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NewLink Genetics Corporation

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Charles J. Link, Jr., M.D. Chairman, CSO, CEO, commented on the timing for data from the IMPRESS trial. He staed, "The IMPRESS and PILLAR phase-III trials of Algenpantucel-L for patients with pancreatic cancer are progressing according to plan. We remain on track to report top-line results from the IMPRESS trial this year. We reported the completion of enrollment in the PILLAR trial in December 2015."
Source: Q4 2015 earnings conference call, 2/29/16.

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May 11, 2015

NewLink Genetics' IMPRESS Phase 3 Pancreatic Cancer Trial with Algenpantucel-L to Continue Following Second Interim Analysis

AMES, Iowa, May 11, 2015 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (Nasdaq:NLNK), a biopharmaceutical company focused on bringing novel immuno-oncology medicines to patients with cancer, today announced the continuation without any modification or sample size adjustment for its pivotal, Phase 3 IMmunotherapy for Pancreatic RESectable cancer Study, called "IMPRESS," of algenpantucel-L for patients with surgically resected pancreatic cancer following the second planned interim data analysis.

"We look forward to bringing this study to its planned end point, as algenpantucel-L has the potential to be the first and only FDA approved drug for resected pancreatic cancer, providing additional treatment options to patients, their families and physicians," said Nicholas N. Vahanian, M.D., President and Chief Medical Officer of NewLink Genetics.

IMPRESS is a multi-center, open-label clinical trial assessing the safety and efficacy of algenpantucel-L, NewLink Genetics' HyperAcute® Pancreatic Cancer immunotherapy candidate, conducted in more than 70 leading cancer centers. With 722 patients enrolled, IMPRESS is the largest trial to be completed in the United States for patients with resected pancreatic cancer. Algenpantucel-L has received fast-track status and orphan drug designation from the U.S. Food and Drug Administration (FDA). NewLink Genetics and the FDA reached agreement in January 2010 on a Special Protocol Assessment (SPA) on the trial design, clinical endpoints and statistical analyses plan for IMPRESS to be used in support of a Biologic License Application (BLA).

"Our fast-track status, orphan drug designation and SPA give us continued confidence in our regulatory strategy. With this in mind, we are thoughtfully preparing for regulatory filings and commercial activities associated with a potentially positive outcome of the trial," said Charles Link, Jr., M.D., Chairman and Chief Executive Officer. "There has been tremendous progress in oncology therapeutics, but there have been only incremental improvements in overall survival rates for pancreatic cancer. Our goal is that the result of the IMPRESS study will contribute to the advancement of immunotherapy as a new treatment option."

After careful consideration, including a series of communications with the FDA regarding the statistical analysis plan, the Company decided to retain the benefit of the SPA and not to change the statistical analysis plan as defined in the original protocol. For the second interim analysis, the independent data safety monitoring committee (DSMC) reviewed available patient data with the originally planned log-rank analysis and sample size recalculation, in all respects consistent with the SPA. No other statistical methods were used. The DSMC recommended the study proceed without any modifications, including sample size adjustment, to final analysis. Therefore the Company believes the trial remains powered to determine efficacy upon the occurrence of 444 events.

The Company expects to provide further guidance regarding its expectations for the IMPRESS trial and other clinical studies as well as any update on financial guidance on its second quarter financial results call in August.
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Source: press release, 5/11/15. http://investors.linkp.com/releasedetail.cfm?ReleaseID=912375

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May 6, 2014

NewLink Genetics Corporation Reports First Quarter 2014 Financial Results

AMES, IA -- (Marketwired) -- 05/06/14 -- NewLink Genetics Corporation (NASDAQ: NLNK) today reported consolidated financial results for the first quarter of 2014 and progress in its development programs.

"In 2013, we achieved a major milestone when we completed patient enrollment in our algenpantucel-L pivotal Phase 3 IMPRESS study," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink. 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. "We continue to look forward to the second interim analysis of our IMPRESS study near the end of this year and, assuming positive data, we plan to file a BLA for algenpantucel-L in 2015," said Dr. Link.

During 2014, the Company plans to continue advancing product development efforts across both HyperAcute and IDO pathway inhibitor platforms. Currently NewLink has six HyperAcute vaccines in various stages of clinical development for multiple indications (pancreas, lung, melanoma, prostate, breast and renal). In 2014, the Company continued expanding the breadth and depth of its IDO pathway inhibitor program. This included additional clinical development for its lead product candidate, indoximod, and also initiation of patient enrollment in a first-in-human clinical study of NLG919, its second compound from this platform.

"During the first quarter of 2014 at AACR we presented promising pre-clinical data demonstrating the synergistic anti-tumor activity of our IDO pathway inhibitors indoximod and NLG919 in combination with other checkpoint inhibitors and cancer immunotherapies," commented Dr. Nicholas Vahanian, President and Chief Medical Officer of NewLink. "At the same meeting, we also presented pre-clinical data on a novel class of anti-cancer agents called TDO inhibitors, which are structurally and functionally related to IDO."

NewLink reported a net loss of $9.2 million or ($.33) per share for the first quarter of 2014 compared to a net loss of $7.9 million or ($.33) per share for the comparable period in 2013.

