Nykode Therapeutics ASA has entered into a strategic manufacturing partnership with Richter-Helm BioLogics GmbH & Co KG to supply plasmid DNA for Nykode’s wholly owned and partnered product portfolio.
“We are excited about the strategic manufacturing partnership with Richter-Helm BioLogics. As a leading manufacturer of DNA vaccines, they will provide the long-term expertise and capacity needed to support our ambitious growth and pipeline development,” said Mette Husbyn, chief technology officer of Nykode Therapeutics.
“We are thrilled to collaborate with Nykode Therapeutics and to support the development of their leading DNA vaccine platform. After 30 years of manufacturing plasmid DNA, we have gained an unparalleled amount of first-hand plasmid DNA process knowledge and experience working with regulatory agencies to ensure cGMP compliance for clinical trials and late-stage product candidates,” said Kai Pohlmeyer, managing director of Richter-Helm BioLogics.
Manufacturing is a strategic focus area for Nykode and its license partners. Under the partnership agreement with Richter-Helm BioLogics, Nykode will have the option to tech transfer the proprietary manufacturing processes to its partners, if requested.
About Nykode Therapeutics
Nykode Therapeutics is a Norwegian clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies for the treatment of cancer and infectious diseases. Nykode’s modular vaccine technology specifically targets antigens to antigen presenting cells, which are essential for inducing rapid, strong and long-lasting antigen specific immune responses and eliciting efficacious clinical responses.
Nykode’s lead product candidates are VB10.16, a therapeutic vaccine for the treatment of human papilloma virus (HPV)-16 induced malignancies which demonstrated positive interim efficacy and safety results from its phase 2 trial for the treatment of cervical cancer; and VB10.NEO, an individualized cancer neoantigen vaccine, which is exclusively out-licensed to Genentech, a member of the Roche Group.
Additionally, Nykode is conducting a phase 1/2 trial with next-generation COVID-19 vaccine candidates.
The company’s partnerships include Genentech within oncology, a multi-target collaboration with Regeneron within oncology and infectious diseases and a collaboration with Adaptive Biotechnologies for COVID-19 T cell vaccine development.
About Richter-Helm BioLogics
Richter-Helm is a Germany-based contract development and cGMP manufacturing organization with its headquarter based in Hamburg. Richter-Helm develops and manufactures recombinant proteins, antibodies, pDNA and vaccines.
The company currently operates a development facility and two cGMP manufacturing facilities for microbial production. Richter-Helm offers highly specialized contract development and manufacturing services to support the global pharmaceutical and biotechnological industries with strain development, process development and supply of products for clinical trials and commercial material.
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