Therapeutic cancer vaccines train the immune system to attack a tumor that is already there. Peptide vaccines deliver short pieces of tumor proteins directly. mRNA vaccines instead give cells genetic instructions to make those pieces, often neoantigens, the mutated proteins found only in a patient's own tumor.
The biggest 2026 readout was mRNA-based. On August 19, 2026, Merck and Moderna said the Phase 3 INTerpath-001 trial of intismeran autogene, which encodes up to 34 neoantigens per patient, plus Keytruda met its main goal of longer recurrence-free survival in resected stage IIB-IV melanoma, compared with Keytruda alone. On the peptide side, Evaxion's personalized vaccine EVX-01 with Keytruda produced responses in 12 of 16 patients with advanced melanoma, and a 20-year follow-up of 51 patients in the Mel39 multipeptide melanoma trial reported 49% overall survival. In October 2026, MimiVax's survivin-targeting vaccine SurVaxM missed its overall survival goal in a Phase 2b glioblastoma trial, though patients 65 and under did better in a prespecified subgroup. None of these vaccines has FDA approval yet.
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In the randomized Phase 2 DOVACC trial (NCT04742075) of 188 patients with BRCA wild-type recurrent ovarian cancer, adding UV1, a vaccine of three synthetic long peptides from the telomerase protein hTERT, to olaparib and durvalumab gave a median progression-free survival of 8.7 months vs. 5.9 months on olaparib alone (hazard ratio 0.83, 95% CI 0.68 to 1.01, P = .066), short of statistical significance. OncLive reported on November 9 on the results, presented at the ESMO Congress in October, including exploratory subgroups such as HRD-negative patients (HR 0.73) that would need confirmation.
Evaxion reported at the Society for Immunotherapy of Cancer meeting in Phoenix that its AI-designed EVX-01 vaccine, given with Merck's Keytruda in a 16-patient Phase 2 trial in advanced melanoma, produced neoantigen-specific T cells that could be detected directly ex vivo. CD4+ T cells dominated those responses, and CD8+ responses appeared in half of patients. The trial previously reported objective responses in 12 of 16 patients at two years, including four complete responses, but it had no comparison arm.
MIT Koch Institute researchers displayed tumor antigens on the coat protein of harmless M13 bacteriophage at densities from 6% to 70%, and mice given a 35%-density vaccine carrying the peptide SIINFEKL were much less likely to grow melanoma than mice given a 6% version, they reported in Advanced Healthcare Materials. A higher-density vaccine against the tumor neoantigen ADPGK also protected mice from colon tumors, and the phage DNA acted as its own adjuvant. The tests were preventive and in mice only.
Researchers at Henan University and MAXVAX Bio-tech reported in ACS Applied Bio Materials on October 28, 2026 a lipid nanoparticle with phenolic groups that holds HPV16 E6/E7 peptide antigens by hydrogen bonding, regardless of their charge, and binds manganese ions that act as an immune booster. The particles helped immune cells take up the antigens, switched on the STING pathway, and reached nearby lymph nodes after injection into muscle. In the TC-1 mouse tumor model they increased tumor-killing CD8 T cells and slowed tumor growth without visible toxicity; the work has not been tested in people.
Elicio Therapeutics presented full results of the randomized Phase 2 AMPLIFY-7P trial at ESMO 2026 in Madrid on October 23, 2026, with a simultaneous Nature Medicine paper, for camupepimut (ELI-002 7P), a vaccine of seven lymph-node-targeted mutant KRAS peptides plus an adjuvant, in 144 patients with KRAS-mutant pancreatic cancer after standard treatment. Disease-free survival, the primary endpoint, was not significantly better than observation overall (hazard ratio 0.85), as the company reported in June; in the 93 patients without circulating tumor DNA at baseline, median disease-free survival was not reached versus 21.2 months (hazard ratio 0.51, nominal p=0.028), and 99% of evaluable treated patients had KRAS-specific T-cell responses. Grade 3 or higher adverse events occurred in 10.4% versus 14.6% on observation; more ctDNA-positive patients were in the vaccine arm, and Elicio plans to discuss a Phase 3 design with the FDA.
MimiVax and Roswell Park Comprehensive Cancer Center reported on October 7, 2026 that in SURVIVE, a randomized, double-blind, placebo-controlled Phase 2b trial in 233 evaluable patients with newly diagnosed glioblastoma at 11 U.S. centers, adding SurVaxM to standard treatment gave a median overall survival of 22.8 months versus 20.3 months on placebo (hazard ratio 0.75, p=0.076), short of statistical significance. In a prespecified group of patients 65 and under, median survival was 24.2 versus 20.2 months (hazard ratio 0.64, p=0.019), and about 42% versus 18% were alive at 30 months or later. SurVaxM is a peptide-mimic vaccine aimed at survivin, a protein found in about 95% of glioblastomas; grade 3 or higher side effects occurred in 48% versus 46% of patients, and MimiVax plans to ask the FDA about faster approval routes.
