Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, announced 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) Virtual Annual Meeting. NEON-1 is a first-in-human, dose escalation and expansion study of ALPN-202 monotherapy in advanced malignancies.
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 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) 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 https://ir.alpineimmunesciences.com/events. A replay will be available on the company website for 90 days following the webcast.
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.
About Alpine Immune Sciences, Inc.
Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics. With world-class research and development capabilities, a highly productive scientific platform, and a proven management team, Alpine is seeking to create first- or best-in-class multifunctional immunotherapies via unique protein engineering technologies to improve patients’ lives. Alpine has entered into strategic collaborations with leading global biopharmaceutical companies and has a diverse pipeline of clinical and preclinical candidates in development. For more information, visit www.alpineimmunesciences.com. Follow @AlpineImmuneSci on Twitter and LinkedIn.
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and preclinical development activities, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash combined with the potential $75 million in pre-option exercise milestones payable under our option and license agreement with AbbVie to fund operations through 2023, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, our ability to achieve milestones in our collaboration with AbbVie, the progress and potential of our other ongoing development programs, the timing of our public presentations and potential publication of future clinical data, the efficacy of our clinical trial designs, anticipated enrollment in our clinical trials and the timing thereof, expectations regarding our ongoing collaborations, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “intend,” and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of the COVID-19 pandemic on our business, research and clinical development plans and timelines and results of operations, including the impact on our clinical trial sites, collaborators, and contractors who act for or on our behalf, may be more severe and prolonged than currently anticipated; clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and preclinical efforts may not yield additional product candidates; our discovery-stage and preclinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
“Secreted Immunomodulatory Proteins”, “SIP”, “Transmembrane Immunomodulatory Protein,” “TIP,” “Variant Ig Domain,” “vIgD” and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.
Director, Investor Relations and Corporate Development
Alpine Immune Sciences, Inc.