News Feed Item

arGEN-X Starts Phase Ib Expansion Cohorts With ARGX-110, a Novel Anti-CD70 Antibody, in Cancer Patients

BREDA, The Netherlands and GHENT, Belgium, January 13, 2014 /PRNewswire/ --

Study supported by a €3.5 million IWT grant from the Flemish Government

arGEN-X, a clinical stage human therapeutic antibody company, announces that it has advanced ARGX-110, a novel anti-CD70 antibody, into the safety and efficacy expansion part of its Phase Ib study. The objective is to further investigate the safety of ARGX-110 in CD70-positive cancer patients with either haematological or solid tumors, and to evaluate efficacy in order to select the indications to be studied in Phase II clinical development. Top-line results are expected in about 12 months. The study is being supported by a €3.5 million grant from the Flemish Government's Institute for the Promotion of Innovation by Science and Technology in Flanders (IWT).

ARGX-110 is a first-in-class monoclonal antibody that potently blocks 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 favorable therapeutic index stem from its virtual absence in healthy tissues.

In the first part of the Phase Ib study, announced in December 2013, ARGX-110 showed a favorable safety profile, exhibited no dose-limiting toxicities and met all translational development goals (i.e. measures of biological activity such as target engagement, effector functions, and immune-modulation). The open-label Phase Ib expansion aims to enrol up to 75 patients at three clinical centers in Belgium (Institut Jules Bordet, UZA, and UZG) and Institut Gustave Roussy in France.

The expansion phase is part of a broader 'Transformational Medical Research' (TGO) project implemented by arGEN-X in close collaboration with leading Flemish research organizations and clinical centers and supported by IWT. The project aims to develop and further the use of innovative, adaptive clinical trial designs that leverage immunohistochemistry, biomarkers, tissue bank materials as well as clinical data to improve the chances of success with novel drug candidates. The project also involves leading academic research on CD70/CD27 signaling for expanding the field of cancer immunotherapy.

 "We are excited to advance ARGX-110 into the expansion phase of the study. The data generated in the first phase of the study and in preclinical testing are very encouraging and reinforce our belief in the broad therapeutic potential of ARGX-110 against CD70-positive haematological and solid tumors," said Tim Van Hauwermeiren, Chief Executive Officer. "We are also delighted to receive the IWT grant, which stimulates collaboration across the Flemish life sciences cluster in search of ground-breaking translational medicines, and has provided great support for arGEN-X to advance this innovative study with ARGX-110."

Katrien Swerts, IWT Advisor and TGO coordinator, added: "On the initiative of Minister Lieten, the Flemish Government initiated the TGO program in order to stimulate the development of more effective and affordable medicines. By joining forces with universities and clinical centers, Flemish companies may be able to accelerate to speed with which they bring their innovative drugs to patients. For small and medium-sized companies, the program could have important added value as the financial support will help them test their innovative products in a faster and more extensive way. By initiating its Phase Ib expansion cohorts, arGEN-X proves that this approach is working. The company opted for an adaptive clinical trial design and is now reaping the fruits of this innovative approach."

About the ARGX-110 Study

The Phase Ib study (ClinicalTrials.gov Identifier: NCT01813539) consists of a dose escalation phase 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 approximately 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.


About IWT

The agency for Innovation by Science and Technology (abbreviated as IWT) is the government agency founded in 1991 by the Flemish Government to support technological innovation projects in Flanders. Each year IWT distributes about EUR 300 million in subsidies for innovation projects to companies, organizations, research and educational institutions in Flanders. In addition to financial support, IWT also assists companies by, for instance helping them find the right information or the right partners at home or abroad, providing assistance with the preparation of projects for European programmes and with technology transfer throughout Europe. IWT also has an important coordination mandate aimed at promoting close cooperation among all the actors involved in technological innovation in Flanders. IWT Monitoring&Analysis, M&A for short, monitors innovation and regularly publishes studies. For more information, please visit http://www.iwt.be or call +32-2-209-09-00.



More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Enterprises have taken advantage of IoT to achieve important revenue and cost advantages. What is less apparent is how incumbent enterprises operating at scale have, following success with IoT, built analytic, operations management and software development capabilities - ranging from autonomous vehicles to manageable robotics installations. They have embraced these capabilities as if they were Silicon Valley startups.
Digital transformation is about embracing digital technologies into a company's culture to better connect with its customers, automate processes, create better tools, enter new markets, etc. Such a transformation requires continuous orchestration across teams and an environment based on open collaboration and daily experiments. In his session at 21st Cloud Expo, Alex Casalboni, Technical (Cloud) Evangelist at Cloud Academy, explored and discussed the most urgent unsolved challenges to achieve fu...
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
Daniel Jones is CTO of EngineerBetter, helping enterprises deliver value faster. Previously he was an IT consultant, indie video games developer, head of web development in the finance sector, and an award-winning martial artist. Continuous Delivery makes it possible to exploit findings of cognitive psychology and neuroscience to increase the productivity and happiness of our teams.
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
The standardization of container runtimes and images has sparked the creation of an almost overwhelming number of new open source projects that build on and otherwise work with these specifications. Of course, there's Kubernetes, which orchestrates and manages collections of containers. It was one of the first and best-known examples of projects that make containers truly useful for production use. However, more recently, the container ecosystem has truly exploded. A service mesh like Istio addr...
Predicting the future has never been more challenging - not because of the lack of data but because of the flood of ungoverned and risk laden information. Microsoft states that 2.5 exabytes of data are created every day. Expectations and reliance on data are being pushed to the limits, as demands around hybrid options continue to grow.
As IoT continues to increase momentum, so does the associated risk. Secure Device Lifecycle Management (DLM) is ranked as one of the most important technology areas of IoT. Driving this trend is the realization that secure support for IoT devices provides companies the ability to deliver high-quality, reliable, secure offerings faster, create new revenue streams, and reduce support costs, all while building a competitive advantage in their markets. In this session, we will use customer use cases...
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing smart devices with AI and BlockChain capabilities prepare to refine compliance and regulatory capabilities in 2018. Volumes of health, financial, technical and privacy data, along with tightening compliance requirements by...
Evan Kirstel is an internationally recognized thought leader and social media influencer in IoT (#1 in 2017), Cloud, Data Security (2016), Health Tech (#9 in 2017), Digital Health (#6 in 2016), B2B Marketing (#5 in 2015), AI, Smart Home, Digital (2017), IIoT (#1 in 2017) and Telecom/Wireless/5G. His connections are a "Who's Who" in these technologies, He is in the top 10 most mentioned/re-tweeted by CMOs and CIOs (2016) and have been recently named 5th most influential B2B marketeer in the US. H...
DevOpsSummit New York 2018, colocated with CloudEXPO | DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City. Digital Transformation (DX) is a major focus with the introduction of DXWorldEXPO within the program. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term. A total of 88% of Fortune 500 companies from a generation ago are now out of bus...
With 10 simultaneous tracks, keynotes, general sessions and targeted breakout classes, @CloudEXPO and DXWorldEXPO are two of the most important technology events of the year. Since its launch over eight years ago, @CloudEXPO and DXWorldEXPO have presented a rock star faculty as well as showcased hundreds of sponsors and exhibitors! In this blog post, we provide 7 tips on how, as part of our world-class faculty, you can deliver one of the most popular sessions at our events. But before reading...
DXWordEXPO New York 2018, colocated with CloudEXPO New York 2018 will be held November 11-13, 2018, in New York City and will bring together Cloud Computing, FinTech and Blockchain, Digital Transformation, Big Data, Internet of Things, DevOps, AI, Machine Learning and WebRTC to one location.
DXWorldEXPO LLC announced today that ICOHOLDER named "Media Sponsor" of Miami Blockchain Event by FinTechEXPO. ICOHOLDER give you detailed information and help the community to invest in the trusty projects. Miami Blockchain Event by FinTechEXPO has opened its Call for Papers. The two-day event will present 20 top Blockchain experts. All speaking inquiries which covers the following information can be submitted by email to [email protected] Miami Blockchain Event by FinTechEXPO also offers s...