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"This orphan drug designation is an important milestone for the nemvaleukin alfa program and underscores nemvaleukin's potential clinical utility in mucosal melanoma, a particularly aggressive form of melanoma for which treatment options remain limited," said
Under the Orphan Drugs Act (ODA), the FDA may grant orphan drug designation to drugs and biologics that are intended to treat diseases or conditions affecting fewer than 200,000 people in the
About nemvaleukin alfa
Nemvaleukin is an investigational, 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 nemvaleukin is designed to leverage the proven antitumor 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 nemvaleukin in patients with advanced solid tumors.
ARTISTRY-1 and ARTISTRY-2 are phase 1/2 studies evaluating the safety, tolerability, efficacy and pharmacokinetic and pharmacodynamic effects of nemvaleukin in patients with refractory advanced solid tumors, in both monotherapy and combination settings with the PD-1 inhibitor pembrolizumab (KEYTRUDA®). In ARTISTRY-1, nemvaleukin is administered as an intravenous infusion daily for five consecutive days. In ARTISTRY-2, nemvaleukin is administered subcutaneously and is being evaluated with once-weekly and once-every-three-week dosing schedules.
ARTISTRY-3 is a phase 2 study evaluating the clinical and immunologic effects of nemvaleukin monotherapy administered intravenously on the tumor microenvironment of a variety of advanced, malignant solid tumors.
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 potential therapeutic value of nemvaleukin as a cancer immunotherapy, including in the treatment of mucosal melanoma; and the company's expectations of continued momentum for the ARTISTRY development program this year. 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 they are necessarily subject to a high degree of uncertainty and risk. Actual results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others, whether nemvaleukin could be shown to be unsafe or ineffective; whether preclinical results and data from ongoing clinical studies for nemvaleukin will be predictive of future or final results from such studies, results of future clinical studies or real-world results; whether future clinical trials for nemvaleukin will be initiated or completed on time or at all; changes in the cost, scope and duration of, and clinical trial operations for, development activities for nemvaleukin, including changes relating to impacts of the COVID-19 pandemic on such operations and activities; 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
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp.
For Media: Sourojit Bhowmick, Ph.D., +1 781 609 6397
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