BioNTech has some cancer convincing to do
BioNTech’s 8% share price dip this morning was likely spurred by weak earnings and guidance – but its oncology pipeline cannot be helping. As Covid vaccine cash dwindles the German group is shifting focus to cancer, but a look at its “highlights” here shows a raft of projects against targets that are either very crowded, or which have so far disappointed. Examples of the former include antibody-drug conjugates against HER2 and TROP2, while the anti-PD-L1 x 4-1BB bispecific acasunlimab falls into the latter camp – Inhibrx recently ditched its similarly acting project, INBRX-105, citing lacklustre data. A couple of BioNTech’s candidates look more novel, but currently carry big question marks. For example, the Claudin6-targeting Car-T candidate BNT211 has produced decent data, but at a dose deemed to be toxic. Meanwhile, the so-called mRNA “cancer vaccines” BNT116 – which encodes six fixed antigens – and autogene cevumeran – which is personalised – still have much to prove. As does BioNTech, if it wants investors to take its oncology ambitions seriously.
BioNTech’s oncology “highlights”
| Project | Description | Partner | Key trial | Note |
|---|---|---|---|---|
| BNT323 | Anti-HER2 ADC | DualityBio | Ph3 Dynasty-Breast02 in HER2-low breast cancer | Crowded field dominated by Astra/Daiichi’s Enhertu |
| BNT325 | Anti-TROP2 ADC | DualityBio | Ph1/2 in solid tumours | Crowded field |
| BNT316 | Anti-CTLA-4 MAb | OncoC4 | Ph3 Preserve-003 in NSCLC | Designed to be a less toxic CTLA-4 inhibitor |
| Acasunlimab (BNT311) | Anti-PD-L1 x 4-1BB MAb | Genmab | Ph2 in 2L NSCLC; data due H1 2024 | Inhibrx recently discontinued its anti-PD-L1 x 4-1BB, citing disappointing data |
| Tecaginlimab (BNT312) | Anti-CD40 x 4-1BB MAb | Genmab | Ph1/2 in solid tumours | Genmab admitted in Nov 2023 that more dose-escalation work was needed; next steps to be determined in 2024 |
| BNT327 | Anti-PD-L1 x VEGF MAb | Biotheus | China trials under way; global studies to start 2024 | Summit Therapeutics ahead with PD-(L)1 x VEGF approach |
| BNT116 | mRNA encoding 6 antigens | N/A | Ph2 in 1L NSCLC | Ph1 Luca-Merit-1 showed 0/10 responses at SITC 2023; more data at AACR 2024 |
| Autogene cevumeran (BNT122) | mRNA-based individualized neoantigen-specific immunotherapy | Roche | Ph2 Imcode-001 in melanoma | Ph1 multi-tumour study reported “modest activity” at AACR 2020 |
| BNT211 | Anti-Claudin6 Car-T | N/A | Ph1/2 in solid tumours | Data at ESMO 2023 showed promising efficacy, but with tox |
Source: OncologyPipeline & company Q4 2023 statement.
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