This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA requires for all participants in gene transfer protocols and assures that adequate follow-up can be maintained for subjects who have received at least one dose of algenpantucel-L.

开始日期2017-09-01

申办/合作机构

NewLink Genetics Corp.

NCT02405585

/ Terminated临床2期

An Exploratory Phase 2 Study of Neoadjuvant Chemotherapy Followed by Stereotactic Body Radiation Therapy (SBRT) With Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Borderline Resectable Pancreatic Cancer

Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with pancreatic cancer continue to die from the rapid progression of their disease. One primary reason for this is that the disease is typically without symptoms until significant local and/or distant spread has occurred and is often beyond the chance for cure at the time of the diagnosis. The lack of any treatment to substantially increase long term survival rates is reflected by the poor outcomes associated with this disease, specifically time to disease progression and overall survival.
However, another important part of the body is now being looked at as a target for therapy against this disease - the immune system. Scientists have clearly shown that pancreatic tumor cells produce a number of defective proteins, or express normal proteins in highly uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can cause an immune response to the cancer cells much in the way one responds to infected tissue. In progressive cancers however, the immune system fails to effectively identify or respond to these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet fully understood. This clinical trial proposes a new way to stimulate the immune system to recognize pancreatic cancer cells and to stimulate an immune response that destroys or blocks the growth of the cancer.
This new method of treatment helps the immune system of pancreatic cancer patients to "identify" the cancerous tissue so that it can be eliminated from the body. As an example, patients with certain diseases may require an organ transplant to replace a damaged kidney or heart. After receiving their transplant, these patients receive special drugs because they are at great danger of having an immune response that destroys or "rejects" the transplanted organ. This "rejection" occurs when their immune system responds to differences between the cells of the transplanted organ and their own immune system by attacking the foreign tissue in the same way as it would attack infected tissue. When the differences between foreign tissues and the patient's body are even larger, as with the differences between organs from different species, the rejection is very rapid, highly destructive, and the immunity it generates is longlasting. This is called hyperacute rejection and the medicine used to immunize patients in this protocol tries to harness this response to teach a patient's immune system to fight their pancreatic cancer just as the body would learn to reject a transplanted organ from an animal.
To do this, Algenpantucel-L immunotherapy contains human pancreatic cancer cells that contain a mouse gene that marks the cancer cells as foreign to patient's immune systems. The immune system therefore attacks these cancer cells just as they would attack any truly foreign tissue, destroying as much as it can. Additionally, the immune system is stimulated to identify differences (aside from the mouse gene) between these cancer cells and normal human tissue as foreign. This "education" of the immune system helps treat the patient because pancreatic cancer cells already present in a treated patient are believed to show some of the same differences from normal tissue as the modified pancreatic cancer cells in the product. Due to these similarities, the immune system, once "educated" by the Algenpantucel-L immunotherapy, identifies the patient's cancer as foreign and attacks.
Historically, external beam radiation has been part of the treatment of pancreatic cancer, both before and after surgical resection. Recent breakthroughs in technology now allow for more intensive doses of radiation to be delivered to the body with greater precision. These newer, more precise radiation treatments, called stereotactic body radiation, deliver more intensive radiation to a locally advanced tumor and are now being employed in the treatment of pancreatic cancer. Stereotactic body radiation may increase the chances that surgery will successfully remove a pancreatic cancer.
In this experimental study, all patients will be given a strong combination of antitumor chemotherapy while receiving injections of an immunotherapy drug consisting of two types of pancreatic cancer cells that have been modified to make them more easily recognized and attacked by the immune system. The investigators propose to test this new treatment paradigm along with stereotactic body radiation in patients with borderline resectable pancreatic cancer to demonstrate that treatment with this combination of therapies increases the time until the tumor progresses as well as overall survival.

开始日期2015-04-01

申办/合作机构

NewLink Genetics Corp.

