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Intismeran autogene (mRNA-4157/V940)Moderna—Intismeran autogene (mRNA-4157/V940)Moderna—

Intismeran autogene (mRNA-4157/V940)

by ModernaUS

DeployStage 4 of 5

Phase 3 met its goals in Aug 2026; filing with regulators is next.

Updated 2d agoChecked 25 Sep1 update this week

Milestones

Next · Filing with regulators
  1. Phase 2: 44% lower risk of cancer return or deathDec 2022Complete.
  2. Phase 3 starts enrollingJul 2023Complete.
  3. Five-year Phase 2 data: 49% lower riskJun 2026Complete.
  4. Phase 3 meets its goals19 Aug 2026Complete.
  5. Filing with regulatorsNowCurrent milestone.

Most important updates

  • 2d ago
  • 19 Aug 2026
  • Feb 2024
  • 6 Apr 2023
  • 22 Feb 2023

Current obstacles

  • A custom batch per patientEvery dose is designed and made for one person, so the tumor-to-vial time must be fast at scale.

Physics limits

  • Tumours with few mutations offer few targetsMelanoma carries many mutations, so there is plenty to target. Many cancers carry only about one mutation per million DNA letters, leaving few neoantigens for a vaccine to aim at.
  • Most predicted targets don't trigger an immune responseOnly a small share of predicted neoantigens are actually displayed and recognised by T cells. Prediction from sequence alone remains imprecise.
  • Cancers evolve to hide from T cellsTumours can lose the molecules (HLA) that display targets, or build suppressive surroundings. Immune pressure selects for the cells that escape.

How it works

3 parts
An Illumina DNA sequencer: machines like this read each patient's tumour DNA to pick the targets for their custom vaccine
An Illumina DNA sequencer: machines like this read each patient's tumour DNA to pick the targets for their custom vaccinePhoto: Magnus Manske · CC BY-SA 3.0 (opens commons.wikimedia.org)
Read

Sequence tumour and blood

DNA from the patient's tumour and healthy blood is sequenced to find mutations that only the cancer carries.

Pick

Choose up to 34 targets

Software predicts which mutant protein pieces immune cells are most likely to see, and picks up to 34 of them.

Make

One mRNA per patient

A single mRNA encoding those pieces is made and packed in fat bubbles, then injected alongside Keytruda, which releases the immune brakes.

Update log

5 updates

Thu 8 Oct

  • Major: PressPartnership

Wed 19 Aug

  • Major: PressTest

Feb 2024

  • Minor: PaperResearch

Thu 6 Apr 2023

  • Minor: PressRegulatory

Wed 22 Feb 2023

  • Minor: PressRegulatory

About Moderna

The team behind Intismeran autogene (mRNA-4157/V940)

Moderna

mRNA vaccines, personal cancer vaccine

US mRNA company whose COVID vaccine Spikevax was one of the first two mRNA products ever cleared. It sells RSV and newer COVID vaccines and, with Merck, is building a personal mRNA cancer vaccine that passed Phase 3 in melanoma in 2026.

  • Aug 2026: its cancer vaccine plus Keytruda met Phase 3 goals, cutting melanoma return and spread after surgery.
  • Revenue fell sharply after the pandemic, forcing cost cuts while it builds new vaccines and cancer drugs.
Founded
201016 yrs
Headquarters
United States
Status
Public
Valuation
public
Works in
BiotechmRNA medicines
Coverage
2 programs · 9 updateslatest 2d agochecked 25 Sep
Primer