Pexa vec hcc

sorafenib 9 Transgene stopped the open-label, international Phase IIb TRAVERSE trial after data from 80 patients with advanced HCC who have failed sorafenib showed that Pexa-Vec plus best supportive care (BSC) missed the primary endpoint of improving Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. Therefore, there is a great need for advances in the treatment of advanced HCC, which for approximately the past decade, has been sorafenib. Pexa-Vec was generally well tolerated with an adverse event profile consistent with previous Pexa-Vec studies in patients with advanced HCC. The presentation and the accompanying oral commentary contain forward-looking statements within the meaning of the relevant securities laws of the Republic of Korea and the United States. The study, named the PHOCUS trial, is designed to enroll 600 patients Research Site. reducing the blood supply to tumors through infection of tumor associate Pexa-Vec is an oncolytic immunotherapy which targets tumors by multiple mechanisms-of-action. Advanced Hepatocellular carcinoma (HCC) – first line, not eligible for locoregional therapies. Pexa-Vec is a genetically engineered virus that is used in the smallpox vaccine. PEXA-VEC Partnership Partnered Unpartnered (SillaJen territory) KOREA Liver Cancer (HCC) KR Develelopment & Commercialization rights CHINA 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 Methods: Treatment-refractory HCC patients received Pexa-Vec for 3 weeks (Day 1 IV, Day 8 IT and Day 22 IT) followed by sorafenib at Day 25. . Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. Pexa-Vec (JX594/TG6006), a novel targeted approach to treat solid tumors with an oncolytic virus, is in clinical development for HCC. Liver cancer is the second leading cause of cancer related death in the world in men and the sixth leading cause of cancer death in women. Ghassan K. Pexa-Vec is an engineered oncolytic virus that selectively destroys cancer cells and induces tumor immune response. A Phase 3 Study (PHOCUS) to determine whether the oncolytic virus immunotherapy called Pexa-Vec (JX-594) can slow the progression of advanced liver cancer (hepatocellular carcinoma or HCC). 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). 1 months for the high-dose group compared to 6. Pexa-Vec has been safely administered to over 200 patients and iscurrently in Phase 2b clinical development for the treatment ofadvanced HCC and is also being evaluated in other solid tumors. Transgene is a French company developing immunotherapy agents for cancer and infectious diseases. 7 Hepatocellular cancer (HCC) is the most common primary tumor of the liver. 2 Secondary objectives of the trialBiopsy analysis of tumors revealed reproducible infection of tumor-associated endothelial cells. 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. 93) and is a growing national and existing global health concern. Jennerex received orphan drug designation on Pexa-Vec for the treatment of HCC from the European Medicines Agency (EMA) in 2009. On this trial, reproducible Pexa-Vec delivery to tumors was established at a dose threshold of 1×10 9 pfu, with tumor biopsies in seven of eight patients containing detectable Pexa-Vec. Finally, Pexa-Vec has demonstrated acute antivascular effects. HCC patients. Transgene (TNG) Business description. 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 . 17 The induction of humoral immunity to the Pexa-Vec transgene β-galactosidase was also used as a surrogate marker of Pexa-Vec replication in patients, as Half of the PHOCUS trial participants will receive sorafenib (Nexavar®), the only drug currently approved for HCC treatment, while the other half will receive injections of Pexa-Vec, an oncolytic vaccinia virus immunotherapy created by SillaJen, Inc. A Phase 2, Open-Label, Randomized Study of Pexa-Vec (JX-594) Administered by Intratumoral Injection in Patients with Unresectable Primary Hepatocellular Carcinoma. Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar®), the only approved drug for advanced HCC. The trial is evaluating the use of Pexa-Vec to treat patients who are eligible for treatment with sorafenib (Nexavar®), currently the only approved drug for advance HCC. Pexa-Vec virus is based on a virus used for decades as a simple vaccine, mainly against smallpox. by SillaJen. 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. Hepatocellular carcinoma is the fifth most common cancer worldwide and the third leading cause of cancer death, with over 600,000 new cases diagnosed annually resulting in more than 90 percent mortality . 2. 2006). 5 years post Pexa-Vec treatment Tumor cells Lymphocytic infiltrate DRUGS UNDER TEST FOR HCC TARGETTED AGENTS EPIGENETIC MODULATORS CELL CYCLE INHIBITORS IMMUNE MODULATORS PRO-APOPTOTIC AGENTS Tivantinib SGI-110 Refametanib Nivolumab Mapatumumab Cabozantinib LY2875358 Pembrolizumab Lenvatinib MSC2156119J Ipilimumab Regorafenib Donafenib Tasquinomod ADI-PEG20 TKM-080301 Pexa-Vec Icaritin Another agent in development is Pexa-Vec ® (pexastimogene devacirepvec, SillaJen), an oncolytic virus that also delivers GM-CSF to tumor cells. Additional analyses will be conducted to further understand these data. However, a separate trial seems to be anticipating the direction in which HCC is heading: Sillagen and Transgene recently announced plans for a phase I/II study to test Pexa-Vec in combination . This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy. 2. A similar approach targeting the HCC tumor-specific antigen glypican-3 is underway. The oncolytic immunotherapy, Pexa-Vec (pexastimogene devacirepvec; JX-594), is being assessed followed by sorafenib (Nexavar) in comparison with sorafenib alone in the ongoing phase III PHOCUS 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 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®). Therapeutic vaccine TG4010 is being trialled inThe trial is evaluating the use of Pexa-Vec to treat HCC patients who have failed locoregional therapies and are eligible for treatment with sorafenib (Nexavar), the only approvedThis is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed bysorafenib versus sorafenib in patients with advanced HCC withoutPexa-Vec utilizes the unique characteristics of vaccinia, which allows the virus to survive in the bloodstream in the presence of neutralizing antibodies, leading to its ability to be administered both intravenously and intratumorally (Kim et al. Pexa-Vec utilizes the unique characteristics of vaccinia, which allows the virus to survive in the bloodstream in the presence of neutralizing antibodies, leading to its