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NewLink Genetics Corporation

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Charles J. Link, Jr., M.D. Chairman, CSO, CEO, responded to a question regarding the timing for the results of the PILLAR trial. He stated, "Because of the timing of the enrollment in PILLAR, we expect that the IMPRESS results will readout sometime this year. Again we are not predicting what time range that might happen, we still believe that PILLAR readout will occur after that. Our intention is to get an update of what the pillar timing is during the year, try to just give a little bit of guidance on that study, but since it is an event driven study and it is based on overall survival that will obviously take a significant portion of time but our current belief is regardless how late in the year the IMPRESS trial result, we still anticipate that will readout somewhat after that."
Source: Q4 2015 earnings conference call, 2/29/16.

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NewLink Genetics Corporation Completes Enrollment of Phase 3 PILLAR Trial Evaluating Algenpantucel-L for Patients With Locally Advanced Pancreatic Cancer

AMES, Iowa, Dec. 15, 2015 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor platforms, to improve the lives of patients with cancer, announced today the completion of enrollment in the Phase 3 PILLAR (Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable cancer) clinical trial of algenpantucel-L for patients with borderline resectable or locally advanced unresectable pancreatic cancer. Total enrollment in the study exceeded 300 patients.

"I am delighted to be part of this important study, with the potential for helping patients with pancreatic cancer in clear need of pioneering immunotherapies like algenpantucel-L," said Harish Lavu, M.D., Associate Professor of Surgery at Thomas Jefferson University and a lead investigator for PILLAR.

"Completion of enrollment in this large phase 3 trial combined with our previous success enrolling 722 patients with resected pancreatic cancer in the IMPRESS registration trial demonstrates our ongoing commitment to patients with this disease," said Charles Link, Jr., M.D., Chairman and CEO of NewLink Genetics. "With the addition of our trial of indoximod, one of our IDO pathway inhibitors, in combination with chemotherapy for patients with metastatic pancreatic cancer, we now have clinical trials in all stages of this disease for which patients have very limited treatment options."
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Source: press release, 12/15/15. http://investors.linkp.com/releasedetail.cfm?ReleaseID=946998

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Algenpantucel-L. Presented clinical data demonstrating encouraging long-term disease-free and overall survival in a Phase 2 clinical study of algenpantucel-L for resected pancreatic cancer at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting. Overall survival data from patients with elevated levels of two or more separate biomarkers correlated with a statistically significant improvement relative to those without elevated levels. NewLink's lead product candidate, algenpantucel-L, is being studied in a Phase 3 trial with enrollment of up to 722 patients with surgically resected pancreatic cancer (IMPRESS). Algenpantucel-L is also being tested in a second Phase 3 study involving patients with locally advanced pancreatic cancer (PILLAR).
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Source: press release, 8/07/13. http://investors.linkp.com/releasedetail.cfm?ReleaseID=783384

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October 10, 2012
NewLink Genetics Launches Phase 3 Clinical Trial of algenpantucel-L Immunotherapy in Patients with Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer

AMES, Iowa, Oct. 10, 2012 /PRNewswire/ -- NewLink Genetics Corporation (Nasdaq: NLNK) announces launching of an open-label, randomized, multi-institutional Phase 3 study in patients with borderline resectable or locally advanced unresectable pancreatic cancer. The projected enrollment will be 280 subjects and patients will be randomized (1:1) to receive standard of care FOLFIRINOX plus or minus algenpantucel-L (HyperAcute®-Pancreas) immunotherapy. The primary endpoint of the study will be to evaluate overall survival. Secondary objectives include evaluation of progression free survival and immunological response.

"We are excited to initiate an additional Phase 3 clinical trial for algenpantucel-L to potentially expand into a new indication for locally advanced pancreatic cancer. We have made significant progress in our Phase 3 trial with algenpantucel-L for resected pancreas cancer patients since its launch in May of 2010," commented Dr. Charles Link, Chief Executive Officer of NewLink. He added, "There is an enormous unmet need in the pancreatic cancer market for both resectable and unresectable patients. The successful expansion of algenpantucel-L into a market segment for locally advanced disease would potentially more than double the patient population who might benefit from this immunotherapy treatment."

"We believe this new study will be favorably perceived by the clinicians as they will have a promising clinical trial to offer patients with this devastating disease," commented Dr. Nick Vahanian, Chief Medical Officer of NewLink Genetics. "We have more than 70 major cancer centers currently enrolling patients in our ongoing Phase 3 trial for resected pancreatic cancer patients. We believe these relationships will enable us to efficiently implement this new Phase 3 clinical trial, since the majority of locally advanced patients are evaluated at the same centers as the resectable patients."
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Source: press release, 10/10/12. http://investors.linkp.com/releasedetail.cfm?ReleaseID=712478

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PILLAR - A Phase III Study of Chemotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer
Estimated Enrollment: 302
Study Start Date: May 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01836432?term=Algenpantucel-L&rank...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Algenpantucel-L Pancreatic cancer (unresected)OncologyPancreatic cancerVaccine (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: 2017-01-01 - 2017-06-30

Results: Pending