dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therap - LARVOL DELTA

ACHIEVEMENT OF LOW DISEASE ACTIVITY AND REMISSION IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS TREATED WITH DAPIROLIZUMAB PEGOL: 48-WEEK RESULTS FROM A PHASE 3 TRIAL (EULAR 2025) - No abstract available

Clinical • P3 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

INHIBITORY EFFECTS OF DAPIROLIZUMAB PEGOL, A MONOVALENT ANTI-CD40L PEG-CONJUGATED ANTIGEN-BINDING FRAGMENT LACKING AN FC DOMAIN, ON IN VITRO T FOLLICULAR HELPER/B CELL INTERACTIONS AND CYTOKINE PRODUCTION IN SYSTEMIC LUPUS ERYTHEMATOSUS (EULAR 2025) - No abstract available

Preclinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG

IMPROVEMENT OF FATIGUE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS TREATED WITH DAPIROLIZUMAB PEGOL: 48-WEEK RESULTS FROM A PHASE 3 TRIAL (EULAR 2025) - No abstract available

Clinical • P3 data • Fatigue • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

DAPIROLIZUMAB PEGOL DEMONSTRATED SIGNIFICANT IMPROVEMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE ACTIVITY: EFFICACY AND SAFETY RESULTS OF A PHASE 3 TRIAL (EULAR 2025) - No abstract available

Clinical • P3 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Dapirolizumab pegol: Data readout from P3 PHOENYCS FLY trial (NCT06617325) for moderately-to-severe SLE in 2028 (Biogen) - Q4 & FY2024 Results

P3 data • Lupus • Systemic Lupus Erythematosus

PHOENYCS FLY: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: UCB Biopharma SRL | Trial completion date: Mar 2027 ➔ Sep 2027 | Trial primary completion date: Mar 2027 ➔ Sep 2027

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

On Growth Path for a Decade plus: Strong Launch Execution driving Company Growth (PRNewswire) - "Recruitment for the phase 3 study with Fenfluramine (5-HT agonist) in the treatment of CDKL5 deficiency disorder (CDD) has required more time than anticipated...The study is now fully recruited, and first headline results are expected in H1 2025...In December 2024, UCB and Biogen initiated the second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY, with first headline results expected in 2028...BE BOLD is the first head-to-head study in PsA evaluating the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor. First headline results are expected in H2 2026."

P3 data • Genetic Disorders • Psoriatic Arthritis • Rare Diseases • Systemic Lupus Erythematosus

PHOENYCS FLY: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: UCB Biopharma SRL | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

The True Value of Living Systematic Reviews (LSRs): A Case Report Within Systemic Lupus Erythematosus (SLE) (ISPOR-EU 2024) - "Belimumab, anifrolumab, dapirolizumab pegol, and deucravacitinib showed promising results in RCTs. An SLR search update 16 months after the primary search generated 18 new publications, providing a significant addition to the available evidence on current therapy options. The update provides insight into the appropriate cadence for LSRs and highlights efficiencies gained with LiveSLRTM."

Case report • Clinical • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial (ACR Convergence 2024) - P3 | "Per protocol, pts with a corticosteroid dose >7.5 mg/day prednisone equivalent were required to start tapering no later than Wk 8 to reach ≤7.5 mg/day. Treatment with DZP, a novel CD40L inhibitor, resulted in improvement in disease activity and corticosteroid tapering in pts with SLE; significantly more pts who received DZP+SOC achieved BICLA response vs PBO+SOC. DZP was generally well tolerated."

Clinical • Late-breaking abstract • P3 data • Cardiovascular • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Myocardial Infarction • Septic Shock • Systemic Lupus Erythematosus • CD40LG

Inhibitory Effects of Dapirolizumab Pegol, a Monovalent Anti-CD40L PEG-Conjugated Antigen-Binding Fragment Lacking a Functional Fc Domain, on In Vitro T Follicular Helper/B Cell Interactions and Cytokine Production in Systemic Lupus Erythematosus (ACR Convergence 2024) - P3 | "DZP was shown to inhibit key germinal center-relevant cell interactions leading to suppression of cytokine and total and antigen-specific IgG production in vitro. These data support clinical and transcriptomic/proteomic findings from patients with SLE treated with DZP, where reductions of immunoglobulins and key pro-inflammatory cytokines have been observed.4–6"

Preclinical • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG • CD8 • IFNG • IL1B • IL6

Dapirolizumab Pegol Impacts Important Immunologic Pathways in Systemic Lupus Erythematosus: Pharmacodynamic Analysis of T Cell and Antigen Presenting Cell Pathways from a Phase 2b Trial (ACR Convergence 2024) - P2, P3 | "Beyond its known effects on B cells and IFN signaling,7 these data demonstrate targeted effects of DZP on T cell activation, antigen presentation, and proinflammatory cytokines, such as IFN-γ, involved in adaptive immune responses related to SLE. These findings support the broad mechanism of action of DZP in modulating multiple aspects of SLE immunopathology."

IO biomarker • P2b data • PK/PD data • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CCL19 • CD40LG • CXCL9 • IFNG • IL12B • TNFA • TNFRSF9

Dapirolizumab Pegol Phase 3 Data Presented at the American College of Rheumatology Shows Significant Reduction in Systemic Lupus Erythematosus Disease Activity (GlobeNewswire) - P3 | N=321 | PHOENYCS GO (NCT04294667) | Sponsor: UCB Biopharma SRL | "UCB...and Biogen Inc...today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP)...demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE). The results were shared during an oral, late-breaker presentation at ACR Convergence 2024, the American College of Rheumatology’s annual meeting, in Washington, DC....On the primary endpoint measuring improvement of moderate-to-severe disease activity as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks, study participants receiving DZP plus SOC had a statistically significant 14.6% (95% confidence interval [CI]: 3.3, 25.8; p=0.0110) higher response rate (49.5%) than those receiving SOC alone (34.6%)."