ability to be administered both intravenously and intratumorally (Kim et al. Pexa-Vec is an engineered oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumour immune response. Current trials for HCC previously untreatedwith systemic therapy Phase 1: SBRT followed by nivolumab or nivolumab/ipilimumab (investigator-initiated) Phase 3: Pexa-vec (intratumoral injection of attenuated vaccinia virus) + sorafenib vs. Pipeline & competitive intelligence. (Pexa Vec) which is Pexa-Vec is currently being evaluated in a Phase 3 trial in hepatocellular carcinoma (HCC, liver cancer) in combination with sorafenib (current standard of care). The ongoing phase III PHOCUS trial is comparing the oncolytic virus Pexa-Vec followed by sorafenib (Nexavar) with sorafenib alone in patients with advanced hepatocellular carcinoma (HCC). As part of a multicenter clinical trial, researchers at University of California, San Diego School of Medicine are evaluating Pexa-Vec (JX-594) to slow the progression of hepatocellular carcinoma (HCC) or liver cancer. Jennerex Announces Nature Medicine Publication Highlighting Randomized Overall Survival Benefit of Lead Product Candidate, Pexa-Vec (JX-594) in Patients with Advanced Hepatocellular Carcinoma (HCC) 2013. Pexa-Vec Clinical Trials, 17 Results, Page 1. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program. "We are pleased to receive FDA orphan drug 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 Methods: Treatment-refractory HCC patients received Pexa-Vec for 3 weeks (Day 1 IV, Day 8 IT and Day 22 IT) followed by sorafenib at Day 25. Opdivo, Pexa-vec (pexastimogene devacirepvec, SillaJen/Transgene), and Imfinzi® (durvalumab, AstraZeneca) with or without tremelimumab (AstraZeneca) are also being evaluated in the first-line setting. Hepatocellular carcinoma is the fifth most common cancer worldwide and the third leading cause of cancer death. 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) In a Phase IIa study in hepatocellular carcinoma (HCC), patients receiving a high dose of Pexa-Vec (JX594/TG6006) had a median overall survival of 13. Half of the PHOCUS trial participants will receive sorafenib (Nexavar®), the only drug currently approved for HCC treatment, while the other half will receive injections of Pexa-Vec, an oncolytic vaccinia virus immunotherapy created by SillaJen, Inc. We believe that Pexa-Vec acts in three ways: 1. A Phase 3 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 Arm A Pexa-Vec injected into 1- 5 intrahepatic tumors using imaging-guidance (ultrasound and/or CT). In a Phase II study of advanced HCC with Pexa-Vec followed by sorafenib, a disease control rate of 62% was achieved with Pexa-Vec alone and 59% after initiation of sorafenib. The virus kills the infected/cancer cells by lysis and also expresses GM-CSF which may help initiate an anti-tumour immune response. nivolumab (HCC). The PHOCUS Study is a phase 3 randomized, open-label, trial of Pexa-Vec plus sorafenib versus sorafenib in patients with advanced HCC who are systemic therapy naive. Additional analyses will be conducted to further About 40 percent of HCC cases are diagnosed at advanced stages, a point when HCC is particularly difficult to treat. Pexa-Vec Clinical Development Program and SOLVE Platform Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. The primary Pexa-Vec was the first engineered oncolytic virus with demonstrated study in front line liver cancer (HCC) patients, high dose Pexa-Vec treatment was 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®). 7 months in those receiving a low dose. This trial is being led by Transgene’s partner, SillaJen, Inc. Transgene (Paris:TNG), a company that designs and develops viral-based immunotherapies, announces that the first patient has been treated in a Phase 1/2 clinical trial evaluating the combination of Pexa-Vec with Opdivo® (nivolumab) as a first-line treatment of advanced hepatocellular carcinoma (HCC The results of the PHOCUS trial are eagerly awaited by the VV community. The study, named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. Pexa-Vec has been shown to be well-tolerated by intravenous infusion and intratumoral injection. Pexa-Vec is an oncolytic and immunotherapeutic vaccinia virus designed to selectively replicate in and destroy cancer cells via direct oncolysis with tumor vascular disruption and antitumor immunity. is focused on developing Pexa-Vec for the North American market and has also granted exclusive development and commercial rights to Pexa-Vec in Hong Kong and The Peoples 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 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 oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first- line treatment of advanced hepatocellular carcinoma (HCC)”. Additional analyses will …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) E. The investigational oncolytic immunotherapy Pexa-Vec is designed to 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. effects; for instance, pexastimogene devacirepvec (Pexa‑Vec) is currently in a phase III trial for the treatment of HCC ( 3). 1 The study plans to enroll 600 patients with advanced HCC who have not received prior systemic therapy. Pexa-Vec, Jennerex's lead product candidate, is an investigational oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via tumor cell lysis, 2) induce a systemic anti-tumor immune Pexa-Vec is an oncolytic and immunotherapeutic vaccinial virus that, when infused into HCC tumors, may have clinical activity. Pexa-Vec Clinical Trials, 17 Results, Page 1. Transgene SA a annoncé aujourd’hui l’inclusion du premier patient dans l’étude randomisée de phase 3, de Pexa-Vec chez des patients atteints d’une forme de cancer du foie avancé, le carcinome hépatocellulaire (HCC: hepatocellular carcinoma). 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 A randomized phase II dose-finding study with 3 Pexa-Vec intratumoral (IT) liver injections in first line advanced HCC patients showed an acceptable safety profile and a significant increase in overall survival (OS) in the highest dose group (10 9 pfu) (Heo et al. Transgene (Paris:TNG) (Euronext Paris: TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, today announced that a poster on the ongoing Pexa-Vec Phase 3 trial in first line advanced HCC patients will be presented at the American Society of Clinical Oncology (ASCO Pexa-Vec is currently being evaluated in a Phase 3 trial in hepatocellular carcinoma (HCC, liver cancer) in combination with sorafenib (current standard of care). 