NCT01836432

/ Terminated临床3期

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

Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with pancreatic cancer continue to die from the rapid progression of their disease. One primary reason for this is that the disease is typically without symptoms until significant local and/or distant spread has occurred and is often beyond the chance for cure at the time of the diagnosis. The lack of any treatment to substantially increase long term survival rates is reflected by the poor outcomes associated with this disease, specifically time to disease progression and overall survival.
However, another important part of the body is now being looked at as a target for therapy against this disease - the immune system. Scientists have clearly shown that pancreatic tumor cells produce a number of defective proteins, or express normal proteins in highly uncharacteristic ways, as part of this cancer. In some cancers, these abnormalities can cause an immune response to the cancer cells much in the way one responds to infected tissue. In progressive cancers however, the immune system fails to effectively identify or respond to these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet fully understood. This clinical trial proposes a new way to stimulate the immune system to recognize pancreatic cancer cells and to stimulate an immune response that destroys or blocks the growth of the cancer.
This new method of treatment helps the immune system of pancreatic cancer patients to "identify" the cancerous tissue so that it can be eliminated from the body. As an example, most people are aware that patients with certain diseases may require an organ transplant to replace a damaged kidney or heart. After receiving their transplant, these patients receive special drugs because they are at great danger of having an immune response that destroys or "rejects" the transplanted organ. This "rejection" occurs when their immune system responds to differences between the cells of the transplanted organ and their own immune system by attacking the foreign tissue in the same way as it would attack infected tissue. When the differences between foreign tissues and the patient's body are even larger, as with the differences between organs from different species, the rejection is very rapid, highly destructive, and the immunity it generates is longlasting. This is called hyperacute rejection and the medicine used to immunize patients in this protocol tries to harness this response to teach a patient's immune system to fight their pancreatic cancer just as the body would learn to reject a transplanted organ from an animal.
To do this, Algenpantucel-L immunotherapy contains human pancreatic cancer cells that contain a mouse gene that marks the cancer cells as foreign to patient's immune systems. The immune system therefore attacks these cancer cells just as they would attack any truly foreign tissue, destroying as much as it can. Additionally, the immune system is stimulated to identify differences (aside from the mouse gene) between these cancer cells and normal human tissue as foreign. This "education" of the immune system helps treat the patient because pancreatic cancer cells already present in a treated patient are believed to show some of the same differences from normal tissue as the modified pancreatic cancer cells in the product. Due to these similarities, the immune system, once "educated" by the Algenpantucel-L immunotherapy, identifies the patient's cancer as foreign and attacks.
The chemotherapy combination to be used in this study has been shown to improve survival in advanced pancreatic cancer and is being combined with an experimental pancreatic cancer immunotherapy that stimulates the immune system to recognize and attack the cancer. One goal of this study is to determine whether chemotherapy and immunotherapies can work cooperatively to increase anti-tumor effects to levels beyond what would be seen with either treatment alone.
In this experimental study, all patients are given a strong combination of anti-tumor chemotherapies while some patients are also given injections of an immunotherapy drug consisting of two types of pancreatic cancer cells that we have modified to make them more easily recognized and attacked by the immune system. We propose to test this new treatment protocol in patients with locally advanced pancreatic cancer to demonstrate that treatment with the immunotherapy increases the time until the tumor progresses or increases overall survival when given in combination with the current standard of care therapy for this disease.

开始日期2013-05-01

申办/合作机构

NewLink Genetics Corp.

100 项与 Algenpantucel-L 相关的临床结果

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100 项与 Algenpantucel-L 相关的转化医学

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100 项与 Algenpantucel-L 相关的专利（医药）

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项与 Algenpantucel-L 相关的文献（医药）

2024-02-01·Journal of hazardous materials

Insight into the transformation of 4-hydroxy-3-aminophenylarsonic acid (HAPA) and its mechanisms under simulated sunlight irradiation

Article

作者: Bai, Wenjing ; Zhang, Yixin ; Tang, Rui ; Yan, Yingjie ; Hu, Zhen-Hu ; Su, Kuizu

