mRNA Platforms Beyond COVID in 2026: Moderna Oncology, BioNTech CAR-T, Pfizer, Arcturus, and the Personalized-Vaccine Pipeline
Moderna's mRNA-4157 oncology pipeline, BioNTech's CAR-T and cancer programs, Pfizer mRNA expansion, Arcturus, Sanofi, the personalized cancer vaccine work, and the Catalent manufacturing scale-up.
The honest summary of mRNA therapeutics in 2026 is that the pandemic was a forcing function rather than a destination. The platforms that COVID vaccines built — at-scale lipid nanoparticle manufacturing, fast IND-enabling toxicology, the regulatory familiarity at FDA and EMA — are now being applied to the much harder problems they were originally invented for: oncology, cardiovascular disease, rare metabolic disease, and personalized cancer vaccines. The clinical readouts through 2024 and 2025 have been encouraging enough that Moderna and BioNTech are reorganizing around the post-COVID pipeline, and Pfizer, Sanofi, and Arcturus are scaling their bets accordingly.
This is the engineer-friendly view of where the field actually sits.
Moderna and the mRNA-4157 melanoma readout#
The Moderna pipeline pivot through 2023-2025 has been one of the more interesting strategic shifts in biopharma. With COVID revenue declining as the pandemic moved to endemic patterns, Moderna shipped roughly half its revenue base each year through 2024 and 2025 while investing heavily in oncology, RSV, and rare-disease programs. The flagship oncology asset is mRNA-4157, an individualized neoantigen therapy run in partnership with Merck on top of Keytruda.
The Phase 2b readout in December 2022 was the inflection — mRNA-4157 plus Keytruda reduced the risk of recurrence or death by roughly 44 percent in resected high-risk melanoma compared to Keytruda alone. The three-year follow-up data through 2024 maintained the magnitude. The Phase 3 INTerpath-001 trial in melanoma initiated in 2023, and additional Phase 3 trials in non-small-cell lung cancer, renal cell, and other indications followed through 2024 and 2025.
The mechanical story is that mRNA-4157 is patient-individualized. Each dose is manufactured against a specific patient’s tumor neoantigens identified by sequencing — up to 34 different mRNA-encoded neoantigens in a single lipid nanoparticle. The manufacturing turnaround from tumor biopsy to dose at the patient is several weeks, which is a real workflow constraint that scales only with serious manufacturing investment.
BioNTech’s CAR-T and cancer-vaccine pipeline#
BioNTech has taken a slightly different post-COVID path. The company kept the Pfizer COVID partnership and used the cash to acquire and build out cell-therapy capability — the InstaDeep AI acquisition in 2023, Autolus partnership for CAR-T manufacturing through 2024, and the OncoCenter acquisition that brought additional clinical infrastructure.
The flagship oncology programs include BNT122 — autogene cevumeran, individualized cancer vaccine in pancreatic and colorectal cancer — and BNT211, a claudin-6 CAR-T for solid tumors. The pancreatic cancer Phase 1 readout in 2023 was striking enough that BioNTech expanded the program; the 2024 follow-up data on immune-response durability has held up. Phase 2 in pancreatic cancer began through 2024.
BioNTech is also one of the more aggressive players on combining mRNA with CAR-T — the CARVac platform amplifies CAR-T expansion in vivo using a complementary mRNA vaccine, and the BNT211 program is the first clinical demonstration. The 2025 readouts showed signs of CAR-T expansion in vivo that no prior CAR-T product had achieved, which if it scales is one of the bigger immuno-oncology stories of the late 2020s.
Pfizer, Sanofi, Arcturus, and the platform diversification#
Pfizer kept the mRNA muscle from Comirnaty and re-deployed it into respiratory and flu programs through 2023-2025. The combined COVID/flu mRNA vaccine entered Phase 3 in 2024. The Seagen acquisition in 2023 gave Pfizer an antibody-drug-conjugate arm that complements rather than competes with mRNA — the conventional read is that Pfizer’s mRNA platform will live on as part of a broader oncology and infectious-disease engine.