試験は Pexa-Vec の使用を locoregional 療法を失敗し、 sorafenib (Nexavar) との処置のために資格がある HCC の患者、 ® 高度 HCC のための唯一の公認の薬剤 HCC also effectively evades the immune response via several mechanisms, not limited to aberrant expression of immune checkpoint molecules. A. In a Phase 2 trial of Pexa-Vec in first-line HCC, overall survival was improved in a dose dependent manner. We present the design of a randomized dose-finding trial of Pexa-Vec in patients with advanced HCC in which Pexa-Vec was delivered by intratumoral injection three times every 2 weeks at one of two dose levels (1 × 10(8) plaque forming units (pfu) versus 1 × 10(9) pfu). Lead Program – The planned Phase 3 trial will assess Pexa-Vec followed by sorafenib in the first-line treatment of patients with advanced HCC. Sorafenib Pts w/ HCC w/o Prior Systemic Therapy (Abi-Jaoudeh) 2nd LINE Therapeutic UCI 16-29** Dynamic Contrast Enhanced Magnetic Resonance Imaging as a Biomarker to Predict Response to Liver Tumor Embolization (Lam) UCI 16-94 Phase IIA Single Arm Study of Risk Disclosure: Fusion Media will not accept any liability for loss or damage as a result of reliance on the information contained within this website including data, quotes, charts and buy/sell This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy. Sorafenib, the standard of care in HCC, was approved by the FDA in 2007. 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) E. TECHNOLOGY DESCRIPTION Pexastimogene devacirepvec (Pexa-vec; JX-594) is under development for the treatment of Hepatocellular carcinoma (HCC). PA), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, and University of Leeds, announce that new clinical data 1 This content is made available for your personal use, educational advancement, or professional development. 1 months on average, while the latter survived 6. The trial is evaluating the use of Pexa-Vec to treat HCC patients who have failed locoregional therapies and are eligible for treatment with sorafenib (Nexavar ®), the only approved drug for Jennerex received orphan drug designation on Pexa-Vec for the treatment of HCC from the European Medicines Agency (EMA) in 2009. 13 Pexa-Vec was engineered from vaccinia, whichhas been used for decades as a vaccine in healthy individuals. Abou-Alfa, MD, discusses research into the use of the immunotherapeutic vaccinia virus Pexa-Vec as a frontline treatment for advanced hepatocellular carcinoma. Pexa-Vec is being paired with Nexavar versus Nexavar monotherapy as first-line therapy in Child-Pugh A advanced HCC in a Phase III trial (NCT02562755). 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。Pexa-Vec可以通过删除其胸苷激酶(TK)基因来增强这一功能,使其依赖于在癌细胞中持续高水平表达的细胞TK。As part of a multicenter clinical trial, researchers at University of California, San Diego School of Medicine are evaluating Pexa-Vec (JX-594) to slow the progression of hepatocellular carcinoma Comprehensive Pexa-Vec, pexastimogene devacirepvec (TG6006, JX-5940TG6006, JX-594) portfolio, including molecular targets, MOA, partnerships, milestones. 2 Secondary objectives of the trial Pexa-vec has demonstrated acceptable tolerability, clinical evidence of tumor necrosis radiographically, and biomarker evidence of prolonged anti-cancer immunity post-treatment in HCC; 48 as a result, an ongoingphase III clinical trial is currently comparing sorafenib plus Pexa-vec to sorafenib alone (ClinicalTrials. Pexa-Vec is an oncolytic immunotherapy product based on an oncolytic vaccinia virus expressing GM-CSF. 7 months. 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。Pexa-Vec可以通过删除其胸苷激酶(TK)基因来增强这一功能,使其依赖于在癌细胞中持续高水平表达的细胞TK。effects; for instance, pexastimogene devacirepvec (Pexa‑Vec) is currently in a phase III trial for the treatment of HCC ( 3). Its partner SillaJen, Inc. A randomized phase II dose-finding study with 3 Pexa-Vec intratumoral (IT) liver injections in first line advanced HCC patients showed an acceptable safety profile and a significant increase in overall survival (OS) in the highest dose group (10 9 pfu) (Heo et al. is focused on developing Pexa-Vec for the North American market and has also granted exclusive development and commercial rights to Pexa-Vec in Hong Kong and The Peoples Therefore, further studies of Pexa-Vec in a less advanced HCC population as well as other indications are warranted. • Pexa-Vec has the potential to overcome challenges with approved active immunotherapy approaches. Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. medical oncologist at Memorial Sloan Kettering Cancer Center and lead investigator on the Phase 3 trial. If this level of efficacy is repeated in the Phase II TRAVERSE trial, data due in Q413, and Pexa-Vec is still Pexa-Vec is an oncolytic virus partnered with SillaJen, its most advanced trial is a pivotal Phase III study in hepatocellular carcinoma (HCC). medical oncologist at Memorial Sloan Kettering Cancer Center and lead This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib. HCC patients treated with Pexa-Vec, as shown by Enzyme-Linked ImmunoSpot (ELISPOT) analysis; this provides proof-of-concept that T cell responses can be induced to transgenes encoded by oncolytic vaccinia viruses. 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)Un premier patient atteint de carcinome hépatocellulaire (HCC, une forme de cancer du foie particulièrement agressive) a pris part à l'essai de phase 3 sur le candidat médicament de Transgene Pexa-Vec. We present the design of a randomized dose-finding trial of Pexa-Vec in patients with advanced HCC in which Pexa-Vec was delivered by intratumoral injection three times every 2 weeks at one of two dose levels (1 × 10 8 plaque forming units (pfu) versus 1 × 10 9 pfu). 01. This is a study 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). JX-594 is an oncolytic virus originally constructed in Dr. Market drivers & investment opportunities. The trial is evaluating the use of Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar®), the only approved drug for advanced HCC. 11 May 2017 A randomized phase II dose-finding study with 3 Pexa-Vec intratumoral (IT) liver injections in first line advanced HCC patients showed an 29 Sep 2015 Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed Sorafenib is approved for the treatment of advanced HCC and is the 6 Mar 2017 Phase IIa part: To evaluate the anti-tumor activity and efficacy of IT Pexa-Vec combined with IV nivolumab in patients with advanced HCC with Methods: Treatment-refractory HCC patients received Pexa-Vec for 3 weeks (Day 1 IV, Day 8 IT and Day 22 IT) followed by sorafenib at Day 25. by infecting and selectively replicating in cancer cells and causing lysis, 2. Pexa-vec has demonstrated acceptable tolerability, clinical evidence of tumor necrosis radiographically, and biomarker evidence of prolonged anti-cancer immunity post-treatment in HCC; 48 as a result, an ongoingphase III clinical trial is currently comparing sorafenib plus Pexa-vec to sorafenib alone (ClinicalTrials. 