This week in immunology: the latest clinical updates, industry progress, and developments from leading biopharma companies.
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🩸 Ianalumab + eltrombopag extends disease control in ITP (VAYHIT2) [1] [EU • 09 Dec 2025]
Context: Phase 3 VAYHIT2 in second-line primary ITP tested ianalumab 9 mg/kg or 3 mg/kg, four once-monthly IV doses, plus eltrombopag vs placebo plus eltrombopag.
Key point: 9 mg/kg arm extended time to treatment failure and improved sustained platelet response at 6 months vs control; safety generally consistent with prior studies.
Implication: May influence prescriber choice and payer reviews pending full data.
🧠 Formation Bio licenses CNS-penetrant TYK2 inhibitor LNK01006 from Lynk [2] [US • 11 Dec 2025]
Context: Deal grants worldwide rights ex-Greater China; asset recently IND-cleared in the US; Bleecker Bio subsidiary to develop.
Key point: Next-generation allosteric TYK2 with CNS exposure targets central immune modulation, with Phase 1 planned H1 2026 and milestones up to $605M plus royalties.
Implication: Signals pipeline investment and modality expansion.
🧪 Arcus halts Phase 3 STAR-221 domvanalimab combo in upper GI cancer for futility [3] [US • 12 Dec 2025]
Context: Interim OS analysis by IDMC showed no improvement vs nivolumab plus chemotherapy; safety similar; Phase 2 EDGE-Gastric and STAR-221 to be discontinued.
Key point: Arcus to redirect resources to casdatifan and early I&I programs, with multiple 2026 readouts planned.
Implication: May influence prescriber choice and payer reviews pending full data.
🌾 Barinthus Bio VTP-1000 shows dose-dependent pharmacology in Phase 1 SAD (celiac) [4] [US • 10 Dec 2025]
https://firstwordpharma.com/story/6738374
Context: First-in-human AVALON trial single-ascending-dose cohorts in adults with celiac disease; SNAP-TI platform delivers gluten peptides plus rapamycin.
Key point: Well tolerated with no treatment-related SAEs and dose-dependent pharmacological effect; MAD with gluten challenge ongoing.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
📏 EULAR issues points to consider for AOSD disease-activity and response criteria [5] [EU • 11 Dec 2025]
https://doi.org/10.1016/j.ero.2025.11.015
Context: Task force outlines 3 overarching principles and 11 points to consider toward standardizing AOSD assessment.
Key point: Core set emphasizes fever, rash, arthritis/arthralgia, systemic involvement, and labs such as ferritin and inflammatory markers; remission definition remains a need.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 Ascletis oral IL-17 inhibitor ASC50 shows best-in-class potential in Phase 1 [6] [15 Dec 2025]
Context: US Phase 1 evaluated safety, PK, and target engagement in psoriasis and healthy participants, using AISBDD-derived small molecule.
Key point: No SAEs reported; dose-dependent target engagement and PK support once-daily or once-weekly dosing across 10–600 mg.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 Biohaven BHV-1510 (Trop2 ADC) + cemiplimab shows early activity with manageable safety [7] [11 Dec 2025]
Context: Phase 1 combo in pretreated advanced cancers, many with prior PD-(L)1; doses up to 2.75 mg/kg Q3W and D1D8Q3W schedules.
Key point: Confirmed responses across NSCLC, endometrial, urothelial, with low rates of payload-related AEs and no ILD; patients remaining on therapy beyond 6 months.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Ianalumab’s short-course approach in ITP could reduce chronic treatment burden if confirmed in full reports [1].
- The Formation–Lynk deal extends TYK2 into CNS-relevant immunology, broadening a validated mechanism’s reach [2].
- The STAR-221 halt reshapes TIGIT expectations in upper GI cancer and reallocates Arcus’s capital to HIF-2α and I&I [3].
- Early AOSD criteria work by EULAR can standardize trials and care pathways in a rare inflammatory disease [5].
- New oral modalities in IL-17 and Trop2 spaces hint at more convenient or safer options in immunology and oncology [6][7].
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FAQ
What did VAYHIT2 show for ianalumab in ITP?
VAYHIT2 reported longer time to treatment failure and higher 6-month platelet responses with ianalumab plus eltrombopag vs placebo plus eltrombopag, with a generally consistent safety profile [1].
What is LNK01006 and why is it notable?
It is an allosteric, highly selective, CNS-penetrant TYK2 inhibitor licensed by Formation Bio from Lynk; IND-cleared with Phase 1 planned in H1 2026 and significant milestone economics [2].
Why was STAR-221 discontinued?
An interim OS analysis found the domvanalimab-based combo did not outperform nivolumab plus chemotherapy, leading to discontinuation for futility and program refocus by Arcus [3].
What is Barinthus’s VTP-1000 platform aiming to do?
VTP-1000 uses nanoparticles to co-deliver gluten peptides with rapamycin to induce antigen-specific tolerance; Phase 1 SAD showed dose-dependent pharmacology and good tolerability [4].
What are EULAR’s AOSD “points to consider”?
They prioritize fever, rash, joint and systemic features plus labs in a core set, moving toward standardized disease-activity and response criteria; remission definitions remain under development [5].
How strong are early data for Ascletis’ ASC50 and Biohaven’s BHV-1510 combos?
ASC50 showed clean Phase 1 safety and target engagement supporting convenient dosing [6], while BHV-1510 plus cemiplimab produced confirmed responses across tumors with differentiated safety in early Phase 1 [7].
Entities / Keywords
Ianalumab, VAYHIT2, eltrombopag, immune thrombocytopenia, Novartis.
Formation Bio, Lynk Pharmaceuticals, LNK01006, TYK2, Bleecker Bio.
Arcus Biosciences, domvanalimab, zimberelimab, STAR-221, upper GI cancer.
Barinthus Biotherapeutics, VTP-1000, SNAP-TI, celiac disease, AVALON.
EULAR, adult-onset Still’s disease, disease-activity criteria.
Ascletis Pharma, ASC50, IL-17 inhibitor, psoriasis, AISBDD.
Biohaven, BHV-1510, Trop2 ADC, cemiplimab, TopoIx payload.
References
- https://www.novartis.com/news/media-releases/novartis-ianalumab-significantly-extends-disease-control-patients-immune-thrombocytopenia-only-four-once-monthly-doses
- https://www.biospace.com/press-releases/formation-bio-licenses-phase-1-ready-cns-penetrant-tyk2-inhibitor-from-lynk-pharmaceuticals
- https://investors.arcusbio.com/investors-and-media/press-releases/press-release-details/2025/Arcus-Provides-Update-on-Phase-3-STAR-221-Study-and-Concentrates-Its-RD-Investment-on-Casdatifan-and-Emerging-Inflammation-and-Immunology-Portfolio/default.aspx
- https://firstwordpharma.com/story/6738374
- https://doi.org/10.1016/j.ero.2025.11.015
- https://www.europeanpharmaceuticalreview.com/news/269358/ai-discovered-il-17-inhibitor-ascletis-pharma-best-in-class-potential/
- https://www.prnewswire.com/news-releases/biohaven-presents-clinical-safety-and-efficacy-data-for-bhv-1510-a-next-generation-trop2-antibody-drug-conjugate-in-combination-with-cemiplimab-at-the-2025-european-society-for-medical-oncology-esmo-immuno-oncology-congress-302638503.html