Pexa vec

Products covered by Phase Phase III, Phase II, Phase I SillaJen is developing an oncolytic viral therapy called Pexa-Vec, currently in phase III and phase Ib/II clinical trials for use against primary liver and colorectal cancers, respectively. Our team of over 100 analysts and investment professionals work with leading companies, fund managers and investment banks worldwide to support their capital markets activity. Pexa-Vec is an oncolytic and immunotherapeutic vaccinial virus that, when infused into HCC tumors, may have clinical activity. The PHOCUS Trial is a Phase 3 trial evaluating an investigational drug called Pexa-Vec (JX-594), to determine if it can slow the progression of advanced liver cancer and improve quality of life. Pexa-Vec, Jennerex's lead product candidate, is an oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via tumor cell lysis, 2) induce a systemic anti-tumor immune response, and 3 Pexa-Vec causes, number one, direct tumor destruction; number two, the ability of the vaccinia to transmit from 1 place to another and affect other tumors, and add to this the altered immune mechanism with the activation of the G-CSF; and third, the antiangiogenic component makes it a multitargeted approach to therapy. SillJen, Transgene, and Lee's Pharmaceutical Unveil Late-Stage Development Plan for Pexa-Vec Enrollment of Phase 3 study in first-line advanced liver cancer is expected to begin by mid-2015. by SillaJen has Closed Transgene SA announced today the closing of the acquisition of Jennerex, Inc. Unauthorized reproduction is prohibited. Tim Greten at the National Cancer Institute (NCI), is Pexa-Vec (pexastimogene devacirepvec; JX-594) is a targeted oncolytic and immunotherapeutic vaccinia virus engineered to express human granulocyte-macrophage colony-stimulati ng factor (GM-CSF). D. 10. Professor, Department of Anatomy, UCSF SillaJen Presents Data Demonstrating Pexa-Vec Synergy with Angiogenesis Inhibitors: A • JX-594 (Pexa-Vec) oncolytic virus – Vaccinia poxvirus with addition of GM-CSF gene and deletion of thymidine kinase gene – Only replicate in cells with high levels of thymidine kinase such as cancer cells – GM-CSF may help initiate anti-tumor immune response – Administered by intra-tumoral injections Replicating wins? Oncolys licensing bid with Hengrui centers on oncolytic virus About 600 patients will be randomized to treatment with Pexa-Vec followed by . Pexa-Vec Clinical Trials, 17 Results, Page 1. 2 In this trial, which tested two doses of the oncolytic Pexa-Vec is a weakened (or attenuated) virus that is based on a vaccine used in the eradication of smallpox. In a preceding phase II dose-escalation trial, Pexa-Vec had an acceptable safety profile and increased OS with the highest dose. Price : $50 * Buy Profile * Final gross price and Drug Development Technology is using cookies. MTN머니투데이방송 38,006 views About Pexa-Vec and the SOLVE™ Platform Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. The company is also developing a robust pipeline of oncolytic immunotherapy products with multiple complementary mechanisms-of-action. The Phase III trial (PHOCUS trial) is designed to evaluate the use of Pexa-Vec in treating HCC patients who have failed locoregional therapies, and are eligible for treatment with sorafenib (Nexavar), the only approved drug for advanced HCC. Pexa-Vec (pexastimogene devacirepvec) is the candidate in question, armed with a granulocyte-macrophage colony stimulating factor (GM-CSF) gene to promote an anti About Pexa-Vec Pexa-Vec (JX-594, pexastimogene devacirepvec) is an investigational oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via direct killing of tumor cells 2) induce a systemic anti-tumor immune response and, 3) selectively target tumor vasculature resulting in a rapid reduction in tumor blood flow. Pexa-Vec (JX594) is an oncolytic immunotherapeutic based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec, whose name is derived from pexastimogene devacirepvec, is an oncolytic virus designed to kill cancer cells in three ways. The article points out that the Pexa-Vec doesn't need direct injection into the tumor, which is a bonus (the trial they're doing at Stanford's vaccine you have to get tumor-injected multiple times -- I'm sure that gets old fast, plus you have to have access to the tumor, period). Transgene (TNG) Business description. Pexastimogene devacirepvec, Alternative Names: JX-594; Pexa-Vec; TG-6006 Latest Information Update: 26 Sep 2018. This documentary film had been aired on March 10, 2013 at a national broadcasting