Vial Doses First Participants in IL13 x TSLP Bi-Specific Antibody Trial

Vial has advanced our IL13 x TSLP bispecific into dosing participants in Phase I This announcement marks a major advancement for the program and a key milestone for Vial

Novartis received FDA Breakthrough Therapy Designation for ianalumab in January 2026, potentially making it the first targeted treatment ever approved for Sjögren's disease. Sjögren's affects millions and has had virtually no targeted therapy options for decades. If ianalumab gains approval, how does that change the conversation between reps and rheumatologists who have been waiting for this? Thoughts? #Rheumatology #SjogrensSyndrome #Novartis #AutoimmuneDisease #BreakthroughTherapy #SpecialtySales #PharmaSales #RareDisease https://lnkd.in/eYQtMuJ9

CM336 to focus on autoimmune diseases with favorable safety profile: According to Gilead’s announcement, global development of CM336 will prioritize autoimmune indications, including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP), both of which have received Fast Track and Orphan Drug Designation from the FDA. CM336 is currently in phase 3 development for multiple myeloma (MM) and multiple phase 1/2 studies for autoimmune indications, with Gilead planning to advance the program into pivotal studies for autoimmune diseases in 2027. While approved BCMA/CD3 bispecific antibodies are currently indicated for MM, exploration in autoimmune diseases remains at an early clinical stage (see landscape in Exhibit 3). Although no autoimmune clinical data for CM336 have been publicly disclosed, we view its safety profile in MM as encouraging, with no Grade ≥3 CRS reported and no ICANS observed across treated patients. This compares favorably with reported CRS incidences of 0.6% / 1% / 2% for Tecvayli, Talvey, and LBL‑034, respectively (see comparisons in Exhibit 4), and supports the rationale for expansion into chronic autoimmune settings.

📣 Bimekizumab Shows Superiority Over Risankizumab in Psoriatic Arthritis Trial 💊 BIMZELX 🏢 UCB 🫀 psoriatic arthritis UCB announced positive topline results from the BE BOLD trial, which demonstrated that BIMZELX® (bimekizumab) achieved statistically significant superiority over SKYRIZI® (risankizumab) in reducing disease activity in adults with active psoriatic arthritis (PsA), as measured by the ACR50 endpoint at Week 16. This study marks the first head-to-head evidence of superiority for bimekizumab against an IL-23 inhibitor in PsA. Bimekizumab, which selectively inhibits interleukin 17A and 17F, was well tolerated with no new safety signals reported. The BE BOLD trial is the fourth study in the bimekizumab clinical program to show superiority in psoriatic disease. UCB plans to present the full results at an upcoming international congress. PsA is a chronic inflammatory condition affecting joints and skin, with significant impacts on quality of life and potential for long-term structural damage if untreated. Read full article: https://lnkd.in/gkyjVUpf #immunology #inflammation #BIMZELX #UCB

A Breath of Hope: New COPD Drug Shows Promise Big news in respiratory health! AstraZeneca’s tozorakimab just showed it can significantly reduce flare-ups in chronic obstructive pulmonary disease (COPD) in late-stage trials, working across patient groups from current and former smokers to varying disease severities. This monoclonal antibody targets interleukin-33, a key inflammatory driver — a promising step forward for millions living with chronic lung disease. If approved, the drug could generate $3–5 billion in annual sales while meaningfully improving patient outcomes. COPD remains a leading global health burden, and therapies like tozorakimab bring hope for fewer hospitalizations and a better quality of life. Read more here: https://lnkd.in/g4cF3xEh

We are pleased to announce that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM7575/SKB575, a long-acting bispecific antibody co-developed by Harbour BioMed and Kelun-Biotech for the treatment of atopic dermatitis. 🎉 🎉 HBM7575/SKB575 is designed to target TSLP, a key upstream driver of type 2 inflammation, along with an undisclosed target. By addressing these pathways, we aim to deliver more effective and durable disease control in atopic dermatitis—an area where significant unmet patient needs persist. This IND approval represents a key milestone in advancing our immunology pipeline. With its long-acting profile and dual-target mechanism, HBM7575/SKB575 has the potential to be a best-in-class bispecific antibody therapy for atopic dermatitis. We look forward to progressing this promising investigational therapy through clinical development and, ultimately, offering a differentiated treatment option for patients worldwide. 👉 Learn more about this news: https://lnkd.in/g78YK4SB #Immunology #AtopicDermatitis #BispecificAntibody #IND #ClinicalDevelopment

