Immunology Today—October 22, 2025

This week in Immunology: the latest clinical updates, regulatory news, industry progress, and developments from leading biopharma companies.

In Today’s Newsletter

🧬 Orano Med & Sanofi’s AlphaMedix™ Shows Potential in GEP-NETs [1] Published: 20 Oct 2025

https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-20-06-30-00-3169092

Context: AlphaMedix™ demonstrated sustained and meaningful responses in treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in Phase 2 trials.

Key Point: Positive results support its first-in-class potential, with further clinical development planned.

Implication: AlphaMedix™ may offer a new treatment for rare, hard-to-treat cancers.

💔 Sanofi’s Rezurock Faces Setback in EU for cGVHD [2] Published: 17 Oct 2025

https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-17-11-00-00-3168524

Context: Sanofi’s Rezurock received a negative opinion from the EMA’s CHMP for chronic graft-vs-host disease (cGVHD) treatment, despite strong clinical evidence.

Key Point: The company plans to request a re-examination of the decision.

Implication: This delay may affect access to an important treatment option for cGVHD patients in the EU.

🌍 Roche’s Gazyva®/Gazyvaro® Recommended for Lupus Nephritis in EU [3] Published: 17 Oct 2025

https://www.roche.com/media/releases/med-cor-2025-10-17

Context: The EMA CHMP recommended Gazyva®/Gazyvaro® for lupus nephritis, based on Phase II and III data.

Key Point: Gazyva®/Gazyvaro® demonstrated superiority over standard therapy, offering a new option for lupus nephritis patients.

Implication: This could lead to better disease management for lupus nephritis, improving quality of life and kidney function preservation.

✅ FDA Approves Roche’s Gazyva®/Gazyvaro® for Lupus Nephritis [4] Published: 20 Oct 2025

https://www.roche.com/media/releases/med-cor-2025-10-20

Context: The FDA approved Gazyva®/Gazyvaro® for lupus nephritis, marking a potential new treatment standard.

Key Point: The approval is based on its ability to improve kidney function and reduce disease activity.

Implication: Gazyva®/Gazyvaro® could become the go-to treatment for lupus nephritis, offering better outcomes and convenience.

💡 Critical Path Institute Launches Pediatric IBD Project [5] Published: 16 Oct 2025

https://www.prnewswire.com/news-releases/c-paths-disease-modeling-coalition-begins-global-pediatric-ibd-work-from-european-hub-302585865.html

Context: C-Path announces the launch of the Pediatric Inflammatory Bowel Disease (IBD) project to improve drug development for pediatric Crohn’s and ulcerative colitis.

Key Point: This public-private initiative aims to create disease models that will inform regulatory submissions and optimize trials.

Implication: This could speed up the development of treatments for pediatric IBD, improving outcomes for children with these conditions.

🔬 Regeneron’s Libtayo® Recommended for EU Approval [6] Published: 17 Oct 2025

https://newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-recommended-eu-approval-chmp-adjuvant

Context: The European Medicines Agency (EMA) recommended Libtayo® for adjuvant treatment of high-risk cutaneous squamous cell carcinoma (CSCC).

Key Point: Libtayo® demonstrated significant reduction in recurrence risk in the C-POST trial.

Implication: If approved, Libtayo® would become a key treatment for preventing CSCC recurrence after surgery and radiation.

🚀 Replimune’s RP1 BLA Resubmission Accepted by FDA [7] Published: 16 Oct 2025

https://www.dermatologytimes.com/view/fda-accepts-rp1-bla-resubmission-for-advanced-melanoma

Context: The FDA has accepted the resubmission of the RP1 Biologics License Application (BLA) for advanced melanoma.

Key Point: The PDUFA date is set for April 10, 2026, with a potential approval for the combination of RP1 and nivolumab in PD-1 refractory melanoma.

Implication: RP1 could represent a new therapeutic approach for patients who have failed traditional PD-1 therapies.

💊 Artiva Biotherapeutics Advances AlloNK® for RA [8] Published: 16 Oct 2025

https://www.sahmcapital.com/news/content/artiva-biotherapeutics-announces-refractory-rheumatoid-arthritis-as-lead-indication-upcoming-data-releases-and-corporate-update-2025-10-16

Context: Artiva prioritizes refractory rheumatoid arthritis (RA) as its lead indication for AlloNK®, which has received FDA Fast Track Designation.

