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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NovalGen is a privately held immuno-oncology company developing breakthrough bispecific therapies that can safely harness the immune system to fight cancer. Our dedicated team of experienced scientists, physicians and professionals are passionate about building a pipeline of disruptive and differentiated bispecific antibody products that are tailored to the needs of the patient enabling life-enhancing treatments for people with hematologic and solid tumors. The company’s lead program, NVG-111, is an ROR1 targeting bispecific antibody T cell engager using our breakthrough bispecific technology which is expected to enter clinical development in H1 2021. For more information, go to: ww.novalgen.com
HALIX B.V. is a fully integrated biopharmaceutical contract development and manufacturing organization (CDMO) for biologics enabling the treatment and prevention of life threatening diseases. The company is focused on mammalian expression systems for the production of viral vectors and recombinant proteins. HALIX leverages scalable single-use, state-of-the-art bioprocessing technologies to supply its customers with the development and GMP manufacturing of drug substance and drug product. As an end-to-end services provider, HALIX supports its customers all the way from clinical development up to commercial launch and product registration. HALIX has entered a number of cooperations for production of oncolytic immunotherapies and vaccines, utilizing innovative technologies. The company recently opened its state-of-the-art 6,700 m2 GMP manufacturing facility, offering 1,000L SUB capacities, at the Leiden Bio Science Park, the Netherlands.
HALIX belongs to the family owned Droege Group AG.
More information is available on: www.halix.nl