BioNTech plans a spin-off
A new company will develop “next-generation mRNA” projects, amid another mRNA setback.
A new company will develop “next-generation mRNA” projects, amid another mRNA setback.
BioNTech’s fourth-quarter results on Tuesday were overshadowed by the announcement that its co-founders are planning to form a new company. Details are currently scarce, including whether the new entity will have a cancer focus; all the German group is saying for now is that the new company will develop “next-generation mRNA innovations”, and will use BioNTech technology.
Meanwhile, it seems like business as usual for BioNTech itself, whose current pipeline is “unaffected” by the plans for the new company. BioNTech was founded in 2008 around mRNA, but has been moving away from this technology in recent years and towards bispecifics and ADCs, via various deals. Its lead project is now the Biotheus-originated and Bristol Myers Squibb-partnered PD-L1 x VEGF asset pumitamig.
The decision by BioNTech’s founders, Ugur Sahin (chief executive) and Özlem Türeci (chief medical officer), to go back to what they know best is therefore not all that surprising. However, there are still big questions around mRNA in cancer, spurred in part by setbacks for BioNTech’s own personalised project autogene cevumeran.
New auto-ran setback
And Tuesday saw another red flag for this asset, which is partnered with Roche. BioNTech disclosed that it had discontinued the phase 2 Imcode-004 trial, testing auto-ran plus Opdivo in adjuvant high-risk muscle-invasive bladder cancer.
The company cited the “rapidly emerging treatment landscape and shifting standard of care”. BioNTech could be referring to the march of Padcev and Keytruda in the perioperative setting, but there have been previous scares around Imcode-004: it was put on hold last July due to a “safety event”, but by November it was enrolling again, without the partners giving more details about the pause.
There have been other bad omens for auto-ran, which is created on demand, encoding up to 20 neoantigens present in each patient’s tumour, with the goal of driving a T-cell response. Last year, auto-ran failed in first-line melanoma, and the phase 2 BNT122-01 trial in adjuvant colorectal cancer crossed the boundary for futility, suggesting that it might fail. However, with data still immature, the trial continues.
An update is expected in early 2026, but final data have been delayed from 2026 to 2027, BioNTech said on Tuesday, blaming a slower rate of events than expected.
The other hope for auto-ran is adjuvant pancreatic ductal adenocarcinoma, where the Imcode-003 trial is ongoing.
Key trials of BioNTech/Roche’s autogene cevumeran
| Trial | Setting | Sponsor | Regimen | Primary endpoint | Note |
|---|---|---|---|---|---|
| BNT122-01 | Adjuvant colorectal cancer | BioNTech | Vs watchful waiting | DFS | First interim analysis reported Nov 2025: crossed futility boundary, but “data not mature enough to draw reliable conclusions about efficacy”; next update early 2026; final readout now 2027, from 2026 |
| Imcode-003 | Adjuvant PDAC | Roche | + Tecentriq + chemo, vs chemo | DFS | Data expected 2029 |
| Imcode-004 | Adjuvant MIUC | Roche | + Opdivo, vs Opdivo | Investigator-assessed DFS | Was put on hold Jul 2025 after “safety event”; discontinued Mar 2026 (“rapidly emerging treatment landscape and shifting standard of care”) |
| Imcode-001 | 1st-line melanoma | Roche | + Keytruda, vs Keytruda | PFS | Fail, as per BioNTech’s Q4 2024 presentation |
| GO41836 | Adjuvant NSCLC | Roche | + Tecentriq, vs Tecentriq | DFS | Withdrawn (“accrual timelines”) |
Source: OncologyPipeline & company release.
Against this backdrop, there could be doubts about the new venture for Sahin and Türeci, who plan to leave BioNTech by the end of the year.
In the meantime BioNTech will search for their successors. The German group plans to contribute mRNA technologies to the new company “on an arm’s length basis”, in exchange for a minority stake, milestones and royalties.
BioNTech also raised the possibility that the groups could collaborate. More details should be available after a binding agreement is signed, expected in the first half of 2026.
While it looks like BioNTech will continue along the same path it’s been travelling on for some years, the markets clearly see the loss of its founders as a blow: the group’s stock opened down 18% on Tuesday.
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