On June 4, 2021 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 presentation of initial data from NEON-1, the company’s Phase 1 clinical trial of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting (Press release, Alpine Immune Sciences, JUN 4, 2021, View Source [SID1234583552]). NEON-1 is a first-in-human, dose escalation and expansion study of ALPN-202 monotherapy in advanced malignancies.

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Presentation highlights include:

ALPN-202 has been generally well-tolerated as of the data cutoff date. The most common treatment-related adverse events have included immune-related toxicities, particularly cutaneous reactions.
Although most enrolled participants have had tumors considered classically non-responsive to immunotherapies, 61% (14 of 23 evaluable) appeared to derive clinical benefit as defined as a best outcome of stable disease or better, as of the data cutoff date. One of these participants, with metastatic colorectal cancer, achieved an unconfirmed partial response.
Dose-dependent pharmacokinetics and pharmacodynamics have been observed, accompanied by expansion of circulating CD4+ T cells with upregulation of the ICOS activation and Ki-67 proliferation markers. An expansion of central memory T cells, and a downregulation of regulatory T cells, were also observed.
"These data represent, to our knowledge, the first demonstration of safe, controlled CD28 agonism in humans, with measurable physiological consequences," commented Dr. Stanford Peng, Alpine’s President and Head of Research and Development. "The circulating T cell changes are particularly exciting and consistent with the expected biology of CD28. Together with the early suggestion of clinical benefit for some cancers not traditionally considered immune-responsive, these findings strongly encourage us to further develop ALPN-202."

The poster is now live on the ASCO (Free ASCO Whitepaper) meeting website. A copy of the presented data is available on the Scientific Publications page of Alpine’s website.

Additionally, Alpine will hold an investor event on Friday, June 4th, 2021 at 7:00pm EDT. During the investor event, Alpine will review these data. Following the presentation, Alpine will hold a question-and-answer discussion.

Investor Event – Conference Call and Webcast Details

Alpine will hold an investor event on Friday, June 4th, 2021 at 7:00pm ET, to coincide with the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting. To access the investor event by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) and reference conference ID: 3439769.

A live webcast of the investor event will be available online in the investor relations section of the company’s website at View Source A replay will be available on the company website for 90 days following the webcast.

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. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling. Alpine also plans the initiation of NEON-2, a combination study of ALPN-202 and a PD-1 inhibitor, later this year.