ANB032 / AnaptysBio - LARVOL DELTA

ANB032-201: This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects with Moderate to Severe Atopic Dermatitis (AD). (clinicaltrials.gov) - P2 | N=201 | Terminated | Sponsor: AnaptysBio, Inc. | Active, not recruiting ➔ Terminated; ANB032 did not meet the primary endpoint in moderate-to-severe atopic dermatitis

Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Anaptys Announces Phase 2b Trial of ANB032, a BTLA Agonist, Did Not Meet Primary or Secondary Endpoints in Atopic Dermatitis (GlobeNewswire) - P2b | N=160 | NCT05935085 | Sponsor: AnaptysBio, Inc. | "AD trial and all further investment in ANB032 will be discontinued....AnaptysBio...today announced that investigational ANB032, a BTLA agonist, did not meet the primary and secondary endpoints in any of the doses studied in the global, 201-patient ARISE-AD trial as a monotherapy for moderate-to-severe atopic dermatitis (AD) or eczema. ANB032 was well tolerated with no safety signals observed...Patients were randomized to receive for 12 weeks either 100mg of subcutaneous ANB032 every four weeks (Q4W), 400mg every four weeks (Q4W) or 400mg every two weeks (Q2W), or placebo. The primary and secondary endpoints were assessed at Week 14."

Discontinued • P2b data • Atopic Dermatitis

ANB032, a BTLA checkpoint agonist antibody, attenuates dendritic cell (DC) maturation and function: A novel mechanism addressing atopic dermatitis pathophysiology (EADV 2024) - P2 | "These data demonstrate the induction of BTLA expression on mature DCs by a stimuli relevant in AD and provides additional insight regarding the effect of BTLA agonism on DC maturation and function. BTLA agonism by ANB032 has the potential to restore immune balance by impacting a broad range of pathogenic immune cells, including T cells and DCs, while inducing Tregs, which may provide therapeutic value in the treatment of autoimmune and inflammatory disorders, including AD. These data, additional in vitro data and results from a Phase 1 healthy volunteer study support the ongoing double-blind, placebo-controlled, global Phase 2b study of ANB032 in moderate-to-severe AD (NCT05935085) ."

IO biomarker • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • BTLA • CD40 • CD80 • CD86 • FOXP3 • TNFSF4

Atopic Dermatitis is Characterized by Enrichment in a BTLA Transcriptomic Signature (EADV 2024) - P2 | "A BTLA transcriptomic signature was derived from experimental data to study the relevance of the BTLA pathway in human disease. Significant overlap between genes modulated by BTLA agonism via ANB032 and clinically validated immune genes/pathways in AD patient skin was demonstrated. Furthermore, this BTLA signature was enriched in AD skin highlighting the potential role for this pathway in the pathogenesis of AD."

IO biomarker • Atopic Dermatitis • Dermatitis • Dermatology • Graft versus Host Disease • Immunology • BTLA • GZMB • IL2RA • IL4R • NFKBIA

ANB032, a BTLA Checkpoint Agonist Antibody, Attenuates Dendritic Cell (DC) Maturation and Function: A Novel Mechanism Addressing Atopic Dermatitis Pathophysiology (EADV 2024) - P2 | "These data demonstrate the induction of BTLA expression on mature DCs by a stimuli relevant in AD and provides additional insight regarding the effect of BTLA agonism on DC maturation and function. BTLA agonism by ANB032 has the potential to restore immune balance by impacting a broad range of pathogenic immune cells, including T cells and DCs, while inducing Tregs, which may provide therapeutic value in the treatment of autoimmune and inflammatory disorders, including AD. These data, additional in vitro data and results from a Phase 1 healthy volunteer study support the ongoing double-blind, placebo-controlled, global Phase 2b study of ANB032 in moderate-to-severe AD (NCT05935085) ."

