|By PR Newswire||
|January 13, 2014 03:12 AM EST||
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.
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.
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.
The industrial software market has treated data with the mentality of “collect everything now, worry about how to use it later.” We now find ourselves buried in data, with the pervasive connectivity of the (Industrial) Internet of Things only piling on more numbers. There’s too much data and not enough information. In his session at @ThingsExpo, Bob Gates, Global Marketing Director, GE’s Intelligent Platforms business, to discuss how realizing the power of IoT, software developers are now focu...
Mar. 4, 2015 03:15 PM EST Reads: 1,530
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. In his session at 15th Cloud Expo, Michael Meiner, an Engineering Director at Oracle, Corporation, will analyze a range of cloud offerings (IaaS, PaaS, SaaS) and discuss the benefits/challenges of migrating to each of...
Mar. 4, 2015 03:15 PM EST Reads: 2,168
Cloud data governance was previously an avoided function when cloud deployments were relatively small. With the rapid adoption in public cloud – both rogue and sanctioned, it’s not uncommon to find regulated data dumped into public cloud and unprotected. This is why enterprises and cloud providers alike need to embrace a cloud data governance function and map policies, processes and technology controls accordingly. In her session at 15th Cloud Expo, Evelyn de Souza, Data Privacy and Compliance...
Mar. 4, 2015 03:00 PM EST Reads: 1,799
It’s been proven time and time again that in tech, diversity drives greater innovation, better team productivity and greater profits and market share. So what can we do in our DevOps teams to embrace diversity and help transform the culture of development and operations into a true “DevOps” team? In her session at DevOps Summit, Stefana Muller, Director, Product Management – Continuous Delivery at CA Technologies, will answer that question citing examples, showing how to create opportunities f...
Mar. 4, 2015 03:00 PM EST Reads: 646
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core...
Mar. 4, 2015 02:30 PM EST Reads: 3,005
Skytap Inc., has appointed David Frost as vice president of professional services. David joins Skytap from Deloitte Consulting where he served as Managing Director leading SAP, Cloud, and Advanced Technology Services. At Skytap, David will head the company's professional services organization, and spearhead a new consulting practice that will guide IT organizations through the adoption of DevOps best practices. David's appointment comes on the heels of Skytap's recent $35 million Series D fundin...
Mar. 4, 2015 02:30 PM EST Reads: 756
Operational Hadoop and the Lambda Architecture for Streaming Data Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing...
Mar. 4, 2015 02:00 PM EST Reads: 1,498
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes ...
Mar. 4, 2015 01:45 PM EST Reads: 1,384
Docker has acquired software-defined networking (SDN) startup SocketPlane. SocketPlane, which was founded in Q4, 2014, with a vision of delivering Docker-native networking, has been an active participant in shaping the initial efforts around Docker’s open API for networking. The explicit focus of the SocketPlane team within Docker will be on collaborating with the partner community to complete a rich set of networking APIs that addresses the needs of application developers and network and system...
Mar. 4, 2015 01:45 PM EST Reads: 584
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile ...
Mar. 4, 2015 01:45 PM EST Reads: 3,289
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, it is now feasible to create a rich desktop and tuned mobile experience with a single codebase, without compromising performance or usability.
Mar. 4, 2015 01:15 PM EST Reads: 1,303
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures...
Mar. 4, 2015 01:00 PM EST Reads: 963
SYS-CON Events announced today Arista Networks will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Arista Networks was founded to deliver software-driven cloud networking solutions for large data center and computing environments. Arista’s award-winning 10/40/100GbE switches redefine scalability, robustness, and price-performance, with over 3,000 customers and more than three million cloud networking ports depl...
Mar. 4, 2015 01:00 PM EST Reads: 1,677
Application metrics, logs, and business KPIs are a goldmine. It’s easy to get started with the ELK stack (Elasticsearch, Logstash and Kibana) – you can see lots of people coming up with impressive dashboards, in less than a day, with no previous experience. Going from proof-of-concept to production tends to be a bit more difficult, unfortunately, and it tends to gobble up our attention, time, and money. In his session at DevOps Summit, Otis Gospodnetić, co-author of Lucene in Action and founder...
Mar. 4, 2015 01:00 PM EST Reads: 1,429
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, will explain the best practices of continuous testing at high scale, which is r...
Mar. 4, 2015 01:00 PM EST Reads: 1,381