29 August 2014: Australian biotechnology company Minomic International Ltd will collaborate with a US partner to develop a potential new therapy for prostate cancer based on its existing antibody screening technology.
The company has struck an agreement with Catalent Pharma Solutions (NYSE:CTLT) to develop Minomic’s MIL-38 antibody drug conjugate (ADC) as a therapeutic product, rather than a screening target.
Minomic currently uses this antibody target in a novel prostate cancer screening technology known as MiStat™, which is expected to be launched globally in 2015.
Under the terms of this latest agreement, Catalent will redesign MIL-38 as a therapeutic antibody using its proprietary GPEx ™ technology for a clinical study, with production to be scaled up on successful outcome.
Minomic Chief Executive Officer Dr Brad Walsh said pre-clinical trials of the MIL-38 antibody target as a therapeutic had been “extremely promising”.
“Our ultimate aim is to leverage our existing technology to not only screen for prostate cancer, but to treat it,” he said.
“This collaboration is an important step to develop our MIL-38 antibody for next stage clinical trials as a therapeutic application. We expect this trial to begin as early as Q2, 2015 in Australia. “We welcome this collaboration and look forward to working with Catalent on this important project.”
President of Catalent Biologics, Barry Littlejohns, said his company’s proprietary GPEx™ technology enabled high-speed creation of mammalian cells lines, ensuring drug development projects were brought to clinic more rapidly than was otherwise possible.
He commented: “We hope that this therapeutic collaboration, combining Minomic’s pioneering work in non-invasive test kits for early detection of prostate cancer and Catalent’s drug development expertise will help bring a potentially life-saving treatment to market as expeditiously as possible.”
All data to date suggests Minomic’s MiStat™ test - a blood or urine test screening for the proprietary MIL-38 biomarker found on prostate cancer cells - is almost twice as specific as the PSA (Prostate Specific Antigen) diagnostic technology, which is the current “gold standard” screening test globally.
PSA has been controversial, largely due to the high number of false positive results delivered. Current PSA tests have a 40% specificity; MiStat™ has a demonstrated specificity of 76% in early studies.
There are currently 200 million PSA tests performed annually around the world.
Ends.
About Minomic
Minomic International Ltd is an Australian privately owned biomarker discovery company specialising in in vitro diagnostics, diagnostic imaging and therapeutics for prostate cancer. Minomic has developed the in vitro diagnostic test called MiStatTM 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 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.
About Catalent
Catalent Pharma Solutions, (NYSE: CTLT), 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 nearly 30 facilities across 5 continents and in fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
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