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Immunology Video Recap—December 17, 2025

Immunology

Immunology

This biweekly video brings you key highlights from across the immunology landscape, featuring the latest data releases, company updates, and research milestones.

🎯 Watch Our Video Summary Capturing Immunology News from the Last Two Weeks

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Top Stories Covered In This Video

Chapters

0:00 Introduction
0:08 Navigator Medicines completes Phase 1b for OX40L–TNFα bispecific NAV-240 in hidradenitis suppurativa
0:35 CONMED to exit gastroenterology product lines, ending VIABIL distribution effective 01 Jan 2026
0:57 Abeona initiates first commercial treatment of Zevaskyn (prademagene zamikeracel) for RDEB
1:20 Fate Therapeutics updates Phase 1 data: FT819 off-the-shelf iPSC CD19 CAR T in systemic lupus erythematosus
1:48 Novartis ianalumab plus eltrombopag meets Phase 3 endpoints in second-line ITP (VAYHIT2)
2:16 Barinthus Bio reports Phase 1 AVALON SAD results: VTP-1000 shows dose-dependent pharmacology in celiac disease
2:41 Arcus halts Phase 3 STAR-221, domvanalimab combo futile in upper GI cancers; pivots to casdatifan and I&I
3:04 Ascletis’ AI-discovered oral IL-17 inhibitor ASC50 shows favorable Phase 1 safety and PK/target engagement
3:26 How to reach us

Transcript

Welcome to the latest edition of Immunology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

First, Navigator Medicines completed a Phase 1b multiple-ascending-dose study of NAV-240, a bispecific targeting OX40L and TNFα, in 24 healthy volunteers. Prior Phase 1a showed good tolerability with no serious adverse events. The Phase 1b readout is planned for Q1 2026.

Next, CONMED will exit its gastroenterology product lines and conclude its U.S. and Canada distribution of the Gore VIABIL biliary stent effective January 1, 2026. The company reaffirmed its 2025 revenue and EPS guidance while refocusing on core surgical platforms.

Abeona initiated the first commercial treatment of prademagene zamikeracel, Zevaskyn, for recessive dystrophic epidermolysis bullosa at Stanford. The autologous, gene-modified epithelial sheet therapy delivers a functional COL7A1 gene to support durable wound closure without immunosuppression.

Fate Therapeutics presented a Phase 1 update of FT819, an off-the-shelf iPSC-derived CD19 CAR T for systemic lupus erythematosus. Twelve SLE patients have been treated, with meaningful SLEDAI-2K reductions, complete renal responses in two patients with lupus nephritis, and no Grade greater than 2 CRS or ICANS reported.

Novartis reported positive Phase 3 VAYHIT2 results for ianalumab plus eltrombopag in second-line primary ITP. Time to treatment failure was 13.0 months versus 4.7 months on placebo plus eltrombopag, and stable response at six months was 62% versus 39%, with a generally consistent safety profile.

Barinthus Bio reported Phase 1 AVALON single-dose results for VTP-1000 in celiac disease. Eighteen adults were enrolled across three cohorts; the therapy was well tolerated with no treatment-related serious adverse events and showed dose-dependent pharmacology. The multiple-dose portion with gluten challenge is ongoing.

Arcus Biosciences will discontinue the Phase 3 STAR-221 study of domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal cancers after a futility determination at an interim overall survival analysis. The company will prioritize casdatifan and early immunology programs.

Finally, Ascletis reported Phase 1 data for ASC50, an AI-discovered oral IL-17 inhibitor. No serious adverse events were observed, and pharmacokinetics and target engagement support once-daily or once-weekly dosing up to 600 mg in psoriasis and healthy participants.

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FAQ

What did VAYHIT2 show for ianalumab in ITP?

Novartis reports longer time to treatment failure and higher 6-month stable platelet response with ianalumab plus eltrombopag vs placebo plus eltrombopag, with a consistent safety profile [5].

How far along is FT819 for autoimmune disease?

Fate’s Phase 1 update in SLE describes durable clinical improvements with favorable safety and less-intensive conditioning; the company plans a registrational study in 2026 [4].

What makes Zevaskyn notable for RDEB?

It is an autologous gene-modified epithelial sheet therapy restoring COL7A1 at wound sites; the first commercial patient has been treated in the US [3].

Why did Arcus stop STAR-221?

An interim analysis found no OS advantage for the domvanalimab-based regimen over nivolumab plus chemotherapy, prompting discontinuation and a pivot to other programs [7].

What is NAV-240 aiming to improve in HS?

By dual targeting OX40L and TNFα, the bispecific aims for synergistic, durable responses beyond TNFα blockade alone; Phase 1b visits are complete with readout planned (endpoint not specified) [1].

What changes with CONMED’s GI exit?

CONMED will end VIABIL distribution on 01 Jan 2026, expects 2026 EPS dilution but improved margins, and reaffirms 2025 guidance as it focuses on core surgical areas [2].

Entities / Keywords

Navigator Medicines, NAV-240, OX40L, TNFα, hidradenitis suppurativa.
CONMED, VIABIL biliary stent, portfolio optimization.
Abeona Therapeutics, prademagene zamikeracel, Zevaskyn, RDEB.
Fate Therapeutics, FT819, iPSC CAR T, SLE, autoimmune.
Novartis, ianalumab, VAYHIT2, ITP, eltrombopag.
Barinthus Biotherapeutics, VTP-1000, SNAP-TI, celiac disease.
Arcus Biosciences, domvanalimab, zimberelimab, STAR-221.
Ascletis Pharma, ASC50, IL-17 inhibitor, psoriasis.

References

  1. https://www.dermatologytimes.com/view/phase-1b-trial-completed-for-potential-hs-therapy-nav-240
  2. https://www.businesswire.com/news/home/20251205036683/en/CONMED-Corporation-Announces-Strategic-Exit-from-Gastroenterology-Product-Lines
  3. https://www.dermatologytimes.com/view/abeona-initiates-first-commercial-treatment-of-zevaskyn-for-rdeb
  4. https://www.globenewswire.com/news-release/2025/12/08/3201474/24675/en/Fate-Therapeutics-Presents-Updated-Phase-1-Clinical-Data-of-FT819-Off-the-shelf-CAR-T-cell-Product-Candidate-for-Systemic-Lupus-Erythematosus-and-Preclinical-Advances-in-Next-Gener.html
  5. https://www.novartis.com/news/media-releases/novartis-ianalumab-significantly-extends-disease-control-patients-immune-thrombocytopenia-only-four-once-monthly-doses
  6. https://firstwordpharma.com/story/6738374
  7. 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
  8. https://www.europeanpharmaceuticalreview.com/news/269358/ai-discovered-il-17-inhibitor-ascletis-pharma-best-in-class-potential/
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