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 oncolytic immunotherapy, Pexa-Vec (pexastimogene devacirepvec; JX-594), is being assessed followed by sorafenib (Nexavar) in comparison with sorafenib alone in the ongoing phase III PHOCUS trial. In vitro, Pexa-Vec was shown to be capable of The trial is evaluating the use of Pexa-Vec to treat HCC patients who have failed locoregional therapies and are eligible for treatment with sorafenib (Nexavar ®), the only approved drug for Pexa-Vec is a genetically engineered virus that is used in the smallpox vaccine. The Phase 3 trial of Pexa-Vec, named PHOCUS, followed by sorafenib in the first-line treatment of patients with advanced HCC, the most common form of liver cancer, is on track to initiate in the fourth quarter of this year. v. pexa vec hcc The clinical study code is TG6006. "We are pleased to receive FDA orphan drug About the PHOCUS Trial. HCC is obviously a disease where innovative treatment options such as Pexa-Vec are needed," stated Ghassan Abou-Alfa, M. (Euronext:TNG) began an open-label, French Phase I/IIa trial to evaluate Pexa-Vec pexastimogene devacirepvec (JX-594, TG6006) plus PD-1 inhibitor Opdivo nivolumab as first-line treatment in up to 36 patients with advanced hepatocellular carcinoma (HCC). Pexa-Vec (JX594/TG6006), a novel targeted approach to treat solid tumors with an oncolytic virus, is in clinical development for HCC. 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 Another agent in development is Pexa-Vec ® (pexastimogene devacirepvec, SillaJen), an oncolytic virus that also delivers GM-CSF to tumor cells. More information on the trial is available on clinicaltrials. 8 Oct 2018 The ongoing phase III PHOCUS trial is comparing the oncolytic virus Pexa-Vec followed by sorafenib (Nexavar) with sorafenib alone in patients 5 Oct 2018 Ghassan K. 4 An alternative to TACE is transarterial radioemboliza- tion (TARE) using β-emitting yttrium-90 (Y-90). by SillaJen has Closed Transgene SA announced today the closing of the acquisition of Jennerex, Inc. Transgene (TNG. The vaccinia virus backbone (Wyeth strain) of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program to eradicate smallpox. 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 We present the design of a randomized dose-finding trial of Pexa-Vec in patients with advanced HCC in which Pexa-Vec was delivered by intratumoral injection three times every 2 weeks at one of two A few months after Jennerex and its partner Transgene reported that their oncolytic cancer vaccine Pexa-Vec flunked a Phase IIb endpoint on overall survival in liver cancer, the private South Sequential therapy of intratumoral Pexa-Vec followed by sorafenib was tested in a phase II trial in 25 treatment-refractory HCC patients (including 20 sorafenib refractory), with a disease-control 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. Transgene (TNG) Business description. A Phase 3 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 Details: True Half of the PHOCUS trial participants will receive sorafenib (Nexavar®), the only drug currently approved for HCC treatment, while the other half will receive injections of Pexa-Vec, an oncolytic vaccinia virus immunotherapy created by SillaJen, Inc. 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. In this context, the safety and efficacy of adenovirus vectors for gene delivery should also be demonstrated in the future. Patients who are eligible for the Phase 2b trial must This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy. Other trials evaluating the oncolytic virus in solid tumors are underway and expected to readout in 2018, including a Phase 2 trial in combination with nivolumab (HCC). 5 promoter. Pexa-vec is a thymidine kinase-deleted vaccinia virus expressing As part of a multicenter clinical trial, researchers at University of California, San Diego School of Medicine are evaluating Pexa-Vec (JX-594) to slow the progression of hepatocellular carcinoma (HCC) or liver cancer. Verified account Protected Tweets @; Suggested users Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. HCC is obviously a disease where innovative treatment options such as Pexa-Vec are needed," stated Ghassan Abou-Alfa, M. A randomized phase II dose-finding study with 3 Pexa-Vec intratumoral (IT) liver injections in first line advanced HCC patients showed an acceptable safety Mar 6, 2017 Phase IIa part: To evaluate the anti-tumor activity and efficacy of IT Pexa-Vec combined with IV nivolumab in patients with advanced HCC with Aug 2, 2016 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 Jun 4, 2018 Pexa-Vec selectively targets tumor tissue after intravenous (i. 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) …This is a study 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 Pexa-Vec is an oncolytic immunotherapy product based on an oncolytic vaccinia virus expressing GMCSF. PEXA-VEC ONCOLYTIC VIROTHERAPY Second Product in Preparation for Phase 3 Lead indication: hepatocellular carcinoma (HCC, liver cancer) Planning underway for Phase 3 trial Potential opportunities in various other tumor types Transgene has development and commercialization rights in Europe, Commonwealth of Independent States and Middle EastBrief description of study. The study is designed to “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”. The virus also has the LacZ gene insertion under control of the p7. Pexa-Vec is an oncolytic immunotherapy product based on an oncolytic vaccinia virus expressing GM-CSF. The Company’s two lead clinical-stage programs are: TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. 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 The Pexa-Vec clinical program in liver cancer includes TRAVERSE, a global Phase 2b trial in advanced HCC patients who have failed sorafenib therapy. This global study will be conducted in Europe, Asia and North America. JX-594 (Pexa-Vec) is an oncolytic and immunotherapeutic vaccinia virus. Enhancing Anti-tumour Immunity with Oncolytic Viruses Tumor biopsy of HCC patient ~1. Pexa-vec is a …With >1,000 Pexa-Vec treatments, there was no evidence of complications stemming from systemic vaccinia infection. A Phase 2, open-label, randomized study of Pexa-Vec (JX-594) administered by intratumoral injection in patients with unresectable primary hepatocellular carcinoma. medical oncologist at Memorial Sloan Kettering Cancer Center and lead Pexa-Vecは、概して、良好な忍容性を示し、副作用の発症は、後期の肝細胞がん(HCC)患者を対象としたPexa-Vecのこれまでの臨床試験とほぼ同様であった。