ModeX Therapeutics Leverages ProBioGen's Expertise for Accelerated COVID-19 Antibody Development

ProBioGen recently announced a pivotal collaboration with ModeX Therapeutics an OPKO Health Company dedicated to combating cancer and infectious diseases with cutting-edge multi-specific biologics. ModeX has signed a Master Services Agreement with ProBioGen to accelerate the development and production of clinical material of their multi-specific COVID-19 antibody. This strategic fee-for-service collaboration encompasses a full spectrum of services, including advanced cell line development, cutting-edge process optimization, and large-scale GMP production. ModeX will harness the power of ProBioGen’s pioneering DirectedLuck Transposase Technology, which enables the production of high-titer, stable expression cell lines that are critical to the success of ModeX’s antibody program.

“ProBioGen is thrilled to work on ModeX’s fascinating complex COVID-19 antibodies,” said Dr. Volker Sandig, CSO at ProBioGen. “Our CHO.RiGHT platform together with the DirectedLuck transposase technology provides the robustness and flexibility to address specific needs of each molecule and create the very best cell line with accelerated time lines. The partnership represents a bold step toward industrial manufacturing of this important drug candidate.”

“We are excited to partner with ProBioGen to advance our COVID-19 antibody program,” added Dr. Peter Bernhardt, CMC Lead at ModeX. “This collaboration marks a pivotal moment in our mission to deliver transformative therapies for infectious diseases, and we are confident that our combined expertise will drive meaningful progress.”

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract 75A50123C00056. This funding is part of Project NextGen, an HHS program to accelerate and streamline the rapid development of the next generation of vaccines and therapeutics.

ProBioGen’s DirectedLuck transposase system combines an optimized highly active transposase and transposon with epigenetic targeting. It is equipped with a recognition domain for specific histone marks that integrates multiple copies of transgene expression units individually at genomic regions with highest transcriptional activity. As a result, it achieves exceptionally high protein expression and maximum stability in clone pools and clones. This reduces time and manual lab work for selecting superior clones for best titers, proven stability and product quality.

The DirectedLuck Transposase is compatible with genetic elements in standard expression vector design and can be used with host cell lines of different species and tissue origin. DirectedLuck delivers superior cell lines for standard mAbs and complex glycoproteins and provides additional benefits for bispecifics and virus producer cell lines where it allows gradual adjustment of relative expression levels for optimal product quality. DirectedLuck is available for out-licensing. Furthermore, ProBioGen applies DirectedLuck as a standard tool in clients’ service projects at no extra charge.

ModeX Therapeutics is a clinical-stage biopharmaceutical company developing innovative multispecific biologics for cancer and infectious disease. Its platforms unite the power of multiple biologics in a single molecule to create multispecific antibodies and vaccines with unprecedented versatility and potency in fighting complex disease. The ModeX pipeline includes candidates against both solid and hematologic tumors, as well as several of the world’s most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is an OPKO Health company based in Weston, MA.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies.

ProBioGen is a Berlin-based specialist for developing and manufacturing biopharmaceutical active ingredients, viral vectors and vaccines with applying proprietary technologies to improve product quality and features.

Combining both state-of-the-art development services, based on ProBioGen’s CHO.RiGHT expression and manufacturing platform, together with intelligent product-specific technologies yields biologics with optimized properties. Rapid and integrated cell line and process development, comprehensive analytical development, and following reliable GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with GMP standards (EMA/FDA).

ProBioGen has been operational for almost 30 years. At four locations in Berlin, about 300 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. ProBioGen’s growth strategy is driven by the expansion of the service value chain through organic growth and potential acquisition. Diversification is a complement driver, while the focus is strict on enabling the development of biopharmaceuticals for tomorrow.