Navigation Links
ARGX-110, a Novel Anti-CD70 Antibody, Meets Translational Development Goals in Dose Escalation Part of Phase Ib Cancer Study

BREDA, The Netherlands and GHENT, Belgium, December 17, 2013 /PRNewswire/ --

Dose confirmed for Phase Ib safety and efficacy expansion study

arGEN-X announces that the dose-escalation part of a Phase Ib study with its lead antibody ARGX-110 has met its translational development goals: all pre-specified biological activity measures (e.g. target engagement, effector functions, immune-modulation) were met. The study also showed that ARGX-110 has a favourable safety profile and a dose has been selected to advance into the Phase Ib safety and efficacy expansion cohorts, which will start early in 2014 and are expected to report top-line results approximately 12 months later.

ARGX-110 is a first-in-class monoclonal antibody potently blocking CD70 induced tumor proliferation and tumor escape from immune surveillance. In addition, the POTELLIGENT®-enhanced antibody-dependent cellular cytotoxicity (ADCC) of ARGX-110 enables selective destruction of CD70-positive tumor cells. CD70 is overexpressed in the majority of cancer patients tested to date. Expectations of a favourable therapeutic index stem from its virtual absence in healthy tissues.

In the study, 19 patients with CD70-positive cancer were treated with escalating doses of ARGX-110, up to 10 mg/kg. The results show predictable pharmacokinetics across the dose range. No dose-limiting toxicity was identified. For Ahmad Awada, MD PhD, principal investigator of the study at the Jules Bordet Institute (Brussels, Belgium), "these results, at the clinical and immunological levels, open the door to study further the antibody as a single agent and in combination trials with small molecules and other immune checkpoint inhibitors."

Based on these data, arGEN-X will begin enrolment to hematology and solid tumor safety and efficacy expansion cohorts early in 2014 and report top-line results approximately 12 months later. According to Alain Thibault, MD, Chief Medical Officer, "We have consistent biomarker data that confirms our understanding of CD70 and the three mechanisms of action of ARGX-110. This is speeding up our program, and we may be in a position to select promising indications for Phase II development by the end of 2014."

About the ARGX-110 Study

The Phase Ib study ( Identifier: NCT01813539) consists of a dose escalation followed by adaptive safety and efficacy expansion cohorts conducted in patients with advanced, refractory cancer. The patient enrichment strategy relies on individual tumor screening for CD70 utilizing a reproducible immunohistochemistry method. In addition to traditional clinical and PK/PD endpoints, biomarkers documenting the three modes of action of ARGX-110 are being evaluated. Patient enrolment is planned at 90 CD70-positive patients with either haematological or solid tumors. The study is managed jointly by arGEN-X and a consortium of leading academic institutions in Belgium.

About arGEN-X

arGEN-X is a clinical stage human therapeutic antibody company that is rapidly developing a product pipeline using its unique suite of antibody technologies. arGEN-X is creating first and best in class antibody therapeutics with highly differentiated target product profiles. Its therapeutic antibody programs, focused on cancer and autoimmune indications, are designed to deliver tangible benefits to patients with these diseases.

For further information, please contact:

Tim Van Hauwermeiren
Chief Executive Officer
T +32(0)9-243-40-70

Debbie Allen
Senior Director, Business Development
T +44(0)7974-979479

Mark Swallow/David Dible
Citigate Dewe Rogerson
T +44(0)207-282-2949

Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. The Market for Non-Small-Cell Lung Cancer (NSCLC) Will Grow to $7 Billion in 2022, Fuelled by the Entry of Twelve Novel Agents
2. The Acute Coronary Syndrome 12-Month Posthospital Market Will Double by 2022, Driven by the Uptake of Novel Lipid Modifying Agents
3. Sutro Biopharma Closes $26 Million Financing, Expands Development of Novel Immuno-Oncology Products
4. High Cost of Biologics and Novel Oral Agents to Treat Immune Diseases Limits Patient Access
5. Opportunity Exists in the U.S. for Novel Agents in Crohns Disease and Ulcerative Colitis, Owing to Discontinued Use of Leading Anti-TNF Agents Driven by Efficacy Failures
6. Synthetic Biologics Enters into License with Cedars-Sinai Medical Center to Develop Novel Anti-infective Approaches for Irritable Bowel Syndrome (IBS), Obesity and Diabetes
7. Bavarian Nordic, the international novel cancer and infectious disease vaccines focused biotech, now covered by Edison.
8. FLAG Therapeutics and Duquesne University Announce Exclusive Worldwide Licensing Agreement for Novel, Dual-action Targeted Oncology Compounds
9. Increasing Use of Allergans Botox and the Launch of Novel Nontriptan Products Will Be Key Drivers of Migraine Market Growth Through 2022
10. Novel Molecular Assay for Patient Screening Detects S. aureus and Newly Emerging MRSA Strains Available in the United States
11. Unilife Announces Clinical Supply Agreement for Delivery of a Novel Drug
Post Your Comments:
(Date:11/24/2015)... 2015  Thanks to a donor with a personal ... Center,s Sister Diane Grassilli Center for Women,s Health now ... San Francisco . Fred ... with a gift of $617,320 that allowed the Center ... Tomosynthesis and Whole Breast Ultrasound. Tomosynthesis, three-dimensional (3-D) mammography ...
(Date:11/24/2015)... Nov. 24, 2015  Natera, Inc. (Nasdaq: ... genetic testing and the analysis of circulating ... present at the 27 th  Annual Piper ... 2015 at 1:00 p.m. ET.  Matthew Rabinowitz, Ph.D., CEO of ... business activities and financial outlook. ...
(Date:11/24/2015)... , Nov. 24, 2015  Array BioPharma Inc. ... Chief Executive Officer, Ron Squarer , will ... in New York.  The public is welcome to ... the Array BioPharma website.Event:Piper Jaffray Annual Healthcare ConferencePresenter:  ... December 2, 2015Time:1:30 p.m. Eastern Time Webcast: ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... November 24, 2015 , ... Charitable giving is at ... are made in the last five weeks of the year totalling over $358 billion ... 2012 to connect the nation’s charities with those individuals who want to “give back” ...
(Date:11/24/2015)... CA (PRWEB) , ... November 24, 2015 , ... ... sizes, has launched their Black Friday sale a week early, offering 40% off ... to transform the intimate apparel industry through both mobile fit technology and the ...
(Date:11/24/2015)... Los Angeles, CA (PRWEB) , ... November 24, 2015 , ... ... author explored the different restrictions and variables that determine which patients are or are ... are those patients that have a BMI over 40, are more than 100 pounds ...
(Date:11/24/2015)... ... November 25, 2015 , ... Catalent ... for drugs, biologics, consumer health and global clinical supply services, today announced that ... Clinical Trial Supply East Asia Conference, to be held at the InterContinental Seoul ...
(Date:11/24/2015)... ... November 24, 2015 , ... DMG Productions announced that they ... airing first quarter 2016 via Discovery Channel. Dates and show times TBA. , Aphria, ... is in the business of producing and supplying medical marijuana pursuant to the Marijuana ...
Breaking Medicine News(10 mins):