Welcome!

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.

http://www.argen-x.com

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.

 

SOURCE arGEN-X

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
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, will discuss recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model f...
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
Digitization is driving a fundamental change in society that is transforming the way businesses work with their customers, their supply chains and their people. Digital transformation leverages DevOps best practices, such as Agile Parallel Development, Continuous Delivery and Agile Operations to capitalize on opportunities and create competitive differentiation in the application economy. However, information security has been notably absent from the DevOps movement. Speed doesn’t have to negat...
While DevOps promises a better and tighter integration among an organization’s development and operation teams and transforms an application life cycle into a continual deployment, Chef and Azure together provides a speedy, cost-effective and highly scalable vehicle for realizing the business values of this transformation. In his session at @DevOpsSummit at 19th Cloud Expo, Yung Chou, a Technology Evangelist at Microsoft, will present a unique opportunity to witness how Chef and Azure work tog...
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lea...
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
Your business relies on your applications and your employees to stay in business. Whether you develop apps or manage business critical apps that help fuel your business, what happens when users experience sluggish performance? You and all technical teams across the organization – application, network, operations, among others, as well as, those outside the organization, like ISPs and third-party providers – are called in to solve the problem.
Digital transformation is too big and important for our future success to not understand the rules that apply to it. The first three rules for winning in this age of hyper-digital transformation are: Advantages in speed, analytics and operational tempos must be captured by implementing an optimized information logistics system (OILS) Real-time operational tempos (IT, people and business processes) must be achieved Businesses that can "analyze data and act and with speed" will dominate those t...
If you had a chance to enter on the ground level of the largest e-commerce market in the world – would you? China is the world’s most populated country with the second largest economy and the world’s fastest growing market. It is estimated that by 2018 the Chinese market will be reaching over $30 billion in gaming revenue alone. Admittedly for a foreign company, doing business in China can be challenging. Often changing laws, administrative regulations and the often inscrutable Chinese Interne...
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Adobe is changing the world though digital experiences. Adobe helps customers develop and deliver high-impact experiences that differentiate brands, build loyalty, and drive revenue across every screen, including smartphones, computers, tablets and TVs. Adobe content solutions are used daily by millions of companies worldwide-from publishers and broadcasters, to enterprises, marketing agencies and household-name brands. Building on its established design leadership, Adobe enables customers not o...
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...