Mitrade Insights is dedicated to providing investors with rich, timely and most valuable financial information to help investors grasp the market situation and find timely trading opportunities.

2021

Best News & Analysis Provider

FxDailyInfo

2022

Best Forex Educational Resources Global

International Business Magazine

Insights

News

BioNTech Threw in the Towel on Its Colorectal Cancer Vaccine Trial. Should Investors Be Worried?

Source The Motley Fool

Key Points

BioNTech terminated a Phase 2 study of autogene cevumeran in treating colorectal cancer.
The setback raises questions about the mRNA vaccine's prospects in treating pancreatic cancer.
However, it's too early to write off BioNTech's chances.
10 stocks we like better than BioNTech Se ›

BioNTech's (NASDAQ: BNTX) shares were flying high in the aftermath of Moderna's (NASDAQ: MRNA) and Merck's (NYSE: MRK) announcement of impressive late-stage results for personalized messenger RNA (mRNA) cancer vaccine intismeran autogene in combination with Keytruda. The surge made sense, considering that BioNTech is developing its own mRNA cancer vaccines.

However, BioNTech's momentum came to a screeching halt with the company's update on Aug. 28, 2026, from a Phase 2 study of mRNA vaccine autogene cevumeran in treating colorectal cancer. BioNTech and its partner, Roche's (OTC: RHHBY) Genentech unit, decided to cancel the clinical trial due to a lack of efficacy. Should this move to throw in the towel worry investors?

Missed AI’s "Act 1"? Act 2 Could Be 15x Bigger. Most investors think they missed the AI boat because they didn't buy Nvidia in 2005. But according to our analysts, we’re only at the end of "Act 1"—the R&D phase. "Act 2" is the global rollout. Continue »

A question mark in front of a person wearing a mask and blue gloves holding a syringe.

Image source: Getty Images.

What is the real impact of BioNTech's setback?

BioNTech's pipeline setback shouldn't have completely surprised investors. The independent Data Safety Monitoring Board (DSMB) for the Phase 2 study of autogene cevumeran concluded in October 2025 that the data were not yet mature enough to support reliable conclusions about efficacy. BioNTech and Genentech decided then to go ahead with the clinical trial.

What is the real impact of the termination of the Phase 2 study of the mRNA vaccine in treating colorectal cancer? It's certainly not as bad as the situation would have been if autogene cevumeran had safety issues. Serious safety concerns would have forced BioNTech to completely abandon the experimental vaccine.

But that isn't the case. BioNTech and Genentech continue to evaluate autogene cevumeran in another Phase 2 study targeting pancreatic cancer.

Both colorectal and pancreatic cancer are "cold" tumors that don't trigger strong immune responses. Moderna's mRNA vaccine achieved successful results in melanoma, a "hot" tumor for which the body's immune system mounts a significant natural response. BioNTech's failure in colorectal cancer, therefore, raises questions about whether or not the vaccine will work in treating pancreatic cancer.

A cause for concern -- but not panic

It's too early to write off BioNTech's prospects in pancreatic cancer, though. Any speculation that the company might reduce emphasis on its mRNA cancer vaccine focus is also premature. BioNTech co-founder and Chief Medical Officer Özlem Türeci stated, "We remain committed to mRNA as a key pillar in our oncology strategy, and our novel combination approaches."

BioNTech continues to advance other experimental mRNA cancer vaccines targeting head and neck cancer and non-small cell lung cancer. Its pipeline also features multiple other types of cancer therapies. The company recently announced that one of them, gotistibart, nearly doubled the median overall survival compared with chemotherapy in previously treated patients with squamous non-small cell lung cancer.

The bottom line is that BioNTech's termination of its Phase 2 study of autogene cevumeran in colorectal cancer is a legitimate cause of concern for investors. However, it isn't a reason to panic about the biotech stock.

Should you buy stock in BioNTech Se right now?

Before you buy stock in BioNTech Se, consider this:

The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and BioNTech Se wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.

Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $412,074!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,314,319!*

Now, it’s worth noting Stock Advisor’s total average return is 932% — a market-crushing outperformance compared to 209% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors.

