Navigation Links
Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-PD-L1 Antibody, MDX-1105

Clinical study planned for advanced or recurrent solid tumors

PRINCETON, N.J., Aug. 5 /PRNewswire-FirstCall/ -- 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-1105, for the treatment of patients with selected advanced or recurrent solid tumors, specifically renal cell carcinoma, melanoma, non-small cell lung cancer or epithelial ovarian cancer. MDX-1105 is a fully human antibody that targets the PD-L1 pathway to promote enhanced T-cell immune responses against cancer and reverse T-cell inactivation in chronic infectious disease.

The open-label, multi-dose, dose-escalation Phase 1 clinical trial is expected to enroll up to 46 patients with selected advanced or recurrent solid tumors. This trial is designed to establish and evaluate the safety, tolerability and maximum tolerated dose, as well as preliminary pharmacodynamics and efficacy, of MDX-1105.

"We are pleased that another product candidate from our proprietary pipeline has progressed into clinical trials," said Howard H. Pien, President and CEO of Medarex. "We believe that our fully human anti-PD-1 and anti-PD-L1 antibodies represent the next stage in immunotherapy beyond the anti-CTLA-4 antibodies. We look forward to exploring the potential of MDX-1105 as a possible new treatment option for patients with cancer and infectious disease."

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. More than 40 of these therapeutic product candidates derived from Medarex technology are in human clinical testing or have had INDs submitted for such trials, with seven of the most advanced product candidates currently in Phase 3 clinical trials or the subject of regulatory applications for marketing authorization. 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

Medarex 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 "expected"; "potential"; "possible"; 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 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(R), the Medarex logo and UltiMAb(R) are registered trademarks of Medarex, Inc. All rights are reserved.

SOURCE Medarex, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Medarex Announces Allowance of Investigational New Drug Applications for Wholly Owned Fully Human Anti-CD19 Antibody, MDX-1342
2. Medarex to Receive Milestone Payment from Amgen
3. Medarex Announces Ipilimumab Program Continues to Move Forward
4. Medarex Reports Interim Data from Ongoing Ipilimumab Combination Phase 1 Studies in Prostate Cancer at American Association for Cancer Research Meeting
5. Medarex Announces Presentations at Annual Meeting of the American Society of Clinical Oncology
6. Medarex Announces Initiation of Phase 2 Clinical Trials for the Treatment of Ulcerative Colitis and Rheumatoid Arthritis
7. Medarex Highlights Strength in Antibody Development and Underlying Pipeline Strategy at R&D Day Event in New York City
8. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
9. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
10. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
11. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 ... addition of the "Radioimmunoassay Market by ... (Hospital, Pharmaceutical Industry, Academics, Clinical Diagnostic Labs), ... Global Forecast to 2020" report to ... has announced the addition of the ...
(Date:11/25/2015)... 25, 2015  Amgen (NASDAQ: AMGN ) today ... with the United States (U.S.) ... biosimilar candidate to Humira ® (adalimumab). Amgen believes ... to the FDA and represents Amgen,s first BLA submission ... Harper , M.D., executive vice president of Research and ...
(Date:11/25/2015)... On Tuesday, November 24, 2015, the ... Wright Medical Technology, Inc. for product liability and ... implant device, awarded $11 million in favor of ... and three days of deliberations, the jury found ... designed and unreasonably dangerous, and that Wright Medical ...
Breaking Medicine Technology:
(Date:11/28/2015)... Aliso Viejo, CA (PRWEB) , ... November 28, 2015 , ... ... 30 new fully customizable media panels to choose from, the possibilities are endless. Users ... angle, and more. With the ProPanel: Pulse masking effects, users are sure to get ...
(Date:11/27/2015)... CO (PRWEB) , ... November 27, 2015 , ... According ... cities are not changing the way that they are handling security in light of ... police and security presence in an attempt to stop an attack from reaching U.S. ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... were," said an inventor from Hillside, N.J. "Many people catch diseases simply from ... that individuals will always be protected from germs." , He developed the patent-pending ...
(Date:11/27/2015)... ... , ... MPWH, the No.1 Herpes-only dating community in the world, revealed that over 50% of ... than 3.7 billion people under the age of 50 – or 67% of the population ... global estimates of HSV-1 infection . , "The data shocks us highly!" said Michelle ...
(Date:11/27/2015)... , ... November 27, 2015 , ... ... Secura Consultants has prided itself for not only fulfilling the needs of advisers ... solutions at an affordable price and providing top-tier customer service. However, there's always ...
Breaking Medicine News(10 mins):