RG6730 / Roche, Pfizer - LARVOL DELTA

Targeting the TL1A pathway in inflammatory bowel disease: mechanistic insights and emerging therapeutic pipeline. (PubMed, Inflamm Bowel Dis) - "Three anti-TL1A monoclonal antibodies (tulisokibart, afimkibart, and duvakitug) have advanced to phase 3 trials across multiple global programs, with phase 2 clinical remission rates of 26%-48% in ulcerative colitis (placebo-adjusted differences 15-26 percentage points) and endoscopic response rates of 26%-48% in Crohn's disease, alongside favorable safety profiles...The pipeline has expanded to at least 19 development programs, including extended half-life antibodies (XmAb942, SPY002, and BCD-261), bispecifics combining TL1A with IL-23 or α4β7 (RO7837195, XmAb412, LQ080, and ALX001), a first-in-class oral anti-TL1A nanobody, and a first-in-class DR3 receptor antagonist (SL-325). We discuss therapeutic positioning and timing, the opportunity in acute severe UC, and the unusual standing of IBD as the lead indication for this mechanism class."

Journal • Review • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • CD40LG • IL23A • TNFA • TNFRSF25 • TNFSF15

A PHASE 1 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF THE P40XTL1A BISPECIFIC ANTIBODY PF-07261271 IN HEALTHY PARTICIPANTS (UEGW 2026) - No abstract available

Bispecific • Clinical • P1 data • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-07261271 in healthy participants. (PubMed, Br J Clin Pharmacol) - P1 | "PF-07261271 demonstrated p40 and TL1A target engagement and a favourable safety profile. Further studies are warranted to evaluate its safety and efficacy in patients with IBD."

Clinical • Journal • P1 data • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • IL12A

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2 | N=224 | Recruiting | Sponsor: Genentech, Inc.

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2 | N=224 | Recruiting | Sponsor: Genentech, Inc.

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the p40xTL1A bispecific antibody PF-07261271 in healthy participants. (ECCO-IBD 2026) - "Conclusion PF-07261271 demonstrated p40 and TL1A target engagement and a favorable safety profile. Further studies are warranted to evaluate its safety and efficacy in patients with IBD."

Clinical • P1 data • PK/PD data • Inflammatory Bowel Disease • IL12A • TNFA

GA45977: A Study to Assess the Efficacy, Safety, and what the body does to RO7837195 in Participants with Moderately to Severely Active Ulcerative Colitis (clinicaltrialsregister.eu) - P1/2 | N=84 | Recruiting | Sponsor: Genentech Inc.

New P1/2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2 | N=224 | Recruiting | Sponsor: Genentech, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2 | N=224 | Not yet recruiting | Sponsor: Genentech, Inc. | Trial completion date: May 2028 ➔ Oct 2028

Trial completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2 | N=224 | Not yet recruiting | Sponsor: Genentech, Inc.

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis