Emerging biotech companies with antibody candidates often face challenges in advancing their biopharmaceutical products to Phase I clinical trials due to limited resources. Partnering with experts who can assist in selecting the final gene sequence, developing a high-expressing cell line, and establishing a robust manufacturing process, while delivering drug substance material on schedule, is crucial for many smaller organizations. In this case study we describe how OncoResponse chose Just -Evotec Biologics for the Phase I clinical manufacturing of their cancer-fighting antibody. 

OncoResponse is a biotech company that specializes in immuno-oncology, the science of using the body’s own immune system to fight cancer. The company uses insights from patients who have exceptional responses to cancer treatments to create new therapies. OncoResponse works closely with MD Anderson Cancer Center at the University of Texas, one of the world’s leading cancer research institutes, to use a unique technology that finds and develops new antibodies that target the immune cells in the tumors.

The company’s most advanced therapy, OR502, is an antibody that blocks a protein called LILRB2 that suppresses the immune system. OR502 restores the immune system’s ability to attack the cancer cells and is currently being tested in clinical trials.

OncoResponse partnered with Just-Evotec Biologics on OR502 to develop a manufacturing process that would supply their Phase I clinical trials.

The partnership was kicked-off by OncoResponse providing several variants of the OR502 antibody. Just-Evotec Biologics used its Abacus™ predictive computational tool from its J.MD™ Molecular Design toolbox to evaluate the manufacturability and stability of the different variants allowing OncoResponse to select a lead candidate with optimal manufacturability properties.

Just-Evotec Biologics then developed a cell line with its J.CHO^TM High Expression System to produce OR502 in its continuous biomanufacturing platform. This system utilizes CHO-K1 host cells, transposon-based expression vectors and proprietary cell culture media. The company’s scientists further developed the process and successfully scaled it up in their J.PLANT™ Seattle GMP manufacturing facility at the 500-L bioreactor scale. This allowed operational teams to manufacture material for the first-in-human trial and provide the necessary CMC data for OncoResponse’s Investigational New Drug submission to the FDA. The CMC development from ordering DNA for transfection through to the shipment of drug substance to the fill finish site took just 11 months.

In November 2023, OncoResponse announced the first person to receive OR502 has been dosed in a Phase I/II trial. The trial aims to test the safety, tolerability, and initial anti-cancer effects of OR502 alone and in combination with anti-PD-1 in people with advanced solid tumors. OR502 clinical studies are being conducted with support from the Cancer Prevention Research Institute of Texas (CPRIT) DP230076.

“Our launch of this trial in cancer patients shows our ongoing dedication to developing treatments that can enhance the outcomes for people with cancer,” said Clifford Stocks, CEO of OncoResponse.

Just - Evotec Biologics is a technology-driven Contract Development and Manufacturing Organization (CDMO) with extensive experience in developing production processes for antibodies, next-generation biologics, and biosimilar products. Our strategically located facilities in the USA and Europe offer comprehensive development and manufacturing capabilities under one roof, ensuring that the experts who develop the processes are readily available for troubleshooting during operations.

We have developed a continuous manufacturing platform to reduce the cost of goods for commercial antibodies and expand global access to affordable, high-quality biologics. Partners who adopt continuous manufacturing from the earliest clinical phases benefit from highly productive processes from the outset, avoiding the costs of clinical resupply batches. Additionally, they can use the same equipment, platform, and facility from Phase I clinical trials through to commercial manufacturing. This avoids the need for new scale-down models or process transfers between sites thereby saving both time and money.

Our dedicated team of scientific and regulatory experts has extensive experience in advancing a range of antibody-based biologics through to IND. We can help you navigate the complexities of Phase I clinical development, providing you with a state-of-the-art production process for your scientific discovery.