Mabion Announces Commercial Manufacturing Agreement for Novavax COVID-19 Vaccine
Poland-based Mabion S.A. to manufacture recombinant protein antigen for Novavax’ COVID-19 vaccine, bolstering global supply
Konstantynów Łódzki, Poland, - October 8, 2021 – Mabion S.A. (WSE: MAB), a biotechnology company headquartered in Poland, today announced the signing of a contract manufacturing agreement with Novavax for the large-scale production of the protein antigen used in Novavax’ recombinant nanoparticle protein-based COVID‑19 vaccine candidate, NVX-CoV2373. The four-year deal provides production capacity at Mabion’s Poland-based facility through 2026.
“The addition of Mabion’s technical expertise and production capacity to Novavax’ global manufacturing network expands our ability to provide broad access to our vaccine across multiple regions,” said Rick Crowley, Executive Vice President, Chief Operations Officer, Novavax. “We look forward to building a long-term and mutually beneficial strategic partnership with Mabion.”
The agreement follows the efficient transfer of technology from Novavax to Mabion for protein antigen production for NVX-CoV2373. Mabion will leverage its process development and organizational abilities to rapidly scale up manufacturing of the vaccine at its state-of-the-art Good Manufacturing Practice (GMP) - certified facility located in central Poland.
“Mabion is proud to leverage our biologics production capabilities in partnership with Novavax to efficiently and effectively commence large-scale manufacturing,” said Krzysztof Kaczmarczyk, President of the Management Board, Mabion. “We thank Novavax for their strong collaboration that will ensure a quick and smooth transition to commercial-scale production and look forward to helping bring their COVID-19 vaccine to many people in need.”
Antigen produced by Mabion will be integrated into Novavax’ global supply chain, which currently includes antigen production at sites across North America, Europe, India and Asia. In August, Novavax announced an advance purchase agreement with the European Commission for the purchase of up to 200 million doses of the Novavax COVID-19 vaccine.
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial
in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response.
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.
About Mabion S.A.
Mabion S.A. (WSE: MAB), is Polish biopharmaceutical company established in 2007 with its core competency being the development of latest generation pharmaceuticals based on recombinant proteins technologies (e.g.. monoclonal antibodies). Mabion’s capabilities begin with the drug design phase, including selection of both upstream and downstream technologies, up through GMP manufacturing operations (DS and DP), as well as development of analytical tools (structural, functional, physicochemical), clinical development, clinical analytics (PK, PD, NAB, ADA) and full regulatory coverage of all development and operational activities. The company’s most advanced project is MabionCD20, a biosimilar to MabThera (Rituximab) with the therapeutic indications for non-Hodgkin’s lymphoma, Leukemia and Rheumatoid Arthritis (RA). Currently, MabionCD20 is in an advanced clinical stage. Furthermore, Mabion S.A. develops and extends its existing platform to CDMO activities, namely contract development, GMP manufacturing services, and GMP/GLP analytical services in full scope of above-mentioned capabilities. Mabion is listed on the Warsaw Stock Exchange.
For more information: www.mabion.eu
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