BNTX Ends Colorectal Cancer Immunotherapy Study, Stock Down

BioNTech BNTX announced that it has discontinued the phase II BNT122-01 study evaluating autogene cevumeran for the treatment of patients with high-risk stage II or stage III colorectal cancer ("CRC") whose tumors had been surgically removed.

BioNTech and Genentech, a subsidiary of Roche RHHBY, are jointly developing autogene cevumeran as an individualized mRNA cancer immunotherapy designed to stimulate an immune response against patient-specific tumor neoantigens.

BNTX stock declined 8.4% on Friday following the announcement.

Year to date, BNTX's shares have gained 7.2% compared with the industry’s 8.8% growth.

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Key Details of BNTX’s BNT122-01 Study in CRC

The phase II BNT122-01 study was initiated in 2021 to evaluate autogene cevumeran as a monotherapy in patients with ctDNA-positive, completely resected high-risk stage II or stage III CRC. The study compared treatment with up to 15 doses of autogene cevumeran against watchful waiting.

The primary objective was to determine whether autogene cevumeran could improve disease-free survival and reduce the risk of cancer recurrence. Secondary endpoints included relapse-free survival, overall survival ("OS"), changes in circulating tumor DNA (ctDNA) status and safety.

The program encountered a setback in October 2025, when BNT122-01 crossed its predefined futility boundary. At that time, the independent data safety monitoring board ("DSMB") considered the available data to be immature and recommended continued follow-up rather than immediately terminating the study.

The futility finding did not lead to the identification of any new safety concerns associated with autogene cevumeran. Therefore, BioNTech and Genentech continued the study according to protocol.

DSMB Recommends Study Discontinuation

Following a subsequent review of the updated clinical data, the DSMB observed a numerical imbalance in OS between the treatment and control groups and concluded that continuing the study would not change the efficacy results. No new safety concerns were identified with autogene cevumeran. Eventually, BioNTech decided to terminate the study in consultation with Genentech.

BioNTech’s Pancreatic Cancer Study Unaffected

The discontinuation of the BNT122-01 study does not affect IMCODE003, a separate phase II study evaluating autogene cevumeran in pancreatic ductal adenocarcinoma.

Initiated in 2023, IMCODE003 is evaluating autogene cevumeran in combination with checkpoint inhibition and chemotherapy as an adjuvant treatment following surgery. Unlike BNT122-01, which evaluated autogene cevumeran as monotherapy, IMCODE003 is testing the candidate as part of a combination regimen designed to enhance the immune response against the tumor.

The study remains ongoing as planned, with both primary completion and overall study completion currently estimated for January 2031.

BNTX’s Zacks Rank & Stocks to Consider

BioNTech currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are AC Immune ACIU and Aldeyra Therapeutics ALDX, both of which carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 30 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU's shares have lost 15.6% year to date.

AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.

Over the past 30 days, loss per share estimates for Aldeyra Therapeutics have narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX's shares have plunged 71.4% year to date.

Aldeyra Therapeutics' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.

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