Swiss biotech company Memo Therapeutics AG (MTx) and Northway Biotechpharma, a biopharmaceutical Contract Development and Manufacturing Organization (CDMO), have formed a new partnership to manufacture MTx’s therapeutic COVID-19 antibody candidate in a four-month fast-track process.

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 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.