Immunology Weekly News - October 1st 2025

Immunology Update: EndoQuest Robotics, $1.8M NIH grant, BMS Patient Connect and More

From EndoQuest Robotics’ first fully robotic ESD procedure in the pivotal PARADIGM trial to Allergan Aesthetics’ AA Signature™ global launch at AMWC Dubai, this week’s news signals strong innovation and growing patient access.

In Today’s Newsletter

🤖 First fully robotic ESD by a gastroenterologist (PARADIGM) [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: PARADIGM plans ~50 subjects across five US centers; follows initial surgeon-led cases; EndoQuest targets a De Novo submission post-trial.

Key point: Mayo Clinic’s Dr. Norio Fukami performed a fully robotic endoscopic submucosal dissection using EndoQuest’s ELS in the FDA IDE pivotal PARADIGM trial; a 4 cm colorectal lesion was removed (descriptive only).

Implication: May expand screening, initiation, and follow-up at scale.

💸 NIH backs TRE-515 for Crohn’s (preclinical) [2] [US • 24 Sep 2025]

https://www.biospace.com/press-releases/trethera-receives-1-8-million-nih-grant-to-advance-tre-515-development-for-crohns-disease

Context: Prior $400k NIH grant; preclinical work reported superiority vs Stelara in mice; TRE-515 also in Phase 1 for solid tumors and ALS.

Key point: Trethera won a $1.8M NIH grant to advance TRE-515, a once-daily oral dCK inhibitor, as a Crohn’s therapy; NIH review cited innovation and favorable safety in prelim data.

Implication: Signals pipeline investment and modality expansion.

✨ Allergan Aesthetics’ AA Signature™ goes global at AMWC Dubai [3] [US • 25 Sep 2025]

https://news.abbvie.com/2025-09-25-Allergan-Aesthetics-to-Showcase-Multimodal-Treatment-Approach-and-Continued-Commitment-to-Skin-Quality-at-AMWC-Dubai

Context: AMI and Global Medical Affairs symposia to focus on skin quality; seven e-posters accepted across products/indications.

Key point: Allergan Aesthetics to showcase AA Signature™ multimodal approach; launched in 25+ countries with live injection demo and education tracks.

Implication: Signals pipeline investment and modality expansion.

📦 BMS “Patient Connect” adds Sotyktu; Eliquis DTP expands [4] [US • 25 Sep 2025]

https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Builds-on-Eliquis-apixaban-Direct-to-Patient-Program-Announces-New-BMS-Patient-Connect-Platform-Offering-Sotyktu-deucravacitinib/default.aspx

Context: Ships across 50 US states and Puerto Rico; supports eligible cash-pay patients; future expansion to other BMS meds contemplated.

Key point: From Jan 2026, Sotyktu offered >80% below list via BMS’s direct-to-patient platform; Eliquis available to cash-pay patients at >40% below list.

Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🇰🇷 Korea to reimburse Bylvay (odevixibat) for PFIC [5] [KR • 25 Sep 2025]

https://www.koreabiomed.com/news/articleView.html?idxno=29105

Context: PFIC is ultra-rare with severe pruritus and liver damage; clinicians expect improved bile acids/pruritus and potential liver function preservation; approved via Korea’s parallel approval-reimbursement pilot.

Key point: Ipsen’s Bylvay to be covered by Korea’s national health insurance starting October, bringing first oral PFIC therapy to patients.

Implication: May expand screening, initiation, and follow-up at scale.

🧬 Aera nominates AERA-109 (in vivo CAR-T for autoimmune) [6] [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: tLNP delivery reprograms T cells in vivo; avoids lymphodepletion, complex manufacturing, and viral vectors; clinical start planned mid-2026.

Key point: Preclinical data show dose-dependent in vivo CAR-T generation and deep B-cell depletion in humanized mice and NHPs; AERA-109 selected as first development candidate.

Implication: Signals pipeline investment and modality expansion.

🌏 J&J’s “Dual Control” IBD campaign in APAC [7] [SG • 30 Sep 2025]

https://www.taiwannews.com.tw/news/6210333

Context: Materials cite low sustained remission in CD (~10%), presenteeism gap in Japan (25.7% vs 20.1%), and low awareness of “mucosal healing”; delivers regional educational tools.

Key point: Johnson & Johnson launched an APAC awareness initiative promoting shared decision-making and endoscopic remission for IBD.

Implication: May expand screening, initiation, and follow-up at scale.

🧪 TCR therapy targets CTNNB1 S37F “public” mutation [8] [NO • 29 Sep 2025]

https://medicalxpress.com/news/2025-09-immunotherapy-common-cancer-mutation-lung.html

Context: Targets a shared driver mutation via common HLA contexts; preclinical results show selectivity for mutant cells and full tumor clearance in models.

Key point: University of Oslo team reports Nature Immunology data: engineered TCRs eliminate CTNNB1S37F-mutant tumors in organoids and animal models.

Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Robotics in endoscopy may lower ESD learning curves and expand organ-sparing options [1].
New Crohn’s mechanisms (dCK inhibition) could diversify beyond cytokine pathways if clinical data emerge [2].
Direct-to-patient channels and steep list-price discounts pressure traditional pharmacy models and may improve affordability [4].
National coverage for ultra-rare diseases can reshape standard of care and reduce transplant reliance [5].
In vivo CAR-T approaches could simplify cell therapy logistics for autoimmune indications [6].

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✅ Contact LucidQuest at info@lqventures.com for strategic guidance on immunology innovations and clinical research.

FAQ

What is EndoQuest’s ELS being evaluated for in PARADIGM?

A robotic endoluminal platform enabling advanced GI procedures, including ESD; the pivotal IDE trial aims for ~50 subjects across five US sites, with De Novo submission planned after completion [1].

How does TRE-515 differ from existing Crohn’s treatments?

It inhibits deoxycytidine kinase (dCK), targeting metabolic pathways of activated immune cells. Current evidence is preclinical; NIH reviewers cited innovation and favorable safety signals in preliminary data [2].

What will BMS Patient Connect change for Sotyktu access?

Starting Jan 2026, eligible US cash-pay patients can buy Sotyktu >80% below list directly from BMS, with nationwide shipping and support; Eliquis is already available >40% below list via a related program [4].

When will Korean PFIC patients get reimbursed access to Bylvay?

From October (2025), via national health insurance, as the first oral therapy option for PFIC under Korea’s parallel approval-reimbursement pilot program [5].

What makes AERA-109 notable among CAR-T approaches?

It generates CAR-T cells in vivo using targeted LNPs, aiming to avoid lymphodepletion, viral vectors, and complex manufacturing; preclinical data show deep B-cell depletion, with clinical entry planned mid-2026 [6].

Which mutation does the Oslo group’s TCR therapy target?

CTNNB1S37F, a shared driver mutation across multiple solid tumors; preclinical models showed selective tumor killing and complete clearance in some settings (organisms/models), pending clinical validation [8].

Entities / Keywords

EndoQuest Robotics; Endoluminal Surgical (ELS) System; PARADIGM trial; Trethera; TRE-515; deoxycytidine kinase (dCK); Allergan Aesthetics (AbbVie); AA Signature™; AMWC Dubai; MD Codes™; Bristol Myers Squibb; Sotyktu (deucravacitinib; TYK2 inhibitor); Eliquis (apixaban); Ipsen; Bylvay (odevixibat); PFIC; Korea NHI; Aera Therapeutics; AERA-109; targeted LNP (tLNP); in vivo CAR-T; Johnson & Johnson; IBD; shared decision-making; endoscopic remission; University of Oslo; CTNNB1S37F; TCR therapy; Nature Immunology.

References