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Nemvaleukin awarded Innovation Passport Designation from MHRA UK

Sotio Biotech

6/3/2023 | 3 minutes to read

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Alkermes announced that its nemvaleukin alfa 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 UK.


Alkermes awarded Innovation Passport Designation by the MHRA UK for nemvaleukin

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 MAA assessment, rolling review and a continuous benefit-risk assessment.

Medicenna strengthns IP protection for MDNA11 and BiSKITs programs

Medicenna Therapeutics announced that USPTO has issued US Patent No. 11,542,312 titled “IL-2 Superagonists in Combination with Anti-PD-1.” The patent provides IP protection for methods of treating cancer with an IL-2 Superkine such as MDNA11 and a PD1, PDL1 or CTLA-4 checkpoint inhibitor in combination, as planned in the on-going ABILITY clinical trial, or as a single agent using our BiSKIT (Bifunctional SuperKine for Immuno-Therapy) platform. The patent’s term extends into at least 2039 without accounting for any potential extensions. MDNA11 is a “beta-only” long-acting IL-2 super-agonist that is being evaluated in patients with advanced solid tumors in the Phase 1/2 ABILITY study. 

Regeneron’s IL2RG antibody for T-cell-mediated disease

Regeneron described in Science Translational Medicine an IL2RG antibody that alleviated T cell-mediated pathogenesis in mouse models of allogeneic and xenogeneic graft-versus-host disease, immune aplastic anemia and multiple sclerosis. By binding to IL2RG with high affinity, the antibody blocked signaling of multiple γ-chain cytokines implicated in T cell-mediated diseases, including IL-2, IL-4, IL-7, IL-9, IL-15 and IL-21; the compound is in Phase 1 testing for aplastic anemia.


Iovance picks up Clinigen’s Proleukin for $207 million upfront

Iovance Biotherapeutics has secured the recombinant IL-2 it needs for its tumor-infiltrating lymphocytes (TIL) programs, acquiring worldwide rights to Proleukin aldesleukin from Clinigen Group for £166.7 million ($207 million) upfront. Iovance said the deal gives the company a revenue stream, helps secure its IL-2 supply chain and logistics related to TIL administration, and lower cost of goods and trial expenses. Clinigen, which acquired Proleukin from Novartis several years ago, said the product’s divestiture was part of its ongoing strategy to focus on pharmaceutical services. Clinigen is eligible for double-digit royalties and a £41.7 million milestone payment upon the first approval of Iovance’s lifileucel – an autologous TIL administered before a dose of IL-2 – in advanced melanoma.

Column Group leads Synthekine’s $100 million Series C

Existing investor The Column Group led the $100 million series C round for Synthekine, which is advancing a clinical cancer program targeting IL-2 as well as a preclinical program combining IL-2 with a CD19 CAR T therapy, due in the clinic this year. The Column Group invested in Synthekine’s $82 million series A round in 2020, as well as its $107.5 million series B in 2021.

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