Four-hydroxy-3-aminophenylarsonic acid (HAPA), the reduced product of roxarsone (4-hydroxy-3-nitro-phenylarsonic acid, ROX) under anaerobic conditions, is resistant to be biologically degraded under anaerobic/anoxic conditions. The transformation of HAPA in aquatic environment under sunlight irradiation is still unknown. In this study, the photodegradation of HAPA and the possible mechanism under simulated sunlight conditions were investigated. The result shows that under visible light irradiation, HAPA wasn't degraded. Under UV₂₅₄ and UV₃₀₂ irradiation, about 60% and 30% HAPA were decomposed, while nearly no HAPA was degraded under UV₃₆₅ irradiation over a period of 240 min. UVC light was the main wavelength for the degradation of HAPA under sunlight conditions. HCO₃^- and NO₃^- slightly enhanced the photodegradation, but Cl^- and SO₄^2- had a marginal influence on the photodegradation. During the photodegradation, HAPA was decomposed into organic intermediates, inorganic arsenics, ammonia and undetermined arsenic species. Arsenite (As(III)) was the dominant inorganic arsenic species from the photodegradation of HAPA. The mechanism analysis shows that singlet molecular oxygen (¹O₂) has little influence on the decomposition of HAPA under UV irradiation, but significantly enhanced the conversion of As(III) to arsenate (As(V)).

2022-01-01·Annals of surgery1区 · 医学

A Phase 3 Randomized Clinical Trial of Chemotherapy With or Without Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy in Subjects With Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer

1区 · 医学

Article

作者: Daniel Brock Hewitt ; Hassan Hatoum ; Raed Al-Rajabi ; Eugene Kennedy ; Emad Elquza ; Benjamin Leiby ; Nicholas Vahanian ; Thomas J. George ; Noelle LoConte ; Charles J. Yeo ; Harish Lavu ; Joshua Banks ; Gina Vaccaro ; Charles Link ; Warren Brenner ; Benjamin Musher ; Lodovico Balducci ; Andrew L. Coveler ; Nicholas Nissen ; Gabriela Rossi ; John Seng

Objectives::

To compare the efficacy and safety of algenpantucel-L [HyperAcute-Pancreas algenpantucel-L (HAPa); IND# 12311] immunotherapy combined with standard of care (SOC) chemotherapy and chemoradiation to SOC chemotherapy and chemoradiation therapy alone in patients with borderline resectable or locally advanced pancreatic ductal adenocarcinoma (PDAC).

Summary Background Data::

To date, immunotherapy has not been shown to benefit patients with borderline resectable or locally advanced unresectable PDAC. HAPa is a cancer vaccine consisting of allogeneic pancreatic cancer cells engineered to express the murine α(1,3)GT gene.

Methods::

A multicenter, phase 3, open label, randomized (1:1) trial of patients with borderline resectable or locally advanced unresectable PDAC. Patients received neoadjuvant SOC chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel) followed by chemoradiation (standard group) or the same standard neoadjuvant regimen combined with HAPa immunotherapy (experimental group). The primary outcome was overall survival.

Results::

Between May 2013 and December 2015, 303 patients were randomized from 32 sites. Median (interquartile range) overall survival was 14.9 (12.2–17.8) months in the standard group (N = 158) and 14.3 (12.6–16.3) months in the experimental group (N = 145) [hazard ratio (HR) 1.02, 95% confidence intervals 0.66–1.58; P = 0.98]. Median progression-free survival was 13.4 months in the standard group and 12.4 months in the experimental group (HR 1.33, 95% confidence intervals 0.72–1.78; P = 0.59). Grade 3 or higher adverse events occurred in 105 of 140 patients (75%) in the standard group and in 115 of 142 patients (81%) in the experimental group (P > 0.05).

Conclusions::

Algenpantucel-L immunotherapy did not improve survival in patients with borderline resectable or locally advanced unresectable PDAC receiving SOC neoadjuvant chemotherapy and chemoradiation.

