rosnilimab (ANB030) / AnaptysBio - LARVOL DELTA

Anaptys Announces Phase 2 Trial of Rosnilimab Did Not Meet Primary or Secondary Endpoints at Week 12 in Moderate-to-Severe Ulcerative Colitis (GlobeNewswire) - "...Lack of adequate efficacy at Week 12 does not support further development of rosnilimab in UC and trial will be discontinued....Regardless of prior treatment, rosnilimab performed no better than placebo at Week 12, with clinical remission achieved by 7% of patients receiving rosnilimab 400mg Q4W or 800 mg Q2W, and 5% and 4% of patients achieving endoscopic remission, respectively. While preliminary data suggest an increase in remission rates between Week 12 and Week 24, Week 24 remission rates did not meet our six-month target product profile."

P2 data • Trial termination • Ulcerative Colitis

Top-line data through Week 12 of global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced) on track for November/December 2025 (GlobeNewswire) - "Will report data on primary statistical analysis at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo Score (mMS) and key secondary endpoints, such as clinical response and remission on mMS."

P2 data • Ulcerative Colitis

Anaptys Announces New Positive Phase 2b Trial Results for Rosnilimab in Rheumatoid Arthritis at ACR Late-Breaking Oral Presentation (GlobeNewswire) - "As previously reported, at Week 12, statistically significant and clinically meaningful efficacy was achieved on the primary endpoint DAS28-CRP, as well as for ACR20, for all doses, including monthly doses (Q4W); At Week 28, CDAI LDA, CDAI remission and ACR50/70 rates continued to improve independent of prior treatments, including anti-TNFα, anti-IL6R or JAK inhibitors; Similar effects were seen for patients previously treated with at least two prior biologic or targeted synthetic disease-modifying antirheumatic drug classes (b/tsDMARDs), particularly at the mid (400mg Q4W) and high (600mg Q2W) doses..."

Late-breaking abstract • P2b data • Rheumatoid Arthritis

Rosnilimab, a Selective and Potent Depleter of Pathogenic T Cells, Demonstrates Efficacy, Safety, and Translational Proof of Mechanism in a Rheumatoid Arthritis Phase 2B Trial (ACR Convergence 2025) - P2 | "Rosnilimab selectively and potently depletes pathogenic T cells in RA leading to clinically meaningful and durable responses. These data support further exploration of rosnilimab in RA. Figure 1."

Clinical • Late-breaking abstract • P2b data • Immunology • Infectious Disease • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Anaptys Announces Late-Breaking Oral Presentation of Complete Phase 2b Data for Rosnilimab in Rheumatoid Arthritis at Upcoming ACR Convergence 2025 (GlobeNewswire)

P2b data • Rheumatoid Arthritis

PHENOTYPING OF HUMAN UC COLONIC TISSUE T CELLS REVEALS INFLAMMATORY PATHWAY GENE EXPRESSION IN PD-1+ CONVENTIONAL AND REGULATORY T CELLS WHICH OVERLAP WITH THOSE REGULATED BY ROSNILIMAB IN A MOUSE MODEL OF COLITIS (UEGW 2025) - P2 | "In UC colonic tissue, PD-1+ CD4 Tcon cells demonstrated increased inflammatory gene expression and PD-1+ Tregs exhibited a pro-inflammatory phenotype, suggesting that targeting both PD-1+ CD4 Tcon and PD-1+ Tregs may contribute to the therapeutic efficacy of rosnilimab in UC. These additional analyses support preclinical findings and suggest beneficial modulation of gene expression pathways of human UC, including reduction of pro-inflammatory cytokines and fibrosis, and upregulation of barrier function genes. These data demonstrate that PD-1 is upstream of multiple clinically validated drivers of UC and support the scientific rationale for studying rosnilimab in an ongoing Phase 2 study in UC (NCT06127043)."

