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iStock, Veronique D Phase III data for dapirolizumab pegol presented at the 2025 conference of the American College of Rheumatology showed quality-of-life benefits in systemic lupus erythematosus that could see Biogen go head-to-head with GSK and AstraZeneca in a blockbuster space. Biogen’s CD40L inhibitor dapirolizumab pegol significantly improved quality of life in a late-stage study of patients with systemic lupus erythematosus, potentially giving the molecule an edge in a competitive field. Jefferies analysts, writing in a note to investors Monday, said Biogen and development partner UCB have already shown dapirolizumab pegol to be a “competitive” therapy for systemic lupus erythematosus (SLE) in previous readouts that were based on “traditional efficacy measures” such as treatment response and disease activity. These additional findings, to be presented Tuesday at the 2025 conference of the American College of Rheumatology, point to “added benefits” across a variety of clinical and patient-reported measures that, according to the analysts, could make a strong market case for dapirolizumab pegol. Additionally, the analysts noted that these quality-of-life advantages could underlie the asset’s “potential to differentiate in SLE.” The group currently models more than $1 billion in peak sales for dapirolizumab pegol. Tuesday’s data come from the Phase III PHOENYCS GO trial, which enrolled more than 300 patients with moderate to severe active SLE. Dapirolizumab pegol was dosed every four weeks on top of standard of care. Patients on the dapirolizumab pegol regimen had greater improvements in fatigue, pain and body image versus placebo comparators. Similarly, Biogen’s therapy resulted in better physical and emotional health outcomes, alongside stronger improvements in the intimate relationships, planning and burden to others domains, as compared with placebo. These findings follow a previous readout from PHOENYCS GO, presented in November 2024, in which dapirolizumab pegol outperformed placebo in terms of clinical outcomes. At the time, data revealed that the CD40L blocker hit a response rate of 49.5%, versus 34.6% in placebo comparators. Dapirolizumab pegol also demonstrated a 1.8-fold greater improvement in a disease activity measure compared with controls. With dapirolizumab pegol, Biogen and UCB are building up to compete with AstraZeneca’s Saphnelo and GSK’s Benlysta, which according to Jefferies have a “combined $3B run rate.” In 2024, Saphnelo surged 70% to make $474 million worldwide, while Benlysta brought in almost $2 billion, representing 14% annual growth. To further boost dapirolizumab pegol’s case, Biogen is also running the Phase III PHOENYCS FLY study , likewise in patients with moderate to severe SLE. The trial is currently recruiting participants, with a primary completion date of May 2028. “We think [dapirolizumab pegol] represents one of BIIB’s several late-stage, $1B+ blockbuster pipeline programs that could garner more credit in 2026, ahead of [its] second Phase III readout in 2027-28,” Jefferies wrote.

From October 24 to 29, 2025, the American College of Rheumatology (ACR) Convergence 2025 was grandly held in Chicago, USA. At this event, Bioheng Therapeutics presented the latest clinical results of CTA311, its allogeneic anti-CD19 CAR-T product for systemic lupus erythematosus (SLE) and ANCA-associated vasculitis (AAV), and CTA313, its allogeneic anti-CD19/BCMA CAR-T product for SLE and lupus nephritis (LN), in the form of academic posters. Abstract Title: Preliminary Safety, Efficacy, and Cellular Kinetics of CTA311, a CD19 Targeted Universal CAR-T Therapy, for Active Autoimmune Diseases Abstract Code: 2129320 Poster Code: 2452 Session: Systemic Lupus Erythematosus – Treatment Poster III Presentation Time: Tuesday, October 28, 10:30 AM - 12:30 PM CT The poster at ACR Convergence 2025 detailed the results of an investigator-initiated trial. This single-arm, open-label, dose-escalation study evaluated the safety and efficacy of CTA311 in patients with SLE and AAV. Four dose levels were explored (DL1: 0.2×106 CAR+ T cells/kg; DL2: 1.0×106 CAR+ T cells/kg; DL3: 3.0×106 CAR+ T cells/kg; DL4: 6.0×106 CAR+ T cells/kg). All patients received lymphodepletion with fludarabine (30 mg/m2/day × 3 days) and cyclophosphamide (300 mg/m2/day × 3 days) prior to CTA311 infusion. As of August 30, 2025, a total of 11 patients were enrolled, including 10 with SLE and 1 with AAV.Ten patients (91%) were female, with a median age of 31 years (range: 21-55), and 64% patients previously received biologics including belimumab and telitacicept. Safety: CTA311 was well tolerated with no dose-limiting toxicities (DLT), neurotoxicity or graft-versus-host disease (GvHD) events reported. Cytokine release syndrome (CRS) events occurred in 82% (n=9), all low grade (G) (7 G1 and 2 G2). Three patients experienced treatment related infections (1 pneumonia (G3) and CMV reactivation (G1), 1 fungal infection (G2), and 1 infection NOS (G1)), which all fully resolved with antimicrobial treatment. Efficacy and Cellular Kinetics: In SLE/LN, preliminary analysis indicates elimination of autoantibodies, improvement in C3 levels, and decline in proteinuria leading to improvement in disease activity scores SLEDAI-2K and PGA. Responses were dose dependent with 100% LLDAS and 50% DORIS at DL4. In AAV, the patient achieved a BVAS score of 0 at M3 and M4 from baseline 8. A minor symptom (arthritis) reappeared at M6 but resolved at M9 without any adjustment in medication. PK analysis revealed peak expansion of CAR-T cells approximately 7-21 days post-infusion, with a dose-dependent pattern, suggesting the potential for deeper remission at higher dose levels. Pharmacodynamics: Complete B cell depletion was observed by Day 4 post-infusion with recovery starting Day 42. In patients that achieved anti-dsDNA antibodies eradication, the anti-dsDNA antibodies remained undetected up to 12 months, and ongoing, despite B-cell recovery. CTA311 exhibited an acceptable safety profile in patients with SLE, LN and AAV, and displayed robust expansion coincided with profound B-cell depletion and concomitant elimination of pathogenic autoantibodies, leading to marked clinical improvement in these patients. Future clinical studies are warranted to further evaluate and characterize the efficacy and safety of CTA311 in patients with SLE or other B cell-driven autoimmune diseases. Abstract Title: Preliminary Safety, Efficacy, and Cellular Kinetics of CTA313, a CD19/BCMA Dual-Targeted Universal CAR-T Therapy, for Active Systemic Lupus Erythematosus Abstract Code: 2129706 Poster Code: 1532 Session: Systemic Lupus Erythematosus – Treatment Poster II Presentation Time: Monday, October 27, 10:30 AM - 12:30 PM CT The poster at ACR Convergence 2025 detailed the results of an investigator-initiated trial. This single-arm, open-label, dose-escalation study evaluated the safety and efficacy of CTA313 in patients with SLE/LN. Three dose levels were explored (DL1: 3×106 CAR+ T cells/kg; DL2: 6×106 CAR+ T cells/kg; DL3: 10×106 CAR+ T cells/kg). All patients received lymphodepletion with fludarabine (30 mg/m2/day × 3 days) and cyclophosphamide (300 mg/m2/day × 3 days) prior to CTA313 infusion. As of September 20, 2025, a total of 15 patients were enrolled, including 6 (40%) with SLE and 9 (60%) with LN, with a median age of 37 years (range: 21-50). In terms of safety, no immune effector cell-associated neurotoxicity syndrome (ICANS) or graft-versus-host disease (GvHD) was observed at any dose level. Only Grade 1 Cytokine release syndrome (CRS) was observed in 6 patients (40%), largely self-limiting. All Grade 3 infections fully resolved with antimicrobial treatment. Regarding efficacy, with a median follow-up of 4 months, 100% of patients achieved the Systemic Lupus Erythematosus Responder Index-4 (SRI-4), 79% achieved Lupus Low Disease Activity State (LLDAS), and 43% achieved Definitions of Remission in SLE (DORIS). Robust in vivo expansion of CAR-T cells was observed, with 28-day persistence in 67% of patients. A single infusion of CAR-T cells induced complete B-cell depletion, sustained undectable anti-dsDNA antibodies, and notable reductions in other autoantibodies, including anti-Sm, anti-histone, and anti-nucleosome antibodies. Preliminary results indicate that CTA313 can rapidly and durably control disease activity in patients with SLE and LN, with an acceptable safety profile. Ongoing clinical studies are further evaluating CTA313 in patients with other B cell-driven autoimmune diseases. About CTA311 and CTA313 Both CTA311 and CTA313 are allogeneic CAR-T products derived from healthy donors. CTA311 targets CD19, whereas CTA313 targets both CD19 and BCMA. Both products are developed based on Bioheng Therapeutics’ proprietary allogeneic CAR-T platform—ANSWER®—which incorporates genetic modifications to prevent graft-versus-host disease (GvHD) and host-versus-graft rejection (HvG). These products can be manufactured in advance and stored for multiple patients, providing an "off-the-shelf" solution for patients in need of CAR-T cell therapy. Leveraging the ANSWER® platform, Bioheng Therapeutics is actively developing a broad pipeline of allogeneic CAR-T programs. These programs have demonstrated robust and durable persistence of allogeneic CAR-T cells, highlighting strong therapeutic potential in both autoimmune diseases and oncology.