Navigation Links
Medarex Announces Allowance of Investigational New Drug Application for Company's First Antibody-Drug Conjugate, MDX-1203
Date:1/28/2009

PRINCETON, N.J., Jan. 28 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) announced today the allowance of an investigational new drug (IND) application filed with the U.S. Food & Drug Administration (FDA) for MDX-1203, the Company's first Antibody-Drug Conjugate (ADC) candidate generated from its proprietary technology. MDX-1203 is comprised of a potent cytotoxic prodrug chemically linked with a fully human anti-CD70 antibody. CD70 is expressed in renal cell carcinoma (RCC), leukemias, lymphomas, and other cancers. The Phase 1 study will evaluate MDX-1203 for the treatment of advanced/recurrent RCC and relapsed/refractory B-cell non-Hodgkin's lymphoma (NHL).

"Antibody-drug conjugates are another important and innovative therapeutic approach used to fight cancer by effectively and selectively killing tumor cells over-expressing specific tumor antigens, so we are extremely excited in achieving the IND filing for MDX-1203, the first candidate from our proprietary ADC technology platform," said Howard H. Pien, Chairman and CEO of Medarex. "We developed our ADC technology to have significant competitive advantages over existing technologies and the Phase 1 trial for MDX-1203 will be the first study to evaluate these potential benefits."

An open-label, multi-dose, dose-escalation Phase 1 clinical trial will be conducted in patients with RCC and NHL. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary distribution, metabolism and pharmacokinetics of MDX-1203.

About Medarex's Antibody-Drug Conjugate (ADC) Technology

Medarex has enhanced its core UltiMAb(R) antibody platform with a suite of technologies that optimize or augment the therapeutic activity of antibodies, and one important technology expansion is the company's proprietary Antibody-Drug Conjugate platform. Medarex's proprietary ADC technology uses a cytotoxic agent that is a potent, synthetically manufactured prodrug (a DNA minor-groove binding alkylating agent) which is attached to an antibody using a stable peptide-based linker. Medarex believes that its ADC technology overcomes many of the key development challenges of drug conjugates, including issues of linker stability, potency and multi-drug resistance while maintaining a wide therapeutic window with minimal toxicity.

Medarex has conducted multiple preclinical studies on several investigational antibody-drug conjugate candidates in development demonstrating enhanced anti-tumor activity in xenograft models, even with single doses as low as 0.005 micro mol/kg, when compared to the anti-cancer antibodies alone. Preclinical studies have also demonstrated that anti-tumor activity is maintained in drug-resistant cancer cells. Additionally, Medarex's activatable prodrug has been shown to accumulate in the targeted tumor cells but not in normal tissue cells, thereby minimizing the toxicity profile but not the anti-tumor activity in animal and primate models.

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, including statements preceded by, followed by, or that include the words "potential", "expect", "believe", or "may" or similar statements are forward-looking statements. Medarex disclaims, however, any intent or obligation to update these forward-looking statements. These risks and uncertainties include those 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, 2007 and its quarterly reports on Form 10-Q. There can be no assurance that MDX-1203 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(R), the Medarex logo and UltiMAb(R) are registered trademarks of Medarex, Inc. All rights are reserved.


'/>"/>
SOURCE Medarex, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Medarex to Present at Thomas Weisel Partners Healthcare Conference 2007
2. Medarex to Present at the Bear Stearns 20th Annual Healthcare Conference
3. Medarex Announces Extension of Broad Antibody Development Relationship with Centocor
4. Medarex to Present at the A.G. Edwards 2nd Annual Emerging Growth Conference
5. Medarex to Present at the UBS Global Life Sciences Conference
6. Medarex Announces Election of Marc Rubin as New Board Member
7. Medarex to Present at the 26th Annual JPMorgan Healthcare Conference
8. Medarex Announces Completion of Sale of Shares in Genmab A/S
9. Medarex to Announce 2007 Fourth Quarter and Year-End Financial Results on Tuesday, February 26, 2008
10. Medarex to Present at the Susquehanna Financial Group Healthcare Conference
11. Medarex Announces Presentations at Annual Meeting of the American Association for Cancer Research
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2017)... FRANCISCO, Calif. , April 19, 2017 /PRNewswire/ ... VCYT ) today announced that it will report ... of market on Wednesday, May 3, 2017. Following the ... webcast at 4:30 p.m. Eastern Time to discuss the company,s ... live webcast and subsequent replay may be accessed ...
(Date:4/18/2017)... ... April 18, 2017 , ... ... conductivity readings to concentration levels and vice-versa. , One of the key applications ... strength in concentration control or monitoring. The principle of this analytical method is ...
(Date:4/18/2017)... , ... April 18, 2017 , ... For a historic ... co-members in the VaxCorps vaccine consortium, were named one of the top two Clinical ... the inception of this category; winning the award four times previously, and first runner ...
(Date:4/18/2017)... ... 18, 2017 , ... Cancer diagnostics and pathology workflow solution ... the role of Chief Medical Officer (CMO) – Precision Medicine, overseeing strategic planning ... considered a visionary leader in precision medicine, and he has extensive experience in ...
Breaking Biology Technology:
(Date:3/23/2017)... 23, 2017 Research and Markets has announced ... & Trends - Industry Forecast to 2025" report to their ... The ... CAGR of around 8.8% over the next decade to reach approximately ... the market estimates and forecasts for all the given segments on ...
(Date:3/20/2017)... PMD Healthcare announces the release of its ... System (WMS), a remote, real-time lung health monitoring and ... is a Medical Device, Digital Health, and Chronic Care ... innovative solutions that empower people to improve their healthcare ... developed the first ever personal spirometer, Spiro PD, which ...
(Date:3/7/2017)... BRIGHTON, England , March 7, 2017 Brandwatch ... been chosen by The Prince,s Trust to uncover insights ... insights across The Trust. The UK,s leading youth charity ... track social campaign results and get a better understanding of the ... ...
Breaking Biology News(10 mins):