Latest Immunology News - Sept 25th to Oct 8th 2025

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

From EndoQuest’s first fully robotic ESD in the PARADIGM trial to Ipsen’s insurance-backed Bylvay launch in Korea, this week’s updates highlight clinical progress and access gains — with Aera’s in vivo CAR-T, Arcutis’ pediatric approval, and a Nobel nod for immune tolerance research leading the way.

🤖 First fully robotic ESD by a gastroenterologist in PARADIGM IDE trial [1] [US • 25 Sep 2025]

https://www.globenewswire.com/news-release/2025/09/25/3156460/0/en/World-s-First-Fully-Robotic-Procedure-by-a-Gastroenterologist-Completed-Using-EndoQuest-s-Endoluminal-Surgical-System-in-the-PARADIGM-Trial.html
Context: Mayo Clinic Arizona physician used EndoQuest’s Endoluminal Surgical System to resect a complex 4 cm colorectal lesion (descriptor, not outcome). Pivotal multicenter IDE study, 50 subjects planned.
Key point: Marks the first fully robotic endoscopic submucosal dissection by a gastroenterologist within an FDA IDE pivotal trial.
Implication: Could streamline initiation and follow-up at scale.

💊 Korea to reimburse Bylvay for PFIC patients [2] [KR; 25 Sep 2025]

https://www.koreabiomed.com/news/articleView.html?idxno=29105
Context: National health insurance in Korea to cover odevixibat for PFIC starting October, addressing severe pruritus and liver damage in a very small patient population.
Key point: Coverage may enable oral disease management and reduce reliance on liver transplantation, per clinical experts.
Implication: May expand screening, initiation, and follow-up at scale.

🧬 Aera-109, in vivo CAR-T for autoimmune disease, named first development candidate [3] [US; 25 Sep 2025]

https://www.biospace.com/press-releases/aera-therapeutics-presents-preclinical-data-and-announces-nomination-of-first-development-candidate-aera-109-a-targeted-in-vivo-car-t-therapy-for-b-cell-mediated-autoimmune-diseases
Context: Preclinical data at CAR-TCR Summit showed targeted, dose-dependent in vivo CAR-T generation with deep B-cell depletion in humanized mice and NHPs.
Key point: AERA-109 leverages targeted LNPs for in vivo reprogramming, with clinical entry planned mid-2026 (timeline per company).
Implication: Signals pipeline investment and modality expansion.

🧒 FDA expands roflumilast to children 2–5 with AD [4] [US; 06 Oct 2025]

https://www.dermatologytimes.com/view/fda-expands-roflumilast-access-to-children-as-young-as-age-2
Context: Approval of roflumilast cream 0.05% for mild to moderate pediatric AD, supported by INTEGUMENT-PED and OLE; once-daily, steroid-free.
Key point: Source reports rapid improvements in severity and itch with favorable tolerability; formulation avoids common sensitizers.
Implication: May expand screening, initiation, and follow-up at scale.

🧫 FDA advises against immediate BLA for IO Biotech’s cylembio [5] [US; 02 Oct 2025]

https://www.dermatologytimes.com/view/fda-recommends-against-immediate-bla-filing-for-melanoma-vaccine-candidate
Context: Pre-BLA meeting following Phase 3 IOB-013/KN-D18. PFS improvement vs pembrolizumab monotherapy narrowly missed statistical significance.
Key point: Company will seek further FDA guidance and consider a new registrational study; EU pathway exploration noted.
Implication: May influence prescriber choice and payer reviews pending full data.

🏅 Nobel Medicine Prize goes to Treg pioneers Brunkow, Ramsdell, Sakaguchi [6] [EU; 07 Oct 2025]

https://www.reuters.com/business/healthcare-pharmaceuticals/brunkow-ramsdell-sakaguchi-win-2025-nobel-medicine-prize-2025-10-06/
Context: Recognized for discoveries in peripheral tolerance, FOXP3 and regulatory T cells; >200 human Treg trials ongoing per source.
Key point: Honors foundational work enabling tolerance-based therapies across autoimmunity and oncology.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧑‍⚕️ Early biologic initiation improves polyarticular JIA outcomes in STOP-JIA [7] [US; 03 Oct 2025]

https://www.prnewswire.com/news-releases/new-results-from-long-term-study-show-early-use-of-biologics-improves-outcomes-for-children-with-polyarticular-juvenile-idiopathic-arthritis-302574794.html
Context: Observational comparative effectiveness using CARRA Registry, ~300 children over 3 years, CTPs compared.
Key point: Early combination (biologic + MTX) linked to more time in inactive disease vs step-up; very early start (≤2 months) favored.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💉 Celltrion launches AVTOZMA (tocilizumab-anoh) IV in the US [8] [03 Oct 2025]

https://www.celltrion.com/en-us/company/media-center/press-release/4191
Context: FDA-approved Jan 2025 as IV biosimilar to Actemra, for RA, GCA, PJIA, SJIA, COVID-19 and CRS; multiple vial sizes.
Key point: Commercial availability announced with support programs; adds IL-6 pathway to Celltrion’s US immunology portfolio.
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

Pediatric access is expanding, with steroid-sparing topical options and an IL-6 biosimilar spanning JIA subtypes.
Early, aggressive treatment strategies in pediatric rheumatology gain real-world support that could influence care pathways.
Robotics and in vivo cell engineering point to less invasive, more scalable interventions across GI and autoimmunity.
The Treg Nobel highlights enduring momentum for tolerance-engineering modalities.

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FAQ

What is EndoQuest’s PARADIGM trial evaluating?

A pivotal IDE study of an endoluminal robotic system for lower GI procedures, including ESD. The first fully robotic ESD by a gastroenterologist was completed in this trial [1].

When will Bylvay be reimbursed in Korea and for whom?

Starting in October, for PFIC patients under the national health insurance program, improving access to oral therapy for a very small population [2].

How does AERA-109 differ from traditional CAR-T?

It uses targeted LNPs for in vivo generation of CAR-T cells to deplete B cells, aiming to avoid ex vivo manufacturing and lymphodepletion, per preclinical data [3].

What exactly did FDA approve for roflumilast?

Roflumilast cream 0.05% for mild to moderate atopic dermatitis in children aged 2–5, once daily and steroid-free, supported by INTEGUMENT studies [4].

Why did FDA discourage IO Biotech’s immediate BLA?

Their Phase 3 showed a PFS trend but missed statistical significance, prompting plans for further dialogue and potential new study design [5].

What does Celltrion’s AVTOZMA launch mean for US clinics?

An IV tocilizumab biosimilar option across Actemra’s indications, which may impact pricing and formulary access [8].

Entities / Keywords

EndoQuest Robotics; PARADIGM; endoluminal robotics; ESD; Ipsen; Bylvay; odevixibat; PFIC; reimbursement; Aera Therapeutics; AERA-109; in vivo CAR-T; targeted LNP; Arcutis; roflumilast 0.05%; pediatric AD; PDE4; IO Biotech; cylembio; imsapepimut; etimupepimut; melanoma; Nobel Prize; regulatory T cells; FOXP3; tolerance; CARRA; STOP-JIA; early biologic; methotrexate; Celltrion; AVTOZMA; tocilizumab-anoh; IL-6; biosimilar.
References