Healthcare Industry News:  PD-L1 

Biopharmaceuticals Oncology FDA

 News Release - August 1, 2006

Ono and Medarex Announce Allowance of Investigational New Drug Application for MDX-1106 for the Treatment of Cancer

First clinical study of fully human anti-PD-1 antibody anticipated for broad application in cancer and infectious diseases

OSAKA, Japan and PRINCETON, N.J., Aug. 1 (HSMN NewsFeed) -- Ono Pharmaceutical Co., Ltd. and Medarex, Inc. (Nasdaq: MEDX ) announced today the allowance of an investigational new drug application (IND) filed with the U.S. Food & Drug Administration (FDA) for MDX-1106 (ONO-4538: development code of Ono Pharmaceutical Co., Ltd.), a fully human anti-PD-1 antibody for the treatment of cancer.

The Phase I dose-escalation trial is the first human study with MDX-1106/ONO-4538 and is expected to enroll up to 39 patients with recurrent or treatment-refractory cancer. The study is intended to evaluate the pharmacokinetics and the safety of MDX-1106/ONO-4538.

Studies suggest that the PD-1 signaling pathway may play an important role in tumor evasion and escape from host immune responses and may also promote the persistence of certain chronic viral infections. Preclinical studies suggest that antibody blockade of the PD-1 signaling pathway promotes anti-tumor responses and control of persistent viral infections.

"MDX-1106/ONO-4538 is designed to suppress tumor growth through the use of the body's own immune system in order to have an effect on cancers for which there currently are no effective treatments," said Dr. Shozo Matsuoka, executive director of Development Headquarters at Ono. "Ono plans to promote the rapid development of this drug for patients all over the world in collaboration with Medarex."

In May 2005, Ono entered into a collaboration agreement with Medarex to research and develop a fully human anti-PD-1 antibody for the treatment of cancer. The two companies plan to share the costs and responsibilities of research and product development up to the completion of a Phase II clinical study. Thereafter, each company will be fully responsible for any continued development and any commercialization in its exclusive territory; Medarex's exclusive territory is North America, and Ono's exclusive territory is all areas outside of North America.

"We believe that MDX-1106 is part of an emerging new class of immunopotentiators -- antibodies that target immune regulatory pathways, such as CTLA-4 -- that are designed to boost a patient's immune response to eliminate cancer and chronic infection," said Dr. Donald L. Drakeman, President and CEO of Medarex. "We are pleased with the progress of our collaboration with Ono and look forward to developing MDX-1106 as an exciting new and potentially effective approach to fight cancer."

About MDX-1106/ONO-4538

MDX-1106/ONO-4538 is a novel fully human antibody designed to target and inhibit the function of PD-1 (programmed cell death 1), a receptor expressed on the surface of lymphocytes that is involved in regulating immune system responses. When PD-1 interacts with its ligands, PD-L1 (also known as B7-H1) and PD-L2 (also known as B7-DC), an inhibitory or negative signal is delivered to suppress activated lymphocytes. Preclinical studies suggest that PD-1 blockade by MDX-1106/ONO-4538 activates T-cell responses and promotes an immune response to fight tumors and infectious diseases. Medarex and Ono Pharmaceutical are investigating the potential of MDX-1106/ONO-4538 for the treatment of cancer.

About Ono Pharmaceutical

For more information about Ono Pharmaceutical, please visit its website at www.ono.co.jp/eng/default.htm.

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® 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. Thirty-three of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with five of the most advanced product candidates currently in Phase III clinical trials. 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.

Medarex Statement on Cautionary Factors

Except for the historical information presented herein, matters discussed herein may constitute forward-looking statements 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, including statements preceded by, followed by, or that include the words "potential"; "believe"; "anticipate"; "intend"; "plan"; "expect"; "estimate"; "could"; "may"; 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 product discovery and development, 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 as well as risks detailed from time to time in Medarex's public disclosure filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and subsequent Quarterly Reports on Form 10-Q. There can be no assurance that such development efforts will succeed or that other 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®, the Medarex logo and UltiMAb® are registered trademarks of Medarex, Inc. All rights are reserved.


Source: Medarex

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