IO biomarker • Preclinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CCL20 • IL2RA • IL6 • MMP9 • PD-1 • TBX21

ROSNILIMAB, A DEPLETER AND AGONIST TARGETING PD-1+ T CELLS, DOWNREGULATED AN INFLAMMATORY MYELOID GENE SIGNATURE IN A MURINE MODEL OF COLITIS THAT WAS UPREGULATED IN HUMAN UC COLON TISSUE (UEGW 2025) - P2 | "In addition to reducing pathogenic T cell numbers in this murine model of colitis, rosnilimab treatment also reduced pathogenic macrophages and the inflammatory myeloid gene signature in the colon. These data support previous preclinical findings demonstrating the potential therapeutic benefits of selectively targeting activated PD-1+ T cells and depleting PD-1high T cells in reducing inflammation and improving UC outcomes in a murine model of colitis. These results, together with existing rosnilimab safety data in humans, support the scientific rationale for evaluating rosnilimab in an ongoing Phase 2 study in UC (NCT06127043)."

Gene Signature • IO biomarker • Preclinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CCL3 • CD14 • CD80 • CD86 • IL6 • MYD88 • PD-1 • STAT4 • TLR2 • TLR4

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA) (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: AnaptysBio, Inc. | Recruiting ➔ Active, not recruiting

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

Biopharma Co Profile (GlobeNewswire) - "AnaptysBio...announced today that its Board of Directors approved plans to explore separating its business into two independent, publicly traded companies, each poised for strong, sustainable growth.....Upon completion, Biopharma Co will be a clinical-stage biotechnology company focused on the development and potential commercialization of innovative therapeutics for autoimmune and inflammatory diseases, including rosnilimab, ANB033 and ANB101."

Commercial • Immunology • Inflammation

Anaptys Announces Second Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Rosnilimab (Pathogenic T Cell Depleter):...(i) 424-patient Phase 2b RA trial:...Trial now complete with CDAI LDA responders at Week 28 demonstrating durable responses for at least 12-14 weeks off drug through Week 38....Plan to present complete RA Phase 2b data at a future medical congress...; (ii) Enrollment complete for global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced)....Top-line data through Week 12, including primary and key secondary endpoints, on track for Q4 2025."

P2 data • Trial status • Rheumatoid Arthritis • Ulcerative Colitis

Toward immune tolerance in rheumatoid arthritis: Emerging immunotherapies and targets for long-term remission. (PubMed, Int Immunopharmacol) - "Clinical trials, including Rheumavax and calcitriol liposomes, demonstrate safety and immunomodulatory promise, particularly in early RA. Programmed cell death-1 (PD-1) agonists, like rosnilimab, show potential in restoring immune homeostasis by reducing pathogenic T cell responses...Challenges include patient classification, biomarker detection, and long-term safety. These therapies represent a paradigm shift from broad immunosuppression to targeted immune reprogramming, offering hope for antigen-specific, drug-free remission in RA."

IO biomarker • Journal • Review • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology • PD-1

Rosnilimab: "JAK-like efficacy in both 3-month placebo-controlled portion and through 6 months"; Rheumatoid arthritis (AnaptysBio) - Rosnilimab Updated Phase 2b Rheumatoid Arthritis (RA) Data

P2b data • Rheumatoid Arthritis

Synovial Expression Levels of PD-1, the Target of Rosnilimab, Correlate with Disease Activity and Persist Across Disease Stages and Lines of Therapy in Rheumatoid Arthritis (FOCIS 2025) - P2 | "Irrespective of treatment, a correlation of PD-1 and CXCL13 expression with disease activity persisted, suggesting the importance of PD-1 in disease pathogenesis and a rationale for exploring rosnilimab's therapeutic potential. This will be evaluated in the RENOIR study, an ongoing Phase 2 trial of rosnilimab in moderate-to-severe RA patients (NCT06041269)."

Biomarker • IO biomarker • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CXCL13 • TNFA

Phenotyping of Human UC Colonic Tissue Reveals Inflammatory Pathway Gene Expression in PD-1+ Conventional and Regulatory T Cells Which Overlap with Those Regulated by Rosnilimab in a Mouse Model of Colitis (FOCIS 2025) - P2 | "These genes, in addition to the barrier gene Muc3 and fibrosis-associated Mmp9, were normal in rosnilimab-treated mice while dysregulated in colitis, and corresponds to published data showing rosnilimab reduced body weight loss, reduced inflammation of the colon, and reduced infiltration of CD4 T cells in mouse colitis. These analyses suggest that PD-1 is upstream of multiple clinically validated drivers of UC, supporting the scientific rationale for studying rosnilimab in an ongoing Phase 2 study in UC (NCT06127043)."

