Welcome!

News Feed Item

NewLink Genetics Dorgenmeltucel-L HyperAcute Immunotherapy for Melanoma Demonstrates Clinical Efficacy With Tumor Regression and Immune Activation

Data Demonstrating Promising Combination Immunotherapy With Dorgenmeltucel-L and Pegylated Interferon-Alpha for Advanced Melanoma Patients in the Upcoming Publication of The Ochsner Journal

AMES, IA -- (Marketwired) -- 05/30/14 -- 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 data from a Phase 2 clinical study of its dorgenmeltucel-L HyperAcute® immunotherapy in combination with pegylated interferon-alpha 2b in patients with advanced metastatic, progressive, refractory or recurrent melanoma. The study will be featured in the upcoming edition of The Ochsner Journal, Volume 14, Number 2, Summer 2014, Academic Division of Ochsner Clinic Foundation. The treatment regimen consisted of 12 weekly vaccinations with 150 million cell dosage of dorgenmeltucel-L in combination with short course, pegylated interferon-alpha 2b given during weeks 5 through 12. These data demonstrated that the combination was capable of inducing complete and durable clinical responses with tumor regression and immune activation.

The study enrolled 25 patients, 21 of which completed the trial and were evaluable for response. The upcoming publication will highlight that of the 16 patients with stage IV disease, two had a complete response (CR) per Response Evaluation Criteria in Solid Tumors (RESIST), one had stable disease (SD), and four had no evidence of disease (NED) after resection. Furthermore, of the nine patients with stage II/III disease, three remained NED, and one stage IIC patient had slow progressive disease (PD) with a single site resected, this patient is currently NED. The median overall survival was 29 months, with 60% of the patients surviving for longer than one year. Of the 25 patients enrolled, 12 (48%) were still alive. All evaluable patients (21/21) seroconverted, developing autoimmune antibodies. Importantly, 4 of 25 patients developed vitiligo, correlating with two CR patients by RECIST criteria and two NED patients. Dorgenmeltucel-L HyperAcute immunotherapy in combination with pegylated interferon-alpha 2b was shown to be safe and well-tolerated in this study with no serious adverse events reported.

"These data demonstrated a complete response rate of 12.5% in patients with metastatic disease, which is on par with some early data from checkpoint inhibitors. Moreover, the complete responses observed were durable. In addition, 4 of the 16 patients with metastatic disease who were resected did not experience disease recurrence during the follow up period. The two patients who achieved complete responses also had more targeted autoimmunity manifested by vitiligo and did not demonstrate any off target autoimmunity as has been observed with checkpoint inhibitors," stated Adam I. Riker, MD, FACS, Director, Advocate Cancer Institute, Advocate Christ Medical Center, the principal investigator of the current phase 2 study.

"A significant unmet need remains for improved treatment options for high-risk resected and metastatic melanoma patients," said Nicholas Vahanian, M.D., President and Chief Medical Officer of NewLink. "We are highly encouraged by these data indicating that NewLink's dorgenmeltucel-L in combination with pegylated interferon-alpha 2b provides the potential for better clinical outcomes including the potential for complete tumor regression and immune activation leading to increased survival. These initial results were obtained with only 12 weeks of vaccine given at 150 million cell dosages of dorgenmeltucel-L. We believe that higher doses and longer duration of therapy may improve outcomes. For example, we currently use 300 million cells per treatment and schedules of a year or more in duration with our more advanced pancreatic and lung cancer trials. We believe that HyperAcute vaccines, like dorgenmeltucel-L, could provide more targeted effects that could be amplified by checkpoint inhibitors. Thus to test this crucial combination, we recently launched a new melanoma trial combining dorgenmeltucel-L with ipilimumab. This trial employs dorgenmeltucel-L at doses of 300 million cells with a vaccine treatment schedule of two years," said Dr. Vahanian.

Dorgenmeltucel-L HyperAcute immunotherapy consists of melanoma cell lines that have been genetically modified to express alpha-gal carbohydrates on cell surface molecules. Alpha-gal has been shown to stimulate an immune response against melanoma-specific antigens in the tumor cell lines enabling the patient's immune system to target and destroy their melanoma cells.

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, dorgenmeltucel-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.

Investor Contact:
Gordon Link
Chief Financial Officer
515-598-2925
[email protected]

Media Contact:
Gina Nugent
The Yates Network
[email protected]

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
To Really Work for Enterprises, MultiCloud Adoption Requires Far Better and Inclusive Cloud Monitoring and Cost Management … But How? Overwhelmingly, even as enterprises have adopted cloud computing and are expanding to multi-cloud computing, IT leaders remain concerned about how to monitor, manage and control costs across hybrid and multi-cloud deployments. It’s clear that traditional IT monitoring and management approaches, designed after all for on-premises data centers, are falling short in ...
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, ...
When applications are hosted on servers, they produce immense quantities of logging data. Quality engineers should verify that apps are producing log data that is existent, correct, consumable, and complete. Otherwise, apps in production are not easily monitored, have issues that are difficult to detect, and cannot be corrected quickly. Tom Chavez presents the four steps that quality engineers should include in every test plan for apps that produce log output or other machine data. Learn the ste...
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.
With more than 30 Kubernetes solutions in the marketplace, it's tempting to think Kubernetes and the vendor ecosystem has solved the problem of operationalizing containers at scale or of automatically managing the elasticity of the underlying infrastructure that these solutions need to be truly scalable. Far from it. There are at least six major pain points that companies experience when they try to deploy and run Kubernetes in their complex environments. In this presentation, the speaker will d...
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the importance of customers being able to use the specific technologies they need, through environments and ecosystems that expose their APIs to make true ...
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
In an era of historic innovation fueled by unprecedented access to data and technology, the low cost and risk of entering new markets has leveled the playing field for business. Today, any ambitious innovator can easily introduce a new application or product that can reinvent business models and transform the client experience. In their Day 2 Keynote at 19th Cloud Expo, Mercer Rowe, IBM Vice President of Strategic Alliances, and Raejeanne Skillern, Intel Vice President of Data Center Group and G...
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.
DXWorldEXPO LLC announced today that "IoT Now" was named media sponsor of CloudEXPO | DXWorldEXPO 2018 New York, which will take place on November 11-13, 2018 in New York City, NY. IoT Now explores the evolving opportunities and challenges facing CSPs, and it passes on some lessons learned from those who have taken the first steps in next-gen IoT services.
The current age of digital transformation means that IT organizations must adapt their toolset to cover all digital experiences, beyond just the end users’. Today’s businesses can no longer focus solely on the digital interactions they manage with employees or customers; they must now contend with non-traditional factors. Whether it's the power of brand to make or break a company, the need to monitor across all locations 24/7, or the ability to proactively resolve issues, companies must adapt to...
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
In this presentation, you will learn first hand what works and what doesn't while architecting and deploying OpenStack. Some of the topics will include:- best practices for creating repeatable deployments of OpenStack- multi-site considerations- how to customize OpenStack to integrate with your existing systems and security best practices.
"DevOps is set to be one of the most profound disruptions to hit IT in decades," said Andi Mann. "It is a natural extension of cloud computing, and I have seen both firsthand and in independent research the fantastic results DevOps delivers. So I am excited to help the great team at @DevOpsSUMMIT and CloudEXPO tell the world how they can leverage this emerging disruptive trend."