Key Data are New Releases for the Company Building on Milestones with Recent FDA Meetings and Technology Discoveries
DENVER, CO, USA | April 20, 2009 | DXL625 monoclonal antibodies appear to be superior to commercial-stage antibodies in their ability to attach and deplete NHL in late stage pre-clinical studies, according to research conducted at InNexus Biotechnology Inc. (Toronto Stock Exchange: IXS.V, http://www.ixsbio.com), a drug development company commercializing the next generation of monoclonal antibodies based on its Dynamic Cross Linking (DXL(TM)) technology. The potency was achieved with comparable safety even at levels one hundred times that required for therapeutic efficacy, according to several studies presented at the American Association of Cancer Research (AACR) 100th Annual Meeting this past weekend. DXL625 is designed to bind CD20, a protein receptor expressed on normal B cells and over-expressed on cancerous B cells.
InNexus has previously announced that the United States Food and Drug Administration had completed its comprehensive review of the development plans for DXL625 (CD20) for the prospective treatment of Non-Hodgkin’s Lymphoma (NHL) and/or Chronic Lymphocytic Leukemia (CLL). InNexus’ submission included detailed information on plans for a Phase I clinical program, preclinical pharmacology and toxicology data and its current manufacturing plans. The FDA noted at the time that the plans were suitable for the manufacture of Phase I product of DXL625 onsite at InNexus.
"The studies are an important validation of our core drug discovery platform and confirm our ability to significantly advance the state of the art in developing potentially superior biologics for major medical and commercial opportunities," said Jeff Morhet, Chairman and CEO at InNexus.
InNexus and institutional researchers authored two studies presented during the AACR meeting. These included:
— One study, to determine whether the superior activity of the modified anti-CD20 human-mouse chimeric antibody exposed unexpected adverse activity that may not have been seen with the less cytotoxic unmodified antibody. The study determined that the increased target activity and cytotoxicity of DXL-modified anti-CD20 does not affect safety even at doses 100 times that normally required for efficacy.
"We have confirmed that the dose of maximally effective DXL-peptide conjugated anti-CD20 DXL625 retains the impressive safety historically seen with therapeutic anti-CD20 antibodies," Dr. Thomas Kindt, Chief Scientific Officer of InNexus.
— The second study defined the ability to "program" self-binding properties into antibodies. These "self-binding" interactions were seen to effectively increase the binding strength between the antibody and the target antigen, as determined repeatedly by measurable kinetic changes.
InNexus’ AACR presentations are titled, "A Novel High Avidity Anti-CD20 With Markedly Increased Cytotoxicity Shows No Systemic Toxicity In The Cynomolgus Monkey At A Dose 100-Fold Above The Anticipated Therapeutic Dose", (AACR# 1231) and "Oxidative Modification Of An Anti-CD20 Antibody Imparts Autophilic Binding Kinetics", (AACR# 1230). Posters and company representatives will also be available within the AACR Antibody and Antibody Targets Session from 1:00-5:00 PM on April 19th in Hall B-F, Poster Section 12. The posters will also be available via the InNexus website beginning April 19th.
About InNexus
InNexus is a drug development company commercializing the next generation of monoclonal antibodies based on its DXL technology, which improves the potency of existing antibody products while opening new markets and disease applications. DXL antibodies utilize unique, novel and patented methods and technologies of InNexus.
InNexus is headquartered in British Columbia with principal management based in Scottsdale, Arizona on the campus of Mayo Clinic and has its own in-house developmental facilities. These development resources provide validation of protein and peptide discoveries, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. To learn more about InNexus, please visit www.ixsbio.com.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company’s control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.
SOURCE: InNexus
Post Views: 126
Key Data are New Releases for the Company Building on Milestones with Recent FDA Meetings and Technology Discoveries
DENVER, CO, USA | April 20, 2009 | DXL625 monoclonal antibodies appear to be superior to commercial-stage antibodies in their ability to attach and deplete NHL in late stage pre-clinical studies, according to research conducted at InNexus Biotechnology Inc. (Toronto Stock Exchange: IXS.V, http://www.ixsbio.com), a drug development company commercializing the next generation of monoclonal antibodies based on its Dynamic Cross Linking (DXL(TM)) technology. The potency was achieved with comparable safety even at levels one hundred times that required for therapeutic efficacy, according to several studies presented at the American Association of Cancer Research (AACR) 100th Annual Meeting this past weekend. DXL625 is designed to bind CD20, a protein receptor expressed on normal B cells and over-expressed on cancerous B cells.
InNexus has previously announced that the United States Food and Drug Administration had completed its comprehensive review of the development plans for DXL625 (CD20) for the prospective treatment of Non-Hodgkin’s Lymphoma (NHL) and/or Chronic Lymphocytic Leukemia (CLL). InNexus’ submission included detailed information on plans for a Phase I clinical program, preclinical pharmacology and toxicology data and its current manufacturing plans. The FDA noted at the time that the plans were suitable for the manufacture of Phase I product of DXL625 onsite at InNexus.
"The studies are an important validation of our core drug discovery platform and confirm our ability to significantly advance the state of the art in developing potentially superior biologics for major medical and commercial opportunities," said Jeff Morhet, Chairman and CEO at InNexus.
InNexus and institutional researchers authored two studies presented during the AACR meeting. These included:
— One study, to determine whether the superior activity of the modified anti-CD20 human-mouse chimeric antibody exposed unexpected adverse activity that may not have been seen with the less cytotoxic unmodified antibody. The study determined that the increased target activity and cytotoxicity of DXL-modified anti-CD20 does not affect safety even at doses 100 times that normally required for efficacy.
"We have confirmed that the dose of maximally effective DXL-peptide conjugated anti-CD20 DXL625 retains the impressive safety historically seen with therapeutic anti-CD20 antibodies," Dr. Thomas Kindt, Chief Scientific Officer of InNexus.
— The second study defined the ability to "program" self-binding properties into antibodies. These "self-binding" interactions were seen to effectively increase the binding strength between the antibody and the target antigen, as determined repeatedly by measurable kinetic changes.
InNexus’ AACR presentations are titled, "A Novel High Avidity Anti-CD20 With Markedly Increased Cytotoxicity Shows No Systemic Toxicity In The Cynomolgus Monkey At A Dose 100-Fold Above The Anticipated Therapeutic Dose", (AACR# 1231) and "Oxidative Modification Of An Anti-CD20 Antibody Imparts Autophilic Binding Kinetics", (AACR# 1230). Posters and company representatives will also be available within the AACR Antibody and Antibody Targets Session from 1:00-5:00 PM on April 19th in Hall B-F, Poster Section 12. The posters will also be available via the InNexus website beginning April 19th.
About InNexus
InNexus is a drug development company commercializing the next generation of monoclonal antibodies based on its DXL technology, which improves the potency of existing antibody products while opening new markets and disease applications. DXL antibodies utilize unique, novel and patented methods and technologies of InNexus.
InNexus is headquartered in British Columbia with principal management based in Scottsdale, Arizona on the campus of Mayo Clinic and has its own in-house developmental facilities. These development resources provide validation of protein and peptide discoveries, enabling InNexus (and its strategic partners) to advance novel drug therapeutics and diagnostics. To learn more about InNexus, please visit www.ixsbio.com.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release. This news release may contain assumptions, estimates, and other forward-looking statements that involve inherent risks and uncertainties and are subject to factors, many of which are beyond the Company’s control, which may cause actual results or performance to differ materially from those currently anticipated in such statements.
SOURCE: InNexus
Post Views: 126