Sanofi acquired Translate Bio in 2021 and has been quietly building an mRNA platform that emphasizes self-amplifying mRNA (saRNA) — RNA constructs that include a replicase enzyme so a smaller dose can produce more protein expression. Sanofi’s mRNA-flu program (Phase 3 through 2024-2025) is the headline program; the saRNA technology gives Sanofi a possible cost and dose-volume advantage over conventional mRNA if it lands.
Arcturus Therapeutics is the saRNA leader on the commercial side. The Arcturus and CSL partnership’s ARCT-154 (Kostaive) saRNA COVID vaccine was approved in Japan in late 2023 and Europe in 2024 — the first commercially approved saRNA therapeutic. The Arcturus pipeline beyond COVID covers cystic fibrosis and ornithine transcarbamylase deficiency, both rare-disease programs where the smaller dose volume that saRNA enables matters.
Personalized cancer vaccines as a clinical pattern#
The most interesting story across Moderna, BioNTech, Genocea (now defunct), and a handful of smaller players is the maturation of personalized cancer vaccines as a clinical pattern. The workflow is roughly: resect or biopsy the tumor, sequence both tumor and germline DNA, identify neoantigens (mutations that are tumor-specific and predicted to bind the patient’s HLA alleles), select 20-40 for the vaccine, manufacture an mRNA encoding those neoantigens, dose alongside a checkpoint inhibitor.
The reasons this works better in 2026 than it did in 2020: neoantigen prediction models have gotten dramatically better (largely from AlphaFold-style structural models and improved HLA-peptide binding predictors), checkpoint inhibitors are now standard of care in many adjuvant settings, manufacturing turnarounds have compressed from months to weeks, and the regulatory pathway for patient-individualized products has been carved out by Casgevy and other autologous therapies.
The current limitations are real. Neoantigen prediction is still imperfect — many predicted neoantigens fail to provoke a real T-cell response. The workflow is data-heavy: each patient generates substantial sequencing and bioinformatics work that needs to be turned around quickly without errors. And the manufacturing supply chain has to scale from dozens of patients per year (where most pilots have lived) to thousands without losing the individualization.
Manufacturing at scale — Catalent and the CDMO landscape#
The mRNA manufacturing story is the part that many investors underestimated through 2023. Pre-COVID, no one was doing commercial-scale lipid nanoparticle manufacturing. By 2024-2025, the global capacity had grown by an order of magnitude — Moderna’s Norwood and Marlborough facilities, BioNTech’s Marburg and the John Crowley acquisition, Pfizer’s Kalamazoo, Lonza’s mRNA capacity, and Catalent’s substantial expansion. Catalent’s acquisition by Novo Holdings in 2024 was the largest CDMO transaction in years and consolidated significant mRNA fill-finish capability.
The capacity question for 2026-2028 is whether the industry can flex from the high-volume COVID-style runs (hundreds of millions of doses against a single sequence) to the personalized-vaccine workflow (one bespoke dose per patient, thousands of patients) without massive idle capital. The technical patterns are different — bench-scale flow chemistry for personalized doses versus stainless-steel bioreactors for high-volume single-sequence runs — and most operators are now running both.
What this means for healthcare platforms#
For healthcare CIOs and operators looking at the mRNA wave, the operational pattern that matters in 2026 is the shift toward patient-individualized workflows. The platforms that COVID vaccines used — straightforward EHR-to-pharmacy distribution — do not work for personalized oncology vaccines. The workflow needs to integrate genomic sequencing, neoantigen prediction, manufacturing turnaround tracking, cold-chain logistics, and outcomes registries — all tied to a specific patient identity over months.
We have helped hospital management systems wire up the early operational pieces of this — sequencing-result intake, manufacturer status APIs, the audit trail that regulators need. The pattern is recognizable to any team that has built complex healthcare workflows; the specifics are new and the precision required is unforgiving.
Related reading#
mRNA platforms moved past COVID and into the harder problems they were built for. If your healthcare organization needs the data plumbing for personalized-vaccine or cell-therapy programs, our data engineering team has wired up the pipelines that connect sequencing, manufacturing, and outcomes registries. Tell us about the workflow.