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Genentech has reported the P-III (ALLEGORY) trial data assessing Gazyva vs PBO in ~300 adults with SLE on SoC for 52wks. followed by ~104wks. OLE period
Trial met its 1EP, with more participants achieving ≥4-point improvement in SRI-4 at 1yr., & achieved all key 2EPs, incl. improved BICLA response & a 6-point SRI-6 improvement at…
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Roche has reported the P-III (INShore) trial findings assessing Gazyva (Obinutuzumab; Wk. 0, 2, 24 & 26) vs mycophenolate mofetil (MMF; QD) in 85 pts (>2-25yrs.) with frequently relapsing or steroid-dependent nephrotic syndrome
Trial met its 1EP, with more pts achieving sustained complete remission at 1yr., & certain 2EPs. Gazyva showed significant benefits in…
Hinge Bio Collaborates with Kyorin Pharmaceutical to Advance HB2198 in Japan for Autoimmune Diseases
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Hinge Bio & Kyorin have entered into a collaboration & license agreement to develop HB2198 in Japan for various autoimmune diseases, starting with systemic lupus erythematosus (SLE), which is expected to enter trials by H2’25
As per the deal, Hinge will lead global HB2198 development & receive $10M upfront, ~$95M in SLE milestones, plus additional…
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AstraZeneca has reported interim P-III (TULIP-SC) trial data assessing Saphnelo (anifrolumab; 120mg, SC, QW, accessorisedPFS) vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC
Interim analysis conducted after the first 220 pts reached Wk. 52, showed Saphnelo reduced disease activity (1EP), measured by BICLA at Wk. 52; data to be…
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Zenas BioPharma has entered into an agreement with Royalty Pharma granting it royalty rights on the future sales of obexelimab
As per the deal, Zenas will receive ~$300M, consisting of a $75M upfront & 3 additional $75M each in milestones tied to P-III (INDIGO) trial achievement & FDA approvals in IgG4-RD & SLE, while Royalty Pharma…
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BMS & Bain Capital have launched a new independent biopharma company focused on autoimmune diseases, which will be backed by $300M funding commitment led by Bain & 5 immunology assets in-licensed from BMS
As per the deal, BMS will retain ~20% equity stake in the new company & is entitled to receive royalties & milestone payments for…
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The P-II (WILLOW) basket trial assessed enpatoran (25, 50 &100mg, BID, PO) vs PBO + SoC in 2 Arms, where Arm 1 has SLE & CLE pts with active lupus rash & Arm 2 has active SLE pts. Discussions with health authorities on a global P-III program are underway
Arm 1 met its 1EP,…
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SDoH screening can help identify patient needs, support faster clinical decisions, and improve patient-centric care
A first-of-its-kind lupus study surveyed 69 patients across two institutions to assess the feasibility of routine SDoH screening in lupus clinics and identify related barriers and enablers at the physician, care team, and patient levels
Vijay Nadipelli, Senior Director…
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GSK presented data at the American College of Rheumatology from a multi-center cohort study highlighting the achievement of complete renal response in patients with active lupus nephritis
The study evaluated the attainment of modified complete renal response (mCRR) in patients with systemic lupus erythematosus (SLE) and active lupus nephritis (LN), comparing characteristics between mCRR…
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Immune reset in oncology has been observed with approved autologous CAR-T products. A recent study published in Nature demonstrated B-cell reconstitution and immune reset in systemic lupus erythematosus (SLE) patients treated with a CD19 autologous CAR-T, showcasing promising potential in autoimmune diseases
Today, at PharmaShots, we have Fred Aslan shedding light on Artiva's AlloNK,…