IO biomarker • Preclinical • Fibrosis • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CCL20 • CD4 • IL6 • MMP9 • PD-1 • TBX21

Anaptys Announces Positive Rosnilimab Data Updated Through Six Months in Robust Phase 2b Trial in RA (GlobeNewswire) - P2b | N=420 | RENOIR (NCT06041269) | Sponsor: AnaptysBio, Inc. | "AnaptysBio...announced that investigational rosnilimab, a depleter and agonist targeting PD-1+ T cells, demonstrated a best-in-disease profile in patients with moderate-to-severe rheumatoid arthritis (RA). In the robust, global 424-patient Phase 2b trial, rosnilimab achieved JAK-like efficacy on multiple clinically meaningful measures, including low disease activity (LDA) and remission on the Clinical Disease Activity Index (CDAI), as well as ACR70 response, over a six-month period. Furthermore, responses were then durable for at least two months off drug. Rosnilimab was safe and well tolerated, particularly when compared to standard of care biologics or JAKs....The rosnilimab patients who entered the all-active treatment period improved on the Pain VAS from a mean baseline of ~65 to ~15, a ~50-point change where the minimal clinically important difference (MCID) is a ~10-point change from baseline."

P2b data • Rheumatoid Arthritis

Anaptys to Announce Updated Data from Phase 2b Trial of Rosnilimab, a PD-1 Depleter and Agonist, for Rheumatoid Arthritis on June 3, 2025 (GlobeNewswire) - "AnaptysBio...will host an investor call and live webcast to review updated data from the global Phase 2b RENOIR clinical trial of investigational rosnilimab, a depleter and agonist targeting PD-1+ T cells, for moderate-to-severe rheumatoid arthritis on Tuesday, June 3, 2025, at 4:15pm ET / 1:15pm PT....Additionally, Anaptys president and chief executive officer, Daniel Faga, and/or other members of its executive leadership team, are scheduled to participate in multiple upcoming investor conferences following the data release..."

P2b data • Rheumatoid Arthritis

Rosnilimab: "Rosnilimab met primary endpoint of mean change from baseline in DAS28-CRP at Week 12 for all active doses"; Rheumatoid arthritis (AnaptysBio) - Corporate Presentation

P2b data • Rheumatoid Arthritis

Anaptys Announces First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "PORTFOLIO UPDATES: Rosnilimab (PD-1 depleter and agonist);...Anaptys to host an investor call featuring Anaptys management and key opinion leaders in the first week of June to present rosnilimab’s updated Phase 2b clinical and translational data....Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC....Initial Phase 2 data anticipated in Q4 2025."

P2 data • Rheumatoid Arthritis • Ulcerative Colitis

ROSNILIMAB, A PD-1 AGONIST ANTIBODY IN CLINICAL DEVELOPMENT FOR ULCERATIVE COLITIS, REDUCES PATHOGENIC PD-1+ T CELLS AND INFLAMMATORY CYTOKINE SECRETION IN PATIENT SAMPLES AND IN A MOUSE MODEL OF COLITIS (DDW 2025) - P2 | No abstract available

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PHENOTYPING OF HUMAN UC COLONIC TISSUE REVEALS INFLAMMATORY PATHWAY GENE EXPRESSION IN PD-1+ CONVENTIONAL AND REGULATORY T CELLS WHICH OVERLAP WITH THOSE REGULATED BY ROSNILIMAB IN A MOUSE MODEL OF COLITIS (DDW 2025) - P2 | "In UC colonic tissue, PD-1+ CD4 Tcon cells demonstrated increased inflammatory gene expression and PD-1+ Tregs exhibited a pro-inflammatory phenotype, suggesting that targeting both PD-1+ CD4 Tcon and PD-1+ Tregs may contribute to the therapeutic efficacy of rosnilimab in UC. These additional analyses support preclinical findings and suggest beneficial modulation of gene expression pathways of human UC, including reduction of pro-inflammatory cytokines and fibrosis, and upregulation of barrier function genes. These data demonstrate that PD-1 is upstream of multiple clinically validated drivers of UC and support the scientific rationale for studying rosnilimab in an ongoing Phase 2 study in UC (NCT06127043)."

