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INDUSTRY NEWS AND PRESS RELEASES |
NovalGen Enters Strategic Partnership with HALIX B.V. to Manufacture Clinical Trial Materials |
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LONDON, United Kingdom and LEIDEN, The Netherlands, February 22, 2021 / B3C newswire / --NovalGen Ltd. (“NovalGen”), a biopharmaceutical company developing breakthrough cancer therapies and HALIX B.V. (“HALIX”), a contract development and manufacturing organisation, today
announced a strategic partnership. Within the scope of this
partnership, HALIX will provide manufacturing of clinical supply of
NovalGen’s therapies.
NovalGen’s innovative platform technology has been successfully
deployed at HALIX to manufacture clinical trial material for NovalGen’s
first clinical program. The program, NVG-111, is a Receptor Tyrosine
Kinase Like Orphan Like Receptor 1 (ROR1) targeting bispecific antibody T
cell engager for the treatment of hematologic malignancies and solid
tumors, is expected to enter the clinic in the first half of 2021. HALIX
has supported NovalGen with the successful completion of GMP
manufacture of NVG-111 from drug substance up to drug product and final
release. The strategic partnership and collective expertise of both
organisations has ensured an efficient technology transfer and further
development of the process leading to a successful GMP manufacturing
campaign.
“This collaboration with HALIX will ensure high quality, rapid and
secure manufacture of clinical supplies for our current and future
products. Using cutting-edge manufacturing technologies at our partner’s
state-of-the-art cGMP facility, we are progressing to become a clinical
stage company,” said Kieran O’Donovan, SVP Chemistry and Manufacturing Controls at NovalGen.“We
developed a manufacturing process around the use of transient
transfection to accelerate timelines and reduce costs, whilst delivering
product of the highest quality. In HALIX we found the ideal partner;
experience in transient transfection, modern facilities, strong
leadership and a laser focus on delivery to bring NVG-111 from contract
signature to vials of clinical drug in less than seven months.”
“The partnership with NovalGen has been a great success,” said Alex Huybens, Chief Operations Officer at HALIX.
“Working closely together and utilizing the collective bispecific
antibody expertise of both teams has enabled us to meet the ambitious
timelines and efficiently transfer the process and deliver the product
to be ready to enter the clinic. We look forward to a long and
productive collaboration with NovalGen.” |
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