CLINICAL AND REGULATORY
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.