This week’s immunology news update includes Zenas BioPharma securing global rights to orelabrutinib, Nilo Therapeutics launching a $101M neuro-immune program, and Everest Medicines reporting Phase 3 ENLIGHT UC results. Lilly, AbbVie, and J&J also provide updates on UC therapies, including FDA approvals, label expansions, and long-term clinical data.
🤝 Zenas licenses orelabrutinib + 2 assets from InnoCare, raises $120M [1] [08 Oct 2025]
Context: Orelabrutinib BTK inhibitor in Phase 3 for PPMS, SPMS planned 1Q26; IL-17AA/AF and brain-penetrant TYK2 in IND-enabling; RRMS Phase 2 showed Gd+ T1 lesion reduction.
Key point: Zenas gains global non-oncology rights to orelabrutinib and ex-Greater China rights to IL-17AA/AF, plus global TYK2; pays up to $100M near term and milestones exceeding $2B total; $120M private placement.
Implication:Signals pipeline investment and modality expansion.
🧠 Nilo Therapeutics debuts with $101M to harness neural circuits in immunology [2] [08 Oct 2025]
Context: Founders from Columbia, Yale, Harvard; focus on vagal neuron–immune pathways; CEO Kim Seth; CSO Laurens Kruidenier.
Key point: Series A led by The Column Group, DCVC Bio, Lux, with Gates Foundation and Alexandria; funds labs in New York and preclinical programs.
Implication: Signals pipeline investment and modality expansion.
📄 Etrasimod ENLIGHT UC Phase 3 (Asia) published in Lancet Gastro & Hepatology [3] [09 Oct 2025]
Context: 340-patient randomized study, 12-week induction, 40-week maintenance; endpoints included clinical remission, endoscopic outcomes; RWE notes guidelines support.
Key point: Etrasimod significantly improved primary and secondary endpoints in induction and maintenance; mucosal healing 51.9% at Week 52 in treated vs 8.8% placebo; safety consistent.
Implication: May influence prescriber choice and payer reviews pending full data.
📈 Omvoh shows 4-year sustained benefit in UC OLE (LUCENT-3) [4] [10 Oct 2025]
https://pmlive.com/pharma_news/lillys-omvoh-shows-improved-outcomes-in-ulcerative-colitis/
Context: Open-label extension following LUCENT-2; assesses long-term outcomes and QoL.
Key point: 78% corticosteroid-free clinical remission, 78% long-term remission, 90% remission on IBD Questionnaire over 4 years; safety consistent.
Implication: May influence prescriber choice and payer reviews pending full data.
🏷️ FDA broadens Rinvoq use earlier in UC and Crohn’s when TNFs inadvisable [5] [13 Oct 2025]
Context: JAK inhibitor previously positioned post-TNF; supported by Phase 3 UC and Crohn’s programs.
Key point: Label now allows use before TNF blockers in adults with moderately to severely active UC and Crohn’s when TNFs are clinically inadvisable and after ≥1 systemic therapy.
Implication: Introduces competition that may affect pricing and formulary access.
📜 Palisade Bio wins Canadian patent for PALI-2108 (PDE4 B/D) [6] [13 Oct 2025]
Context: Ileocolonic-targeted, gut microbiota–bioactivated PDE4 inhibitor for FSCD and UC; composition-of-matter protection to 28 May 2041.
Key point: Patent covers PALI-2108’s galactose-derived prodrug design aiming for colon-specific activation; FSCD Phase 1b dosing expected H2 2025, topline Q1 2026.
Implication: Signals pipeline investment and modality expansion.
🧪 Icotrokinra (oral IL-23R peptide) hits Phase 2b endpoints in UC [7] [07 Oct 2025]
Context: ANTHEM-UC randomized Phase 2b; Week 12 analyses across doses; safety similar to placebo through Week 12.
Key point: All doses met primary clinical response; at 400 mg, 63.5% clinical response vs 27% placebo and 36.5% endoscopic improvement; Phase 3 ICONIC-UC and Phase 2b/3 ICONIC-CD initiated.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 TREMFYA fully SC regimen sustains UC outcomes through 48 weeks (ASTRO) [8] [07 Oct 2025]
Context: Phase 3 SC induction and maintenance; outcomes reported at Week 48; analyses include prior-therapy subgroups.
Key point: Clinical remission 36.7%–42.9% and endoscopic remission 25.9%–26.4% at Week 48 vs 7.2% and 5% placebo; safety consistent; SC induction now approved in US.
Implication: May influence prescriber choice and payer reviews pending full data.
🧒 FDA approves SIMPONI for pediatric UC, ≥15 kg, monthly maintenance [9] [07 Oct 2025]
Context: PURSUIT program open-label pediatric studies.
Key point: Week 6 clinical remission 32%, response 58%, endoscopic improvement 40%; 57% maintained remission at Week 54 among Week 6 remitters; dosing by weight with SC admin.
