The future of mRNA: companies and trials to watch in 2025
Exploring the next wave of mRNA innovation in cancer, infectious diseases, and beyond. What will 2025 bring?
The Covid-19 pandemic propelled the development of mRNA vaccines and shot Moderna, BioNTech, Pfizer and others into the limelight. Today, these companies are looking past Covid-19 and exploring new ways to apply the mRNA technology. Cancer, HIV, and rare diseases top the list for 2025, as companies push mRNA vaccines into new territory.
The path hasn’t been smooth. Last year brought tougher regulations, tighter wallets, and the tricky shift from emergency pandemic shots to precise medical treatments. But the industry is adapting. Gone are the days of rushing out vaccines for a global crisis. Instead, firms are fine-tuning their approach, developing treatments that can target specific cancer markers or block HIV infection.
Cancer is the main focus. BioNTech and Moderna have late stage trials testing personalized cancer vaccines. The idea is compelling: take a patient’s tumor profile, create a custom mRNA vaccine that teaches their immune system to spot the cancer, and pair it with existing immunotherapy drugs. Early results in melanoma have turned heads. Patients who received Moderna’s mRNA vaccine alongside Merck’s Keytruda showed significantly better outcomes.
HIV presents a different challenge. Here, Moderna is testing whether mRNA can train the immune system to produce antibodies that might prevent infection. It’s a bold bet on a virus that has evaded traditional vaccines for decades.
The respiratory disease front looks promising too. After Covid-19, companies have set their sights on RSV, flu, and other viruses. The appeal is clear: mRNA vaccines can be updated quickly as viruses mutate, and manufacturing can be scaled rapidly.
Yet questions remain. Can these complex treatments be made affordable? Will they work as well outside of cancer? The technology’s future may depend less on scientific breakthroughs and more on practical matters of cost, scale, and delivery.
Still, 2025 could mark mRNA’s second act. If even a few of these trials succeed, the Covid-19 vaccines might be remembered not as a one-off triumph, but as the opening chapter of a medical revolution.
Moderna personalized cancer vaccines
As Moderna’s Covid-19 windfall fades, the biotech pioneer is betting its future on a bolder vision. Personalized cancer treatment. At the heart of this strategy is mRNA-4157, a cancer vaccine that’s turning heads in melanoma trials.
As mentioned above, the approach is clever. Take a patient’s tumor DNA, create a custom vaccine that targets up to 34 cancer markers, and pair it with proven cancer drug Keytruda (PD-1 blocker). Early results are promising — patients in the phase 2b trial lived longer without their cancer returning. Now, as phase 3 trials approach in 2025, Moderna isn’t stopping at skin cancer. The company has its sights set on lung, kidney, and bladder cancers too.
A breakthrough in mRNA vaccines could be a catalyst for the stock price. Moderna’s stock has tumbled from its pandemic heights of $400 to around $42, as Covid vaccine sales dry up. While analysts see potential for recovery, with price targets averaging $198 by 2025 and nearly $500 by 2027, the company needs a win. Recent political headwinds from anti-vaccine rhetoric (as in RFK Jr.’s nomination for HHSS) haven’t helped.
Meanwhile, Moderna is taking on another tough challenge: HIV. The virus has long outsmarted vaccine makers by mutating rapidly, creating a vast diversity of viral strains. The company’s two-pronged attack includes mRNA-1574 and mRNA-1644, the latter developed with help from the Gates Foundation. Both are in early trials, testing they can generate effective broadly neutralizing antibodies against the virus. For Moderna, 2025 could mark a turning point. Success in cancer or HIV would prove that its Covid-19 triumph was no fluke. Failure would raise hard questions about mRNA’s limits. Either way, the stakes are high, not just for Moderna’s investors, but for the future of personalized medicine.
More personalized cancer shots and HIV by BioNTech
BioNTech has also been quietly building an impressive cancer pipeline. Like Moderna, they’re chasing the holy grail of personalized cancer vaccines. But their approach goes broader and deeper.
Their flagship program, BNT122 (now called autogene cevumeran), made waves in pancreatic cancer trials, a notoriously hard-to-treat disease. By creating custom vaccines based on each patient’s tumor mutations, they aim to help the immune system spot and destroy cancer cells that typically slip under its radar.
