Medarex Highlights Oncology Pipeline at Needham Cancer Therapeutics Conference in New York City
Highlights from Medarex’s oncology portfolio included the following:
- Ipilimumab is a fully human anti-CTLA-4 antibody in development for melanoma, prostate cancer and other cancers. Guidance for the completion of the first-line Phase 3 chemotherapy combination trial in melanoma (study 024) remains unchanged and is expected in late 2009, with overall survival as the primary endpoint under the amended Special Protocol Assessment agreement with the U.S. Food and Drug Administration. Initiation of the second-line Phase 3 radiotherapy combination trial in prostate cancer remains on track for mid-2009. Additional data, including survival and biomarker analyses from the melanoma Phase 2 program and data from the Phase 2 prostate program, will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in May/June.
- MDX-1105 and MDX-1106 are two fully human antibodies that target the PD-L1/PD-1 pathway for the treatment of cancer. MDX-1105 is in an ongoing multi-dose Phase 1 trial for advanced or recurrent renal cancer, melanoma, non-small cell lung cancer or epithelial cancer. MDX-1106 is in an ongoing multi-dose Phase 1b trial for prostate cancer, melanoma, non-small cell lung cancer and renal cancer. Complete MDX-1106 Phase 1 data will be presented at the upcoming annual meeting of ASCO in May/June.
- MDX-1342 is a fully human anti-CD19 antibody in Phase 1 development for chronic lymphocytic leukemia (CLL). Proof-of-concept pharmacologic Phase 1 data for CLL, as well as for rheumatoid arthritis, is expected in 2009. Initiation of the Phase 1 trial in acute lymphocytic leukemia remains on track for fourth-quarter 2009.
- MDX-1401 is a fully human non-fucosylated anti-CD30 antibody in Phase 1 development for Hodgkin Lymphoma. Interim data from the ongoing multi-dose Phase 1 trial will be presented at the upcoming annual meeting of the American Association for Cancer Research (AACR) in April.
- MDX-1411 is a fully human anti-CD70 antibody in Phase 1 development for clear cell renal cancer and lymphoma. Additional enrollment in the expansion cohorts is expected by the end of 2009, with interim Phase 1 data expected in early 2010.
- MDX-1203 is the first antibody-drug conjugate generated from Medarex’s Antibody-Drug Conjugate (ADC) platform to reach clinical testing. Enrollment initiation in the Phase 1 trial for renal cancer remains on track for mid-2009.
- Additional preclinical data from Medarex’s ADC platform and selected ongoing research programs will be presented at the upcoming annual meeting of AACR in April.
In addition to the highlighted oncology portfolio, Medarex is developing a number of promising products outside of oncology, including antibodies to IP-10 and CD19 for inflammation and antibodies for infectious diseases. Throughout this year and next, Medarex anticipates a strong flow of research and development milestones, including the goal of moving one or two more antibodies into clinical development.
Medarex is a biopharmaceutical company focused on the discovery, development and potential commercialization of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders and infectious diseases. Medarex applies its UltiMAb(R) technology and product development and clinical manufacturing experience to generate, support and potentially commercialize a broad range of fully human antibody product candidates for itself and its partners. Over forty of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with the most advanced product candidates currently in Phase 3 clinical trials, the subject of regulatory applications for marketing authorization or approved in
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