See the 10 stocks »

*Stock Advisor returns as of September 18, 2026.

Keith Speights has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends BioNTech Se, Merck, and Moderna. The Motley Fool recommends Roche Holding AG. The Motley Fool has a disclosure policy.

Disclaimer: For information purposes only. Past performance is not indicative of future results.

Recommended Articles

Fed hike odds near 90% into Wednesday's decision — how to trade the dollar, gold and the S&P 500 A 0.3% monthly core CPI print has lifted the market-implied probability of a 25bp Fed hike on 16 September to roughly 86.5% ~ 90%, which would be the first increase since July 2023. Here is the decision timeline, the pricing versus the forecasts, both scenarios, and the key levels for the dollar, gold and the S&P 500.

Author Suzie

Sep 14, Mon

A 0.3% monthly core CPI print has lifted the market-implied probability of a 25bp Fed hike on 16 September to roughly 86.5% ~ 90%, which would be the first increase since July 2023. Here is the decision timeline, the pricing versus the forecasts, both scenarios, and the key levels for the dollar, gold and the S&P 500.

Silver breaks $64 as precious metals rebound — can gold hold the $4,280 line into the Fed decision?Silver has climbed back above $64 an ounce for the first time this week, leading a broad rebound across precious metals hours before the Federal Reserve delivers what is expected to be its first rate hike since 2023. Spot silver was last at $64.64, up 1.49% on the day, while gold reclaimed $4,300 and platinum and palladium both advanced. The question now is whether the bounce is a genuine turn — or a pause before the Fed's dot plot decides the next move.

Author Suzie

Sep 16, Wed

Silver has climbed back above $64 an ounce for the first time this week, leading a broad rebound across precious metals hours before the Federal Reserve delivers what is expected to be its first rate hike since 2023. Spot silver was last at $64.64, up 1.49% on the day, while gold reclaimed $4,300 and platinum and palladium both advanced. The question now is whether the bounce is a genuine turn — or a pause before the Fed's dot plot decides the next move.

Bitcoin falls below $75,000 as the CLARITY Act fails in the Senate — what the vote means for crypto The US Senate blocked the Digital Asset Market CLARITY Act in a 49-50 procedural vote, sending Bitcoin briefly below $75,000 — its biggest one-day drop since June. Ethereum fell more than 8%, Coinbase slid 10% and $75 billion of crypto market value evaporated. Here is what the vote was, why it failed, and the levels that matter now.

Author Suzie

Sep 16, Wed

The US Senate blocked the Digital Asset Market CLARITY Act in a 49-50 procedural vote, sending Bitcoin briefly below $75,000 — its biggest one-day drop since June. Ethereum fell more than 8%, Coinbase slid 10% and $75 billion of crypto market value evaporated. Here is what the vote was, why it failed, and the levels that matter now.

Dow drops 631 points as the Fed hikes — but futures are rebounding: what's next for US stocks?The Dow fell 631 points and the S&P 500 closed below 7,600 after the Fed hiked rates for the first time since 2023, with the dot plot showing 16 of 18 officials expect more tightening. Asia-session futures are already recovering — here are the levels and analyst views that decide whether 7,500 holds.

Author Irene Q.

Yesterday 02: 54

The Dow fell 631 points and the S&P 500 closed below 7,600 after the Fed hiked rates for the first time since 2023, with the dot plot showing 16 of 18 officials expect more tightening. Asia-session futures are already recovering — here are the levels and analyst views that decide whether 7,500 holds.

Dollar index tops 100 for the first time since July as the Fed's hawkish dot plot sinks in The U.S. dollar index broke back above 100 for the first time since 31 July after the Fed delivered its first rate hike since 2023, with the dot plot showing 16 of 18 officials expect at least one more increase this year. Here are the levels that matter for DXY, the currencies feeling it most, and what to watch next.

Author Irene Q.

Yesterday 02: 45

The U.S. dollar index broke back above 100 for the first time since 31 July after the Fed delivered its first rate hike since 2023, with the dot plot showing 16 of 18 officials expect at least one more increase this year. Here are the levels that matter for DXY, the currencies feeling it most, and what to watch next.

Popular Symbols