNA.
Merck and Moderna Launch Phase 3 Trial of V940 Plus Keytruda in NSCLC
• Merck and Moderna have initiated the Phase 3 INTerpath-009 trial to assess V940 (mRNA-4157) combined with Keytruda in NSCLC patients.
• The trial targets patients with resectable Stage II, IIIA, or IIIB (N2) NSCLC who did not achieve a pathological complete response after neoadjuvant therapy.
• INTerpath-009 expands the INTerpath clinical program, evaluating individualized neoantigen therapy to improve outcomes in early-stage lung cancer.
• The global recruitment for INTerpath-009 has commenced, with the first patients now enrolling in Canada.
Moderna and MSD Launch Phase III Trial of mRNA-4157 Plus Keytruda for NSCLC
• Moderna and MSD have initiated a Phase III clinical trial, INTerpath-009, to evaluate mRNA-4157 (V940) in combination with Keytruda for non-small cell lung cancer (NSCLC).
• The global, double-blind, randomised trial will involve 680 participants with Stage II, IIIA, or IIIB (N2) NSCLC who did not achieve a pathological complete response after initial treatment.
• mRNA-4157 is an investigational individualized neoantigen therapy that uses synthetic mRNA to code for up to 34 neoantigens based on the patient's tumor mutational signature.
• This trial is part of a broader program exploring mRNA-4157 with Keytruda across various cancer types, including melanoma, renal cell carcinoma, and urothelial carcinoma.
Merck and Moderna Launch Phase 3 Trial of mRNA-4157 with Keytruda for NSCLC
• Merck and Moderna have initiated a Phase 3 trial (INTerpath-009) to evaluate mRNA-4157 (V940) combined with Keytruda for non-small cell lung cancer (NSCLC).
• The trial targets patients with resectable Stage II, IIIA, or IIIB (N2) NSCLC who did not achieve a pathological complete response after neoadjuvant Keytruda plus platinum-based chemotherapy.
• mRNA-4157 is an individualized neoantigen therapy designed to stimulate an anti-tumor immune response based on the patient's unique tumor mutation signature.
• The primary endpoint of the trial is disease-free survival, with secondary endpoints including overall survival and distant metastasis-free survival.
Merck and Moderna Launch Phase III Trial of V940 Plus Keytruda for Resectable NSCLC
• Merck and Moderna have initiated a Phase III trial (INTerpath-009) to evaluate V940 (mRNA-4157) in combination with Keytruda for resectable non-small cell lung cancer (NSCLC).
• The trial will enroll 680 patients who did not achieve a pathological complete response after neoadjuvant Keytruda plus chemotherapy, with the primary endpoint being disease-free survival.
• This follows positive Phase IIb results of V940 with Keytruda in high-risk melanoma and expands the evaluation of this combination to other cancer types.
• Lung cancer is a leading cause of cancer death worldwide, and NSCLC accounts for 85% of all lung cancers, highlighting the need for new treatment options.
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