Pexa-Vec for the treatment of HCC from the European Medicines Agency (EMA) in 2009. The primary objective of the study was to determine the safety of Pexa-Vec followed by sorafenib. In addition, it has an inactivated thymidine kinase gene that provides for selective replication that is dependent upon high levels of thymine production, which is common to many cancer cells [ 71 ]. 2016 · Another promising example of oncolytic viruses as a treatment option is the use of an altered vaccinia virus, JX-594 (pexastimogene devacirepvec [Pexa-Vec]), for the treatment of hepatocellular carcinoma (HCC). Abou-Alfa, MD, discusses the potential of the oncolytic virus Pexa-Vec and other developments in hepatocellular carcinoma. 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 PEXA-VEC Partnership Partnered Unpartnered (SillaJen territory) KOREA Liver Cancer (HCC) KR Develelopment & Commercialization rights CHINAThe Phase 3 trial of Pexa-Vec, named PHOCUS, followed by sorafenib in the first-line treatment of patients with advanced HCC, the most common form of liver cancer, is on track to initiate in the About Pexa-Vec Pexa-Vec (JX594/TG6006 - pexastimogene devacirepvec) is an oncolytic immunotherapy product based on an oncolytic vaccinia virus armed with a …The company have treated more than 160 patients with JX-594 to date and are actively enrolling a multinational PIIb study in second line treatment of HCC, a PII all-IV trial in first line HCC patients, and a PII study in colorectal cancer [6]. Edmund Lattime's lab at Thomas Researchers believe that Pexa-Vec may be a systemic treatment of HCC by inducing tumor necrosis and shrinkage of both injected and non-injected A Phase 2, Open-Label, Randomized Study of Pexa-Vec (JX-594) Primary liver cancer (hepatocellular carcinoma; HCC) in patients not eligible for surgery or PHOCUS trial is evaluating an investigational drug, Pexa-Vec (JX-594), advanced liver cancer (hepatocellular carcinoma, HCC) alongside sorafenib (Nexavar). Pexa-Vec is an oncolytic and immunotherapeutic vaccinia virus designed to selectively replicate in and destroy cancer cells via direct oncolysis with tumor vascular disruption and antitumor immunity. PEXA-VEC ONCOLYTIC VIROTHERAPY Development Plan Phase 3 trial in first-line HCC planned with goal of first patient in by mid-2015 Large unmet medical need; only one treatment approved for this indication Pexa-Vec followed by sorafenib (Nexavar®) versus sorafenib alone Pexa-Vec is an oncolytic immunotherapy which targets tumors by multiple mechanisms-of-action. Thedevelopment plan for Pexa-Vec. 2013 · Pexa-Vec (JX-594, pexastimogene devacirepvec) is an investigational oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via direct killing of …What is BioCentury? BioCentury employs a fully integrated multimedia platform — including publications, video, online data solutions and conferences — to provide its audience with authoritative and up-to-date intelligence about corporate strategy, partnering, emerging technology, clinical data, public policy and the financial markets. Edmund Lattime's lab at Thomas Researchers believe that Pexa-Vec may be a systemic treatment of HCC by inducing tumor necrosis and shrinkage of both injected and non-injected Oct 8, 2018 The ongoing phase III PHOCUS trial is comparing the oncolytic virus Pexa-Vec followed by sorafenib (Nexavar) with sorafenib alone in patients Oct 5, 2018 Ghassan K. Currently, there are few approved treatment options for advanced HCC patients. However, a separate trial seems to be anticipating the direction in which HCC is heading: Sillagen and Transgene recently announced plans for a phase I/II study to test Pexa-Vec in combination Pexa-Vec was generally well tolerated with an adverse event profile consistent with previous Pexa-Vec studies in patients with advanced HCC. The scientists hope that Pexa-Vec, a genetically engineered virus used in smallpox vaccine, will slow the progression of liver cancer. To determine the optimal JX-594 dose in subjects with advanced hepatocellular carcinoma (HCC), we conducted a randomized Ph II trial of Pexa-Vec (pexastimogene devacirepvec; JX-594), an oncolytic and immunotherapeutic vaccinia virus, followed by sorafenib in patients with advanced HCC (Abst# 4122) Oncolytic viruses are a novel approach in oncology, particularly in HCC. Greten has published more than 150 peer-reviewed papers on basic tumor immunology, translational research studies in hepatocellular carcinoma (HCC) as well as on clinical trials in different gastrointestinal malignancies, including HCC. Philippe Archinard, Chairman and Chief Executive Officer of Transgene, said, "Together with SillaJen and our other partners, we are pleased to be moving forward our joint development plan for Pexa-Vec. The ongoing phase III PHOCUS trial is comparing the oncolytic virus Pexa-Vec followed by sorafenib (Nexavar) with sorafenib alone in patients with advanced hepatocellular carcinoma (HCC). The trial is evaluating the use of Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar®), the only approved drug for advanced HCC. As part of a multicenter clinical trial, researchers at University of California, San Diego School of Medicine are evaluating Pexa-Vec (JX-594) to slow the progression of hepatocellular carcinoma 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). ) of an ongoing Phase 1/2 trial in the first-line treatment of liver cancer (HCC). Pexa-Vec was engineered from vaccinia, whichhas been used for decades as a vaccine in healthy individuals. pexa vec hccJX-594 is an oncolytic virus originally constructed in Dr. Anticancer vaccines are also being actively tested in the treatment of HCC. 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®). , followed by sorafenib. Phase 3 trial in HCC expected to initiate soon. In a Phase 2 trial of Pexa-Vec in first-line HCC, overall survival was improved in a dose 转基因宣布在晚期肝癌中进行Pexa-Vec溶瘤免疫治疗的多国3期试验中随机分入第一位患者。转基因S. 02. Preclinical and clinical data suggested complimentary effects when combined with sorafenib, and a current phase 3 trial comparing Pexa-Vec HCC patients treated with Pexa-Vec, as shown by Enzyme-Linked ImmunoSpot (ELISPOT) analysis; this provides proof-of-concept that T cell responses can be induced to transgenes encoded by oncolytic vaccinia viruses. medical oncologist at Memorial Sloan Kettering Cancer Center and lead PEXA-VEC Partnership Partnered Unpartnered (SillaJen territory) KOREA Liver Cancer (HCC) KR Develelopment & Commercialization rights CHINA The oncolytic immunotherapy, Pexa-Vec (pexastimogene devacirepvec; JX-594), is being assessed followed by Nexavar (sorafenib) in comparison with Nexavar alone in the ongoing phase 3 PHOCUS trial. 