Welcome!

News Feed Item

NewLink Genetics Presents Algenpantucel-L Clinical Data in Poster Discussion Session at ASCO 2014 Annual Meeting

Algenpantucel-L Shows Improved Overall Survival in Pancreatic Cancer Patients with Increased Anti-Calreticulin Antibody

AMES, IA -- (Marketwired) -- 06/02/14 -- NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutics to improve treatment options for patients with cancer, today announced additional data with its drug candidate algenpantucel-L that is currently under development for multiple indications in pancreatic cancer.

Additional immunological correlative data from the NLG0205 Phase 2 study of adjuvant algenpantucel-L for treatment of resected pancreatic cancer patients was discussed at a poster presentation in Chicago during the 50th Annual meeting of the American Society of Clinical Oncology (ASCO). The NLG0205 Phase 2 clinical study evaluated algenpantucel-L plus standard-of-care adjuvant therapy (gemcitabine and 5-FU based chemoradiotherapy) in 69 patients with resected pancreatic cancer where one year disease-free survival was 62 percent and overall one year survival was 86 percent. Newlink presented data demonstrating that increased anti-calreticulin antibody (anti-CALR Ab) levels following algenpantucel-L treatment correlate with a statistically significant improvement in overall survival. Specifically, the data show median overall survival was 35.8 months in patients with elevated levels of anti-CALR Ab versus 19.2 months in patients without elevated levels(p=0.03).

Furthermore, the company presented additional patient demographic data from its ongoing IMPRESS phase 3 pivotal trial. The company evaluated the characteristics of "High Risk vs Low Risk" populations including age, gender, disease, nodal status, CA19-9 levels, resection margin, tumor location and tumor size for all 722 patients enrolled in the IMPRESS study. Specifically, IMPRESS has enrolled a significant majority (92%) of patients with high risk characteristics that were defined as being node positive or having tumor size ≥ 2.5 cm. The patient demographic profile and stage of disease severity were shown to be highly similar across all parameters when compared with the previously reported U.S.-based, multi-center RTOG 9704 clinical study of adjuvant therapy in this patient population, supporting projected survival rates for the control arm of the IMPRESS study.

---------------------------------------------------------------------------
Characteristics                        IMPRESS (n=722)   RTOG 9704 (n=221)
---------------------------------------------------------------------------
Age (median)                                 65                 61
---------------------------------------------------------------------------
Gender (male)                                52%                53%
---------------------------------------------------------------------------
Tumor location (head)                        80%                85%
---------------------------------------------------------------------------
Tumor location (body)                        20%                15%
---------------------------------------------------------------------------
CA19-9 ( >180)                               9%                 9%
---------------------------------------------------------------------------
Tumor Grade (poor/undifferentiated           35%                30%
---------------------------------------------------------------------------
Nodal Status (N+)                            70%                68%
---------------------------------------------------------------------------
Tumor Size (median) > 3.0 cm                 55%                59%
---------------------------------------------------------------------------
High risk status: N+ or > 2.5 cm             92%                N/A
---------------------------------------------------------------------------
Low risk status: N0, < 2.5 cm, R0/R1    8% (low risk)           N/A
---------------------------------------------------------------------------

"Algenpantucel-L is the most advanced program to emerge through our HyperAcute platform, and we are highly encouraged by this additional data supporting our belief that algenpantucel-L may provide a much needed survival benefit for pancreatic cancer patients," said Charles J. Link, Jr., M.D., Chairman and Chief Executive Officer of NewLink. "We also presented patient population characteristics from our IMPRESS Phase 3 clinical study with algenpantucel-L which were consistent, across the board, with those previously reported in the RTOG 9704 clinical study, supporting our expectations regarding survival rates for patients enrolled in the control arm of the IMPRESS study."