Key Point: AlloNK® aims to enhance B-cell depletion in RA, with clinical data expected by 2026.

Implication: AlloNK® could become a breakthrough therapy for refractory RA, offering a potential solution for patients who do not respond to existing treatments.

🔬 Augurex Expands JOINTstat® Test Availability in Canada [9] Published: 16 Oct 2025

https://www.businesswire.com/news/home/20251015955737/en/Augurex-Announces-Expansion-of-Availability-of-the-JOINTstat-Diagnostic-Test-for-Rheumatoid-Arthritis-with-MitogenDx

Context: Augurex partners with MitogenDx to expand access to JOINTstat® diagnostic testing for rheumatoid arthritis (RA) in Canada.

Key Point: JOINTstat® detects 14-3-3eta, a biomarker that supports early diagnosis and monitoring of RA progression.

Implication: This test could improve RA diagnosis and treatment, offering better outcomes for Canadian patients.

Why it Matters

AlphaMedix™ from Orano Med and Sanofi shows promise for treating advanced GEP-NETs, addressing a significant unmet need in rare cancers [1].
Sanofi’s Rezurock faces challenges in the EU, but the company is committed to seeking re-examination to offer a treatment option for cGVHD patients [2].
Roche’s Gazyva®/Gazyvaro® offers a new treatment option for lupus nephritis, both in the EU and the US, with strong efficacy data [3][4].
C-Path’s Pediatric IBD Project could accelerate the development of pediatric Crohn’s disease and ulcerative colitis treatments by using disease models [5].
Regeneron’s Libtayo® could offer a significant benefit in treating CSCC, reducing the risk of recurrence and improving patient outcomes [6].
Replimune’s RP1 could provide a new treatment option for advanced melanoma, particularly for patients who have failed PD-1 therapies [7].
Artiva Biotherapeutics’ AlloNK® shows potential to become a breakthrough therapy for refractory RA, improving treatment outcomes [8].
Augurex’s JOINTstat® expands access to a diagnostic tool that could significantly enhance RA management in Canada [9].

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FAQ

What is AlphaMedix™?

AlphaMedix™ is an investigational lead-212 based targeted alpha therapy (TAT) showing promising results in GEP-NETs, a rare and hard-to-treat cancer [1]

What happened with Sanofi’s Rezurock in the EU?

The EMA issued a negative opinion for Rezurock in treating cGVHD, but Sanofi plans to seek a re-examination [2]

What makes Gazyva®/Gazyvaro® effective for lupus nephritis?

Gazyva®/Gazyvaro® is effective in lupus nephritis by achieving a complete renal response and reducing corticosteroid use [3],[4]

What is C-Path’s Pediatric IBD project?

C-Path is developing disease models to accelerate drug development for pediatric inflammatory bowel diseases, aiming to improve treatment for Crohn’s and ulcerative colitis in children [5]

How does Libtayo® help with CSCC?

Libtayo® significantly reduces the risk of disease recurrence in patients with high-risk CSCC, offering a new adjuvant treatment option [6]

What is RP1’s role in treating melanoma?

RP1, combined with nivolumab, may provide a new treatment option for PD-1 refractory melanoma patients, with a potential approval in 2026 [7]

What is AlloNK® used for?

AlloNK® is a deep B-cell depleting therapy for refractory rheumatoid arthritis, showing promising early data [8]

How does JOINTstat® improve RA diagnosis?

JOINTstat® detects the 14-3-3eta biomarker, which supports earlier and more accurate diagnosis and monitoring of RA [9]

Entities / Keywords

Sanofi; Orano Med; AlphaMedix™; GEP-NETs; Rezurock; cGVHD; Roche; Gazyva®; Gazyvaro®; lupus nephritis; Critical Path Institute; Pediatric IBD; Regeneron; Libtayo®; CSCC; Replimune; RP1; melanoma; Artiva Biotherapeutics; AlloNK®; rheumatoid arthritis; Augurex; JOINTstat®.