Researchers at the University of Hong Kong and BayVax Biotech reported in Advanced Science on Friday, October 2, 2026 a vaccine platform called SaPAC that chemically links neoantigen peptides to the TLR7-activating adjuvant 1V209, so the conjugates assemble into nanoparticles of about 100 to 200 nm. In mice, the particles reached lymph nodes better than peptide nanoparticles mixed with free adjuvant, and SaPAC alone slowed tumor growth in melanoma and bladder cancer models. In a triple-negative breast cancer model, combining multivalent SaPAC with anti-PD-1 therapy gave durable tumor suppression comparable to a Poly(I:C)-adjuvanted benchmark without detectable systemic toxicity; all results come from mice.
Moderna (NASDAQ: MRNA) announced Thursday August 27, 2026 a private placement of $2 billion in convertible senior notes due 2032, with proceeds directed to the cancer vaccine business (led by intismeran autogene / mRNA-4157, the individualized neoantigen therapy that encodes up to 34 tumor-specific neoantigen peptides per patient) and to repay existing debt. The raise follows the Wednesday August 19 announcement that the Phase 3 INTerpath-001 melanoma trial of intismeran plus Keytruda met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival, which added roughly $44.5 billion in market cap to MRNA in a single session as shares surged 177%. Moderna is advancing intismeran in nine total Phase 2 and Phase 3 trials across melanoma, NSCLC, bladder cancer, and renal cell carcinoma, and the raise positions the company to accelerate manufacturing scale-out and expansion into new tumor types.
Sell-side analysts published Tuesday August 25, 2026 projections that Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) intismeran autogene (V940 / mRNA-4157) will exceed $1 billion in annual sales by 2031 following the August 19 positive Phase 3 INTerpath-001 melanoma readout. Product context: intismeran autogene is an individualized neoantigen therapy that uses each individual patient's tumor mutation signature to design a personalized mRNA vaccine encoding up to 34 tumor-specific neoantigen peptides. The mRNA is delivered as a lipid nanoparticle injection; cells at the injection site translate the mRNA into the neoantigen peptides, which are then presented to the immune system to generate a targeted T-cell response against the patient's tumor. The INTerpath-001 Phase 3 trial met its primary endpoint of recurrence-free survival and key secondary endpoint of distant metastasis-free survival in adults with completely resected Stage IIB-IV cutaneous melanoma. The $1+ billion 2031 sales trajectory assumes approvals across additional adjuvant indications currently in Phase 3 development including non-small-cell lung cancer (INTerpath-002), renal cell carcinoma (INTerpath-003), and cutaneous squamous cell carcinoma (INTerpath-005). Manufacturing scale-up remains a substantial commercial constraint because each patient dose requires an individualized manufacturing run driven by that patient's tumor sequence, unlike traditional off-the-shelf drugs; Moderna is investing in automated manufacturing infrastructure to support the projected launch volumes. The sales trajectory reset materially resets investor expectations about the personalized neoantigen therapy modality that had traded largely on Phase 2 data until the August 19 confirmatory Phase 3 result.
Merck (NYSE: MRK) and Moderna (NASDAQ: MRNA) announced Wednesday August 19, 2026 that the Phase 3 INTerpath-001 trial of intismeran autogene (V940 / mRNA-4157, an individualized neoantigen therapy) plus pembrolizumab (Keytruda) met its primary endpoint of recurrence-free survival (RFS) and the key secondary endpoint of distant metastasis-free survival (DMFS) in adults with high-risk (Stage IIB-IV) resected cutaneous melanoma compared to Keytruda alone. Mechanism: intismeran autogene is a personalized mRNA therapy that encodes up to 34 tumor-specific neoantigen peptides selected from the individual patient's tumor mutation signature. The mRNA is delivered as a lipid nanoparticle injection; cells at the injection site translate the mRNA into the neoantigen peptides, which are then presented to the immune system to generate a targeted T-cell response against the patient's tumor. The Phase 3 readout is the first positive Phase 3 for an individualized neoantigen therapy and the first Phase 3 to demonstrate substantial improvement over Keytruda alone in the adjuvant melanoma setting. Trial design: randomized, double-blind, placebo- and active-comparator-controlled global Phase 3 evaluating safety and efficacy of the combination versus Keytruda alone. Phase 2b KEYNOTE-942 five-year follow-up data presented at the 2026 ASCO Annual Meeting had shown a 49% reduction in risk of recurrence or death and a 59% reduction in risk of distant metastasis or death for the combination versus Keytruda alone, and the Phase 3 readout confirms and extends those benefits. The result validates the personalized neoantigen mRNA vaccine platform and opens a substantial commercial pathway for the Merck-Moderna collaboration in adjuvant oncology settings beyond melanoma including non-small-cell lung cancer, renal cell carcinoma, and cutaneous squamous cell carcinoma where INTerpath studies are ongoing.
A post-hoc analysis in the International Journal of Cancer followed 51 patients from the Mel39 randomized Phase 2 trial, in which people with resected stage IIB-IV melanoma received a vaccine of 4 or 12 melanoma peptides. At a median follow-up of 16.1 years (21.2 years for living participants), overall survival across both arms was 65% at 10 years and 49% at 20 years. Survival favored the 12-peptide vaccine (hazard ratio 0.64, 95% CI 0.29-1.40), but the difference was not statistically significant (p = 0.26), and the authors concluded that adding more peptides did not significantly improve clinical efficacy; women had significantly better recurrence-free survival than men after either vaccine.