Trial Registration::

ClinicalTrials.gov Identifier: NCT01836432

2021-01-05·Environmental science & technology1区 · 环境科学与生态学

Enhancing Roxarsone Degradation and In Situ Arsenic Immobilization Using a Sulfate-Mediated Bioelectrochemical System

1区 · 环境科学与生态学

Article

作者: Jamieson, James ; Prommer, Henning ; Sun, Jing ; Wang, Wei ; Tang, Rui ; Hu, Zhen-Hu ; Yuan, Shoujun

Roxarsone (ROX) is widely used in animal farms, thereby producing organoarsenic-bearing manure/wastewater. ROX cannot be completely degraded and nor can its arsenical metabolites be effectively immobilized during anaerobic digestion, potentially causing arsenic contamination upon discharge to the environment. Herein, we designed and tested a sulfate-mediated bioelectrochemical system (BES) to enhance ROX degradation and in situ immobilization of the released inorganic arsenic. Using our BES (0.5 V voltage and 350 μM sulfate), ROX and its metabolite, 4-hydroxy-3-amino-phenylarsonic acid (HAPA), were completely degraded within 13-22 days. In contrast, the degradation efficiency of ROX and HAPA was <85% during 32-day anaerobic digestion. In a sulfate-mediated BES, 75.0-83.2% of the total arsenic was immobilized in the sludge, significantly more compared to the anaerobic digestion (34.1-57.3%). Our results demonstrate that the combination of sulfate amendment and voltage application exerted a synergetic effect on enhancing HAPA degradation and sulfide-driven arsenic precipitation. This finding was further verified using real swine wastewater. A double-cell BES experiment indicated that As(V) and sulfate were transported from the anode to the cathode chamber and coprecipitated as crystalline alacranite in the cathode chamber. These findings suggest that the sulfate-mediated BES is a promising technique for enhanced arsenic decontamination of organoarsenic-bearing manure/wastewater.

项与 Algenpantucel-L 相关的新闻（医药）

2023-07-17

·生物谷

Health Psychology:从基因应激交互模型的角度揭示过劳肥之谜

本研究通过扩展和丰富现有的健康行为改变模型（HAPA），发现基因型和工作压力在意愿和执行阶段都起到了阻碍作用。因此，研究者提出了一种新的基因×应激交互模型，用以解释人们在压力环境下的饮食选择。近日，北京大学心理与认知科学学院甘怡群教授课题组在健康心理学旗舰期刊Health Psychology在线发表题为“Eating Healthy Under Work Stress: A Gene Stress Interaction Model”的论文。本研究提出了基因×应激交互模型，旨在解释工作压力下人们为何会做出不同的饮食选择。研究发现，DRD2基因在这一过程中发挥了关键作用，有助于解释工作压力环境下饮食选择的个体差异。在高压的工作环境中，保持健康饮食对很多人来说是一项巨大挑战。有趣的是，在面对工作压力时，有些员工会选择较不健康的食物，而另一些员工却能坚持健康饮食。这种不同的饮食选择背后的原因一直不明朗。本研究提出了基因×应激交互模型，认为这种差异可能与DRD2基因有关。DRD2基因在调节人体奖赏回路方面具有重要作用，并与酒精摄入、肥胖和饮食行为等密切相关。为了验证这一假设，研究人员对12,269名员工进行了唾液样本基因分型，并收集了他们关于工作压力、健康饮食意愿和健康饮食行为的问卷调查数据。通过非线性多元回归分析，研究人员探讨了DRD2基因与工作压力在健康饮食意愿和行为上的交互作用。研究发现，工作压力较高的个体健康饮食意愿较低，健康饮食行为呈现出倒U型关系。其中，DRD2基因显著地调节了工作压力与健康饮食的关系：在C等位基因携带者身上，研究人员观察到了工作压力与健康饮食呈显著相关关系；而对AA基因型个体来讲，工作压力似乎与他们健康饮食的意愿和行为无关。这项研究的结论揭示了健康饮食的意愿和行为在与工作压力关联上呈现出不同的模式，而DRD2基因有助于解释工作压力环境下饮食选择的个体差异。 Gene DRD2 and Work Stress Interaction on Healthy Dietary Intention and Behavior Note. The dashed line represents the loess smoothing of the raw data, and the solid line represents the linear or quadratic polynomial regression as an approximation. 本研究通过扩展和丰富现有的健康行为改变模型（HAPA），发现基因型和工作压力在意愿和执行阶段都起到了阻碍作用。因此，研究者提出了一种新的基因×应激交互模型，用以解释人们在压力环境下的饮食选择。从研究方法论的角度来看，本研究选用了大型代表性的样本，并运用了稳健的统计方法。这为研究所提出的新模型提供了有力的初步证据。这一突破性发现为我们提供了全新的视角，有助于了解为什么在面临工作压力时，有些人会选择不健康的食物，而另一些人却能保持健康饮食。这一发现有潜在的实际应用价值，例如帮助企业和个人制定更有针对性的营养干预措施，以应对工作压力带来的不良影响。此外，这一研究还为心理学、营养学和遗传学等多个领域的研究提供了新的启示。通过深入了解基因与环境因素的交互作用，我们可以更好地认识到为何不同的人在面临类似的压力情境下，会产生不同的行为反应。这给预防与压力相关的健康问题提供了新的思路。本研究获得国家自然科学基金的资助。甘怡群和微基因技术有限公司研究员王理中为本文共同第一作者，北京师范大学教授胡月琴为本文的通讯作者。论文信息： Gan, Y. Wang, L., Schwarzer, R., Chen, G., &Hu, Y.* (in press). Eating Healthy Under Work Stress: A Gene Stress Interaction Model. Health Psychology. DOI: 10.1037/hea0001296

