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Alpine Immune Sciences Provides Clinical Update of its Phase 1 Trial of ALPN-101 in Healthy Volunteers at the European League Against Rheumatism (EULAR) E … A Phase 1 clinical trial with ALPN-101 in healthy volunteers is underway, in preparation for future trials in multiple autoimmune diseases. Alpine Immune Sciences has commenced dosing of patients in a Phase I clinical trial of its investigational product ALPN-101 intended for treating autoimmune and inflammatory diseases. As far as actual clinical trials, ALPN-101 completed enrollment of a Phase I healthy volunteer study in October 2019. In a recently completed Phase 1 trial (NCT03748836), researchers tested ALPN-101’s safety in healthy volunteers. Initial data was presented at the American Society of Hematology annual meeting in December 2019 and more data from this Phase I trial are expected in 2020. TLPLDC vaccine is a personalised immunotherapy formulated using a … The treatment was found to be well-tolerated by participants, either as an into-the-vein (intravenous) or an under-the-skin (subcutaneous) injection. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. SEATTLE–(BUSINESS WIRE)–Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, today announced successful initiation of dosing in its first-in-human Phase I study of ALPN-101, a first-in … Further clinical development of ALPN‐101 in inflammatory and/or autoimmune diseases is therefore warranted. “This first dosing in the initial clinical trial of ALPN-101 is an important milestone for Alpine as we have now transitioned to a clinical-stage development company,” stated Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Figure 1: ALPN-101 Potently Inhibits T Cell Activation In Vitro in PBMC from Healthy Donors and Sjogren’s Syndrome Patients. AIS-A02 is a Phase 1b open-label study of ALPN-101 administered to adult subjects with steroid-resistant or steroid-refractory acute graft versus host disease (aGVHD). Up to 72 subjects will be enrolled in Part A (dose escalation) and up to 25 subjects will be enrolled in Part B (dose expansion). ALPN-101 is in a Phase I healthy volunteer trial with data expected to be reported later in 2019. In conclusion, ALPN‐101 was well‐tolerated in healthy subjects with dose‐dependent PK and PD consistent with the known biology of the CD28 and ICOS costimulatory pathways. Alpine Immune Sciences recently initiated a strategic partnership with AbbVie for the development of Alpine’s first-in class novel immunotherapeutic, ALPN‑101. It will be conducted at approximately 10 US sites. “This first dosing in the initial clinical trial of ALPN-101 is an important milestone for Alpine as we have now transitioned to a clinical-stage development company,” stated Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. First Subjects Dosed in Phase I Clinical Trial for Lead Autoimmune/Inflammatory Disease Program, ALPN-101; Completed $25 Million Private Placement; … First Dual ICOS/CD28 Inhibitor to Enter Clinical Trials. Together with the Clinical Trial Manager, may recruit clinical investigators and negotiate study design and costs. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. Clinical Trials in Patients Now Open for Both Development Programs: A phase 1b/2 trial of ALPN-101 in acute GVHD (BALANCE, NCT04227938) and a phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) are now both open for enrollment. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. ALPN 101 is a first in class dual ICOS/CD28 antagonist, being developed by Alpine Immune Sciences, using its soluble proprietary variant immunoglobulin domain ALPN 101 - AdisInsight Either you have JavaScript disabled or your browser does not support Javascript .

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