IO biomarker • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • BTLA • CD40 • CD80 • CD86 • FOXP3 • TNFSF4

ANB032, an Investigational BTLA Agonist Antibody, Reduced T Cell Proliferation, Inflammatory Cytokine Secretion, and Prolonged Survival in a Mouse Model of Graph versus Host Disease (GvHD) (ESDR 2024) - P2 | "These data suggest the importance of sparing the HVEM/ BTLA binding interaction together with the requirement of Fc receptor engagement for optimizing potency and the potential therapeutic benefit of BTLA agonism with ANB032 in the treatment of inflammatory diseases such as atopic dermatitis (AD). This study, additional in vitro data, and results from a Phase 1 study in healthy volunteers support the ongoing double-blind, placebo-controlled, global Phase 2b study of ANB032 in moderate-to-severe AD (NCT05935085)."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Graft versus Host Disease • Immunology • Inflammation • BTLA

ANB032, an Investigational BTLA Checkpoint Agonist Antibody, Attenuates Dendritic Cell (DC) Maturation and Function: A Novel Mechanism Addressing Atopic Dermatitis (AD) Pathophysiology (ESDR 2024) - P2 | "ANB032 has the potential to restore immune balance in the treatment of AD by impacting a broad range of pathogenic immune cells, including T cells and DCs, while inducing Tregs. These data, additional in vitro data, and results from a Phase 1 healthy volunteer study support the ongoing double-blind, placebo-controlled, global Phase 2b study of ANB032 in moderate-to-severe AD (NCT05935085)."

IO biomarker • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • BTLA • CD40 • CD80 • CD86 • FOXP3 • TNFSF4

ANB032-201: This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD). (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: AnaptysBio, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

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

ANB032, a BTLA (B and T Cell Lymphocyte Attenuator) Checkpoint Receptor Agonist, Modulates Dendritic Cell (DC) Maturation and Function (FOCIS 2024) - P2 | "Therefore, BTLA agonism by ANB032 inhibits a broad range of immune cells and modulates DC function, while inducing Tregs, and potentially restoring immune balance, which may provide therapeutic value in the treatment of autoimmune and inflammatory disease. ANB032 is currently being studied in a Phase 2 clinical trial in atopic dermatitis (NCT05935085)."

Atopic Dermatitis • Dermatitis • Immunology • Inflammation • BTLA • FOXP3

ANB032, an investigational BTLA agonist monoclonal antibody, reduced T cell proliferation, inflammatory cytokine secretion, and prevented graft-versus-host disease (GvHD) in a mouse model (SID 2024) - No abstract available

Preclinical • Graft versus Host Disease • Immunology • BTLA

ANB032, a novel BTLA agonist monoclonal antibody, reduced T cell proliferation, inflammatory cytokine secretion and prevented graft versus host disease in a mouse model (IMMUNOLOGY 2024) - P2 | "Compared to the reference antibodies, ANB032 demonstrated superior in vivo efficacy on key endpoints, including improved survival, body weight maintenance, reduced human T cell expansion and reduced plasma inflammatory cytokines. ANB032 demonstrated, both in vitro and in vivo, the potential therapeutic benefit that BTLA agonism may provide in the treatment of autoimmune or inflammatory diseases and is being evaluated in an ongoing Phase 2 study in atopic dermatitis (NCT05935085)."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Graft versus Host Disease • Immunology • Inflammation • BTLA

ANB032, a novel BTLA agonist monoclonal antibody, reduced T cell proliferation, inflammatory cytokine secretion and prevented graft versus host disease in a mouse model (IMMUNOLOGY 2024) - P2 | "Compared to the reference antibodies, ANB032 demonstrated superior in vivo efficacy on key endpoints, including improved survival, body weight maintenance, reduced human T cell expansion and reduced plasma inflammatory cytokines. ANB032 demonstrated, both in vitro and in vivo, the potential therapeutic benefit that BTLA agonism may provide in the treatment of autoimmune or inflammatory diseases and is being evaluated in an ongoing Phase 2 study in atopic dermatitis (NCT05935085)."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Graft versus Host Disease • Immunology • Inflammation • BTLA

ANB032, a B and T Cell Lymphocyte Attenuator (BTLA) Checkpoint Receptor Agonist, Modulates Dendritic Cell (DC) Maturation and Function: A Novel Mechanism Addressing Atopic Dermatitis Pathophysiology (AAD 2024) - P2 | "BTLA agonism by ANB032 inhibits a broad range of immune cells, including DCs, while inducing Tregs, and potentially restoring immune balance, which may provide therapeutic value in the treatment of autoimmune and inflammatory disorders, including AD. A double-blind, placebo-controlled, global Phase 2b study of ANB032 in moderate-to-severe AD is actively enrolling subjects (NCT05935085)."

Atopic Dermatitis • Dermatitis • Dermatology • Immunology • BTLA • FOXP3

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Global Study to Evaluate the Efficacy and Safety of ANB032 in the Treatment of Moderateto-Severe Atopic Dermatitis (ISDS 2023) - P2 | "Subjects who are either dupilumab/IL-13 blocker-naïve or -experienced are eligible. Secondary endpoints include EASI75, IGA 0/1, PNRS, DLQI, SCORAD50, and safety. This study of ANB032 will further the understanding of the biology of this heterogenous disease."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • BTLA • IL13

ANB032, a Novel BTLA Agonist Monoclonal Antibody, Inhibits T Cell Proliferation, Reduces Inflammatory Cytokines, and Down Modulates BTLA Expression on Circulating T and B Cells (ISDS 2023) - "This study demonstrated robust PK, favorable safety, and target engagement in humans. A global Phase 2b trial in AD began May 2023 with results expected EOY 2024."

Infectious Disease • Inflammation • Novel Coronavirus Disease • BTLA

Anaptys to Present Phase 1 Data on ANB032, its BTLA Agonist Antibody, at the 32nd EADV Congress (GlobeNewswire) - "AnaptysBio, Inc...today announced two upcoming presentations at the 32nd European Academy of Dermatology and Venerology (EADV) Congress in Berlin, Germany, Oct. 11-14, 2023. The oral presentation will focus on ANB032’s previously reported healthy volunteer Phase 1 data and the trial-in-progress poster presentation will focus on ANB032’s Phase 2b study in moderate to severe atopic dermatitis."

P1 data • P2b data • Atopic Dermatitis

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center, Global Study to Evaluate the Efficacy and Safety of ANB032 in the Treatment of Subjects with Moderate to Severe Atopic Dermatitis (EADV 2023) - "Importantly, subjects who are either dupilumab/IL-13 blocker- naïve or -experienced are eligible for enrolment. Current treatment options in AD do not target all of the diverse immune cells and cytokines that contribute to the pathogenesis of this disease. This Phase 2b study of ANB032 will add to the evolving treatment landscape of AD and further the understanding of the biology of this heterogenous disease."

Clinical • P2b data • Atopic Dermatitis • Dermatitis • Dermatology • Gastroenterology • Immunology • Rheumatology • BTLA • IL13

ANB032, a novel BTLA agonist monoclonal antibody, inhibits T cell proliferation, reduces inflammatory cytokines, and down modulates BTLA expression on circulating T and B cells: Results from a first-in-human Phase 1 study (EADV 2023) - "ANB032 demonstrated favorable safety, tolerability and PK with rapid and sustained PD activity. These results coupled with robust pre-clinical data and AD disease heterogeneity involving Th1, Th2, Th17, and Th22 and DCs support the rationale for advancing the clinical development of ANB032 in AD. Thus, a global Phase 2b trial in AD was initiated in May 2023 with results expected EOY 2024."

P1 data • Infectious Disease • Inflammation • Novel Coronavirus Disease • BTLA

ANB032, a novel BTLA agonist monoclonal antibody, inhibits T cell proliferation, reduces inflammatory cytokines, and down modulates BTLA expression on circulating T and B cells: Results from a first-in-human Phase 1 study (EADV 2023) - "ANB032 demonstrated favorable safety, tolerability and PK with rapid and sustained PD activity. These results coupled with robust pre-clinical data and AD disease heterogeneity involving Th1, Th2, Th17, and Th22 and DCs support the rationale for advancing the clinical development of ANB032 in AD. Thus, a global Phase 2b trial in AD was initiated in May 2023 with results expected EOY 2024."

P1 data • Infectious Disease • Inflammation • Novel Coronavirus Disease • BTLA

This Study Will Evaluate the Safety, Tolerability, and Efficacy of ANB032 in Subjects With Moderate to Severe Atopic Dermatitis (AD). (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: AnaptysBio, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ANB032, a novel BTLA agonist monoclonal antibody, inhibited T cell proliferation, reduced inflammatory cytokines, and down modulated BTLA expression on circulating T and B cells in phase 1, progresses into a phase 2 study in atopic dermatitis (ISID 2023) - "The phase 1 data demonstrated robust PK and target engagement in humans. These clinical data, in conjunction with preclinical translational data from AD patients, support progression of ANB032 into a phase 2 trial in AD."

P1 data • P2 data • Atopic Dermatitis • Dermatitis • Dermatology • Immune Modulation • Immunology • BTLA • IFNG • IL13 • IL17A • IL5