Patrys Limited Release: Commencement of GMP Production Project for Lead Anti-Cancer Product PAT-LM1
Published: May 13, 2011
PAT-LM1 is a natural human antibody that has been shown to have anti-cancer properties in multiple animal models, including a potent effect in models of pancreatic, lung and colon cancers.
Laureate is a U.S. based full-service biopharmaceutical contract manufacturing organisation and has extensive experience in the production of both clinical and marketed products in the biotechnology sector.
Patrys has an existing arrangement with Laureate for the production of another lead anti-cancer product, PAT-SM6. The PAT-SM6 project at Laureate has been very successful with production yields far exceeding expectations. PAT-SM6 is currently being evaluated in a human clinical trial targeting patients with melanoma.
“Given the success with PAT-SM6 production, which is similar to what will be needed for PAT-LM1, Patrys is confident that Laureate can produce yields of PAT-LM1 sufficient to support clinical development and commercialisation,” said Mike Conner, Patrys Vice President, Manufacturing.
Michael A. Griffith, Chief Executive Officer of Laureate, added: “We are pleased to be Patrys’ chosen manufacturing partner, giving Laureate the opportunity to share in the advancement of their novel anti-cancer products through clinical development.”
“From what we have experienced first-hand with the successful production of PAT-SM6, the Patrys’ production platform for its natural human antibodies is robust and productive. We expect that this platform will be very competitive in the field of antibody production.”
Patrys CEO Dan Devine added that securing the manufacturing for PAT-LM1 was an important milestone toward evaluating PAT-LM1 in a first-in-human clinical trial.
The PAT-LM1 production project at Laureate has already commenced.
For further information, please contact:
Chief Executive Officer
P: +61 3 9670 3273
P: 0417 382 391
P: +61 3 9866 4722
About Patrys Limited:
Based in Melbourne, Australia, Patrys (ASX: PAB) is focused on the development of natural human antibodies as therapies for cancer. Patrys has a deep pipeline of anti-cancer natural human antibodies that enable both internal development and partnering opportunities. More information can be found at www.patrys.com.
PAT-LM1 is a natural human antibody that has been shown to have potent anti-cancer properties in a large number of laboratory and animal studies. This lead product binds to a proprietary disease target that is expressed on the surface of cancer cells, but not on the surface of the healthy tissues screened. With over 200 individual patient tumours screened, covering several different cancers, PAT-LM1 binds to nearly 98% of those tumours regardless of cancer type, age, gender or disease stage. Patrys has filed patent applications to cover the PAT-LM1 molecule and its disease target.
The natural human antibody PAT-SM6 has been shown to have potent anti-cancer properties in a large number of laboratory and animal studies. More specifically, Patrys has now screened PAT-SM6 against more than 200 tumours from individual patients with various cancers, and the product binds to over 90% of the tumours screened regardless of cancer type or patient age, gender or disease stage. With respect to melanoma, PAT-SM6 has shown particularly strong promise. Patrys has filed patent applications to cover the PAT-SM6 antibody molecule, disease target, and the mechanism of action. In October 2010, Patrys initiated a human clinical trial to evaluate PAT-SM6 as a therapy for melanoma. To date, the first group of patients has been treated and Patrys received approval to progress the clinical trial. The clinical trial is taking place at the Royal Adelaide Hospital (RAH) Cancer Centre and associated Pain and Anaesthesia Research Clinic, and is projected to be completed by June 2011.
About Laureate Biopharmaceutical Services:
Laureate is a full-service biopharmaceutical contract development and manufacturing organisation. Laureate’s scientists are expert in process development and GMP production of therapeutic proteins including monoclonal antibodies and Fc-fusion proteins. In addition, the company’s portfolio of services includes aseptic filling, cell line development, analytical and stability testing, and regulatory support. Laureate has served a global client base from its Princeton, New Jersey facility since 1981 and is a portfolio company of Saints Capital, LLC.