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 factor (oxMIF). The companies will combine their respective expertise in drug discovery and manufacturing to bring the resulting mAb candidates into the clinic

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."