13. Preclinical data suggests that the addition of Pexa-Vec may sensitize the tumors to the antiangiogenic effects of sorafenib. The researchers found that the former have survived up to 14. What is BioCentury? BioCentury employs a fully integrated multimedia platform — including publications, video, online data solutions and conferences — to provide its audience with authoritative and up-to-date intelligence about corporate strategy, partnering, emerging technology, clinical data, public policy and the financial markets. Hepatocellular carcinoma is the fifth most common cancer worldwide and the third leading cause of cancer death, with over 600,000 new cases diagnosed annually resulting in more than 90 percent mortality(1). It has an extremely high mortality to incidence ratio (0. 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) This content is made available for your personal use, educational advancement, or professional development. Overview. Pexa-Vec was generally well tolerated with an adverse event profile consistent with previous Pexa-Vec studies in patients with advanced HCC. A randomized Phase 2b trial incorporating IV Pexa-Vec dosing is underway in HCC patients who have failed prior sorafenib. In this conversation. Advanced Hepatocellular carcinoma (HCC) – first line, not eligible for locoregional therapies. Methods: Treatment-refractory HCC patients received Pexa-Vec for 3 weeks (Day 1 IV, Day 8 IT and Day 22 IT) followed by sorafenib at Day 25. Another agent in development is Pexa-Vec ® (pexastimogene devacirepvec, SillaJen), an oncolytic virus that also delivers GM-CSF to tumor cells. Pexa-Vec is designed to target and destroy cancer cells . 01. 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 …A randomized phase II dose-finding study with 3 Pexa-Vec intratumoral (IT) liver injections in first line advanced HCC patients showed an acceptable safety profile and a significant increase in overall survival (OS) in the highest dose group (10 9 pfu) (Heo et al. Pexa-Vec is currently being evaluated in an international, randomized Phase 2b clinical trial (TRAVERSE) in patients with advanced HCC who have failed sorafenib therapy. Medical Presentation. A total of 600 patients will be randomly assigned to 2 treatment arms in a 1:1 ratio (300 …About the PHOCUS Trial. Brief description of study. Transgene has exclusive rights to develop and commercialize Pexa-Vec for the treatment of solid tumors in Europe. oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first- line treatment of advanced hepatocellular carcinoma (HCC)”. “More to come,” includes the anticipated phase 3 findings of the Pexa-Vec oncolytic immunotherapy in patients who previously received Nexavar, as well as the early studies starting to explore chimeric antigen receptor (CAR) T-cell therapy in liver cancer. 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. UC San Diego Moores Cancer Center. Additional analyses will …A few months after Jennerex and its partner Transgene reported that their oncolytic cancer vaccine Pexa-Vec flunked a Phase IIb endpoint on overall survival in liver cancer, the private South Pexa-Vec is a virus (called vaccinia virus) that has been genetically modified in a laboratory to selectively infect and destroy cancer cells and release a protein called GM-CSF which plays a role in the immune system against cancer. 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 TherapyTransgene (Paris:TNG), a company that designs and develops viral-based immunotherapies, announces that the first patient has been treated in a Phase 1/2 clinical trial evaluating the combination of Pexa-Vec with Opdivo® (nivolumab) as a first-line treatment of advanced hepatocellular carcinoma (HCC PubFacts seeks to make the world's scientific research easy to locate, access, and collaborate on. NCT03071094 - 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) mismatch repair gene de˚cient,HCC hepatocellular carcinoma a Approval granted for use in combination with another therapeutic agent Drug name Target Manufacturer Approved disease Pexa-Vec Clinical Trials, 17 Results, Page 1. gov. completed an insider-based $21. This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib. Jennerex Biotherapeutics Inc. This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy. Pexa-Vec, Jennerex's lead product candidate, is an investigational oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via tumor cell lysis, 2) induce a systemic anti-tumor immune response, and 3) selectively target tumor vasculature resulting in a rapid reduction in tumor blood flow. This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions. The Pexa-Vec clinical program in liver cancer includes TRAVERSE, a global Phase 2b trial in advanced HCC patients who have failed sorafenib therapy. 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 granulocytecalled Pexa-Vec (JX-594) is being developed as a novel therapy for patients with refractory or advanced HCC. Methods Mol Biol . Furthermore, it is clear that HCC‐specific antigens are recognized by the immune system and contemporary clinical studies have indicated that manipulating the immune response can be deleterious to HCC. Purpose. Transient Grade 3/4 lymphopenia was observed. Brief description of study. This research study is for people with advanced liver cancer who have never received systemic medicine (affecting the entire body) for advanced liver cancer. D. The trial is evaluating the use of Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar®), the only approved drug for advanced HCC. Pexa-Vec (pexastimogene devacirepvec, JX-594) Our lead Investigational product Pexa-Vec is a Wyeth strain vaccinia virus engineered to directly lyse tumor cells and stimulate anti-tumor immunity. Pexa-Vec is currently being evaluated in a Phase 3 trial in hepatocellular carcinoma (HCC, liver cancer) in combination with sorafenib (current standard of care). Pexa-Vec demonstrated replication, GM-CSF expression, and tumor responses in previous phase 1 trials. Stanford is currently not accepting patients for this trial. HCC Management Patterns from the HCC BRIDGE Study Pexa-Vec selectively targets tumor tissue after intravenous (i. PubFacts seeks to make the world's scientific research easy to locate, access, and collaborate on. As part of a multicenter clinical trial, researchers at University of California, San Diego School of Medicine are evaluating Pexa-Vec (JX-594) to slow the progression of hepatocellular carcinoma (HCC) or liver cancer. 