Beyond personalized vaccines, BioNTech has a clever twist: off-the-shelf mRNA treatments targeting common cancer markers. Think of it as a ready-made solution rather than a bespoke one. Their pipeline includes treatments for melanoma, colon cancer, and various solid tumors, with several programs expected to yield key data in 2025.
But perhaps most intriguing is their CAR T cell therapy program. Here, they’re using mRNA to modify immune cells to better fight cancer, potentially offering a more efficient and cheaper alternative to current cell therapies.
Just like Moderna, BioNTech isn’t focusing solely on cancer. They’re also advancing programs in infectious diseases, including better flu shots and tropical disease vaccines. But curing cancer remains their north star - a fitting focus for a company that started as a cancer research firm before Covid-19 thrust them into the spotlight.
The mRNA giant seeks new ground
After dominating the Covid-19 vaccine market with BioNTech, Pfizer is charting its own course in mRNA. But 2024’s steep revenue drop, as Covid vaccine sales plummeted, has added urgency to their quest for the next breakthrough.
Unlike its smaller rivals, Pfizer is playing a different game. Rather than chase personalized cancer vaccines, they’re leveraging their massive infrastructure to target more traditional vaccine markets. Their partnership with BioNTech continues, but Pfizer is also building independent mRNA capabilities through strategic acquisitions and internal development.
Flu shots lead their non-covid pipeline. Early trials of their mRNA flu vaccine showed promise, potentially offering better protection than traditional shots. The appeal is clear. mRNA vaccines can be updated quickly as flu strains change, and manufacturing can be scaled rapidly —lessons learned from Covid.
The company has also bet big on shingles, partnering with BioNTech to develop an mRNA vaccine. This might seem less exciting than cancer therapy, but it’s smart business. The current shingles vaccine market is worth billions, and an mRNA version could offer better protection with fewer doses.
More quietly, Pfizer is exploring rare diseases and other chronic conditions where mRNA could deliver therapeutic proteins. These programs are still early, but they hint at a broader strategy of using mRNA not just for vaccines, but as a platform for protein replacement therapy.
But questions remain. Can Pfizer translate its Covid success into these new areas? Will its more conservative approach pay off compared to the moonshots its competitors are chasing? 2025 could provide some answers, as key trials read out and the post-Covid strategy faces its first real test.
The rest of the mRNA pack
While Moderna, BioNTech, and Pfizer grab headlines, others are quietly making moves in the mRNA space. CureVac, after its Covid-19 setback, has reinvented itself with a more stable mRNA technology. Their partnership with GSK focuses on second-generation Covid shots and seasonal flu vaccines, but more intriguing is their oncology program - though they’re playing catch-up to their larger rivals.
Arcturus Therapeutics might be the dark horse to watch. Their self-amplifying mRNA technology (STARR) could be a game changer, potentially delivering stronger immune responses with smaller doses. STARR is a type of mRNA that can make copies of itself within cells, unlike conventional mRNA which degrades after protein production. This self-replication leads to increased protein production, potentially requiring lower vaccine doses and potentially providing a more durable immune response. Arcturus is advancing vaccines for Covid and flu, but their rare disease programs, particularly for ornithine transcarbamylase deficiency, could bring significant results in 2025.
Sanofi, despite its late start, is going all-in on mRNA. After acquiring Translate Bio, they’ve built a dedicated mRNA Center of excellence. Their focus remains practical: improved flu shots, respiratory vaccines, and chlamydia vaccines. Less exciting than cancer therapy, perhaps, but potentially more profitable in the near term.
The most intriguing developments, however, might come from new delivery methods. Several companies are working on oral and inhaled mRNA vaccines —advances that could solve the cold chain problems that have limited mRNA vaccines’ global reach.
Happy holidays and thanks for reading Biotech Blueprint. I wish everyone all the best in 2025.
DISCLAIMER: This content is for informational purposes only. It should not be taken as legal, tax, investment, financial, or other advice. The views expressed here are my own and do not reflect the opinions of any company or institution.
DISCLOSURE: I have no business relationships with any company mentioned in this article.