Alkermes received Fast Track for IL-2 therapy nemvaleukin alfa against mucosal melanoma

Earlier this year, FDA also granted Orphan Drug designation to nemvaleukin for the treatment of mucosal melanoma. The company recently initiated enrollment in ARTISTRY-6, a global Phase 2 trial evaluating the anti-tumor activity, safety and tolerability of nemvaleukin monotherapy in patients with melanoma who have been previously treated with anti-PD-L1 therapy. The study is evaluating intravenously administered nemvaleukin in patients with mucosal melanoma and subcutaneously administered nemvaleukin in patients with advanced cutaneous melanoma. Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need.

Moderna doses first subject in Phase 1 trial of IL-2 mRNA treatment

Moderna announced the first participant has been dosed in the Phase 1 study of mRNA-6231, the Company’s mRNA-encoded IL-2 modified for the expansion of regulatory T cells. mRNA-6231 is Moderna’s first autoimmune candidate to enter the clinic. It is also Moderna’s first subcutaneously administered therapeutic program. Moderna now has active clinic programs in five different therapeutic areas: infectious disease, oncology, cardiovascular, rare disease and autoimmune disease.

DEALS

Werewolf announced clinical trial collaboration with Merck on its WTX-124 INDUKINE program

Werewolf Therapeutics has entered into a clinical trial collaboration and supply agreement with Merck to evaluate WTX-124, a systemically-delivered, conditionally activated IL-2 INDUKINE product candidate, in combination with Keytruda. The planned clinical trial will be conducted by Werewolf and is designed to evaluate the safety and preliminary efficacy of WTX-124 as a monotherapy and in combination with KEYTRUDA in patients with solid tumors. WTX-124 is a systemically-delivered, conditionally activated IL-2 INDUKINE molecule that has been engineered to minimize the severe toxicities that have been observed with recombinant IL-2 therapy and maximize clinical benefit when administered as monotherapy or in combination with checkpoint inhibitors in multiple tumor types. Werewolf Therapeutics plans to submit IND application for WTX-124 in the first half of 2022.