IO biomarker • Preclinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CCL20 • IL2RA • IL6 • MMP9 • PD-1 • TBX21

Anaptys Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Rosnilimab (PD-1 depleter and agonist): Presented preclinical data in Q4 2024 and Q1 2025...evaluating –The PD-1 depletion and agonism mechanisms of rosnilimab in vitro with UC patient-derived PBMCs and a mouse model of colitis at the 2024 United European Gastroenterology Week (UEGW). Inflammatory pathway gene expression in PD-1+ conventional and regulatory T cells in human UC tissue and rosnilimab’s effects in a mouse model of colitis at the European Crohn’s and Colitis Organisation (ECCO) Congress."

Preclinical • Ulcerative Colitis

Anaptys Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "ANB033 (CD122 antagonist): Enrollment ongoing for Phase 1a trial in healthy volunteers. Phase 1b indication to be disclosed at a 2025 R&D event. ANB101 (BDCA2 modulator): Phase 1a trial to initiate in healthy volunteers in Q1 2025....Research and development expenses were $42.6 million and $163.8 million for the three and twelve months ended December 31, 2024, compared to $33.5 million and $132.3 million for the three and twelve months ended December 31, 2023. The increase was due primarily to development costs for rosnilimab, ANB032, ANB033 and ANB101 offset by a decrease in development costs for imsidolimab."

Commercial • New P1 trial • Trial status • Immunology

Phenotyping of human UC colonic tissue reveals inflammatory pathway gene expression in PD-1+ conventional and regulatory T cells which overlap with those regulated by rosnilimab in a mouse model of colitis (ECCO-IBD 2025) - P2 | "These additional analyses support preclinical findings and suggest beneficial modulation of gene expression pathways of human UC, including reduction of pro-inflammatory cytokines and fibrosis, and upregulation of barrier function genes. These data demonstrate that PD-1 is upstream of multiple clinically validated drivers of UC and support the scientific rationale for studying rosnilimab in an ongoing Phase 2 study in UC (NCT06127043)."

IO biomarker • Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CCL20 • IL2RA • IL6 • MMP9 • PD-1 • TBX21

Anaptys Announces Rosnilimab Achieved Positive Results in RA Phase 2b Trial and Highest Ever Reported CDAI LDA Response Over 6 Months (GlobeNewswire) - P2B | N=420 | RENOIR (NCT06041269) | Sponsor: AnaptysBio, Inc. | "Achieved statistical significance on primary endpoint at Week 12 on mean change from baseline DAS-28 CRP across all rosnilimab doses vs. placebo; Achieved statistical significance on key secondary endpoints at Week 12 on ACR20, ACR50 and CDAI LDA; Demonstrated highest ever reported responses on key secondary endpoints at Week 14 on ACR20, ACR50, ACR70 and CDAI LDA; 69% of rosnilimab-treated patients achieved CDAI LDA at Week 14 and appear to show sustained CDAI LDA and ACR50 responses and potentially deepening ACR70 responses out to Week 28; Robust pharmacological activity observed in reduction of PD-1high T cells, increase in total Tregs and reduction of CRP across all doses; Rosnilimab was safe and well tolerated with similar adverse event rates vs. placebo; Full Week 28 and additional translational RA data in Q2 2025; Top-line Week 12 Phase 2 ulcerative colitis data for rosnilimab, now in Q4 2025..."

P2 data • P2b data • Rheumatoid Arthritis • Ulcerative Colitis

Anaptys to Announce Top-line Data from Phase 2b Trial of Rosnilimab, a PD-1 Depleter and Agonist, in Rheumatoid Arthritis on Feb. 12, 2025 (GlobeNewswire) - "AnaptysBio...will host an investor call and live webcast to review top-line data from the global Phase 2b RENOIR clinical trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis on Wednesday, Feb. 12, 2025, at 8:30am ET / 5:30am PT."

P2b data • Rheumatoid Arthritis