|By Marketwired .||
|May 30, 2014 07:10 AM EDT||
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.
"Storage is growing. All of IDC's estimates say that unstructured data is now 80% of the world's data. We provide storage systems that can actually deal with that scale of data - software-defined storage systems," stated Paul Turner, Chief Product and Marketing Officer at Cloudian, in this SYS-CON.tv interview at 17th Cloud Expo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Feb. 26, 2017 02:30 PM EST Reads: 7,035
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Feb. 26, 2017 02:30 PM EST Reads: 2,422
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Feb. 26, 2017 01:30 PM EST Reads: 2,335
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
Feb. 26, 2017 01:15 PM EST Reads: 1,809
Cloud Expo, Inc. has announced today that Aruna Ravichandran, vice president of DevOps Product and Solutions Marketing at CA Technologies, has been named co-conference chair of DevOps at Cloud Expo 2017. The @DevOpsSummit at Cloud Expo New York will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and @DevOpsSummit at Cloud Expo Silicon Valley will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Feb. 26, 2017 01:15 PM EST Reads: 2,175
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
Feb. 26, 2017 01:00 PM EST Reads: 3,005
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Feb. 26, 2017 01:00 PM EST Reads: 1,793
SYS-CON Events announced today that Hitrons Solutions 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. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
Feb. 26, 2017 12:45 PM EST Reads: 549
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
Feb. 26, 2017 12:45 PM EST Reads: 6,395
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
Feb. 26, 2017 12:30 PM EST Reads: 2,001
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.
Feb. 26, 2017 11:30 AM EST Reads: 6,679
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business. Though, IoT is far more complex than most firms expected with a majority of IoT projects having failed. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, Chief IoTologist at Wipro, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology portfolios and business models to adopt and leverage IoT. He will delve in...
Feb. 26, 2017 11:00 AM EST Reads: 2,760
In his session at @ThingsExpo, Steve Wilkes, CTO and founder of Striim, will delve into four enterprise-scale, business-critical case studies where streaming analytics serves as the key to enabling real-time data integration and right-time insights in hybrid cloud, IoT, and fog computing environments. As part of this discussion, he will also present a demo based on its partnership with Fujitsu, highlighting their technologies in a healthcare IoT use-case. The demo showcases the tracking of patie...
Feb. 26, 2017 11:00 AM EST Reads: 1,315
DevOps and microservices are permeating software engineering teams broadly, whether these teams are in pure software shops but happen to run a business, such Uber and Airbnb, or in companies that rely heavily on software to run more traditional business, such as financial firms or high-end manufacturers. Microservices and DevOps have created software development and therefore business speed and agility benefits, but they have also created problems; specifically, they have created software securi...
Feb. 26, 2017 11:00 AM EST Reads: 4,095
In today's enterprise, digital transformation represents organizational change even more so than technology change, as customer preferences and behavior drive end-to-end transformation across lines of business as well as IT. To capitalize on the ubiquitous disruption driving this transformation, companies must be able to innovate at an increasingly rapid pace. Traditional approaches for driving innovation are now woefully inadequate for keeping up with the breadth of disruption and change facing...
Feb. 26, 2017 10:45 AM EST Reads: 8,115