"During the last few years, despite some recent reports of novel therapeutic agents showing promise in pancreatic cancer, overall benefits are marginal at best and unfortunately offer only limited survival advantage achieved with significant toxicities," said Dr. Nick Vahanian, President and Chief Medical Officer of NewLink Genetics. He added, "In fact, during the last 3 decades there has been such limited progress made in fighting pancreatic cancer that reports of 1-2 months of survival benefit are still considered significant. We hope our data will shift treatment paradigms by helping to demonstrate the promise of immunotherapy in treating pancreatic cancer patients."

These data were presented in a discussed poster presentation entitled "Anti-Calreticulin Antibody Titers Correlate with Improved Overall Survival in a Phase 2 Clinical Trial of Algenpantucel-L Immunotherapy for Patients with Resected Pancreatic Cancer," by NewLink researchers and collaborators at the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO).

Patient enrollment (n=722) is complete in the IMPRESS study (Immunotherapy for Pancreatic Resectable cancer Survival Study). Following completion of the first interim analysis in March of this year, the NewLink Genetics' Independent Data Safety Monitoring Committee (DSMC) reviewed patient data and, as anticipated, recommended study continuation without modification. A second interim analysis is planned upon reaching 333 patient events and, if needed, a final analysis is planned at 444 patient events.

About HyperAcute Immunotherapy

NewLink's HyperAcute® immunotherapy platform creates novel biologic products that are designed to stimulate the human immune system to recognize and attack cancer cells. HyperAcute product candidates are composed of human cancer cells that are tumor specific, but not patient specific. These cells have been modified to express alpha-gal, a carbohydrate for which humans have pre-existing immunity. These alpha-gal-modified cells stimulate a rapid and powerful human immune response that trains the body's natural defenses to seek out and destroy cancer cells. The objective of HyperAcute immunotherapies is to elicit an antitumor response by "educating" the immune system to attack a patient's own cancer cells. HyperAcute immunotherapies do not require any tissue from individual patients and use intact whole cells rather than cell fragments or purified proteins. We believe these unique properties of HyperAcute products result in the stimulation of a robust immune response.

NewLink's lead product candidate, algenpantucel-L (HyperAcute pancreas), is being studied in a Phase 3 trial (IMPRESS: "Immunotherapy for Pancreatic Resectable cancer Survival Study") under a Special Protocol Assessment with the U.S. Food and Drug Administration. This trial involves up to 722 patients with surgically resected pancreatic cancer. Algenpantucel-L is also being tested in a second Phase 3 study (PILLAR: "Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable"), involving patients with locally advanced pancreatic cancer.

NewLink has several HyperAcute product candidates focused on other tumor types in various stages of development, including tergenpumatucel-L, which is in an adaptive design, randomized Phase 2b/3 clinical trial currently accruing up to 240 patients with non-small cell lung cancer.

About NewLink Genetics Corporation
NewLink is a biopharmaceutical company focused on discovering, developing and commercializing novel immuno-oncology products to improve treatment options for patients with cancer. 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. For more information please visit http://www.linkp.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 and efficacy of algenpantucel-L, tergenpumatucel-L, and our other HyperAcute product candidates and related clinical trials, plans to develop and commercialize our product candidates; ongoing and planned preclinical studies and clinical trials, the timing for completion of enrollment and outcomes of our other ongoing clinical studies; and any other statements other than statements of historical fact. 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 those risks discussed in "Risk Factors" and elsewhere in NewLink's Annual Report on Form 10-K for the period ended December 31, 2013, Quarterly Report on Form 10-Q for the period ended March 31, 2014, 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.

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
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 ...
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.
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...
"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.
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...
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...
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.
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 ...
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.
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.
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, ...
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.
StackIQ has announced the release of Stacki 3.2. Stacki is an easy-to-use Linux server provisioning tool. Stacki 3.2 delivers new capabilities that simplify the automation and integration of site-specific requirements. StackIQ is the commercial entity behind this open source bare metal provisioning tool. Since the release of Stacki in June of 2015, the Stacki core team has been focused on making the Community Edition meet the needs of members of the community, adding features and value, while ...
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.