TV program known as "KBS special", which has been abstracted by a volume of 18 minutes. , Lancet Oncol 9:533-542, 2008; Breitbach et al. This virus has been utilized as a vaccine for several decades now. Pexa-Vec demonstrated replication, GM-CSF expression, and tumor responses in previous phase 1 trials. Pexa-Vec is designed to Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: the lysis (breakdown) of cancer cells through viral replication, the reduction of HCC hepatocellular carcinoma Lee’s Pharmaceutical Liver cancer oncolytic immunotherapy Pexa-Vec SillaJen TransGene Transgene Reports that the Acquisition of Jennerex, Inc. v. pexa vec. Direct oncolysis plus GM-CSF expression is accompanied by tumor vascular disruption and anti-tumoral immunity. “Pexa-Vec is a ground-breaking oncolytic product with significant potential in the treatment of HCC, and we are excited to apply our 20 years of expertise in virus manufacturing to help bring this promising treatment to patients”. SillaJen has initiated a phase 1/2 clinical trial of pexastimogene devacirepvec (Pexa-Vec) in combination with checkpoint inhibitor therapy for the treatment of metastatic colon cancer. Pexa-Vec (JX594) is an oncolytic immunotherapeutic based on an oncolytic vaccinia virus armed with a GM- CSF gene that promotes an anti-tumor immune response. Pexa-Vec cible sélectivement les tumeurs et augmente les réponses immunitaires antitumorales adaptatives et innées après administration par voie intraveineuse (i. Transgene - TG4010 and Pexa-Vec readouts to define 2019 Edison, the investment intelligence firm, is the future of investor interaction with corporates. Pexa-Vec is designed to Pexa-Vec is a weakened (or attenuated) virus that is based on a vaccine used in the eradication of smallpox. About Pexa-Vec Pexa-Vec (JX594/TG6006 - pexastimogene devacirepvec) is an oncolytic immunotherapy product based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor Imlygic™ (T-VEC) is a local immunotherapy that kills melanoma cells in the skin and lymph nodes and stimulates the immune system to fight cancer. Cancer-killing virus acts by alerting immune system The Pexa-Vec virus was originally developed by Michael Mastrangelo, MD, and Edmund Lattime, PhD, of Thomas Jefferson University in SillaJen, Inc. Oncolytic virus efficiency inhibited growth of tumour cells with multiple drug resistant phenotype in vivo and in vitro dose-finding trial of Pexa-Vec in patients 4 juin 2018 - Pexa-Vec, virus oncolytique le plus avancé du portefeuille de Transgene, génère une forte activité antitumorale après administration intraveineuse. Marketwired. JX-594 (Pexa-Vec) is a targeted oncolytic vaccinia virus designed to selectively replicate in and destroy cancer cells with epidermal growth factor receptor (EGFR)/ras pathway activation. Immunization Strategy With Intra-tumoral Injections of Pexa-Vec With Ipilimumab in Metastatic / Advanced Solid Tumors. Subscribe to our email newsletter The study, led by Dr. Pexa-Vec is designed to selectively target and Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. is a clinical-stage company that focuses on developing and commercializing oncolytic immunotherapy products to treat cancer. Citigate Dewe Rogerson David Dible/Marine Perrier + 44 (0)20 7638 9571 transgene@citigatedewerogerson. Pexa-Vec "is designed to multiply in and subsequently destroy cancer cells, while at the same time making the patients' own immune defence system attack cancer cells also," said Kirn from This is an important milestone for Pexa-Vec development, and is a result of our tremendous team work with SillaJen," stated Dr. Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: selectively destroy cancer cells through Pexa-Vec is an oncolytic immunotherapy product based on an oncolytic vaccinia virus expressing GM-CSF. Share. Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. Kirn et al), induction of cancer Human GM-CSF Quantikine ELISA Kit DGM00 41 Citations 3 Phase 1b Trial of Biweekly Intravenous Pexa-Vec (JX-594), an Oncolytic and Immunotherapeutic Vaccinia Virus SillJen, Transgene, and Lee's Pharmaceutical Unveil Late-Stage Development Plan for Pexa-Vec Enrollment of Phase 3 study in first-line advanced liver cancer is expected to begin by mid-2015. First data readout expected in 2019. In advanced colorectal cancer, Sillajen in August 2017 announced a partnership with the National Cancer Institute to initiate clinical trials of Pexa-Vec in combination other checkpoint inhibitors. Market drivers & investment opportunities. 