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OncoOne and GenScript ProBio Enter Agreement for the Manufacturing of Monoclonal Antibody Drugs Targeting oxMIF

17 novembre 2021 | 09.01
LETTURA: 3 minuti

LEIDEN, Netherlands, Nov. 17, 2021 /PRNewswire/ -- OncoOne, a biotechnology company focused on discovering precision medicines for cancer and other indications and GenScript ProBio, a leading CDMO in biologics and gene cell therapy, today announced that the companies have entered into an agreement for the cell line development, drug substance and drug product manufacturing of therapeutic and diagnostic monoclonal antibodies (mAbs) directed against the promising immuno-oncology target, oxidized macrophage migration inhibitory factory (oxMIF). The companies will combine their respective expertise in drug discovery and manufacturing to bring the resulting mAb candidates into the clinic. Further terms of the agreement have not been disclosed.

OncoOne's founders identified oxMIF as the disease-related isoform of macrophage migration inhibitory factor (MIF). OxMIF contributes to immune evasive and immune tolerant phenotypes in cancer and is characterized by its presence in diseased tissue. This represents significant potential for the treatment of various solid tumors such as colorectal, lung, pancreatic, and ovarian cancers and the opportunity for combination with a companion diagnostic for precise detection and targeted treatment. By partnering with GenScript ProBio's high-end manufacturing practices, OncoOne aims to have its first two oxMIF candidates, the therapeutic program ON203 as well as the companion radio-labeled diagnostic, ON102, enter phase I clinical trials in 2023.

GenScript ProBio's GMP manufacturing center follows internationally leading design concepts and is a true zero-crossover, unidirectional flow plant which meets FDA, EMA and NMPA regulatory requirements. Strict physical isolation measures are adopted throughout the entire facility, ensuring the manufacturing of multiple samples simultaneously which will greatly aid the efficient and high-quality development of ON203 and ON102.

"Based on our expertise in the understanding of oxMIF and its broad therapeutic potential, it is exciting to have selected a monoclonal antibody theranostic approach as our lead program and to have put in place this manufacturing collaboration with GenScript ProBio to bring our lead candidates to the clinic. Equipped with GenScript ProBio's world-class manufacturing practices, we believe this partnership places us on the path toward bringing our therapeutics to cancer patients in need," said Randolf Kerschbaumer, CEO of OncoOne.

"It is our pleasure to offer our superior manufacturing services to support the development and manufacturing of this innovative mAbs project," said Dr. Brian Min, CEO of GenScript ProBio. "We look forward to our continued collaboration with OncoOne in an effort to provide new solutions to patients in high-need indications."

About OncoOne

OncoOne seeks to overcome the limitations of targeting macrophage migration inhibitory factor by harnessing the high tumor–specificity of the disease–related isoform, oxidized macrophage migration inhibitory factor (oxMIF). The Company is focused on developing multiple proprietary drug modalities to leverage oxMIF's potential as a target for systemic treatment of pancreatic, colorectal, ovarian and lung cancers, as well as for chronic inflammatory diseases. Equipped with a successful track–record in early–stage drug development, as well as a deep understanding of the target, OncoOne's leadership will advance a pipeline based on oxMIF's promise in oncology, with the goal of expanding into other disease areas. www.oncoone.com

About GenScript ProBio

GenScript ProBio is the biologics CDMO segment of GenScript Biotech, proactively providing end-to-end service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in antibody drug and gene and cell therapy to accelerate drug development for customers.

Toward the mission of "Innovation through Collaboration", GenScript ProBio is committed to helping customers shorten the timeline for the development of biological drugs from discovery to commercialization, significantly lowering R&D costs and building a healthier future.https://www.genscriptprobio.com/

For OncoOne:

Randolf Kerschbaumer, Ph.D., CEO Website: http://www.oncoone.com/E-mail: office@oncoone.comPhone: +43 1 909 2208 - 6000

For Media Inquiries:

Trophic CommunicationsGretchen Schweitzer or Valeria FisherE-mail: OncoOne@trophic.euPhone: +49 892 388 7735 or +49 172 861 8540

For GenScript ProBio

Website: https://www.genscriptprobio.com/Berkan Unal, Director Business DevelopmentE-mail: berkan.unal@genscript.comPhone: +49 176 233 22 401

Shanlin Yang, Media Relations ManagerE-mail: shanlin.yang@genscript.comPhone: +86 150 7138 1167

Photo - https://mma.prnewswire.com/media/1689426/2222.jpg

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