#LegendCapital #PortfolioNews The NMPA’s IND approval for HBM7575/SKB575 marks a significant advancement for our portfolio company, Harbour BioMed, and its partner, Kelun-Biotech. This long-acting bispecific antibody targets TSLP and a secondary undisclosed pathway, addressing the fundamental drivers of type 2 inflammation in atopic dermatitis. Regulatory clearances of this nature underscore the importance of sustained R&D investment and differentiated scientific strategies in translating early-stage discovery into meaningful clinical impact. By focusing on a long-acting profile and a dual-target mechanism, the program is well-positioned to address persistent unmet needs and deliver more durable therapeutic options within the global immunology landscape. #BiotechInnovation #Immunotherapy #DrugDiscovery #ClinicalResearch

🧠 A potential new migraine preventive treatment just reached an important milestone. 💊 In a recent press release, Lundbeck announced positive phase IIb top-line results for bocunebart (Lu AG09222), an investigational anti-PACAP monoclonal antibody for migraine prevention. 🔬 In the PROCEED trial, the intravenous (IV) portion met its primary endpoint, demonstrating a statistically significant reduction in monthly migraine days compared to placebo over 12 weeks. 💡 Key highlights: ⚡ Studied in patients who've tried 1–4 prior preventive treatments over the last 10 years 📉 Significant reduction in monthly migraine days 🩺 Generally well tolerated, with no new safety signals identified 🌍 431 patients enrolled across 14 countries 🧬 Bocunebart targets PACAP, a pathway distinct from anti-CGRP therapies—potentially representing a new class of migraine prevention treatments. 📌 Lundbeck plans to meet with regulatory authorities to discuss next steps and phase III trial design. 📊 The results are expected to be presented at an upcoming scientific conference and later submitted for peer-reviewed publication. Bocunebart is investigational and not approved by the FDA or any other regulatory agency. 🔗 Read the press release: https://lnkd.in/egRBt7rv

Insmed Incorporated is eyeing a frontline label expansion for its Mycobacterium avium complex (MAC) lung disease therapy, Arikayce (amikacin), following the drug's win in a Phase IIIb study. In the ENCORE study, Arikayce plus a multidrug combination significantly improved the baseline change in respiratory symptom scores over a placebo-multidrug pair at month 13 – meeting the trial’s primary endpoint. The biopharma company plans to submit a supplemental new drug application (sNDA) for Arikayce to American and Japanese regulators in H2 2026. GlobalData Healthcare, forecasts that Arikayce will become a blockbuster seller for Insmed, generating $1.3bn in sales in 2031. https://lnkd.in/eV2VPzZm #pharma #clinicaltrials #MAClunginfection #respiratorydisease

New Study Strengthens Teplizumab's Powerful Effects Teplizumab, the first FDA-approved therapy designed to delay type 1 diabetes, targets the autoimmune attack that destroys insulin-producing beta cells in the pancreas. As with any new medication, additional research is constantly being done to see what other benefits it may have, at the Diabetes Research Institute and elsewhere. A new study from researchers at the Barbara Davis Center for Diabetes at the University of Colorado, published in Diabetologia followed 30 children and adults with stage 2 type 1 diabetes treated with teplizumab in real-world clinical care and compared them with 10 individuals who did not receive the therapy. The results are encouraging. People who received teplizumab showed stable or improved blood sugar levels, with improvements in glucose tolerance and HbA1c during follow-up. Even more important, researchers observed that the therapy reduced specific immune cells involved in attacking beta cells, and those immune changes were linked to better preservation of insulin production. During the follow-up period, 13% of treated participants progressed to stage 3 type 1 diabetes compared with 30% in the untreated group, suggesting the therapy may slow disease progression in real-world practice. These findings add to growing evidence that intervening early in the autoimmune process can delay or slow type 1 diabetes, bringing the field closer to prevention, and ultimately a cure. We are recruiting for Teplizumab clinical trials. Visit our clinical trials page here: https://lnkd.in/gVxcM2Wr to see how you can participate. Read the study: https://lnkd.in/eQ66BQW8