2 In this trial, which tested two doses of the oncolytic Pexa-Vec was engineered to target common genetic defects in cancer cells by deleting their thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. About Pexa-Vec Pexa-Vec (JX594/TG6006 - pexastimogene devacirepvec) is an oncolytic immunotherapy product based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor Pexa-Vec is the lead product candidate from Jennerex' SOLVE™ platform, a groundbreaking approach offering new therapeutic options for patients with life-threatening cancers that can be injected September 3, 2013 - Transgene Announces that its Phase 2 study of Pexa-Vec in Secondline Advanced Liver Cancer did not Meet its Primary Endpoint July 3, 2013 - Transgene Grants Ascend Biopharmaceuticals a License to TG1042, an Immunotherapy to Treat Basal Cell Carcinoma, a Common Type of Skin Cancer Pexa-Vec demonstrated an acceptable safety profile and increased OS with the highest dose in results from a previous phase II dose-escalation trial. Pexa-Vec is also being evaluated in a phase 1/2 clinical trial in patients with treatment-refractory colorectal cancer as monotherapy and in combination with irinotecan, and in a Phase 2a clinical Pexa-Vec a été conçu pour renforcer cet effet de ciblage par la suppression de son gène thymidine kinase (TK), rendant le virus dépendant de ces TK cellulaires, hautement exprimés dans les Some of the emerging products include Pexa-Vec of Transgene/SillaJen, Telomelsin of Oncolys, and Canerpaturev (TBI-1401) of Takara Bio. Reblog. ) infusion. Pexa-Vec is an investigational oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via tumor cell lysis, 2) induce a durable immune response against tumors, and 3) selectively target Pexa-Vec virus is based on a virus used for decades as a simple vaccine, mainly against smallpox. The primary objective is to determine and compare the overall survival of patients with advanced HCC without prior systemic therapy, treated with Pexa-Vec followed by sorafenib (Arm A) versus sorafenib (Arm B). • Pexa-Vec has the potential to overcome challenges with approved active immunotherapy approaches. The emerging therapeutic potential of the oncolytic immunotherapeutic Pexa-Vec (JX-594) Caroline J Breitbach,1 John C Bell,2,3 Tae-Ho Hwang,1 David H Kirn,1 James Burke1 1SillaJen Inc, Seoul, South Korea; 2Department of Biochemistry, Microbiology and Immunology, University of Ottawa, Ottawa, ON, Canada; 3Centre for Cancer Therapeutics, Ottawa Please select whether you prefer to view the MDPI pages with a of Oncolytic Virotherapy in Gastrointestinal Malignancies. Its product includes Pexa-Vec SillaJen reports initiation of multinational randomized Phase 3 study of Pexa-Vec in HCC patients Pexa-Vec is an oncolytic therapeutic vaccinia virus (Wyeth strain) designed to selectively replicate in and destroy cancer cells, while at the same time stimulating a systemic antitumoral immune response through the expressio-macrophage n of its transgene, human granulocyte The article points out that the Pexa-Vec doesn't need direct injection into the tumor, which is a bonus (the trial they're doing at Stanford's vaccine you have to get tumor-injected multiple times -- I'm sure that gets old fast, plus you have to have access to the tumor, period). Uncontrolled cell division, inactivation of the interferon pathway that is necessary to defend against viral infections, and constitutively active EGFR - Ras signaling pathway, are common features of cancer cells . 02 Jennerex and Lee’s Pharm announces that its phase 2 study of Pexa-Vec in second-line advanced liver cancer did not meet its primary endpoint Another combination, Pexa-Vec and REGN2810 by US biotech firm Regeneron going through a Trial 1 for kidney cancer therapy, is also garnering attention, with REGN2810, a cure for squamous cell An oncolytic vaccinia virus armed with GM-CSF (Pexa-Vec) was associated with a 15% objective response rate in patients with advanced hepatocellular carcinoma in a randomized phase II clinical Pexa-Vec (JX-594) is an oncolytic and immunotherapeutic vaccinia virus which was shown to be well tolerated by intratumoral injection and intravenous infusions in Phase 1 trials (Park et al. A clinical trial is underway to examine the effects of Pexa-Vec on the hepatocellular carcinoma form of liver cancer. Secondary endpoints were pharmacokinetics and pharmacodynamics as well as antitumor activity. Background: Pexa-Vec is a vaccinia virus engineered to express granulocyte-macrophage colony stimulating factor (GM-CSF), thereby stimulating anti-tumor immunity, direct oncolysis, and tumor vascular disruption. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program. ) Pexa-Vec induit la Pexa-Vec is an engineered virus based on the harmless vaccinia cowpox virus -- also the basis for the original smallpox vaccine. A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination with Immune Checkpoint Inhibition in Refractory Colorectal Cancer. Pexa-Vec has been engineered from the vaccinia virus, which has been used in the past to treat smallpox. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program, and over 300 cancer patients have been treated with Pexa-Vec to date. Pexa-Vec is designed to selectively target and Pexa-Vec is an oncolytic therapeutic vaccinia virus (Wyeth strain) designed to selectively replicate in and destroy cancer cells, while at the same time stimulating a systemic antitumoral immune response through the expressio-macrophage n of its transgene, human granulocyte Phase 3 trial in progress in advanced liver cancer patients, using Pexa-Vec in combination with Sutent (sorafenib), expected to conclude in 2018. 85, 86 JX‐594 (Pexa‐Vec; Jennerex Biotherapeutics Inc, San Francisco, Calif) is derived from a strain of vaccinia that has been engineered to target Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The Pexa-Vec virus was originally developed by Michael Mastrangelo, MD, and Edmund Lattime, Ph. 02 Jennerex and Lee’s Pharm announces that its phase 2 study of Pexa-Vec in second-line advanced liver cancer did not meet its primary endpoint This content is made available for your personal use, educational advancement, or professional development. Open - Recruiting. The vaccinia strain Donald M. 90 on Wednesday after it said data from 80 patients showed Pexa-Vec ( JX-594) as second-line treatment missed the primary endpoint in the Phase IIb TRAVERSE trial for advanced hepatocellular carcinoma (HCC). Jennerex researchers showed that Pexa-Vec acts in three distinct ways to attackcancer: by infecting and killing cancer cells, by cutting off the blood supply totumors, and by activating the body’s own immune system to fight cancer. , of Thomas Jefferson University in Philadelphia, who engineered the harmless vaccinia virus to Pexa-Vec treatment has been derived from a type of virus called vaccinia virus. In late 2013, a Phase II B clinical trial for Pexa-Vec failed to meet its overall survivability endpoint, and Jennerex lacked the capital to continue development without a new investment. About Pexa-Vec Pexa-Vec (JX-594, pexastimogene devacirepvec) is an investigational oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via direct killing of tumor cells 2) induce a systemic anti-tumor immune response and, 3) selectively target tumor vasculature resulting in a rapid reduction in tumor blood flow. The primary endpoint was to determine the maximum tolerated dose. The patient was treated with JX594 (Pexa-vec®) via intravenous injection on December 19, 2012. It triggers the breakdown of cancer cells through viral replication. Clinical & deal history. Pexa-Vec Clinical Development Program and SOLVE Platform Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVEtm (Selective Oncolytic Vaccinia Engineering) platform Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. The NCI Drug Dictionary contains technical definitions and synonyms for drugs/agents used to treat patients with cancer or conditions related to cancer. Phase 3: Pexa-Vec + Nexavar (sorafenib) in first-line liver cancer. (ISI-JX) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. About the PHOCUS Trial. Its lead product is Pexa-Vec, which is in Phase III clinical trial for the treatment of About Pexa-Vec Pexa-Vec (JX594) is an oncolytic immunotherapeutic based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor immune response. A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination with Immune Checkpoint Inhibition in Refractory Colorectal Cancer 17-C-0090: DART: Dual Anti-CTLA-4 And Anti-Pd-1 Blockade In Rare Tumors Pexa-Vec was engineered to target common genetic defects in cancer cells by deleting its thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently About Pexa-Vec. Tim Greten at the National Cancer Institute (NCI), is Pexa-Vec virus is based on a virus used for decades as a simple vaccine, mainly against smallpox. McDonald, MD, PhD. Pexa-Vec是SillaJen专有的SOLVE平台中最先进的候选药物。 Pexa-Vec牛痘菌株骨架曾做为全球接种计划的一部分在数百万人中安全使用。 这一菌株由于癌细胞中常见的遗传缺陷可以自然靶向癌细胞。 