LFRP Collaborators Now Report One Approved Product, Fifteen Clinical-Stage Candidates and Dyax Reports Three New Technology License Agreements
CAMBRIDGE, MA, USA | August 26, 2009 | Dyax Corp. (NASDAQ:DYAX) announced today successful advancement into Phase 1 clinical trials of two candidates identified using Dyax’s proprietary phage display technology by licensees of the Company’s Licensing and Funded Research Program (LFRP).
LFRP licensee ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, recently announced it initiated clinical development for oncology candidate IMC-EB10, ImClone’s anti-FLT3 antibody, for the treatment of acute myelogenous leukemia. Dyax received a milestone payment of $1.5 million for commencement of the Phase 1 trial which was initiated in the second quarter of 2009. Additionally, Dyax licensee MedImmune, the biologics business of AstraZeneca, announced it has advanced MEDI-547, an antibody-drug conjugate targeting EphA2 receptor for oncology indications. Dyax will receive an undisclosed milestone payment for the Phase 1 trial initiation. Dyax is eligible to receive additional future milestones associated with the development of IMC-EB10 and MEDI-547, as well as royalties on potential future net sales.
In addition to IMC-EB10, ImClone has three other antibodies in clinical development that it identified using Dyax’s phage display technology. ImClone’s anti-VEGFR2 antibody IMC-1121B is currently in Phase 3 development for metastatic breast cancer and gastric cancer. Additionally, Phase 3 development is expected to begin for ImClone’s anti-EGFR antibody IMC-11F8 by the end of 2009 and for ImClone’s anti-IGF-1R antibody IMC-A12 in either late 2009 or early 2010. The ten additional clinical-stage candidates of LFRP collaborators include three in Phase 2 trials and seven in Phase 1 trials. The LFRP also has yielded one marketed product, a purification ligand for Xyntha™ marketed by Wyeth Pharmaceuticals.
Overall LFRP Portfolio Also Grows
Dyax also announced the expansion of its extensive LFRP portfolio of licensees and collaborators with the signing of three new licensing agreements. These include an antibody research agreement with Novo Nordisk, an antibody therapeutic funded research collaboration with Kolltan Pharmaceuticals, and a patent license agreement with Sangamo BioSciences, Inc. To date, Dyax maintains more than 70 revenue-generating licenses and collaborations under the LFRP.
“The LFRP is a key component of our overall business strategy, and we are delighted to report on these new developments,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “The expansion and maturation of our licensee clinical-stage pipeline and the additions to our portfolio of LFRP licenses and collaborations continue to validate our proprietary phage display as an important drug discovery tool for the industry.”
About Dyax’s Phage Display
Dyax’s proprietary drug discovery platform, phage display, provides an efficient means to identify compounds that interact with a wide array of therapeutic targets. Dyax’s discovery capabilities have been further enhanced through automation, which has enabled the Company to evaluate a large number of molecules binding to each target. In this way, Dyax is able to rapidly identify and select a specific antibody, peptide or small protein with the desired biochemical and biological characteristics. Dyax’s state-of-the-art antibody phage display libraries allows for the rapid isolation of fully human target-specific antibodies from a library of billions of unique antibodies. These extensive libraries are screened using in vitro selection strategies that are tailored to increase the yield of lead candidates with the desired therapeutic properties.1,2
About Dyax
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax’s lead product candidate is DX-88 (ecallantide), a recombinant small protein that is currently being evaluated for its therapeutic potential in two separate indications. On June 1, 2009, Dyax submitted a response to the FDA’s Complete Response letter regarding the review of Dyax’s Biologics License Application (BLA) of DX-88 for the treatment of hereditary angioedema (HAE). The FDA accepted the submission and assigned Dyax’s BLA a new Prescription Drug User Fee Act (PDUFA) action date of December 1, 2009. DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for this indication. Additionally, DX-88 is being evaluated in two Phase 2 trials for the reduction of blood loss during on-pump cardiothoracic surgery (CTS), which are being conducted by Dyax’s partner, Cubist Pharmaceuticals. Dyax licensed to Cubist the intravenous formulation of DX-88 for surgical indications in North America and Europe. DX-88 and other compounds in Dyax’s pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. Under a debt financing agreement between Cowen Health Care Royalty Partners (CHRP) and Dyax, CHRP is entitled to receive a specified percentage of the net royalties, including all milestones fees and other payments, receivable by Dyax under the LFRP through 2016. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
REFERENCES
1. Hoet RM et al. (2005). Generation of high-affinity human antibodies by combining donor-derived and synthetic complementarity-determining-region diversity. Nature Biotechnology, 23(3):344-8.
2. Wassaf D. et al. (2006). High-throughput affinity ranking of antibodies using surface plasmon resonance microarrays. Analytical Biochemistry. 351(2):241-253
SOURCE: Dyax Corp.
