Gaithersburg

Gaithersburg-based miRecule, Inc., an innovator of next-generation RNA therapeutics, earlier this week announced a strategic collaboration and exclusive license agreement with Sanofi to develop and commercialize a best-in-class antibody-RNA conjugate (ARC) for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The collaboration marks miRecule’s first licensing transaction leveraging its proprietary DREAmiR platform. It was first reported by BizJournals.

Per miRecule’s press release: FSHD is the second most common type of muscular dystrophy – affecting more than one million individuals worldwide with no approved treatments. Patients with causative genetic mutations experience lifelong deterioration of muscle function and progressive disability. The collaboration will combine miRecule’s anti-DUX4 RNA therapy (discovered through its proprietary DREAmiR platform) with Sanofi’s proprietary muscle-targeted NANOBODY technology to join the two molecules into an ARC utilizing miRecule’s NAVIgGatorTM conjugation and formulation chemistry. The potential resulting best- in-class therapy may become a disease-modifying treatment that selectively targets and suppresses the underlying cause of FSHD in muscle tissue. This groundbreaking approach would enable FSHD patients to resume their normal course of aging free from the debilitating effects of this progressive disease.

Gaithersburg-based Novavax’s Covid-19 vaccine was approved a few months back, but is not receiving the demand the company expected, according to a report from FiercePharma. Due to the low demand for the vaccine, which has been approved for first and second doses, but not as a booster, Novavax is terminating its supply agreement with manufacturing partner Fujifilm Diosynth Biotechnologies. Novavax may have to pay early termination fees up to $185 million. According to BizJournals, “The Gaithersburg company said in a Securities and Exchange Commission filing Thursday that the contract, which dates to June 2020, was terminated on Sept. 30. Under an agreement struck in August 2021, Fujifilm was to continue manufacturing the antigen component of Novavax’s Covid-19 vaccine through 2025, according to SEC filings.”

The security filing can be seen here: “On September 30, 2022, Novavax, Inc. (the “Company”), FUJIFILM Diosynth Biotechnologies UK Limited (“FDBK”), FUJIFILM Diosynth Biotechnologies Texas, LLC (“FDBT”) and FUJIFILM Diosynth Biotechnologies USA, Inc. (“FDBU” and together with FDBK and FDBT, “Fujifilm”) entered into a Confidential Settlement Agreement and Release (the “Settlement Agreement”) regarding amounts due to Fujifilm in connection with the termination of manufacturing activity at FDBT under the Commercial Supply Agreement (the “CSA”) dated August 20, 2021 and Master Services Agreement dated June 30, 2020 and associated statements of work (the “MSA”) by and between the Company and Fujifilm.