Apart from the direct oncolytic activity, oncolytic viruses such as Pexa-Vec have been shown to mediate tumor cell death via the induction of innate and adaptive immune responses - Tremelimumab is a fully human monoclonal antibody that binds to CTLA-4 expressed on the surface of activated T lymphocytes and causes inhibition of B7-CTLA-4 About Pexa-Vec Pexa-Vec (JX594) is an oncolytic immunotherapeutic based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor immune response. SillaJen, Lee’s Pharmaceutical cleared for third phase testing cancer treatment Pexa-Vec July 21, 2017 July 21, 2017 pharmaceuticaldaily 0 Comments China , Lee's Pharmaceutical , SillaJen A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination with Immune Checkpoint Inhibition in Refractory Colorectal Cancer. Phase 1b Trial of Biweekly Intravenous Pexa-Vec (JX-594), an Oncolytic and Immunotherapeutic Vaccinia Virus in Colorectal Cancer The trial will investigate the combination of Pexa-Vec with an anti-PDL1 antibody durvalumab, as well as with both durvalumab and anti-CTLA4 antibody tremelimumab in participants suffering from refractory metastatic colorectal cancer (CRC). Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, and University of Leeds, announce that new clinical data1 obtained with Pexa-Vec further demonstrate anti-tumor activity after intravenous (i. Once Pexa-Vec reached phase II, we started conducting trials worldwide. Pexa-Vec is designed to Clinical trial to test effectiveness of Pexa-Vec on liver cancer 10 Apr 2013. Lee’s Pharm announces that China registration study of Trazodone Hydrochloride Tablets for depression has met its primary endpoint 2013. Pexa-Vec (pexastimogene devacirepvec, JX-594) is an oncolytic and immunotherapeutic vaccinia virus, engineered to preferentially infect tumor cells, disrupt vasculature, and stimulate anti-tumor immune responses. Some of the emerging products include Pexa-Vec of Transgene/SillaJen, Telomelsin of Oncolys, and Canerpaturev (TBI-1401) of Takara Bio. , Nature 477:99-102, 2011). The first patient has been dosed in the Phase 2 portion of a clinical trial evaluating a combination of the cancer vaccine Pexa-Vec and chemotherapy in solid tumor patients. 2 THE AMERICAN JOURNAL OF HEMATOLOGY/ONCOLOGY® 31 Dates of certification: February 28, 2017, to February 28, 2018 Medium: Print with online posttest, evaluation, and request for credit The American Journal of Hematology/Oncology® Editorial Board Debu Tripathy, MD Professor and Chairman About Pexa-Vec and the SOLVE Platform Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. (Euronext:TNG) fell EUR 1. Pipeline & competitive intelligence. 671. Pexa-Vec is the lead product candidate from Jennerex' SOLVE(TM) platform, a groundbreaking approach offering new therapeutic options for patients with life-threatening cancers that can be injected Pexa-Vec double agent engineered vaccinia: oncolytic and 1 active immunotherapeutic Caroline 3 J Breitbach , Kelley Parato2, James Burke1, Tae-Ho Hwang ,4, John C Bell2 and David H Kirn1 Oncolytic immunotherapies (OI) selectively infect, amplify within and destroy cancer cells, thereby representing a novel class of anti-cancer therapy. Preclinical data suggests that the addition of Pexa-Vec may sensitize the tumors to the antiangiogenic effects of sorafenib. Jennerex Presents Pexa-Vec Clinical Data at 2013 American Society of Clinical Oncology Annual Meeting. A Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC) Pexa-Vec: an oncolytic immunotherapy that has shown efficacy. A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. pexa vec Oncolytic viruses lead to tumor eradication in 2 ways: selective direct viral replication within tumor cells leading to lysis and activation of cell‐mediated, tumor‐specific immunity. A recent US study shows its positive effects on thirty patients with liver cancer. 4 Monotherapy: Over 300 patients in clinical trials have been treated with Pexa-Vec 5 . intravenous Pexa-Vec (JX-594), an “I am very happy to see, and very proud that I am involved in, the effort with Pexa-Vec, which is being looked at as an intratumoral injection on top of sorafenib,” Abou-Alfa says of the oncolytic virus, designed to specifically target and kill liver cancer cells. Pexa-Vec is designed to Pexa-Vec: an oncolytic immunotherapy that has shown efficacy. Pexa-Vec (pexastimogene devacirepvec; JX-594) is a targeted oncolytic and immunotherapeutic vaccinia virus engineered to express human granulocyte-macrophage colony-stimulating factor (GM-CSF). Transgene expects to publish mid-stage trial results on TG4010 “at the very beginning About Pexa-Vec. The investigational therapy, Pexa-Vec (JX-594), is an oncolytic immunotherapy that is being evaluated to determine if it may be effective in targeting and destroying liver tumors in people who are eligible to be treated with an approved therapy called sorafenib (Nexavar®). Pexa-Vec is a genetically engineered virus that is used in the smallpox vaccine. The emerging therapeutic potential of the oncolytic immunotherapeutic Pexa-Vec (JX-594) Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. Comprehensive Pexa-Vec, pexastimogene devacirepvec (TG6006, JX-5940TG6006, JX-594) portfolio, including molecular targets, MOA, partnerships, milestones. advertisement "This clinical trial is evaluating a drug already known to be safe as a vaccine. A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination with Immune Checkpoint Inhibition in Refractory Colorectal Cancer 17-C-0090: DART: Dual Anti-CTLA-4 And Anti-Pd-1 Blockade In Rare Tumors The Pexa-Vec virus was originally developed by Michael Mastrangelo, MD, and Edmund Lattime, PhD, of Thomas Jefferson University in Philadelphia, who engineered the harmless vaccinia virus to Just a FYI the FDA will NOT allow treatment based on the above mice tests. Pexa-Vec is the lead product candidate from Jennerex' SOLVE™ platform, a groundbreaking approach offering new therapeutic options for patients with life-threatening cancers that can be injected Despite treatment with entecavir, radiofrequency ablation and transarterial chemoembolization for recurrent local tumors, the tumors recurred in both lobes and lung metastases were detected by computed tomography on September 12, 2012. We 经中国食品药品监督管理总局(CFDA)批准(批准文号:2017L04441),用于治疗晚期肝癌的溶瘤免疫药品Pexa-Vec(原名JX-594)即将开展三期临床试验,即PHOCUS研究项目。 Pexa-Vec was the first armed oncolytic virus to demonstrate 1) intravenous (IV) tumor targeting and efficacy (Nature, 2011), and 2) a significant overall survival benefit in a randomized clinical trial (Nature Medicine 2013). About Pexa-Vec and the SOLVE Platform Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE® (Selective Oncolytic Vaccinia Engineering) platform. 02 Jennerex and Lee’s Pharm announces that its phase 2 study of Pexa-Vec in second-line advanced liver cancer did not meet its primary endpoint Oncolytic Virus Cancer Therapy Pipeline Insights Report 2018: Some of the Emerging Products include Pexa-Vec of Transgene/SillaJen, Telomelsin of Oncolys, and Canerpaturev (TBI-1401)The "Oncolytic Ongoing Trial Exploring Oncolytic Virus Pexa-Vec In HCC 8 October 2018 There is a phase 3 clinical trial that is comparing the use of Pexa-Vec and then Nexavar versus treatment with only Nexavar with the primary endpoint of the study being overall survival (OS). Transgene (TNG. Phase 2 evaluating TG4010 + Opdivo (nivolumab) in first-line NSCLC. A. Pexa-Vec, Jennerex's lead product candidate, is an oncolytic immunotherapy designed to rapidly de-bulk tumours via tumour cell lysis, induce a systemic anti-tumour immune response, and selectively target tumour vasculature resulting in a rapid reduction in tumour blood flow. ISI-JX is a multicentric, Phase I dose escalation trial followed by an extension part aiming to evaluate the safety, feasibility, and anti-tumor effects of an in situ immunization strategy with IT injections of ipilimumab with Pexa-Vec in adults patients (pts) with solid tumors. PA), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, and University of Leeds, announce that new clinical data1 Pexa-Vec is viral therapy designed to target and destroy cancer cells through the breakdown of cancer cell replication, the reduction of blood flow to the tumors and by stimulating the body’s immune system to fight the cancer cells. 17 Systemic delivery of Pexa-Vec to tumors was tested by collecting tumor biopsies in all patients between 7 and 10 days postinfusion. Oncolytic Virus Cancer Therapy Pipeline Insights Report 2018: Some of the Emerging Products include Pexa-Vec of Transgene/SillaJen, Telomelsin of Oncolys, and Canerpaturev (TBI-1401) of Takara Bio SillaJen has initiated a phase 1/2 clinical trial of pexastimogene devacirepvec (Pexa-Vec) in combination with checkpoint inhibitor therapy for the treatment of metastatic colon cancer. Tim Greten at the National Cancer Institute (NCI), is A Phase III Randomized, Open-Label Study Comparing Pexa-Vec (Vaccinia GM-CSF /Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy “As published in Nature, Pexa-Vec is also the only agent in this therapeutic class that can reproducibly target and destroy tumors by intravenous administration, a key point of