NovalGen, a biopharmaceutical company developing breakthrough cancer therapies and HALIX B.V., a contract development and manufacturing organisation, have agreed a strategic partnership wherein HALIX will manufacture clinical supplies for 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 haematologic malignancies and solid tumours, is expected to enter the clinic in the first half of 2021.
HALIX has supported NovalGen with the successful completion of GMP (Good Manufacturing Practice) manufacture of NVG-111 from drug substance 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.”
Alex Huybens, Chief Operations Officer at HALIX, commented: “The partnership with NovalGen has been a great success. 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.”