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). … Read the full story from the UCSD Newsroom Physician-scientist Tony Reid, MD, PhD , is principal investigator of this clinical trial of Pexa-Vec (JX-594) at UC San Diego, which is one of 42 sites participating in the study. A total of 600 patients will be randomly assigned to 2 treatment arms in a 1:1 ratio (300 in each arm) to reach at least 570 evaluable patients. Therapeutic vaccine TG4010 is being trialled in HCC is obviously a disease where innovative treatment options such as Pexa-Vec are needed," stated Ghassan Abou-Alfa, M. 已经宣布,在晚期肝癌患者(也称为肝细胞癌)(HCC)的情况下,开展了一项跨国,随机三期开放标签研究,其中包括溶瘤免疫治疗,Pexa-Vec。Pexa-Vec to treat HCC patients who are eligible for treatment with sorafenib (Nexavar®), the only approved drug for advanced HCC. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. Pexa-Vec (pexastimogene devacirepvec, JX-594) is an oncolytic vaccinia virus that expresses the human GM-CSF and beta-galactosidase transgenes . Of the thirty patients with hepatocellular carcinoma (HCC, a primary liver cancer), sixteen received high doses of the virus, while fourteen were administered lower doses of Pexa-Vec. We present the design of a randomized dose-finding trial of Pexa-Vec in patients with advanced HCC in which Pexa-Vec was delivered by intratumoral injection three times every 2 weeks at one of two Jennerex received orphan drug designation on Pexa-Vec for the treatment of HCC from the European Medicines Agency (EMA) in 2009. 6 million private placement, capping a fruitful week that included the full enrollment of a Phase IIb study of oncolytic cancer vaccine Pexa-Vec (JX-594, pexastimogene devacirepvec) in hepatocellular carcinoma (HCC), publication of This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy. "Indeed we need new options for patients with advanced HCC and the immunotherapeutic approach with Pexa-Vec is a new weapon and a great opportunity for our patients. It was designed “to multiply and then destroy cancer cells while strengthening the immune system of the patient,” said David Kirn. D. The oncolytic immunotherapy, Pexa-Vec (pexastimogene devacirepvec; JX-594), is being assessed followed by sorafenib (Nexavar) in comparison with sorafenib alone in the ongoing phase III PHOCUS 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 The Phase 3 trial of Pexa-Vec, named PHOCUS, followed by sorafenib in the first-line treatment of patients with advanced HCC, the most common form of liver cancer, is on track to initiate in the We present the design of a randomized dose-finding trial of Pexa-Vec in patients with advanced HCC in which Pexa-Vec was delivered by intratumoral injection three times every 2 weeks at one of two dose levels (1 × 10 8 plaque forming units (pfu) versus 1 × 10 9 pfu). 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. This is a multi-centre, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy. Notes: (A) Complete response of HCC tumor directly injected with Pexa-Vec. The coxsackie and adenovirus receptor (CAR), a trans‑ Once Pexa-Vec reached phase II, we started conducting trials worldwide. 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 This is a study 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 is a modified vaccinia poxvirus which selectively infects malignant cells with high expression of thymidine kinase. 27 Furthermore, a subset of HCC patients treated with Pexa-Vec by IT injection on a Phase II study exhibited an acute reduction in tumor perfusion as measured by dynamic magnetic resonance imaging (MRI) 5 days after the initial Pexa-Vec injection. The study is being conducted to determine and compare overall survival for patients in the two treatment arms. 05. As part of a multicenter clinical trial, researchers at University of California, San Diego School of Medicine are evaluating Pexa-Vec (JX-594) to slow the progression of hepatocellular carcinoma HCC is obviously a disease where innovative treatment options such as Pexa-Vec are needed," stated Ghassan Abou-Alfa, M. About the PHOCUS Trial. ) administration and stimulates the adaptive and innate anti-tumor immune response Hepatocellular carcinoma (HCC) is a cancer with a high mortality rate due to the (Pexa-Vec) Sorafenib VS sorafenib + Pexa-Vac in advanced HCC ((< < "Indeed we need new options for patients with advanced HCC and the immunotherapeutic approach with Pexa-Vec is a new weapon and a great opportunity for our patients. ( B ) Radiographic evidence of progressive necrosis and peripheral enhancement over time in noninjected tumors. HCC,9 only 20% of patients with HCC are eligible for this therapy. • 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 This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed bysorafenib versus sorafenib in patients with advanced HCC without 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 contains an oncolytic vaccinia virus that has been modified to express the immunogenic cytokine, GM-CSF. Oncolytic virus Pexa-Vec (Phase III for HCC) and cancer vaccine TG4010 (Phase II for NSCLC) are the lead clinical candidates. Pexa-Vec is an oncolytic virus partnered with SillaJen, its most advanced trial is a pivotal Phase III study in hepatocellular carcinoma (HCC). HCC hepatocellular carcinoma Lee’s Pharmaceutical Liver cancer oncolytic immunotherapy Pexa-Vec SillaJen TransGene Transgene Reports that the Acquisition of Jennerex, Inc. Clinical & deal history. 56 Oncolytic viruses such as pexastimogene devacirepvec (Pexa-Vec) have been developed. In a Phase 2 trial of Pexa-Vec in first-line HCC, overall survival was improved in a dose development plan for Pexa-Vec. The clinical study code is TG6006. The coxsackie and adenovirus receptor (CAR), a trans‑The investigational oncolytic immunotherapy Pexa-Vec is designed to 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. Risk Disclosure: Fusion Media will not accept any liability for loss or damage as a result of reliance on the information contained within this website including data, quotes, charts and buy/sell "Indeed we need new options for patients with advanced HCC and the immunotherapeutic approach with Pexa-Vec is a new weapon and a great opportunity for our patients. Otherwise, the regimen was well tolerated with flu-like symptoms, nausea, and abdominal pain . For example, Pexa-Vec (pexastimogene devacirepvec) is an oncolytic and immunotherapeutic vaccinia virus that disrupts tumor vasculature and mediates antitumor immunity via GM-CSF expression. called Pexa-Vec (JX-594) is being developed as a novel therapy for patients with refractory or advanced HCC. 7 Jennerex received orphan drug designation on Pexa-Vec for the treatment of HCC from the European Medicines Agency (EMA) in 2009. Besides above-mentioned agents, various other viruses were shown to have oncolytic and/or immunostimulating properties, and are presently used in clinical trials. (San Diego, CA)—As part of a multicenter clinical trial, researchers at University of California, San Diego School of Medicine are evaluating Pexa-Vec (JX-594) to slow the progression of hepatocellular carcinoma (HCC) or liver cancer. Pexa-Vec is an oncolytic immunotherapy with therapeutic potential, we believe, in several hard-to-treat cancers. 