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Clinical Daily Summary

Clinical Daily Summary: What Happened on November 5, 2026

BioNTech raises revenue outlook amid mixed cancer-trial results

UK industry-trial enrollment fell for a fifth year. Intellia completed enrollment in a gene-editing study, and Tango and Erasca opened a cancer-combination trial.

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  • Read from 4 articles, 2 publications

Today in brief

BioNTech raised its 2026 revenue outlook and reported mixed results across its cancer pipeline.1 Gotistobart showed a survival benefit in an initial analysis, while BNT113 missed a progression-free-survival endpoint and a colorectal cancer vaccine trial will stop early.1

UK enrollment in industry-sponsored clinical trials fell for a fifth consecutive year, to 17,618 NHS participants in 2025/26.2 Intellia completed enrollment in a Phase 3 gene-editing trial for hereditary transthyretin amyloidosis with polyneuropathy.3 Tango Therapeutics and Erasca began enrolling patients in a Phase 1/2 trial combining two drugs for selected lung and pancreatic cancers.4

BioNTech’s cancer pipeline posts gains and setbacks

BioNTech raised its 2026 revenue outlook to €1.7 billion–€1.9 billion, from a previous range of €1.6 billion–€1.9 billion.1 Third-quarter revenue was €1.289 billion, including €613 million from its Bristol Myers Squibb collaboration and €554 million from COVID-19 vaccines.1

In the non-pivotal portion of a Phase 3 trial, gotistobart improved overall survival versus chemotherapy. BioNTech said median survival was nearly twice as long.1 BioNTech expects interim results from the trial’s second portion before the end of 2026, after review by an independent monitoring committee.1

The Phase 3 DYNASTY-Breast02 trial of trastuzumab pamirtecan met its primary endpoint, progression-free survival. BioNTech described the effect as moderate and reported more interstitial lung disease, including severe and fatal cases.1 BioNTech and partner DualityBio are reviewing breast and uterine cancer data before deciding next steps, leaving a previously anticipated regulatory filing uncertain.1

BNT113 did not significantly improve progression-free survival when added to pembrolizumab, compared with pembrolizumab alone, in the AHEAD-MERIT trial.1 BioNTech will continue assessing overall survival. A separate Phase 2 trial of autogene cevumeran after colorectal cancer surgery and chemotherapy is being stopped early.1 A Phase 2 autogene cevumeran trial in pancreatic cancer continues, with recruitment completed in August.1

UK industry-trial recruitment falls for a fifth year

The UK recorded 17,618 NHS participants in industry clinical trials in 2025/26, down from 19,507 the year before and 31% below 2022/23.2 Industry-sponsored studies accounted for 3.8% of interventional-trial participants, compared with a share that had consistently exceeded 10% before the pandemic.2

The Association of the British Pharmaceutical Industry said trial initiations had improved, but the UK ranked seventh for Phase 1 and Phase 3 starts and fifth for Phase 2 in 2025/26.2 Every study received an approval decision within 60 days in August 2026. But only 35% of studies opened to patients within 60 days of approval during 2025/26, against a 90% target.2 The report called for a UK-wide NHS data service to identify potential participants and more funding for trial delivery.2

Intellia completes enrollment in hereditary amyloidosis trial

Intellia completed enrollment of about 60 adults in MAGNITUDE-2, a randomized Phase 3 trial of nexiguran ziclumeran for hereditary transthyretin amyloidosis with polyneuropathy.3 The treatment uses in vivo CRISPR gene editing to disable TTR in liver cells, reducing production of transthyretin protein.3

The trial compares a single infusion with placebo. It will assess changes in blood TTR at day 29 and neuropathy impairment at month 18.3 Intellia is also studying the treatment in a separate Phase 3 trial for transthyretin amyloidosis with cardiomyopathy.3

Tango and Erasca start combination-trial enrollment

Tango Therapeutics and Erasca opened enrollment in a Phase 1/2 study of ERAS-0015 plus vopimetostat for selected pancreatic and lung cancers.4 The open-label trial will test escalating doses to determine the combination’s maximum tolerated dose. It will also assess safety, drug exposure and antitumor activity.4

ERAS-0015 is an oral pan-RAS inhibitor, while vopimetostat blocks PRMT5, a protein involved in cell growth.4 Erasca has reported partial responses at dose levels starting at 8 mg once daily in an early dose-escalation study of ERAS-0015 alone.4

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