A proposed separation of Alkermes’ oncology business into a new public company will offer investors optionality around a late-stage clinical asset and preclinical pipeline, while giving the biotech’s core neuroscience business a path to profitability as a stand-alone entity.
Among the factors driving the decision to explore a spinout is the Inflation Reduction Act fundamentally shifting the relative economic value of biologic medicines of cancer.
The move would separate a commercial CNS business that includes an antipsychotic franchise from a cancer pipeline led by nemvaleukin alfa (ALKS 4230), which is in a Phase 3 trial to treat ovarian cancer and a Phase 2 trial Alkermes described as a potential registration enabling study to treat mucosal melanoma. Nemvaleukin is a fusion protein of circularly permuted IL-2 and CD25 that activates and proliferates immunostimulatory tumor-killing immune cells. Pops would remain with Alkermes and the neuroscience business, while the as-yet-unnamed spinout will have its own leadership. Alkermes expects to provide more financial details as it moves forward with the process, which would culminate in a separation in 2H23.
Scientists from the Baker lab at the University of Washington revealed in Nature Biotechnology a new type of IL-2 mimetic that enhanced antitumor efficacy in mouse models of melanoma and lymphoma by expanding CD8+ T cells and CAR T cell activation, and reduced systemic toxicity compared with a more standard IL-2 immunotherapy. The study provides proof-of-concept for the “split” mimetic strategy devised by Neoleukin Therapeutics, which aims to reduce dose-limiting toxicities of monomeric cytokines by splitting them into two fragments that reconstitute the cytokine’s activity when they co-localize, thereby restricting activity to cells expressing two surface markers, one for each component. Neoleukin’s Phase 1 program, NL-201, is an IL-2/IL-15 agonist which structurally resembles IL-2 but has only about 15% sequence homology, and completely lacks an IL2RA binding domain, belonging to a group of compounds known as a “not-alpha” therapies. Because IL-15 shares the same IL2RB and IL2RG chains as IL-2, NL-201 also has full IL-15 activity.
Medicenna announced new safety, PK, and PD data from the first four dose escalation cohorts of the Phase 1/2 ABILITY study of MDNA11, the company’s beta-only long-acting IL-2 super-agonist. The data were featured in two posters presented at SITC. MDNA11’s selectivity and dose-dependent stimulation of anti-cancer immune cells indicates potential for increased anti-tumor activity with continued dose escalation. New data reaffirm MDNA11’s potential to overcome the major safety, pharmacokinetic, and pharmacodynamic shortcomings of IL-2 therapies.