2015;1317:343–357. A Phase 2, Open-Label, Randomized Study of Pexa-Vec (JX-594) Primary liver cancer (hepatocellular carcinoma; HCC) in patients not eligible for surgery or PHOCUS trial is evaluating an investigational drug, Pexa-Vec (JX-594), advanced liver cancer (hepatocellular carcinoma, HCC) alongside sorafenib (Nexavar). Pexa-Vec is currently being evaluated in a Phase 3 trial in hepatocellular carcinoma (HCC, liver cancer) in combination with sorafenib (current standard of care). The median overall survival was 14. , Nat Med 2013). , Nat Med 2013). Initial studies investigated the safety of Pexa-Vec when administered by IT injection into skin (melanoma) 23 and liver tumors (primary HCC or liver metastases) 18 (Table 2). 試験は Pexa-Vec の使用を locoregional 療法を失敗し、 sorafenib (Nexavar) との処置のために資格がある HCC の患者、 ® 高度 HCC のための唯一の公認の薬剤 HCC is obviously a disease where innovative treatment options such as Pexa-Vec are needed," stated Ghassan Abou-Alfa, M. A Phase 3 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: Objective UCI 15-80 Phase III Comparing Pexa -Vec Followed by Sorafenib vs. 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 This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy. This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib. 8 months compared to 6. IV Pexa-Vec resulted in reproducible delivery and pharmacodynamic activity in HCC patients regardless of baseline neutralizing antibodies. This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy. HCC patients. 15. The study plans to enroll 600 patients with advanced HCC who have not received prior systemic therapy. Jennerex received orphan drug designation on Pexa-Vec for the treatment of HCC from the European Medicines Agency (EMA) in 2009. Transgene S. medical oncologist at Memorial Sloan Kettering Cancer Center and lead Pexa-Vec: an oncolytic immunotherapy that has shown efficacy Pexa-Vec is an oncolytic immunotherapy product based on an oncolytic vaccinia virus expressing GM-CSF. Risk Disclosure: Fusion Media will not accept any liability for loss or damage as a result of reliance on the information contained within this website including data, quotes, charts and buy/sell This is a multi-centre, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy. This trial provides evidence that regorafenib is the first systemic treatment • 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 A multi-center clinical trial, known as TRAVERSE and sponsored by Jennerex Biotherapeutics, San Francisco, CA, is underway evaluating Pexa-Vec (JX-594) as a means of slowing the progression of HCC. gov Identifier: NCT02562755). A Phase III study, PHOCUS, of Pexa-Vec in patients with HCC started in 2016, with the first European patient being enrolled in April 2017. "Indeed we need new options for patients with advanced HCC and the immunotherapeutic approach with Pexa-Vec is a new weapon and a great opportunity for our patients. A. oncolytic immunotherapy Pexa-Vec with the PD-1 receptor blocking antibody nivolumab in the first- line treatment of advanced hepatocellular carcinoma (HCC)”. The company have treated more than 160 patients with JX-594 to date and are actively enrolling a multinational PIIb study in second line treatment of HCC, a PII all-IV trial in first line HCC patients, and a PII study in colorectal cancer [6]. Dr. The Company has several other programs in clinical and pre-clinical development. Ph II trial of Pexa-Vec (pexastimogene devacirepvec; JX-594), an oncolytic and immunotherapeutic vaccinia virus, followed by sorafenib in patients with advanced HCC (Abst# 4122) Oncolytic viruses are a novel approach in oncology, particularly in HCC. Stockage et publication de matériel didactique et thématique, tous pour l'étudeor intolerance to sorafenib), Pexa-Vec 109 IV: no benefit in overall survival (probably because very advanced disease) Confirmed an acceptable safety profile • HEP007 (Phase2 Frontline dose-finding trial in HCC), 30 pt, high dose vs low dose of Pexa-Vec Overall survival increase with High dose Pexa-Vec 301er patient traité avec Pexa-Vec chez Transgene. gov Identifier: NCT02562755). sorafenib Phase 3: atezolizumab + bevacizumab vs. 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 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). Unauthorized reproduction is prohibited. Hepatocellular carcinoma (HCC) is the most dominant form of liver cancer, accounting for approximately 85% of liver cancer cases. Additional exploratory trials in Europe include the combination of Pexa-Vec with checkpoint blockade, Pexa-Vec combined with Nivolumab in advanced HCC, and Pexa-Vec combined with Ipilimumab in solid tumors. In vitro, Pexa-Vec was shown to be capable ofIV Pexa-Vec resulted in reproducible delivery and pharmacodynamic activity in HCC patients regardless of baseline neutralizing antibodies. Researchers at the University of Tennessee Medical Center treated the first patient in the phase 3 clinical trial for the hepatocellular carcinoma medication Pexa-Vec, according to an announcement Personalizzazione della Cura in Epatologia pexa-vec, tremelimumb, nivolumag, AMG 386. Preclinical and clinical data suggested complimentary effects when combined with sorafenib, and a current phase 3 trial comparing Pexa-Vec Research Site. The oncolytic immunotherapy, Pexa-Vec (pexastimogene devacirepvec; JX-594), is being assessed followed by sorafenib (Nexavar) in comparison with sorafenib alone in the ongoing phase III PHOCUS patients with advanced liver cancer, also known as hepatocellular carcinoma (HCC). The PHOCUS clinical trial is a multinational, randomized Phase 3 open label study with the oncolytic immunotherapy, Pexa-Vec, in patients with advanced liver cancer, also known as hepatocellular 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

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