Post Views: 61
LFRP Collaborators Now Report One Approved Product, Fifteen Clinical-Stage Candidates and Dyax Reports Three New Technology License Agreements
CAMBRIDGE, MA, USA | August 26, 2009 | Dyax Corp. (NASDAQ:DYAX) announced today successful advancement into Phase 1 clinical trials of two candidates identified using Dyax’s proprietary phage display technology by licensees of the Company’s Licensing and Funded Research Program (LFRP).
LFRP licensee ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, recently announced it initiated clinical development for oncology candidate IMC-EB10, ImClone’s anti-FLT3 antibody, for the treatment of acute myelogenous leukemia. Dyax received a milestone payment of $1.5 million for commencement of the Phase 1 trial which was initiated in the second quarter of 2009. Additionally, Dyax licensee MedImmune, the biologics business of AstraZeneca, announced it has advanced MEDI-547, an antibody-drug conjugate targeting EphA2 receptor for oncology indications. Dyax will receive an undisclosed milestone payment for the Phase 1 trial initiation. Dyax is eligible to receive additional future milestones associated with the development of IMC-EB10 and MEDI-547, as well as royalties on potential future net sales.
In addition to IMC-EB10, ImClone has three other antibodies in clinical development that it identified using Dyax’s phage display technology. ImClone’s anti-VEGFR2 antibody IMC-1121B is currently in Phase 3 development for metastatic breast cancer and gastric cancer. Additionally, Phase 3 development is expected to begin for ImClone’s anti-EGFR antibody IMC-11F8 by the end of 2009 and for ImClone’s anti-IGF-1R antibody IMC-A12 in either late 2009 or early 2010. The ten additional clinical-stage candidates of LFRP collaborators include three in Phase 2 trials and seven in Phase 1 trials. The LFRP also has yielded one marketed product, a purification ligand for Xyntha™ marketed by Wyeth Pharmaceuticals.
Overall LFRP Portfolio Also Grows
Dyax also announced the expansion of its extensive LFRP portfolio of licensees and collaborators with the signing of three new licensing agreements. These include an antibody research agreement with Novo Nordisk, an antibody therapeutic funded research collaboration with Kolltan Pharmaceuticals, and a patent license agreement with Sangamo BioSciences, Inc. To date, Dyax maintains more than 70 revenue-generating licenses and collaborations under the LFRP.
“The LFRP is a key component of our overall business strategy, and we are delighted to report on these new developments,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “The expansion and maturation of our licensee clinical-stage pipeline and the additions to our portfolio of LFRP licenses and collaborations continue to validate our proprietary phage display as an important drug discovery tool for the industry.”
About Dyax’s Phage Display
Dyax’s proprietary drug discovery platform, phage display, provides an efficient means to identify compounds that interact with a wide array of therapeutic targets. Dyax’s discovery capabilities have been further enhanced through automation, which has enabled the Company to evaluate a large number of molecules binding to each target. In this way, Dyax is able to rapidly identify and select a specific antibody, peptide or small protein with the desired biochemical and biological characteristics. Dyax’s state-of-the-art antibody phage display libraries allows for the rapid isolation of fully human target-specific antibodies from a library of billions of unique antibodies. These extensive libraries are screened using in vitro selection strategies that are tailored to increase the yield of lead candidates with the desired therapeutic properties.1,2
About Dyax
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax’s lead product candidate is DX-88 (ecallantide), a recombinant small protein that is currently being evaluated for its therapeutic potential in two separate indications. On June 1, 2009, Dyax submitted a response to the FDA’s Complete Response letter regarding the review of Dyax’s Biologics License Application (BLA) of DX-88 for the treatment of hereditary angioedema (HAE). The FDA accepted the submission and assigned Dyax’s BLA a new Prescription Drug User Fee Act (PDUFA) action date of December 1, 2009. DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for this indication. Additionally, DX-88 is being evaluated in two Phase 2 trials for the reduction of blood loss during on-pump cardiothoracic surgery (CTS), which are being conducted by Dyax’s partner, Cubist Pharmaceuticals. Dyax licensed to Cubist the intravenous formulation of DX-88 for surgical indications in North America and Europe. DX-88 and other compounds in Dyax’s pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. Under a debt financing agreement between Cowen Health Care Royalty Partners (CHRP) and Dyax, CHRP is entitled to receive a specified percentage of the net royalties, including all milestones fees and other payments, receivable by Dyax under the LFRP through 2016. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
REFERENCES
1. Hoet RM et al. (2005). Generation of high-affinity human antibodies by combining donor-derived and synthetic complementarity-determining-region diversity. Nature Biotechnology, 23(3):344-8.
2. Wassaf D. et al. (2006). High-throughput affinity ranking of antibodies using surface plasmon resonance microarrays. Analytical Biochemistry. 351(2):241-253
SOURCE: Dyax Corp.
Post Views: 61
