On June 24, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported that the first patient has been successfully dosed in its NEON-1 Phase 1 study of ALPN‑202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in patients with advanced malignancies (Press release, Alpine Immune Sciences, JUN 24, 2020, View Source [SID1234561439]).
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"This is a particularly exciting milestone," said Mitchell Gold, MD, Alpine’s Chairman and CEO, "because ALPN-202 embodies the unique founding concepts of Alpine’s vIgD platform, incorporating tri-functional agonism and antagonism in a single proprietary functional domain. As we continue with the study, ALPN-202 will hopefully help establish the clinical relevance of localized CD28 costimulation to checkpoint inhibition in cancer."
NEON-1 includes two parts: dose escalation and expansion cohort(s). It will enroll adults with advanced solid tumors or lymphoma refractory or resistant to standard therapy, including checkpoint inhibitors when indicated. Measurable disease is required for most participants, as are an ECOG status of 0 to 2 and adequate hematological, renal, and hepatic function. Dose escalation begins with single-participant cohorts to minimize the number of participants anticipated to receive subtherapeutic doses, followed by standard 3 + 3 cohorts where two dose regimens, weekly versus every three weeks, will be studied in parallel. Expansion cohorts will explore specific tumor types and/or biomarker-selected tumors, based upon the experience during dose escalation. Safety endpoints include dose-limiting toxicities, adverse events, and circulating cytokines. Objective responses will be assessed by RECIST v1.1 for solid tumors and Lugano criteria for lymphoma. Pharmacokinetics and pharmacodynamics will also be evaluated. More information is available at www.clinicaltrials.gov (NCT04186637).
About ALPN-202
ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor designed to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling.