🔬 This week in Immunology Updates: Immunology Licensing Deal, Phase II SKYWAY trial and More!
From major industry deals to fresh clinical milestones, these stories are driving immunology innovation and shaping the future of patient care. Here’s a snapshot of this week’s top updates:
In Today’s Newsletter
💊 Novartis inks up to $5.7B Monte Rosa immunology licensing deal [1] [15 Sep 2025]
https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-signs-up-57-billion-licensing-deal-with-monte-rosa-therapeutics-2025-09-15/
Context: Second tie-up in <1 year; prior MRT-6160 deal ($150M upfront, up to $2.1B); Monte Rosa’s QuEEN molecular glue platform; shares +50%.
Key point: Novartis gets exclusive rights to an undisclosed immunology target and options on two programs; $120M upfront plus milestones/royalties.
Implication: Signals pipeline investment and modality expansion.
🧬 Spyre starts Phase II SKYWAY of TL1A mAb SPY072 in RA/axSpA/PsA [2] [16 Sep 2025]
https://www.clinicaltrialsarena.com/news/spyre-rheumatic-trial/
Context: Randomised, placebo-controlled basket; SPY072 is extended half-life anti-TL1A; Phase I interim: tolerated, extended PK, reduced free TL1A.
Key point: Dosing initiated; topline 12-week (RA) and 16-week (PsA/axSpA) readouts planned 2026 (proof-of-concept).
Implication: May influence prescriber choice and payer reviews pending full data.
🍽️ GLP-1s linked to RA symptom reductions (observational) [3] [15 Sep 2025]
Context: Records review (n=229) in overweight/obese RA on semaglutide (SC/oral) or tirzepatide; ~⅓ discontinued (insurance/GI); limited diversity.
Key point: 32% vs 17% symptom improvement over 1 year for GLP-1 users vs non-users; P=0.16; pain −0.6 vs +1.3; weight −9.7 lbs.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🏛️ AbbVie settles Rinvoq generic suits; US entry blocked until Apr 2037 [4] [US • 11 Sep 2025]
Context: Resolves 2023 litigation vs Sandoz, Hetero, Aurobindo, Intas, Sun; Orange Book protections run 2033–2038.
Key point: Settlements prevent upadacitinib generics from entering the U.S. before Apr 2037.
Implication: Introduces competition that may affect pricing and formulary access.
🧴 Rocatinlimab (Amgen/Kyowa Kirin) long-term AD data signal durability [5]
Context: ASCEND (~2,600) ongoing to 104 weeks; adult responders on Q4W/Q8W monotherapy evaluated.
Key point: Preliminary topline: low discontinuation due to AEs; adult responders generally maintained benefit at ~1 year (metrics not specified).
Implication: May influence prescriber choice and payer reviews pending full data.
🌊 Amlitelimab hits primary endpoints in Phase 3 COAST 1 (AD) [6]
Context: Global, randomised, double-blind Phase 3 (n=601); SC Q4W or Q12W; anti-OX40L, non-T-cell depleting.
Key point: Week 24 vIGA-AD 0/1: 26.5% (Q4W)/29.1% (Q12W) vs 10.5%; EASI-75: 46%/50.3%; acceptable safety.
Implication: May influence prescriber choice and payer reviews pending full data.
📜 J&J files EMA application for icotrokinra (oral IL-23R) in plaque psoriasis [7] [EU • 11 Sep 2025]
https://finance.yahoo.com/news/johnson-johnson-seeks-first-european-115600457.html
Context: ICONIC program: four Phase 3s (LEAD, TOTAL, ADVANCE 1/2); includes adolescents and difficult-to-treat sites.
Key point: Company reports all primary/co-primary endpoints met and superiority vs deucravacitinib; once-daily oral peptide.
Implication: May influence prescriber choice and payer reviews pending full data.
💸 Jeito joins $213M Series D for Odyssey Therapeutics (IBD, IRAK4/RIPK2) [8] [EU • 10 Sep 2025]
https://uk.finance.yahoo.com/news/jeito-capital-announces-significant-participation-123000650.html
Context: Jeito adds board seat; Odyssey (founded 2021) with US/EU footprint and partnerships.
Key point: Funds advance OD-07656 (oral RIPK2 scaffolding inhibitor) for IBD and preclinical IRAK4 scaffolding program (AD, HS, OA).
Implication: Signals pipeline investment and modality expansion.
Why it matters
- Big Pharma is leaning into novel immunology modalities (molecular glues, oral IL-23R, OX40/OX40L).
- Exclusivity extensions (Rinvoq) shape U.S. pricing and access into the 2030s.
- TL1A is emerging across rheum/IBD, broadening anti-inflammatory options.
- Early RWE hints GLP-1 benefits may extend into autoimmune inflammation.
- VC funding fuels innate-immunity small molecules (RIPK2/IRAK4) for IBD and derm.
📢 Stay Ahead in Immunology Updates!
✅ Contact LucidQuest at info@lqventures.com for strategic guidance on immunology innovations and clinical research.
FAQ
What did Novartis license from Monte Rosa?
Context: Second collaboration in <1 year leveraging Monte Rosa’s QuEEN platform.
Answer: An undisclosed immunology target (exclusive) plus options on two programs; $120M upfront, up to $5.7B total per Reuters [1].
When could U.S. Rinvoq generics arrive?
Context: Multiple Orange Book patents list protections to 2038.
Answer: Under the settlements, not before April 2037 in the U.S. [4].
How strong are the GLP-1 data in RA?
Context: Observational analysis (n=229) with discontinuations and limited diversity.
Answer: Directional signal (32% vs 17% improvement; P=0.16) with pain/weight benefits; needs prospective trials [3].
How do amlitelimab and rocatinlimab differ mechanistically?
Context: Both target the OX40 axis.
Answer: Amlitelimab blocks OX40L; rocatinlimab targets OX40. Amlitelimab’s Phase 3 met endpoints; rocatinlimab topline emphasizes durability/safety without detailed efficacy figures [5][6].
What’s distinctive about icotrokinra vs current oral options?
Context: First-in-class oral peptide blocking IL-23R.
Answer: EMA filing cites four Phase 3s meeting endpoints and superiority vs deucravacitinib; once-daily dosing [7].
Entities / Keywords
Novartis; Monte Rosa Therapeutics; molecular glue degrader; QuEEN; TL1A; SPY072; rheumatoid arthritis (RA); psoriatic arthritis (PsA); axial spondyloarthritis (axSpA); GLP-1 RA (semaglutide; tirzepatide); AbbVie; Rinvoq (upadacitinib); Sandoz; Hetero; Aurobindo; Intas; Sun; Amgen; Kyowa Kirin; rocatinlimab; OX40; Sanofi; amlitelimab; OX40L; Johnson & Johnson; icotrokinra; IL-23 receptor; deucravacitinib; ustekinumab; Jeito Capital; Odyssey Therapeutics; OD-07656; RIPK2; IRAK4; IBD; atopic dermatitis (AD).
References
- https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-signs-up-57-billion-licensing-deal-with-monte-rosa-therapeutics-2025-09-15/
- https://www.clinicaltrialsarena.com/news/spyre-rheumatic-trial/
- https://www.managedhealthcareexecutive.com/view/glp-1s-improve-rheumatoid-arthritis-symptoms-study-suggests
- https://www.fiercepharma.com/pharma/abbvie-settles-generic-rinvoq-hopefuls-shielding-immunology-blockbusters-us-sales-until-2037
- https://pmlive.com/pharma_news/amgen-and-kyowa-kirin-announce-rocatinlimab-results-for-atopic-dermatitis/
- https://www.pharmacytimes.com/view/amlitelimab-meaningfully-clears-skin-in-moderate-to-severe-atopic-dermatitis
- https://finance.yahoo.com/news/johnson-johnson-seeks-first-european-115600457.html
- https://uk.finance.yahoo.com/news/jeito-capital-announces-significant-participation-123000650.html