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Medarex Highlights Oncology Pipeline at Needham Cancer Therapeutics Conference in New York City

March 26, 2009

PRINCETON, N.J., March 26 /PRNewswire-FirstCall/ — Medarex, Inc. (Nasdaq: MEDX) today announced that Dr. Geoffrey M. Nichol, Senior Vice President of Product Development at Medarex presented highlights from key programs in Medarex’s oncology portfolio at the Needham & Company Cancer Therapeutics: Today & Tomorrow Conference in New York. The archived edition of the presentation webcast is available in the Investor Relations section of the Medarex website at www.medarex.com.

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.

About Medarex

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 Canada and Europe. Medarex is committed to building value by developing a diverse pipeline of antibody products to address the world’s unmet healthcare needs. For more information about Medarex, visit its website at www.medarex.com.

Statement on Cautionary Factors

Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, such as statements preceded by, followed by or including the words “believe”; “expect”; “may”; “anticipate”; “projected”; “estimated”; “preliminary”; “suggest”; or “potential”; or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. Risks and uncertainties include risks associated with the development of ipilimumab and other product candidates, uncertainties related to the outcome of clinical trials, slower than expected rates of patient recruitment, unforeseen safety issues resulting from the administration of antibody products in patients, uncertainties related to product manufacturing, risks associated with the enforceability of our patents, as well as risks detailed from time to time in Medarex’s public disclosure filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and its quarterly reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. Copies of Medarex’s public disclosure filings are available from its investor relations department.

Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks of Medarex, Inc. All rights are reserved.

SOURCE Medarex, Inc.


Source: newswire