Implication: May expand screening, initiation, and follow-up at scale.
🛡️ FDA approves adjuvant cemiplimab for high-risk CSCC (post-surgery/radiation) [10] [13 Oct 2025]
Context: Phase 3 C-POST randomized, placebo-controlled adjuvant trial; priority review.
Key point: Cemiplimab reduced risk of recurrence or death by 68% (HR 0.32); 24-month DFS 87.1% vs 64.1% placebo; safety aligned with known profile.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Oral and subcutaneous options are expanding in UC, potentially improving access and adherence across patient types.
- Label evolution for JAKs could shift first-line advanced therapy choices when TNFs are inadvisable.
- Novel modalities, including oral IL-23 receptor blockade and neuro-immune circuit targeting, diversify mechanisms in immunology.
- Patent and financing moves bolster runway for emerging programs in IBD and fibrostenotic Crohn’s.
- Adjuvant immunotherapy in CSCC fills a high-risk gap after surgery and radiation.
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FAQ
What rights did Zenas gain for orelabrutinib and other assets?
Zenas obtained global non-oncology rights for orelabrutinib in MS and ex-Greater China and Southeast Asia rights for an oral IL-17AA/AF inhibitor, plus global rights for a brain-penetrant TYK2 inhibitor [1].
How strong were etrasimod’s results in Asian UC patients?
In ENLIGHT, etrasimod significantly improved clinical remission and endoscopic endpoints in induction and maintenance; mucosal healing reached 51.9% at Week 52 vs 8.8% placebo, with consistent safety [3].
What does Rinvoq’s updated FDA label change in IBD?
It allows use before TNF blockers in adults with UC or Crohn’s when TNFs are clinically inadvisable and after at least one systemic therapy, expanding prescriber flexibility [5].
What distinguishes icotrokinra from existing IL-23 therapies?
It is a targeted oral peptide that selectively blocks the IL-23 receptor; Phase 2b showed higher clinical response and endoscopic improvement vs placebo at Week 12, with Phase 3 underway in UC [7].
Is TREMFYA fully subcutaneous through induction and maintenance in UC?
Yes. ASTRO shows sustained Week 48 clinical and endoscopic outcomes with SC induction and SC maintenance, with safety consistent with prior data [8].
What is new for pediatric UC treatment with SIMPONI?
FDA approved SIMPONI for children ≥15 kg with moderately to severely active UC, offering SC dosing and monthly maintenance, supported by PURSUIT data [9].
Entities / Keywords
Zenas BioPharma; InnoCare Pharma; orelabrutinib (BTK inhibitor); IL-17AA/AF inhibitor; TYK2 inhibitor; Nilo Therapeutics; neuro-immune circuits; Everest Medicines; etrasimod, VELSIPITY; ulcerative colitis; Eli Lilly; Omvoh, mirikizumab; AbbVie; upadacitinib, Rinvoq; Palisade Bio; PALI-2108; Johnson & Johnson; icotrokinra; TREMFYA, guselkumab; SIMPONI, golimumab; Regeneron; cemiplimab, Libtayo; CSCC.
References
- https://www.globenewswire.com/news-release/2025/10/08/3163133/0/en/Zenas-BioPharma-and-InnoCare-Pharma-Announce-License-Agreement-Granting-Zenas-Rights-for-Three-Autoimmune-Product-Candidates-Including-Orelabrutinib-a-BTK-Inhibitor-in-Phase-3-Deve.html
- https://www.fiercebiotech.com/biotech/immunology-biotech-nilo-launches-101m-and-mission-harness-neural-circuits
- https://www.everestmedicines.com/news/everest-medicines-announces-publication-of/4af6c384-88b5-40a8-93f1-85a5bde6c12d
- https://pmlive.com/pharma_news/lillys-omvoh-shows-improved-outcomes-in-ulcerative-colitis/
- https://www.pharmacytimes.com/view/fda-approves-updated-indication-for-upadacitinib-in-patients-with-ibd
- https://www.globenewswire.com/news-release/2025/10/13/3165548/0/en/Palisade-Bio-Granted-Canadian-Patent-Covering-Composition-of-Lead-Product-Candidate-PALI-2108.html
- https://www.jnj.com/media-center/press-releases/icotrokinra-data-in-ulcerative-colitis-show-potential-for-a-standout-combination-of-therapeutic-benefit-and-a-favorable-safety-profile-in-once-daily-pill
- https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-is-first-and-only-il-23-inhibitor-to-demonstrate-sustained-clinical-and-endoscopic-outcomes-with-a-fully-subcutaneous-regimen-through-48-weeks-in-ulcerative-colitis
- https://www.jnj.com/media-center/press-releases/u-s-fda-approves-simponi-golimumab-for-the-treatment-of-pediatric-ulcerative-colitis
- https://www.dermatologytimes.com/view/fda-approves-cemiplimab-as-adjuvant-immunotherapy-for-high-risk-cscc