|By PR Newswire||
|April 2, 2013 07:00 AM EDT||
AMES, Iowa, April 2, 2013 /PRNewswire/ -- NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced the initiation of a double-blind, randomized, placebo-controlled Phase 2 clinical study of its first IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitor, indoximod, in patients with metastatic breast cancer. The Phase 2 clinical study will evaluate indoximod as a new approach to treating cancer by administering this novel IDO pathway inhibitor, designed to counteract a key mechanism by which tumors evade immune-mediated destruction, in combination with a conventional cytotoxin, docetaxel. This Phase 2 clinical study follows the successful Phase 1b dose-escalation study of indoximod in patients with advanced solid tumors in which a favorable safety profile and promising early signs of activity were observed. Indoximod is the most advanced product candidate to enter clinical trials based on NewLink's proprietary IDO pathway inhibitor platform for small-molecule, orally bioavailable cancer immunotherapies.
"There is significant unmet need for new approaches that may offer more effective treatment options for patients with metastatic breast cancer, a leading cause of death in women in the United States," said Hatem Soliman, MD, a medical oncologist specializing in breast cancer in The Center for Women's Oncology at Moffitt Cancer Center and the principal investigator for this study. "Indoximod has demonstrated promising safety, pharmacokinetic and biologic activity in earlier clinical studies and we look forward to increasing our understanding of its potential in metastatic breast cancer with this robust Phase 2 study designed to evaluate the activity of indoximod in combination with a conventional chemotherapy across a number of clinically relevant endpoints."
"Indoximod, an IDO pathway inhibitor is an immune check point inhibitor akin to the recently developed antibodies targeting CTLA-4 and PD-1. IDO can be expressed within both tumor cells and/or antigen presenting cells to create local immune suppression to impair immunological detection and destructions of tumors," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. "We are excited about the promising approach of using novel therapies, like indoximod, to harness key mechanisms of the immune system to enhance the body's cancer-fighting abilities and enhance the effect of other therapies. NewLink intends to pursue this strategy as we advance other clinical candidates from our IDO pathway inhibitor platform as well as our novel candidates from our HyperAcute immunotherapy platform."
This randomized, double-blind, placebo-controlled Phase 2 clinical study is designed to evaluate the safety and efficacy of indoximod in combination with docetaxel as compared to docetaxel alone in up to 120 patients with metastatic breast cancer. Study endpoints include progression-free survival, objective response rate, median overall survival and evaluation of pharmacodynamic tumor markers, in addition to safety. For more information about the study please refer to www.clinicaltrials.gov.
About indoximod and inhibition of the IDO pathway
IDO (indoleamine-(2,3)-dioxygenase) pathway inhibitors, also known as one of the key class of checkpoint inhibitors, represent a potential breakthrough approach to cancer therapy using small-molecule, anti-toleragenic product candidates intended to counteract a key mechanism by which tumors evade immune-mediated destruction. IDO is an enzyme that regulates immune response by suppressing T-cell function and enabling local tumor immune escape. Recent studies have demonstrated that IDO is overexpressed in many cancers, within both tumor cells as a direct defense against T-cell attack, and also within antigen presenting cells in tumor draining lymph nodes whereby IDO promotes peripheral tolerance to tumor associated antigens (TAAs). When hijacked by developing cancers in this manner, IDO may facilitate the survival, growth, invasion, and metastasis of malignant cells expressing TAAs that might otherwise be recognized and attacked by the immune system. Indoximod is currently in multiple Phase 1B/2 studies targeting breast cancer. These include combination studies with docetaxel and with an autologous p-53 Dendritic Cell vaccine. In addition to its clinical product candidate indoximod, NewLink has an active program directed at synthesizing other IDO pathway inhibitors.
About NewLink Genetics Corporation
NewLink Genetics Corporation is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve treatment options for cancer patients. NewLink's portfolio includes biologic and small-molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as a monotherapy or in combination with other treatment regimens. NewLink's lead product candidate, algenpantucel-L (HyperAcute® Pancreas) is being studied in a Phase 3 clinical trial in surgically resected pancreatic cancer patients (under a Special Protocol Assessment with the U.S. FDA) as well as in a separate study in locally advanced pancreatic cancer patients. NewLink has recently launched an adaptive design Phase 2B/3 clinical trial of tergenpumatucel-L (HyperAcute® Lung) in patients with non-small cell lung cancer. NewLink is developing indoximod, a small-molecule, orally bioavailable product candidate from NewLink's proprietary indoleamine-(2,-3)-dioxygenase pathway inhibitor technology. NewLink is studying indoximod in various chemotherapy and immunotherapy combination studies independently and in collaboration with the National Cancer Institute. For more information please visit http://www.linkp.com. Patient information is available at http://www.pancreaticcancer-clinicaltrials.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan,""target," "potential," "will,""could," "should,""seek," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the prospects of algenpantucel-L, indoximod and our other HyperAcute product candidates and related clinical trials. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including risks relating to: the initiation of clinical trials and the completion of enrollment; adverse general economic and industry conditions; and those risks discussed in "Risk Factors" and elsewhere in NewLink's Quarterly Report on Form 10-K for the period ended December 31, 2012, Form S-3 Registration Statement filed December 28, 2012 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent NewLink's views as of the date of this press release. NewLink anticipates that subsequent events and developments will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing NewLink's views as of any date subsequent to the date of this press release.
Chief Financial Officer
SOURCE NewLink Genetics Corporation
Redis is not only the fastest database, but it is the most popular among the new wave of databases running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 19th Cloud Expo, Dave Nielsen, Developer Advocate, Redis Labs, will share the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
Jul. 30, 2016 07:30 PM EDT Reads: 1,752
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Jul. 30, 2016 07:30 PM EDT Reads: 1,314
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.
Jul. 30, 2016 07:00 PM EDT Reads: 2,768
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Jul. 30, 2016 05:00 PM EDT Reads: 1,300
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Jul. 30, 2016 04:30 PM EDT Reads: 576
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus...
Jul. 30, 2016 04:30 PM EDT Reads: 1,121
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 30, 2016 04:30 PM EDT Reads: 2,271
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
Jul. 30, 2016 04:15 PM EDT Reads: 634
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Jul. 30, 2016 02:30 PM EDT Reads: 1,064
Security, data privacy, reliability, and regulatory compliance are critical factors when evaluating whether to move business applications from in-house, client-hosted environments to a cloud platform. Quality assurance plays a vital role in ensuring that the appropriate level of risk assessment, verification, and validation takes place to ensure business continuity during the migration to a new cloud platform.
Jul. 30, 2016 02:00 PM EDT Reads: 533
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Jul. 30, 2016 01:30 PM EDT Reads: 979
Ovum, a leading technology analyst firm, has published an in-depth report, Ovum Decision Matrix: Selecting a DevOps Release Management Solution, 2016–17. The report focuses on the automation aspects of DevOps, Release Management and compares solutions from the leading vendors.
Jul. 30, 2016 01:00 PM EDT Reads: 1,858
Continuous testing helps bridge the gap between developing quickly and maintaining high quality products. But to implement continuous testing, CTOs must take a strategic approach to building a testing infrastructure and toolset that empowers their team to move fast. Download our guide to laying the groundwork for a scalable continuous testing strategy.
Jul. 30, 2016 01:00 PM EDT Reads: 2,130
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
Jul. 30, 2016 12:00 PM EDT Reads: 1,365
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
Jul. 30, 2016 11:30 AM EDT Reads: 1,409