DUBLIN, Nov. 4, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it will present new data from its ARTISTRY clinical development program related to ALKS 4230, an investigational engineered fusion protein designed to selectively expand cancer-fighting immune cells, at the Society for Immunotherapy of Cancer's (SITC) 34th Annual Meeting being held Nov. 6-10, 2019 in National Harbor, MD. The company will present preliminary clinical data from the ARTISTRY-1 phase 1/2 study investigating ALKS 4230 as monotherapy and in combination with pembrolizumab in adults with advanced solid tumors, and study design details and preliminary safety data from the ARTISTRY-2 phase 1/2 study evaluating subcutaneous administration of ALKS 4230 as monotherapy and in combination with pembrolizumab. The SITC posters and a corporate presentation related to the ALKS 4230 program will be posted on the Investors section of the company's website, available at www.alkermes.com, on Friday, Nov. 8.
Alkermes' planned presentations at SITC will include:
- Poster #447: "ALKS 4230, an Engineered IL-2 Fusion Protein, in Monotherapy Dose-Escalation and Combination Therapy With Pembrolizumab in Patients With Solid Tumors: ARTISTRY-1 Trial," will be presented by Ulka N. Vaishampayan, M.D., Karmanos Cancer Institute at Wayne State University
- Poster #441: "ARTISTRY-2: A Phase 1/2 Study of Subcutaneously Administrated ALKS 4230 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors," will be presented by John Powderly, M.D., President and CEO of Carolina BioOncology Institute
The poster sessions will take place in Prince George's Exhibition Hall (A and B) on Friday, Nov. 8 from 12:30 – 2:00 p.m. ET and 6:30 – 8:00 p.m. ET. For more information, including a complete list of abstracts, please visit the SITC website at https://www.sitcancer.org/2019/.
About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.
About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a recently initiated monotherapy expansion stage, and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA® (pembrolizumab) in patients with select advanced solid tumors.
ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.
About Alkermes plc
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases and oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for diseases that include schizophrenia, depression, addiction, multiple sclerosis and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the design hypothesis and potential therapeutic value of ALKS 4230, including in combination with pembrolizumab; clinical development plans for ALKS 4230, including details of the ongoing ARTISTRY-1 and ARTISTRY-2 phase 1/2 studies and the company's plans for presentation of data relating to the ARTISTRY development program. You are cautioned that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond the company's control, which could cause actual results to differ materially from those expressed or implied in the forward-looking statements. These risks and uncertainties include, among others, whether preliminary, interim or final data from preclinical and early clinical studies of ALKS 4230, as a monotherapy or in combination with pembrolizumab, will be predictive of future data from the same studies, results of future clinical studies or real-world results; whether ALKS 4230, as a monotherapy or in combination, could be shown to be unsafe or ineffective; whether future clinical trials or future stages of ongoing clinical trials for ALKS 4230, as a monotherapy or in combination, will be initiated or completed on time or at all; changes in the cost, scope and duration of development activities for ALKS 4230; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2018 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
KEYTRUDA® is a registered trademark of Merck & Co., Inc.
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