P3 data • Immunology • Lupus • Systemic Lupus Erythematosus

Lupus Research Alliance Announces Lupus Research Highlights at ACR Convergence 2024 (PRNewswire) - "The Lupus Research Alliance (LRA), the largest private funder of lupus research worldwide, today announced that a total of 33 studies, funded by the organization or supported by its clinical research affiliate Lupus Therapeutics, will be presented at ACR Convergence 2024. The annual meeting of the American College of Rheumatology takes place November 14-19, at the Walter E. Washington Convention Center in Washington, D.C."

Clinical data • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus

Dapirolizumab pegol: Initiation of P3 PHOENYCS FLY trial (NCT06617325) for moderately-to-severe SLE in 2024 (Biogen) - Q3 2024 Results: Pivotal data from readout P3 trial for moderately-to-severe SLE between 2027 and 2029

P3 data • Trial initiation date • Lupus • Systemic Lupus Erythematosus

Dapirolizumab pegol: Regulatory filing for moderately-to-severe SLE between 2027 and 2029 (Biogen) - Q3 2024 Results

Filing • Lupus • Systemic Lupus Erythematosus

PHOENYCS FLY: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: UCB Biopharma SRL

New P3 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

UCB and Biogen Announce Positive Topline Results From Phase 3 Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus and are Initiating Second Phase 3 Study in 2024 (GlobeNewswire) - P3 | N=321 | PHOENYCS GO (NCT04294667) | Sponsor: UCB Biopharma SRL | "UCB...and Biogen Inc...today announced positive topline results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol....Dapirolizumab pegol, in addition to standard-of-care (SOC) treatment, met the primary endpoint to demonstrate greater improvement of moderate-to-severe disease activity as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks versus placebo in addition to SOC. Clinical improvements were observed among key secondary endpoints measuring disease activity and flares....Based on the successful outcome of the PHOENYCS GO study, UCB and Biogen are initiating a second Phase 3 trial of dapirolizumab pegol in 2024, PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study."

New P3 trial • P3 data: top line • Immunology • Systemic Lupus Erythematosus

PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=321 | Completed | Sponsor: UCB Biopharma SRL | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Jun 2024

Trial completion • Trial completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

PHOENYCS GO: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=321 | Active, not recruiting | Sponsor: UCB Biopharma SRL | Trial primary completion date: Sep 2024 ➔ May 2024

Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

DAPIROLIZUMAB PEGOL IMPACTS IMPORTANT IMMUNOLOGIC PATHWAYS IN SYSTEMIC LUPUS ERYTHEMATOSUS: PHARMACODYNAMIC ANALYSIS OF B CELL AND TYPE I INTERFERON PATHWAYS FROM A PHASE 2B TRIAL (EULAR 2024) - P2, P3 | "DZP broadly suppresses B cell biology, decreasing the expression of numerous gene sets involved in B cell activation and immunoglobulin production. DZP also decreases expression of type I IFN signatures in pts with high baseline type I IFN expression. The impacts of DZP were seen as early as Wk 2 following a single dose."

IO biomarker • P2b data • PK/PD data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG

DAPIROLIZUMAB PEGOL IMPACTS IMPORTANT IMMUNOLOGIC PATHWAYS IN SYSTEMIC LUPUS ERYTHEMATOSUS: PHARMACODYNAMIC ANALYSIS OF T CELL AND ANTIGEN PRESENTING CELL PATHWAYS FROM A PHASE 2B TRIAL (EULAR 2024) - P2, P3 | "Beyond its known effects on B cells and IFN signaling,[8] these data demonstrate targeted effects of DZP on T cell activation and additional proinflammatory cytokines, such as IFN-γ, involved in T cell activation and adaptive immune responses related to SLE. The identified biomarkers will undergo further validation in planned pharmacodynamic studies in relation to clinical efficacy."

IO biomarker • P2b data • PK/PD data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CCL19 • CD40LG • CXCL9 • IFNG • IL12B • TNFA • TNFRSF9

Dapirolizumab Pegol Impacts Important Immunologic Pathways in SLE: Pharmacodynamic Analysis of B Cell and Type I Interferon Pathways from a Phase 2b Trial (ACR Convergence 2023) - P2, P3 | "DZP exerts a broad suppressive effect on B cell biology, decreasing the expression of numerous gene sets involved in B cell activation and immunoglobulin production. Moreover, DZP decreases expression of type I IFN signatures in pts with high baseline type I IFN expression. The impacts of DZP were seen as early as Wk 2."

IO biomarker • P2b data • PK/PD data • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG

Dapirolizumab Pegol Efficacy by Subgroups in Patients with SLE: A Post Hoc Analysis of Phase 2b Clinical Trial Data (ACR Convergence 2023) - P2 | "Albeit in a limited sample size, pts with acute flare and normal complement were more likely to achieve response to SOC+PBO than pts with acute flare and low complement or persistent disease activity. These data suggest that SLE trial design may need to consider baseline clinical and serologic activity patterns to adequately assess treatment efficacy."

Clinical • P2b data • Retrospective data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG

Disease Course and Complement as Predictors of Response to Standard of Care Plus Placebo in Patients with SLE: A Post Hoc Analysis of Dapirolizumab Pegol and Epratuzumab Clinical Trial Data (ACR Convergence 2023) - P2, P3 | "In both EMBODY 1/2 and RISE, acute flare predicted SOC+PBO response. In RISE, normal complement levels also predicted SOC+PBO response; low complement has been described as a predictor of increased treatment effect in previous studies. 5 Recent medical history of pts may have to be considered when defining SLE study populations."

Clinical • Retrospective data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG