Memo Therapeutics (MTx), a Swiss biotech company, has entered into a partnership with Northway Biotechpharma, under which the latter will manufacture the former’s MTX-COVAB – a COVID-19 antibody candidate in a four-month fast-track process.
Northway Biotechpharma is a biopharmaceutical contract development and manufacturing organization (CDMO) based in Lithuania.
MTX-COVAB, which is the lead antibody candidate of Memo Therapeutics for COVID-19 treatment, is a fully human, highly potent antibody, which is said to be isolated from clinically selected convalescent COVID-19 donors having picomolar neutralizing activity against wild-type SARS-CoV-2 virus, and also newly described mutants.
The selected antibody will go through a fast-tracked development path as an immunotherapy and for the prevention of the novel coronavirus, said the Swiss biotech company.
As per the manufacturing agreement terms, Northway Biotechpharma will be developing the cell line and produce cGMP batches of Memo Therapeutics’ antibody for clinical studies.
The Lithuanian CDMO is said to be well poised to undertake commercial production once MTX-COVAB gets marketing authorization from the European Commission. The agreement with the CDMO is claimed to help Memo Therapeutics to supply the Covid-19 antibody to the market in time for the expected second wave of the pandemic.
Dr. André Markmann – VP of Northway Biotechpharma Business Development said: “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.”
Northway Biotechpharma is engaged in producing antibodies and other mammalian cell-based therapeutics up to the 2.000 L scale using single-use bioreactors at its existing facilities. The Lithuanian CDMO is expected to begin operations at a larger-scale production facility with stainless-steel bioreactors by the start of next year to enable ramping-up of capacity to meet the demand of Memo Therapeutics.
Dr. Karsten Fischer – CEO of Memo Therapeutics said: “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.”