Nykode Therapeutics and Richter-Helm BioLogics Announce Strategic Manufacturing Partnership

19 Dec 2022 06:45 CET

Oslo, Norway, December 19, 2022 – Nykode Therapeutics ASA (OSE: NYKD), a
clinical-stage biopharmaceutical company dedicated to the discovery and
development of novel immunotherapies, today announced that it 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,” stated 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 Dr. 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 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.

Nykode Therapeutics’ shares are traded on the Oslo Stock Exchange (OSE: NYKD).
Further information about Nykode Therapeutics may be found at
http://www.nykode.com.


About Richter-Helm BioLogics
Richter-Helm is a leading Germany-based contract development and cGMP
manufacturing organization with its headquarter based in Hamburg. Over the past
30 years Richter-Helm gained substantial experience in the development and
manufacture of different product classes e.g. 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. Due to the close cooperation with its mother company Gedeon
Richter Plc, Richter-Helm also offers services in the areas of mammalian
cell-based Drug Substance production and fill and finish. For more information
visit www.richter-helm.eu or on LinkedIn.


Forward-looking statements for Nykode Therapeutics
This announcement and any materials distributed in connection with this
announcement may contain certain forward-looking statements. By their nature,
forward-looking statements involve risk and uncertainty because they reflect the
company's current expectations and assumptions as to future events and
circumstances that may not prove accurate. A number of material factors could
cause actual results and developments to differ materially from those expressed
or implied by these forward-looking statements.


Contact for Nykode Therapeutics ASA:

Chief Business Officer, Agnete Fredriksen
Nykode Therapeutics ASA
IR@nykode.com

Nykode Therapeutics ASA
Oslo Science Park
Gaustadalléen 21
N-0349 Oslo, Norway


Contact for Richter-Helm BioLogics GmbH & Co KG:

Dr. Kai Pohlmeyer
Managing Director
T: +49-40-55 290-430
e: k.pohlmeyer@richter-helm-biologics.eu

More information:
Access the news on Oslo Bors NewsWeb site

578504_221219 Nykode-RH PR Manufacturing Agreement - Final.pdf