Alpine Immune Sciences Presents Design of the ALPN-202 Phase 1 Study (NEON-1) at AACR Virtual Annual Meeting I

- NEON-1 is now open for enrollment for patients with advanced malignancies -

Alpine Immune Sciences, Inc. ALPN, a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, today presented the design of NEON-1, the first-in-human study of ALPN-202, a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor, at the American Association of Cancer Research (AACR) Virtual Annual Meeting I, in the Phase I Trials in Progress Virtual Poster Session.

Many patients treated with checkpoint inhibitors fail to achieve an objective or complete anti-tumor response. This could be due to a lack of sufficient T cell costimluation in the tumor microenvironment, such as inadequate CD28 ligands. To address this, ALPN-202 was designed to inhibit both the PD-L1 and CTLA-4 checkpoints, while also providing a CD28 costimulatory signal. Importantly, ALPN-202's costimulatory function is designed to depend upon PD-L1, to help ensure clinical safety and tolerability.

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.

"We are particularly pleased to see ALPN-202 enter the clinic," said Mitchell Gold, MD, Alpine's Chairman and CEO. "ALPN-202 embodies the unique founding concepts of Alpine's vIgD platform, incorporating tri-functional agonism and antagonism in a single proprietary functional domain. It is now positioned to determine the clinical relevance of localized CD28 costimulation to the immunotherapy of cancer. We look forward to opportunities to report upon its progress in appropriate future settings."

AACR has made the 2020 virtual Annual Meeting presentations freely available. Alpine's recorded oral presentation of the NEON-1 trial design can be accessed here.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. A phase 1 trial of ALPN-202 in advanced malignancies (NEON-1, NCT04186637) is open for enrollment.

About Alpine Immune Sciences, Inc.

Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients' lives via unique protein engineering technologies. Alpine has two programs in clinical development. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation antagonist engineered to reduce pathogenic T and B cell immune responses by inhibiting ICOS and CD28. ALPN-101 has recently completed a phase 1 healthy volunteer study, and enrollment is currently open in BALANCE, a phase 1b/2 study in acute GVHD. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor, and enrollment is open in NEON-1, a phase 1 study in advanced malignancies. Alpine is backed by world-class research and development capabilities, a highly productive scientific platform, and a proven management team. For more information, visit www.alpineimmunesciences.com.

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