Somerset, N.J. – Catalent, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it is collaborating with privately held Australian biomarker research company, Minomic International Limited, to develop MIL-38, an antibody drug conjugate (ADC) for prostate cancer therapy. Under the agreement, Catalent will initially produce the antibody for a clinical study with a view to larger scale production subject to a successful outcome.
The antibody production project incorporates Catalent's proprietary GPEx® technology, which creates stable, high-yielding mammalian cell lines with high speed and efficiency, typically getting drug development projects to clinic in one-third the time of traditional approaches. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production.
Should the initial clinical study prove successful, the antibody will be produced at Catalent's state-of-the-art biomanufacturing facility in Madison, WI.
"Early signs in the study are extremely encouraging," commented Brad Walsh, CEO of Minomic. "We are pleased to be working with Catalent on this exciting project as Catalent's flexibility on smaller cGMP batch production allows material supply quickly and efficiently.""We are already close to bringing a new, non-invasive testing kit for prostate cancer to market using the same antibody target. Leveraging our existing technology to develop a therapeutic antibody in conjunction with Catalent is our ultimate aim."
"GPEx technology offers many advantages compared to conventional cell line engineering systems, including increased flexibility and higher, more stable yields," commented Barry Littlejohns, President of Advanced Delivery Technologies for Catalent. "We hope that this therapeutic collaboration, combined with Minomic's pioneering work in non-invasive test kits for early detection of prostate cancer, will enable Minomic to help bring a potentially life-saving treatment to market as quickly as possible."
Developed in response to customer demand, Catalent's Madison biomanufacturing facility, constructed through an investment of approximately $20m and completed in June 2013, quadrupled the company's biologics manufacturing capacity. Designed for flexible cGMP production from 10L up to 1000L, and non-GMP production up to 250L, the site features single-use technologies and unidirectional flow to maximize efficiency and safety.
Minomic International Ltd is an Australian privately owned biomarker discovery company specialising in in-vitro-diagnostics (IVD), diagnostic imaging and therapeutics for prostate cancer. Minomic has developed the in vitro diagnostic test called MiStat™ for the early detection of prostate cancer. The key reagents, including the MIL-38 antibody and antigen and related applications are protected by international patents.
Following a successful proof-of-concept clinical study on 125 Australian patients demonstrating good sensitivity and specificity for discriminating prostate cancer patients from those with benign prostatic hyperplasia or no disease, the test is about to enter a multi-centre clinical validation in mid-2014.
Minomic is interested in partnerships or collaborations with a larger pharmaceutical/diagnostic global partner able to produce, register and distribute the MiStat™ ELISA test and collaborate through clinical validation, registration and commercialization of future diagnostic imaging and therapeutic applications of the MIL-38 antibody for prostate cancer.
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,000 people, including over 1,000 scientists, at 27 facilities across 5 continents. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com.