Immunology Today—May 13, 2026

This week’s Immunology update highlights regulatory actions, clinical progress, partnership activity, and data releases across autoimmune and inflammatory diseases.

In Today’s Newsletter

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🧬 J&J JNJ-4804 Phase 2b DUET IBD data [1] [US • 05 May 2026]

https://www.jnj.com/media-center/press-releases/johnson-johnson-investigational-co-antibody-therapy-jnj-4804-shows-potential-to-raise-the-bar-for-clinical-efficacy-in-treating-refractory-inflammatory-bowel-disease
Context: JNJ-4804 (Johnson & Johnson; IL-23/TNF co-antibody) was evaluated in Phase 2b DUET-UC and DUET-CD studies in refractory ulcerative colitis and Crohn’s disease.
Key point: At Week 48 in DUET-CD, JNJ-4804 showed clinical remission of 50.8% and endoscopic response of 38.1%, versus 25.4% and 19.8% for golimumab, and numerically above guselkumab.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Mabwell 9MW5211 FDA IND clearance [2] [US/China • 08 May 2026]

https://www.prnewswire.com/news-releases/worlds-first–mabwells-9mw5211-receives-fda-clearance-for-clinical-trial-application-302767139.html
Context: 9MW5211 (Mabwell; depleting antibody) is described as a first clinical-stage drug candidate for its target in autoimmune disease.
Key point: FDA cleared an IND for clinical studies in IBD, while China NMPA accepted clinical trial applications for IBD, multiple sclerosis, and other indications.
Implication: Signals pipeline investment and modality expansion.

🩺 AbbVie DDW 2026 IBD portfolio data [3] [US • 05 May 2026]

https://news.abbvie.com/2026-05-05-AbbVie-Highlights-New-Long-Term-Data-Advancing-Treatment-Standards-in-Inflammatory-Bowel-Diseases-IBD-at-2026-Digestive-Disease-Week-R
Context: AbbVie presented 18 DDW 2026 abstracts across risankizumab-rzaa (SKYRIZI) and upadacitinib (RINVOQ) in Crohn’s disease and ulcerative colitis.
Key point: ASPIRE-CD showed 52-week symptom, quality-of-life, and treatment-satisfaction gains with risankizumab; US claims analyses reported lower switch rates and lower odds of hospitalization after switching to upadacitinib.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💊 BMS Sotyktu EU approval in active psoriatic arthritis [4] [EU • 08 May 2026]

https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Receives-European-Commission-Approval-of-Sotyktu-deucravacitinib-for-the-Treatment-of-Active-Psoriatic-Arthritis-in-Adults/default.aspx
Context: Sotyktu (deucravacitinib; Bristol Myers Squibb; oral TYK2 inhibitor) was evaluated in Phase 3 POETYK PsA-1 and POETYK PsA-2.
Key point: The European Commission approved Sotyktu for active psoriatic arthritis in adults with inadequate response or intolerance to prior DMARD therapy.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Artiva AlloNK autoimmune data and Phase 3 RA alignment [5] [US • 08 May 2026]

https://www.globenewswire.com/news-release/2026/05/08/3290957/0/en/artiva-announces-positive-initial-clinical-data-with-allonk-across-multiple-autoimmune-diseases-and-fda-alignment-to-initiate-phase-3-registrational-trial-in-rheumatoid-arthritis-i.html
Context: AlloNK (Artiva; AB-101; allogeneic NK cell therapy) was studied with rituximab across refractory rheumatoid arthritis, Sjögren disease, and systemic sclerosis.
Key point: In company-sponsored Phase 2a RA patients with six months of follow-up, 71% achieved ACR50; FDA aligned on a planned single Phase 3 registrational RA trial of about 150 patients.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 AffyXell and ProAbTech LYTAC protein degrader partnership [6] [South Korea • 12 May 2026]

https://www.koreabiomed.com/news/articleViewAmp.html?idxno=31615
Context: AffyXell Therapeutics (Daewoong affiliate) and ProAbTech signed a joint research, development, and licensing agreement for LYTAC protein degrader therapeutics.
Key point: The companies will combine AffyXell’s eTPD platform with ProAbTech’s SelecAll site-specific protein-conjugation platform to develop autoimmune disease candidates.
Implication: Signals pipeline investment and modality expansion.