基因疗法

2016-07-11

·BioSpace

3 Nauseating Clinical Trial Flops of 2016 So Far

July 11, 2016 By Alex Keown , BioSpace.com Breaking News Staff Sometimes promising drug trials fail. It’s nothing new to the pharma industry. Despite the appeal of the drug, things can fall apart as the potential therapy moves through regulatory hurdles. A recent Fox Business story suggested that investors estimate about 90 percent of experimental therapies fail to win approval. Several promising drugs have fallen flat this year, including BioMarin ’s stumble when the U.S. Food and Drug Administration rejected BioMarin’s application for Kyndrisa (drisapersen), for the treatment of Duchenne muscular dystrophy. That rejection caused BioMarin’s stock to tumble a bit, but there have been other notable hiccups this year. Fox Business highlighted three failed drugs in the first six months of 2016 that caused stocks to tumble by 50 percent. Rintega The failure of Celldex Therapeutics ’ cancer vaccine Rintega was cause for the company’s stock to fall about 80 percent this year. The stock has climbed back a bit, but is still down about 71 percent since January. The company ultimately terminated its research on Rintega, which had at one time earned Breakthrough Therapy Designation by the FDA for treatment of glioblastoma. Despite that loss, Celldex has another promising treatment in its pipeline, this time for triple negative breast cancer. Celldex’s candidate, glembatumumab vedotin, is a protein that binds to gpNMB, a protein found on the surface of tumors. Renauer believes the promise of glembatumumab vedotin for triple negative breast cancer, as well as other cancers, could turn the company around and send its shares back up. Shares of Celldex are currently trading at $4.65. Rociletinib Clovis Oncology ’s Rociletinib looked to be a promising drug. However, in the late spring the failure to gain regulatory approval for rociletinib , prompted Clovis Oncology to end all trials of the lung cancer drug and ultimately forced the company to terminate 35 percent of its workforce to address shifting costs. With the failure of rociletinib, Clovis is now focused on the potential U.S. launch of rucaparib, a monotherapy treatment for patients with advanced ovarian cancer with deleterious BRCA-mutated tumors. Rucaparib was granted Breakthrough Therapy designation by the FDA in April 2015 and the company has commenced the submission of a rolling New Drug Application. Clovis said it anticipates the completion of its NDA submission soon. Clovis said it will also seek approval of rucaparib in Europe later this year. Shares of Clovis are down about 57 percent since the beginning of the year. Clovis is currently trading for $14.58 per share. Algenpantucel-L In May, shares of NewLink Genetics cratered after the company announced its pancreatic cancer vaccine Algenpantucel-L failed to meet Phase III endpoints and could even ultimately harm patients. Study results showed that patients taking drug during the trial actually fared worse when it came to survivability than patients taking placebo. Newlink is now looking at its experimental cancer drug indoximod to turn things around. It is also continuing to see if algenpantucel-L has legs when used for other purposes. Shares of the stock fell about 70 percent and is currently trading at $11.71 per share.

