– Leading journal publishes data on successful scale-up and manufacturing of
– PAT-SM6 Patrys to present data at international conference
Melbourne, Australia | October 17, 2011 | Patrys Limited (ASX: PAB; “the Company”), a clinical stage biopharmaceutical company focused on the development of novel treatments for cancer, is pleased to announce the publication and presentation of data from the scale-up and manufacture of its lead IgM antibody candidate PAT-SM6.
The data will be published in the December 2011 issue of BioProcess International, a leading biopharmaceutical journal.
This is the second scientific paper Patrys has published on outcomes from its IgM antibody manufacturing platform, and further documents how Patrys has successfully overcome the challenges of producing IgMs, which are more complex and six times larger than the more commonly produced IgGs. Confirmation of the scalability of Patrys’ process is a significant technical advancement that broadens the versatility of the Company’s antibody manufacturing platform.
In March 2010, Patrys appointed Laureate Biopharmaceutical Services, Inc. to scale-up and manufacture PAT-SM6 for preclinical and clinical purposes. In May 2011, the first batch of PAT-SM6 was manufactured and released for use. This material is being used in the current PAT-SM6 melanoma trial underway at the Royal Adelaide Hospital and the Princess Alexandra Hospital, Brisbane.
“We are excited at the opportunity to share the data from the scale-up and manufacturing of our lead IgM antibody, PAT-SM6. The successful completion of our first 250 litre run was essential to advancing PAT-SM6. The work in the paper outlines the production, scalability and purification processes for this antibody,” said Michael Conner, Patrys VP of Manufacturing.
In addition to the publication, the data will be presented at the BioProcess International Conference and Exhibition, on November 1, 2011 by Michael Conner of Patrys and Dr. Michiel E. Ultee, Chief Scientific Officer at Laureate Biopharmaceutical Services, Inc.
About Patrys Limited:
Based in Melbourne, Australia, Patrys (ASX: PAB) is focused on the development of natural human antibody therapies for cancer. Patrys has a deep pipeline of internal development candidates and additional products that are the subject of a collaboration agreement with a larger industry partner. More information can be found at www.patrys.com.
About PAT-SM6:
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. In October 2010, Patrys initiated a human clinical trial to evaluate PAT-SM6 as a therapy for melanoma. To date, the second group of patients has been treated and Patrys received approval to progress the clinical trial. Significantly, no safety issues have been observed or reported for any patients treated, to date, with PAT-SM6. Additionally, recent analysis of tumour samples from two patients treated with PAT-SM6 found that the antibody had penetrated into the tumour biopsies, even though the doses were substantially below the anticipated therapeutic levels. The clinical trial is taking place at the Royal Adelaide Hospital Cancer Centre and associated Pain and Anaesthesia Research Clinic and the Princess Alexandra Hospital, Brisbane. Patrys has filed patent applications to cover the PAT-SM6 antibody molecule, disease target, and the mechanism of action.
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.
SOURCE: Patrys Limited
Post Views: 89
– Leading journal publishes data on successful scale-up and manufacturing of
– PAT-SM6 Patrys to present data at international conference
Melbourne, Australia | October 17, 2011 | Patrys Limited (ASX: PAB; “the Company”), a clinical stage biopharmaceutical company focused on the development of novel treatments for cancer, is pleased to announce the publication and presentation of data from the scale-up and manufacture of its lead IgM antibody candidate PAT-SM6.
The data will be published in the December 2011 issue of BioProcess International, a leading biopharmaceutical journal.
This is the second scientific paper Patrys has published on outcomes from its IgM antibody manufacturing platform, and further documents how Patrys has successfully overcome the challenges of producing IgMs, which are more complex and six times larger than the more commonly produced IgGs. Confirmation of the scalability of Patrys’ process is a significant technical advancement that broadens the versatility of the Company’s antibody manufacturing platform.
In March 2010, Patrys appointed Laureate Biopharmaceutical Services, Inc. to scale-up and manufacture PAT-SM6 for preclinical and clinical purposes. In May 2011, the first batch of PAT-SM6 was manufactured and released for use. This material is being used in the current PAT-SM6 melanoma trial underway at the Royal Adelaide Hospital and the Princess Alexandra Hospital, Brisbane.
“We are excited at the opportunity to share the data from the scale-up and manufacturing of our lead IgM antibody, PAT-SM6. The successful completion of our first 250 litre run was essential to advancing PAT-SM6. The work in the paper outlines the production, scalability and purification processes for this antibody,” said Michael Conner, Patrys VP of Manufacturing.
In addition to the publication, the data will be presented at the BioProcess International Conference and Exhibition, on November 1, 2011 by Michael Conner of Patrys and Dr. Michiel E. Ultee, Chief Scientific Officer at Laureate Biopharmaceutical Services, Inc.
About Patrys Limited:
Based in Melbourne, Australia, Patrys (ASX: PAB) is focused on the development of natural human antibody therapies for cancer. Patrys has a deep pipeline of internal development candidates and additional products that are the subject of a collaboration agreement with a larger industry partner. More information can be found at www.patrys.com.
About PAT-SM6:
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. In October 2010, Patrys initiated a human clinical trial to evaluate PAT-SM6 as a therapy for melanoma. To date, the second group of patients has been treated and Patrys received approval to progress the clinical trial. Significantly, no safety issues have been observed or reported for any patients treated, to date, with PAT-SM6. Additionally, recent analysis of tumour samples from two patients treated with PAT-SM6 found that the antibody had penetrated into the tumour biopsies, even though the doses were substantially below the anticipated therapeutic levels. The clinical trial is taking place at the Royal Adelaide Hospital Cancer Centre and associated Pain and Anaesthesia Research Clinic and the Princess Alexandra Hospital, Brisbane. Patrys has filed patent applications to cover the PAT-SM6 antibody molecule, disease target, and the mechanism of action.
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.
SOURCE: Patrys Limited
Post Views: 89
