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Alkermes to split into two entities separating its CNS business from cancer pipeline

SOTIO Biotech

31/1/2023 | 2 minuty čtení

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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.


Alkermes mulling cancer spinout, giving neuro business path to profitability

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.

A split IL-2 mimetic enhances systemic cytokine therapy

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 presented updated clinical data from Phase 1/2 study of MDNA11

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.

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