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February 22, 2021

NovalGen and HALIX enter clinical trial materials manufacturing partnership

Biopharmaceutical company NovalGen has entered a strategic partnership with contract development and manufacturing organisation HALIX to manufacture clinical trial materials.

Biopharmaceutical company NovalGen has entered a strategic partnership with contract development and manufacturing organisation HALIX to manufacture clinical trial materials.

As part of the partnership, HALIX will be responsible for providing manufacturing of the clinical supply of NovalGen’s breakthrough cancer therapies.

NovalGen has deployed its innovative platform technology at HALIX for the manufacture of clinical trial material for its first clinical programme NVG-111.

The NVG-111 programme is a Receptor Tyrosine Kinase Like Orphan Like Receptor 1 (ROR1) targeting bispecific antibody T cell engager to treat hematologic malignancies and solid tumours.

This programme is expected to enter clinical trials in the first half of this year.

NovalGen received support from HALIX in the completion of GMP manufacture of NVG-111 from drug substance up to drug product and final release.

It also noted that the strategic partnership of both organisations has ensured an efficient technology transfer, as well as the development of a process that leads to a successful GMP manufacturing campaign.

NovalGen Chemistry and Manufacturing Controls senior vice-president Kieran O’Donovan said: “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.

“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.”

Together, the companies used the collective bispecific antibody expertise of both teams under the partnership.

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