differentiation Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. The modified virus is injected directly into the cancer tumour, to grow inside these rapidly growing cancer cells and hopefully kill them. 36 (13%) to EUR 8. IV Pexa-Vec infusion was well-tolerated up to a dose of 3×10 7 plaque forming units per kg (pfu/kg). Pexa-Vec, which is designed by SillaJen to be injected directly into the HCC tumor, is a vaccinia virus modified to destroy cancer cells and to create an immune response to the cancer, according Pexa-Vec causes, number one, direct tumor destruction; number two, the ability of the vaccinia to transmit from 1 place to another and affect other tumors, and add to this the altered immune mechanism with the activation of the G-CSF; and third, the antiangiogenic component makes it a multitargeted approach to therapy. Cancer-killing virus acts by alerting immune system: Vaccine Jennerex Presents Pexa-Vec Clinical Data at 2013 American Society of Clinical Oncology Annual Meeting. A Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC) SillaJen and NCI entered a cooperative research and development agreement to evaluate Pexa-Vec for the treatment of patients with advanced colorectal cancer. Some of the side effects included flu-like symptoms lasting a day or two in all patients and severe nausea and vomiting was reported in another patient. Pexa-Vec was the first engineered oncolytic virus to cause partial and complete tumor responses, intravenous delivery to tumors (Nature 2012, Breitbach, Hwang, D. Products covered by Phase. 13, NO. It is a new hope for patients with cancer: a virus developed by the American company Jennerex would extend the life of patients with end-stage liver cancer. Oncolytic virus Pexa-Vec (Phase III for HCC) and cancer vaccine TG4010 (Phase II for NSCLC) are the lead clinical candidates. Transgene is a French company developing immunotherapy agents for cancer and infectious diseases. Pexa-Vec was administered intravenously every 14 days, at dose levels of 1 × 106, 1 × 107, or 3 × 107 plaque-forming units (pfu)/kg. Enrollment of Phase 3 study in first-line advanced liver cancer expected to begin by mid-2015 – To initiate several additional Phase 1/2 trials during 2014 Marchc 26, 2014 Transgene SA, Lee’s Pharmaceutical and SillaJen today unveiled their late-stage clinical development plan for Pexa-Vec oncolytic immunotherapy. The Company’s lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a therapeutic vaccine against HPV-positive head and neck cancers. Findings from this study, which compared 2 Pexa-Vec (pexastimogene devacirepvec, JX-594) is an oncolytic and immunotherapeutic vaccinia virus designed to destroy cancer cells through viral lysis and induction of granulocyte-macrophage colony-stimulating factor (GM-CSF)-driven tumor-specific immunity. “This clinical trial is evaluating a drug already known to be safe as a vaccine. by SillaJen. Tweet. , a biotechnology company, develops and commercializes oncolytic immunotherapy products. For inquiries, please send an email to BD@sillajen. You will have to go somewhere where the recommended drug or drug combo can be provided to you. “We’ll see that phase 3 trial soon. Pexa-Vec is also engineered to express the potent immune stimulatory cytokine granulocyte-macrophage colony stimulating factor (GM-CSF), which may stimulate a tumor specific immune response. Results on primary Pexa-Vec and the experimental lung-cancer treatment TG4010 are Transgene’s priorities, Archinard said. Pexa-Vec is a weakened (or attenuated) virus that is based on a vaccine used in the eradication of smallpox. SillaJen Biotherapeutics, Inc. com Jennerex was an early leader in the oncolytic virus field. “I am very happy to see, and very proud that I am involved in, the effort with Pexa-Vec, which is being looked at as an intratumoral injection on top of sorafenib,” Abou-Alfa says of the oncolytic virus, designed to specifically target and kill liver cancer cells. SillaJen is actively seeking development partners and/or licensing opportunities for all of its assets. Aside from liver cancer, Pexa-Vec treatment is also being tried in other forms of tumors to gauge further on its efficacy. Benjamin Li, chief executive officer of Lee's Pharmaceutical. In a Phase 2 trial of Pexa-Vec in first-line HCC, overall survival was improved in a dose Pexa-Vec is an oncolytic immunotherapy with therapeutic potential, we believe, in several hard-to-treat cancers. 