On January 17, 2023 Alkermes plc (Nasdaq: ALKS) reported that nemvaleukin alfa (nemvaleukin), the company’s investigational, novel engineered interleukin-2 (IL-2) variant immunotherapy, has been granted an Innovation Passport for the treatment of mucosal melanoma under the Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory body of the United Kingdom (UK) (Press release, Alkermes, JAN 17, 2023, View Source [SID1234626281]). The Innovation Passport designation is the entry point to the ILAP, which aims to accelerate time to market and facilitate patient access to medicines in the UK for life-threatening or seriously debilitating conditions, or conditions for which there is a significant patient or public health need. Benefits of ILAP include access to a range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit-risk assessment.
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"We believe in the potential of nemvaleukin to help address persistent unmet needs faced by patients with mucosal melanoma," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "The granting of the Innovation Passport represents an exciting step in the clinical development program of our IL-2 candidate, and we look forward to working closely with the MHRA and the ILAP partner agencies in an effort to bring nemvaleukin to people living with mucosal melanoma in the UK."
The U.S. Food and Drug Administration previously granted Orphan Drug designation and Fast Track designation to nemvaleukin for the treatment of mucosal melanoma.
About Innovation Passport and ILAP
ILAP was launched by the MHRA in January 2021 with an aim to accelerate the development of and facilitate patient access to medicines. The Innovation Passport is granted by the UK’s ILAP Steering Group, which consists of representatives from MHRA, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the All Wales Therapeutics and Toxicology Centre (AWTTC) and the National Health Service (NHS) England. It is the first step in the ILAP process and awarded to companies developing therapies with the potential to offer significant benefit to patients who have conditions that are life-threatening or seriously debilitating. A single Innovation Passport can cover multiple future indications for the same molecule.
About Nemvaleukin Alfa (nemvaleukin)
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 preferentially expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by selectively binding to the intermediate-affinity IL-2 receptor complex. The selectivity of nemvaleukin is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations. Nemvaleukin is currently the most advanced IL-2-based immuno-therapy in clinical development, with two actively recruiting, potentially registrational studies, ARTISTRY-6 and ARTISTRY-7 in mucosal melanoma and platinum-resistant ovarian cancer, respectively.
About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating nemvaleukin as a potential immunotherapy for cancer. The ARTISTRY program is comprised of multiple clinical trials evaluating intravenous and subcutaneous dosing of nemvaleukin, both as a monotherapy and in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors. Trials in the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, ARTISTRY-6 and ARTISTRY-7.