📈 Almirall Q1 2026 dermatology growth and pipeline update [7] [Europe • 11 May 2026]

https://www.businesswire.com/news/home/20260510507231/en/Almirall-Continues-Its-Positive-Trajectory-in-Q1-2026-in-Line-With-Expectations-Led-by-19.3-YoY-Growth-of-Its-European-Dermatology-Business
Context: Almirall reported Q1 2026 results, led by European Dermatology sales of €166.3 million, up 19.3% year over year.
Key point: Ebglyss (lebrikizumab) delivered €41.9 million in quarterly sales, Ilumetri (tildrakizumab) reached €61.6 million, and Almirall initiated Phase 1 testing of an anti-IL-13/OX40L bispecific antibody.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Dual-pathway and cell-therapy approaches are moving deeper into refractory autoimmune disease settings, including IBD and rheumatoid arthritis.
Real-world evidence remains central for marketed IBD assets, particularly persistence, switching, hospitalizations, and quality-of-life outcomes.
The Sotyktu EU psoriatic arthritis approval adds another oral targeted option for adults after prior DMARD failure or intolerance.
Protein degradation partnerships are expanding beyond intracellular targets toward extracellular and membrane proteins.
Dermatology growth remains biologics-led, with Almirall highlighting lebrikizumab and tildrakizumab as core commercial drivers.

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FAQ

What is JNJ-4804 in inflammatory bowel disease?

JNJ-4804 is Johnson & Johnson’s investigational fixed-dose co-antibody targeting IL-23 and TNF pathways. Phase 2b DUET data were reported in refractory ulcerative colitis and Crohn’s disease. [1]

What did Mabwell announce for 9MW5211?

Mabwell said FDA cleared the IND for 9MW5211 clinical studies in IBD. China NMPA also accepted clinical trial applications for IBD, multiple sclerosis, and other indications. [2]

Which AbbVie IBD assets were highlighted at DDW 2026?

AbbVie highlighted risankizumab-rzaa (SKYRIZI) and upadacitinib (RINVOQ). The data included ASPIRE-CD follow-up, US claims analyses, and Phase 3 post-hoc results in perianal fistulizing Crohn’s disease. [3]

What changed for Sotyktu in Europe?

The European Commission approved Sotyktu (deucravacitinib) for active psoriatic arthritis in adults with inadequate response or intolerance to prior DMARD therapy. It is described by BMS as the first TYK2 inhibitor approved for this EU indication. [4]

What is Artiva’s Phase 3 plan for AlloNK in rheumatoid arthritis?

Artiva said FDA aligned on a single randomized registrational trial of AlloNK plus rituximab versus rituximab alone in about 150 refractory RA patients. ACR50 at six months is the planned primary endpoint. [5]

What are AffyXell and ProAbTech developing together?

AffyXell and ProAbTech are developing LYTAC-based protein degrader candidates for autoimmune diseases. The collaboration combines AffyXell’s eTPD design platform with ProAbTech’s SelecAll conjugation platform. [6]

Entities / Keywords

Johnson & Johnson, JNJ-4804, IL-23/TNF co-antibody, DUET-UC, DUET-CD, ulcerative colitis, Crohn’s disease, inflammatory bowel disease, IBD
Mabwell, 9MW5211, FDA IND, NMPA, inflammatory bowel disease, multiple sclerosis, depleting antibody
AbbVie, SKYRIZI, risankizumab-rzaa, RINVOQ, upadacitinib, ASPIRE-CD, DDW 2026, Crohn’s disease, ulcerative colitis
Bristol Myers Squibb, BMS, Sotyktu, deucravacitinib, TYK2 inhibitor, psoriatic arthritis, POETYK PsA-1, POETYK PsA-2, DMARD
Artiva Biotherapeutics, AlloNK, AB-101, rituximab, rheumatoid arthritis, Sjögren disease, systemic sclerosis, ACR50, B-cell depletion
AffyXell Therapeutics, ProAbTech, Daewoong Pharmaceutical, LYTAC, eTPD, SelecAll, targeted protein degradation, TPD
Almirall, Ebglyss, lebrikizumab, Ilumetri, tildrakizumab, Wynzora, Klisyri, anti-IL-13/OX40L bispecific antibody, Huaota, medical dermatology