4122^ Background: Pexa-Vec is a vaccinia virus engineered to express granulocyte-macrophage colony stimulating factor (GM-CSF), thereby stimulating direct oncolysis, tumor vascular disruption and anti-tumor immunity (Nat Rev Cancer 2009). Each drug entry includes links to check for clinical trials listed in NCI's List of Cancer Clinical Trials. A clinical trial is testing how well Paxa-Vec could act on liver cancer. It was designed “to multiply and then destroy cancer cells while strengthening the immune system of the patient,” said David Kirn. Pexa-Vec and cyclophosphamide are combined to target two different steps in immune response against tumour cells. In a Phase 2 trial of Pexa-Vec Trial design. Pexa-Vec French biotech firm Transgene (Euronext Paris: TNG) has revealed that TRAVERSE, a randomized Phase IIb… To continue reading The Pharma Letter please login , subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and Just a FYI the FDA will NOT allow treatment based on the above mice tests. Pexa-Vec is an oncolytic immunotherapy which targets tumors by multiple mechanisms-of-action. The Phase I/II METROmaJX trial is designed to assess the tolerability and efficacy of the combination therapy. Pexa-Vec is in mid-stage development for kidney cancer and other solid tumors. The trial will investigate the combination of Pexa-Vec with an anti-PDL1 antibody durvalumab, as well as with both To continue reading The Pharma Letter please login, subscribe or claim a 7 day free trial subscription and access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space. In a Phase 2 trial of Pexa-Vec in first-line HCC, overall survival was improved in a dose Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. Pexa-Vec (pexastimogene devacirepvec, JX-594) is an oncolytic and immunotherapeutic vaccinia virus designed to destroy cancer cells through viral lysis and induction of granulocyte-macrophage colony-stimulating factor (GM-CSF)-driven tumor-specific immunity. Transgene S. com. Vaccinia virus is also known to eradicate smallpox. May 15, 2013. 17 The induction of humoral immunity to the Pexa-Vec transgene β-galactosidase was also used as a surrogate marker of Pexa-Vec replication Pexa-Vec was the first armed oncolytic virus to demonstrate 1) intravenous (IV) tumor targeting and efficacy (Nature, 2011), and 2) a significant overall survival benefit in a randomized clinical trial (Nature Medicine 2013). NEW HEPATOCELLULAR CARCINOMA THERAPIES VOL. Pexa-Vec (JX-594) is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. Pexa-Vec double agent engineered vaccinia: oncolytic and 1 active immunotherapeutic Caroline 3 J Breitbach , Kelley Parato2, James Burke1, Tae-Ho Hwang ,4, John C Bell2 and David H Kirn1 Oncolytic immunotherapies (OI) selectively infect, amplify within and destroy cancer cells, thereby representing a novel class of anti-cancer therapy. [기업 리포트 - 신라젠] '고평가 논란' 신라젠 실체는? - 이인철, 이관영, 김지산 - Duration: 39:52. In a Phase 2 trial of Pexa-Vec Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed bysorafenib versus sorafenib in patients with advanced HCC without In July 2017, SillaJen received approval from the China CFDA to commence phase 3 clinical trial for Pexa-Vec in liver cancer. Another combination, Pexa-Vec and REGN2810 by US biotech firm Regeneron going through a Trial 1 for kidney cancer therapy, is also garnering attention, with REGN2810, a cure for squamous cell Pexa-Vec, a genetically engineered virus was developed to target cancer cells and destroy them. About Pexa-Vec Pexa-Vec (JX594) is an oncolytic immunotherapeutic based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec (pexastimogene devacirepvec, JX-594) is an oncolytic and immunotherapeutic vaccinia virus designed to destroy cancer cells through viral lysis and induction of GM-CSF-driven tumor ible Pexa-Vec delivery to tumors was established at a dose threshold of 1×109 pfu, with tumor biopsies in seven of eight patients containing detectable Pexa-Vec. Pexa-Vec is an oncolytic immunotherapy product based on an oncolytic vaccinia virus expressing GM-CSF. Pexa-Vec is an engineered oncolytic virus that selectively destroys cancer cells and induces tumor immune response. In Aug 2017, Sillajen signs collaborative agreement with the National Cancer Institute for development of combination therapy with Pexa-Vec and immune checkpoint inhibitors. Pexa-Vec causes, number one, direct tumor destruction; number two, the ability of the vaccinia to transmit from 1 place to another and affect other tumors, and add to this the altered immune mechanism with the activation of the G-CSF; and third, the antiangiogenic component makes it a multitargeted approach to therapy