Research and development expense in the first quarter of 2014 was $6.4 million compared to $6.3 million during the comparable period in 2013. The increase was primarily due to an increase in personnel-related expenses, offset by a decrease in contract research, manufacturing and consulting fees.

General and administrative expense in the first quarter of 2014 was $3.3 million compared to $2.0 million during the comparable period in 2013. The increase was primarily due to an increase in share-based compensation expense.

NewLink ended the quarter on March 31, 2014 with cash, cash equivalents, and certificates of deposit totaling $84.0 million and expects to end the year with approximately $40 million in cash, cash equivalents and marketable securities. NewLink received gross proceeds from sales under its ATM of approximately $28.3 million in the first quarter of 2014. NewLink ended the first quarter of 2014 with 27,862,390 shares outstanding.

Recent Accomplishments

HyperAcute Platform. Completed first interim analysis for Phase 3 IMPRESS clinical trial and DSMC recommended study continuation without modification. Continued advancing the platform across multiple indications including pancreas, lung, melanoma and renal cancer.
IDO Inhibitors. Presented preclinical data at the American Association for Cancer Research (AACR) 2014 Annual Meeting demonstrating that combining multiple checkpoint inhibitors that target the IDO (indoleamine-(2,3)-dioxygenase) pathway is effective in reducing local tumor-mediated immunosuppression and providing potential for enhanced anti-tumor activity. These data demonstrated the synergistic effects of combining NLG919, indoximod and anti-PD-1/PD-L1/PD-L2 antibodies to block both the IDO and PD pathways resulting in enhanced anti-tumor effects compared to blocking each pathway independently. This synergy was demonstrated in the context of established tumors treated with otherwise ineffective chemo-immunotherapy regimens.
TDO Inhibitors. A novel class of compounds that mediate TDO (tryptophan-2,3-dioxygenase) activity were also presented at the AACR meeting. These data showed novel compounds with potent and selective TDO inhibition as well as IDO-specific inhibition and dual inhibition of TDO and IDO.
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Source: press release, 5/06/14. http://investors.linkp.com/releasedetail.cfm?ReleaseID=845493

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Mar 7, 2014
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NewLink Genetics' Independent Review Committee Recommends Study Continuation Without Modification After Completion of First Interim Analysis of IMPRESS Phase 3 Pancreatic Cancer Trial With Algenpantucel-L

AMES, IA -- (Marketwired) -- 03/07/14 -- 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 the continuation of the Phase 3 IMPRESS clinical study of algenpantucel-L for patients with surgically resected pancreatic cancer following the first of two planned interim data analyses.

As part of the planned interim analysis, scheduled to occur following 222 patient events, the independent data safety monitoring committee (DSMC) met to review available patient data. Following their review, the DSMC recommended that the study should proceed as planned, 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.

"As we have previously emphasized, continuation of this study was an anticipated outcome considering the high statistical threshold assigned to this first interim analysis under the special protocol assessment," commented Dr. Charles Link, Chairman and Chief Executive Officer of NewLink.

"In any case, it is reassuring that no unexpected safety issues or other concerns were raised by the independent data safety monitoring committee," said Dr. Nicholas N. Vahanian, President and Chief Medical Officer of NewLink Genetics. "Now, with the first interim analysis behind us, we look forward to continuing the study and to gathering additional, more mature data in support of our mission to provide improved treatment options for patients with pancreatic cancer."
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Source: press release, 3/07/14. http://investors.linkp.com/releasedetail.cfm?ReleaseID=831235

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Sep 17, 2013

NewLink Genetics Completes Patient Enrollment in Phase 3 Algenpantucel-L (IMPRESS) Clinical Study

Ames, IA - September 17, 2013 -- NewLink Genetics Corporation (NASDAQ: NLNK), an oncology-focused biopharmaceutical company specializing in immunotherapy, today announced that a major milestone has been reached in the IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival Study) Phase 3 clinical trial of algenpantucel-L. The accrual goal of 722 subjects with surgically resected pancreatic cancer has been met. The study examines the lead product candidate from NewLink's proprietary HyperAcuteTM immunotherapy platform, algenpantucel-L, which is designed to stimulate the human immune system to recognize and attack cancer cells. Two interim analyses and a final analysis are planned for the IMPRESS study. In addition to the IMPRESS trial, algenpantucel-L is also being studied in a second Phase 3 trial involving patients with locally advanced pancreatic cancer (PILLAR).

“On behalf of the entire NewLink organization, I would like to take this opportunity to extend our deepest gratitude to all the patients who participated in this pivotal study as well as to their families. I would also like to thank all the health care professionals including physicians, nurses and study coordinators who have contributed to the successful enrollment of this landmark trial” commented Charles Link, Jr., M.D., Chairman and CEO of NewLink Genetics.

“Our promising Phase 2 results enabled us to successfully collaborate with many major medical centers and the leaders within those institutions,” Dr. Link remarked. “To date, IMPRESS is the largest corporate sponsored resected pancreatic cancer study yet conducted. We are confident in the stringency of this study design and the statistical power provided by the large number of patients participating in this trial as we enthusiastically look forward to the clinical results.”

“We are increasingly confident in the progress made with the clinical development of algenpantucel-L,” said Nicholas N. Vahanian, M.D., President, Chief Medical Officer of NewLink Genetics. “As we enter a critical data collection and analysis phase of the study we are encouraged by the progress made in such a short period of time. Completion of study enrollment is a critical step towards our mission of bringing better treatment options to pancreatic cancer patients who are in desperate need of more promising alternatives.”
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Source: press release, 9/17/13. http://investors.linkp.com/releasedetail.cfm?ReleaseID=791024

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IMPRESS - A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without HyperAcute®-Pancreas (Algenpantucel-L) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer
Estimated Enrollment: 722
Study Start Date: April 2010
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01072981?term=Algenpantucel-L&rank...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Algenpantucel-L Pancreatic cancer (resected)OncologyPancreatic cancer (resected)Vaccine (cancer)pancreatic cancer cells

Mechanism of action: Algenpantucel-L is a cancer vaccine comprised of irradiated allogeneic pancreatic cancer cells transfected to express murine alpha-1,3-galactosyltransferase with potential antitumor activity. Vaccination is associated with the expression of murine alpha-1,3-galactosyl (alpha-gal) carbohydrate residues on cell membrane glycoproteins and glycolipids of the vaccine pancreatic cancer cell allograft; murine alpha-gal epitopes, not present on human cells, then induce a hyperacute rejection of the vaccine pancreatic cancer cell allograft. The hyperacute rejection involves the binding of pre-existing human anti-alpha-gal antibodies (which naturally occur against gut flora) to murine alpha-gal epitopes, resulting in the rapid activation of antibody-dependent cell-mediated cytotoxicity (ADCC) towards allograft cells. The host immune system then attacks endogenous pancreatic cancer cells, resulting in ADCC towards endogenous pancreatic cancer cells.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-06-01 - 2016-12-31

Results:

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NewLink Genetics Announces Results from Phase 3 IMPRESS Trial of Algenpantucel-L for Patients with Resected Pancreatic Cancer

Management to Host Conference Call

Tuesday, May 10th at 8:30 a.m. ET

AMES, Iowa, May 09, 2016 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK) announced today results of its Phase 3 clinical trial for algenpantucel-L for patients with resected pancreatic cancer.

The IMPRESS Phase 3 study of algenpantucel-L for patients with resected pancreatic cancer did not achieve its primary endpoint. Overall survival from time of randomization was 29.3 months for both groups combined. There was no statistically significant difference between the two groups. The median survival was 30.4 months and 27.3 months for the control and study groups, respectively. There was also no statistical difference for long-term survival. Three year survival was 41.4% and 42.1% and four year survival was 32.6% and 32.7% for the control and study groups, respectively.

"We are deeply disappointed for patients that the IMPRESS Phase 3 study was not successful," said Nicholas N. Vahanian, M.D., President and Chief Medical Officer of NewLink Genetics. "We want to extend our sincere appreciation to all the patients, caregivers, investigators, research nurses, employees and others who contributed to the study. Given these results, we are evaluating the future of the HyperAcute® platform. We remain committed to achieving our mission of developing immunotherapies to bring patients with cancer better treatment options."

The IMmunotherapy for Pancreatic RESectable cancer Study (IMPRESS) trial is a randomized, controlled, two-arm Phase 3 trial for patients with resected pancreatic cancer testing algenpantucel-L (300M cells every two weeks for six months followed by every month for another six months) in combination with the standard of care versus standard of care alone. A total of 722 patients with surgically removed cancers were enrolled at more than 70 sites in the United States from May 2010 to September 2013.

"Immunotherapy is rapidly establishing a role in the management of multiple malignancies," said George Fisher, M.D., Ph.D., Professor of Medicine at Stanford University, one of the investigators in the IMPRESS study. "The median overall survival of 29.3 months in this study represents a significant increase compared with prior trials and may be due to multiple factors, including the emergence of more effective treatment regimens for recurrent or metastatic disease. Although a negative study, these results represent an important and meaningful contribution to the understanding of the modern treatment of resected pancreatic cancer."

"In light of these negative results, our scientific and clinical teams will focus on other promising opportunities in our pipeline," said Charles Link, Jr., M.D., Chairman and Chief Executive Officer. "Our lead projects focus on our IDO checkpoint inhibitor technology employing indoximod and GDC-0919. We have substantial near-term catalysts in 2016 for these IDO inhibitor programs, including multiple trial updates from our proprietary and partnered IDO pathway inhibitors, and the financial resources to realize the potential of our product pipeline."

NewLink Genetics ended the first quarter on March 31, 2016, with cash, cash equivalents, and certificates of deposit totaling $178 million. The Company reiterates that its goal and expectation is to finish 2016 with two years of cash on hand.

Conference Call Details

The Company has scheduled a conference call for 8:30 a.m. ET Tuesday, May 10 to discuss the IMPRESS trial results. NewLink Genetics' senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.

Access to the live conference call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 10318415.
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Source: press release, 5/09/16. http://investors.linkp.com/releasedetail.cfm?ReleaseID=969978

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