SEATTLEâ(BUSINESS WIRE)âAlpine 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 ⦠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 is in a Phase I healthy volunteer trial with data expected to be reported later in 2019. In conclusion, ALPNâ101 was wellâtolerated in healthy subjects with doseâdependent PK and PD consistent with the known biology of the CD28 and ICOS costimulatory pathways. 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 . 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. A Phase 1 clinical trial with ALPN-101 in healthy volunteers is underway, in preparation for future trials in multiple autoimmune diseases. TLPLDC vaccine is a personalised immunotherapy formulated using a ⦠First Dual ICOS/CD28 Inhibitor to Enter Clinical Trials. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. It will be conducted at approximately 10 US sites. Together with the Clinical Trial Manager, may recruit clinical investigators and negotiate study design and costs. 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 ⦠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. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. 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). âThis 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,â stated Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. In a recently completed Phase 1 trial (NCT03748836), researchers tested ALPN-101âs safety in healthy volunteers. First Subjects Dosed in Phase I Clinical Trial for Lead Autoimmune/Inflammatory Disease Program, ALPN-101; Completed $25 Million Private Placement; ⦠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 has recently completed enrollment in a Phase 1 healthy volunteer trial. âThis 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,â stated Mitchell H. Gold, MD, Executive Chairman and Chief Executive Officer of Alpine. Further clinical development of ALPNâ101 in inflammatory and/or autoimmune diseases is therefore warranted. As far as actual clinical trials, ALPN-101 completed enrollment of a Phase I healthy volunteer study in October 2019. Figure 1: ALPN-101 Potently Inhibits T Cell Activation In Vitro in PBMC from Healthy Donors and Sjogrenâs Syndrome Patients. Alpine Immune Sciences recently initiated a strategic partnership with AbbVie for the development of Alpineâs first-in class novel immunotherapeutic, ALPNâ101. 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. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial.