We're happy to announce topline data from our Phase 3 EQUATOR study in acute graft-versus-host disease (aGVHD).?Treatment with itolizumab did not improve complete response (CR) of overall response (OR) rates at Day 29, but did achieve statistical significance in multiple secondary endpoints demonstrating compelling clinical benefit in longer-term outcomes, including CR at Day 99, duration of CR and failure free survival. - Stat sig in duration of CR favoring itolizumab, with a median 336 days vs. 72 days, p-value 0.017 - Stat sig in failure-free survival favoring itolizumab, with a median 154 vs. 70 days, p-value 0.043 - Stat sig in complete response at Day 99 favoring itolizumab, with 35 (44.9%) vs. 22 (28.6%) patients, p-value 0.035 - Positive trend in overall survival favoring itolizumab, with mortality of 19 (24.4%) vs. 25 (32.5%) patients Based on these data, encouraging feedback from leading KOLs, and prior FDA guidance, we have filed for Breakthrough Therapy designation and have a meeting with the agency to discuss potential for Accelerated Approval of itolizumab, which has already received Orphan Drug and Fast Track designations in this indication. We expect feedback from the FDA within 60 days, and if positive we would plan to submit a biologics license application during the first half of 2026. Full press release here: https://lnkd.in/gnAGUuBG Webcast here: https://lnkd.in/gsAejSiJ
关于我们
Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to pioneer new products with a mission to dramatically improve the lives of patients with severe autoimmune and inflammatory diseases who continue to suffer with high unmet medical needs. By bringing treatments designed to restore the balance of the immune system, we hope to restore the balance of life for patients in need. Our lead product candidate, itolizumab, is a first-in-class monoclonal antibody that targets the CD6-ALCAM signaling pathway, which plays a central role in the activation and trafficking of pathogenic effector T cells that drive inflammation in a number of diseases. We believe itolizumab may have broad therapeutic utility and our current pipeline is focused on developing itolizumab as a best-in-class treatment for multiple severe immuno-inflammatory disorders – this includes acute graft-versus-host disease, SLE / lupus nephritis and uncontrolled asthma.
- 网站
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https://www.equilliumbio.com
Equillium, Inc.的外部链接
- 所属行业
- 生物技术研究
- 规模
- 11-50 人
- 总部
- San Diego,California
- 类型
- 上市公司
- 创立
- 2017
地点
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主要
2223 Avenida de la Playa
US,California,San Diego
Equillium, Inc.员工
动态
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Today we announced that an abstract was accepted for poster presentation at the 39th?Annual Meeting of the Society for Immunotherapy of Cancer (SITC). Title:?Interleukin (IL)-15 and IL-21 synergistically enhance NK and CD8+ T cell responses Presenting Author:?Phoi Tiet, Senior Research Associate, Equillium, Inc. Abstract Number: 908 Location:?Exhibit Halls A & B Date:?Saturday, November 9, 2024 The abstract highlights that cytokines are a focus of anti-cancer therapeutic development due to their central role in regulating anti-tumoral immune responses, and that data demonstrates that IL-15 and IL-21 synergistically augment NK and CD8 T cells activities, which further enhanced their proliferation and cytolytic function. With the ability to rescue T cell dysfunction, this cytokine combination could be a promising treatment approach to stimulating anti-tumor immune responses.
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Reminder...Get out and walk to end Lupus! https://walktoendlupus.org
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Help us #WalktoEndLupusNow. Gather your friends, raise some $ and earn the exclusive Walk t-shirt when you hit $100! Register today at https://walktoendlupus.org
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Join us on September 28 as we #WalkForAlopecia to help raise money for @NAAF_org https://www.naaf.org/walk/
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It's conference season again! Equillium, Inc. presenting tomorrow, Tuesday, September 10th at 8:00 am ET at the H.C. Wainwright & Co., LLC Investor Conference. CEO, Bruce Steel, will provide an update on the full pipeline and milestones, including itolizumab and our Ono Pharmaceutical partnership. Live webcast and replay available on EQs events page: https://lnkd.in/gsAejSiJ
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Equillium CEO, Bruce Steel, presenting today at 4:30 pm ET at the 2024 Wells Fargo Healthcare Conference in Boston. Presentation will provide an overview of the EQ's multi-cytokine inhibitor programs and platform, currently focused on dermatological and gastrointestinal indications, as well as the ongoing development of itolizumab in partnership with Ono Pharmaceutical and Ono’s pending option exercise decision to potentially acquire Equillium’s rights to itolizumab. https://lnkd.in/gsAejSiJ
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Please join us in welcoming our newest Clinical Operations Team member, Annie Huynh.?She joins us as a Clinical Trial Manger and will be supporting the EQUATOR program for acute Graft-Versus-Host Disease.? ? Annie previously worked as a Sr. Project Manager in both Project Management and Clinical Operations at Nitto BioPharma and as a coordinator at UCSD Health. ? In her spare time, Annie enjoys Pilates, cycling and catching the occasional halibut under the Coronado Bridge. ? Welcome Annie!
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"At Equillium, our community matters!" Thank you Life Science Cares San Diego and Feeding San Diego for your partnership! #LifeScienceCaresSanDiego #FeedingSanDiego #CommunityDay #SocialResponsibility #FunWellnessDay
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