Swiss biotech company Memo Therapeutics AG (MTx) and Northway Biotechpharma (Northway), a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announce a new partnership to manufacture MTx's therapeutic COVID-19 antibody candidate in a four-month fast-track process.
MTx today announces a collaboration with Northway for fast-track cGMP manufacturing of its lead antibody candidate for the treatment of COVID-19. MTX-COVAB is a fully human, highly potent antibody isolated from clinically selected convalescent COVID-19 donors with picomolar neutralizing activity against wild-type SARS-CoV-2, as well as newly described mutants. The selected antibody will undergo an accelerated development path as an immunotherapy and for the prevention of COVID-19.
Under the terms of the manufacturing agreement, Northway will develop the cell line and the manufacturing process, and will further produce cGMP batches of MTx's antibody for clinical studies. Northway is also perfectly positioned to execute commercial production once MTX-COVAB receives marketing authorization. This will enable MTx to supply the market in time for the anticipated second wave of the pandemic.
Northway produces antibodies and other mammalian cell-based therapeutics up to the 2.000 L scale in single-use bioreactors at its current facilities. A larger-scale production facility using stainless-steel bioreactors will be made operational by the start of 2021 to facilitate ramping-up of capacity to meet MTx's demand. This project leverages the innovative discovery research and applied cGMP manufacturing know-how of the two partners.
"Based on outstanding efficacy data from our MTX-COVAB clinical candidate, regulatory authorities fully support MTx's development plan for a fast-track approach towards market authorization. We are confident that we will be equipped to serve patients' needs by the start of 2021," explained Dr. Karsten Fischer, CEO of Memo Therapeutics.
"It is a great pleasure to support MTx's programs and to personally contribute to the global fight against COVID-19 by employing our technical know-how and excellent cGMP manufacturing capabilities," said Dr. Vladas Bumelis, Executive Chairman of the Board of Northway Biotechpharma.
Dr. André Markmann, VP Business Development of Northway Biotechpharma, added: "MTx has very aggressive timelines due to the global health threat and, therefore, needs a partner that is able to respond to their demands rapidly while also providing a high-quality service. They have selected Northway Biotechpharma as we are able to meet these needs."