突破性疗法临床3期临床结果优先审批疫苗

2016-05-09

·GlobeNewswire

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. About NewLink Genetics Corporation NewLink Genetics is a biopharmaceutical company focused on discovering, developing and commercializing novel immuno-oncology products to improve treatment options for patients with cancer. NewLink Genetics’ portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink Genetics’ 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 . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements of NewLink Genetics 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 NewLink Genetics’ financial guidance for 2016; enrollment in or results of its clinical trials for product candidates; its timing of release of data from ongoing clinical studies; its plans related to moving additional indications into clinical development; NewLink Genetics’ future financial performance, results of operations, cash position and sufficiency of capital resources to fund its operating requirements; 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 Genetics makes due to a number of important factors, including those risks discussed in “Risk Factors” and elsewhere in NewLink Genetics’ Annual Report on Form 10-K for the year ended December 31, 2015 and other reports filed with the U.S. Securities and Exchange Commission (SEC). The forward-looking statements in this press release represent NewLink Genetics’ views as of the date of this press release. NewLink Genetics 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 Genetics’ views as of any date subsequent to the date of this press release.

临床3期免疫疗法临床结果

100 项与 Algenpantucel-L 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D10351	-	-	-

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适应症	最高研发状态	国家/地区	公司	日期
局部晚期不可切除癌	临床3期	美国	NewLink Genetics Corp.	2013-05-01
不能切除性胰腺癌	临床3期	美国	NewLink Genetics Corp.	2013-05-01
胰腺腺癌	临床3期	美国	NewLink Genetics Corp.	2010-04-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01836432 (Pubmed \| Ann Surg) 人工标引	临床3期	晚期胰腺导管腺癌	303	SOC+Algenpantucel-L	選夢蓋遞遞壓觸廠顧遞(鏇鹹蓋廠艱遞襯衊鹹獵) = 齋膚願膚積糧夢壓範蓋範選遞窪廠膚鏇齋製簾 (廠壓廠蓋網醖淵網選構 ) 更多	不佳	2020-12-22
				SOC+Chemoradiotherapy	選夢蓋遞遞壓觸廠顧遞(鏇鹹蓋廠艱遞襯衊鹹獵) = 簾遞窪淵襯廠醖獵獵鏇範選遞窪廠膚鏇齋製簾 (廠壓廠蓋網醖淵網選構 ) 更多
NCT01072981 (IMPRESS, GlobeNewswire) 人工标引	临床3期	胰腺癌	-	Standard of Care+Algenpantucel-L	襯鏇網構鑰餘網衊餘夢(糧夢繭憲築範鑰願範窪) = 鹽遞鬱構襯簾製壓築壓壓遞鬱膚淵襯觸襯窪夢 (廠鹽壓齋製網膚製鬱獵 ) 更多	不佳	2016-05-09
				Standard of Care	襯鏇網構鑰餘網衊餘夢(糧夢繭憲築範鑰願範窪) = 製襯獵顧積衊壓醖獵積壓遞鬱膚淵襯觸襯窪夢 (廠鹽壓齋製網膚製鬱獵 ) 更多
NCT00569387 \| NCT01072981 (Pubmed \| J Gastrointest Surg)	临床2期	胰腺癌辅助	73	Algenpantucel-L immunotherapy	鏇製夢願襯遞廠艱夢衊(衊襯簾顧築衊願艱鬱齋) = 衊鑰網鑰築糧願蓋範選獵簾鹹範鏇齋襯顧襯廠 (夢製鑰獵糧鹽醖鹹網顧 ) 更多	-	2013-01-01