rosnilimab (ANB030) / AnaptysBio - LARVOL DELTA

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) - No abstract available

Gene Signature • IO biomarker • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • PD-1

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) - No abstract available

IO biomarker • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • PD-1

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

Anticipate top-line Phase 2b data in rheumatoid arthritis…Phase 2 data in ulcerative colitis for rosnilimab... (GlobeNewswire) - "We look forward to sharing for rosnilimab, a depleter and agonist targeting PD-1+ T cells, top-line Phase 2b rheumatoid arthritis data in February 2025 and top-line Phase 2 ulcerative colitis data in Q1 2026, followed by Phase 1b data from our two additional programs."

P2 data • P2b data • Rheumatoid Arthritis • Ulcerative Colitis

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 (ACR Convergence 2024) - P2 | "PD-1 associated pathways were analyzed using Gene Set Variation Analysis (GSVA) on two gene sets: a nivolumab-induced gene set (Choueiri et al 2016), and a rosnilimab-induced gene set generated using RNA-seq data from purified T cells co-cultured with monocyte-derived DCs and rosnilimab. Synovial PD-1 and CXCL13 expression levels correlate with clinical markers of disease and persist across naïve, DMARD-IR, and TNF-IR patients with RA. This supports an important role for PD-1 in disease pathogenesis and the biologic rationale for using rosnilimab following different lines of therapy. This will be tested in the RENOIR study, an ongoing Phase 2 trial of rosnilimab in moderate/severe RA including biologic naïve and experienced patients (NCT06041269)."

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

A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR) (clinicaltrials.gov) - P2 | N=420 | Active, not recruiting | Sponsor: AnaptysBio, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ May 2025 | Trial primary completion date: Mar 2025 ➔ Nov 2024

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

ROSNILIMAB, A PD-1 AGONIST ANTIBODY IN CLINICAL DEVELOPMENT FOR ULCERATIVE COLITIS, REDUCES PATHOGENIC PD-1+ T CELLS AND INFLAMMATORY CYTOKINE SECRETION IN PATIENT BLOOD AND IN A MOUSE MODEL OF ULCERATIVE COLITIS (UEGW 2024) - P2 | "Rosnilimab, a PD-1 checkpoint agonist antibody, functions to reduce pathogenic PD-1+ T cells by both depletion and agonism. These in vivo and in vitro results are consistent with the mechanisms of depletion and agonism and support the strong rationale for evaluating the therapeutic potential of rosnilimab in an ongoing phase 2 study in UC."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CXCL13 • IFNG • IL12A

Anaptys Announces Pricing of $100 Million Underwritten Registered Direct Offering (GlobeNewswire) - "AnaptysBio, Inc...today announced the pricing of an underwritten offering of 2,750,498 shares of its common stock at a price of $36.50 per share, representing a premium of approximately 10% to Anaptys’ closing price on Aug. 13, 2024. The gross proceeds from this offering are expected to be approximately $100 million, before deducting underwriting discounts, commissions and other offering expenses payable by Anaptys....Anaptys intends to use the net proceeds of this offering primarily for general corporate purposes, which may include funding Phase 3 enabling activities for ANB032 and rosnilimab, working capital and general corporate purposes. Sanofi did not receive rights to any of Anaptys’ programs as a part of their equity investment."

Financing • Atopic Dermatitis • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Anaptys Announces Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Updates on Wholly Owned ICM Pipeline: (i) ANB032 (BTLA agonist antibody): Completed enrollment for global Phase 2b trial in moderate-to-severe AD....Top-line Week 14 data expected in December 2024....(ii) Rosnilimab (PD-1 agonist antibody): Enrollment ongoing for global Phase 2b trial in moderate-to-severe RA....Top-line Week 12 data anticipated in Q1 2025....Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC....Top-line Week 12 data anticipated in Q1 2026."

Enrollment closed • P2 data • P2b data • Atopic Dermatitis • Rheumatoid Arthritis • Ulcerative Colitis

Cellular immunotherapies and immune cell depleting therapies in inflammatory bowel diseases: the next magic bullet? (PubMed, Gut) - "This article discusses novel cellular immunotherapies and immune cell depleting therapies in IBD, including CAR-T cell approaches, Tr1 and T regulatory (Treg) cells and cell depleting antibodies such as rosnilimab. These novel approaches have the potential to overcome current therapeutic limitations in the treatment of IBD."

Immune cell • Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease