ABIVAX Recruits First Patient in a Pivotal Phase IIb/III Clinical Trial with ABX203, a Novel Immunotherapy Against Chronic Hepatitis B Information contained on this page is provided by an independent third-party content provider. WorldNow and this Station make no warranties or representations in connection therewith. If you have any questions or comments about this page please contact [email protected].
SOURCE ABIVAX
PARIS, February 26, 2015 /PRNewswire/ --
ABIVAX, a clinical stage biotech company developing and commercialising anti-viral compounds and human vaccines, today announced that it has dosed in New Zealand the first patient in a Phase IIb/III clinical trial of ABX203 which is taking place in several countries of the Asia-Pacific region. The study is designed to assess whether ABX203 can deliver a significant improvement in the treatment of chronic hepatitis B (CHB) via controlling viral load for a much longer period of time when compared to current treatment options.
ABX203 is a therapeutic vaccine composed of 2 recombinant proteins from HBV, the surface antigen (HBsAg) and the nucleocapsid (core) structure (HBcAg). ABX203 has been designed to induce the production of neutralizing serum antibodies to HBsAg and the induction of strong cellular responses which are weak or undetectable in patients with CHB. These immune responses are similar to those that occur in patients with a self-resolving acute HBV infection. ABX203 is formulated as a nasal spray solution and as a solution for sub-cutaneous injection.
ABIVAX owns distribution rights for ABX203 for more than 80 territories in Asia, Europe and Africa. They were licensed in 2013 from the Center for Genetic Engineering and Biotechnology (CIGB, Havana, Cuba) following the completion of successful phase I, I/II and III clinical trials run by CIGB in Cuba and Bangladesh. These studies showed that ABX203 was well tolerated and had an antiviral effect similar to that of PEG-IFNa but that this effect on HBV viral load was, in contrast with PEG-IFNa, sustained for at least 6 months after treatment cessation. This unique sustained effect, in addition to a shorter duration of administration, means that ABX203 may offer important therapeutic advantages over standard treatments for CHB.
Professor Christian Trepo, MD, one of the top hepatitis experts worldwide, commented: "The previous studies of ABX203 have provided clinical proof of the concept of therapeutic vaccination in chronic hepatitis B. Its unique sustained effect, in addition to a shorter duration of administration, means that ABX203 could deliver important therapeutic advantages over standard treatments forpatients suffering from chronic hepatitis B."
The pivotal Phase IIb-III study is expected to be conducted at 50 clinical centres in 7 countries in the Asia-Pacific region. The study aims to recruit approximately 230 patients with HBeAg negative active chronic hepatitis B.
In this large scale study a group of patients will receive ABX203 for 24 weeks on top of their NUCs therapy (current standard of care together with PEG-IFNa) and these patients will be evaluated against a control group receiving only NUCs. The study will assess the following objectives at week 48 - 24 weeks after treatment with ABX203 has completed:
Characterization of the level of sustained control of Hepatitis B disease following cessation of treatment with NUCs
Assessment of safety and reactogenicity of ABX203
Characterization of the antibody and cellular immune responses to ABX203
The results from this Phase IIb-III study are expected in Q3 2016. A positive outcome from this study is expected to allow ABIVAX to file for marketing approval in certain Asian countries.
Professor Hartmut Ehrlich, M.D., CEO of ABIVAX, said: "Weareconfident that ABX203,our therapeutic vaccine against chronic hepatitis B could be a major progress in the treatment ofpatients with this devastating disease. This pivotalPhase IIb-III study that we have announced today is designed toconfirmthat ABX203can delivermeaningful clinical benefits in terms oflong-term viral control, a goal thatcannot beachieved today withthecurrent standard of care."
Gerardo Guillen, PhD, head of R&D at CIGB in Havana, commented: "This first-in class therapeutic vaccine is awaiting market approval in Cuba and we are very pleased to see the great progress our partner Abivax is makingwith the international development of this world leading immunotherapeutic to treat chronic hepatitis B." About Chronic Hepatitis
Hepatitis B virus (HBV) infection is a major public health problem worldwide. Infection with HBV causes a broad spectrum of liver disease, including subclinical infection, acute self-limited hepatitis, and fulminant hepatitis. Persons infected with HBV can also develop persistent infection, which can lead to chronic disease and death from cirrhosis or hepatocellular carcinoma (HCC).
According to the World Health Organization (WHO), an estimated 2 billion persons worldwide have been infected with HBV, and more than 350 million persons, or 5% of the world's population, have chronic, lifelong infections. HBV infection is an established cause of acute and chronic hepatitis, cirrhosis, liver failure and liver cancer. It is the cause of up to 80% of hepatocellular carcinomas. Around 1 to 1.5 million people die every year due to the consequences of hepatitis B.
With nearly 200 million people with chronic HBV, South-East Asia and the Pacific Regions account for ¼ of the world population and bears 30% of world's total disease burden. About ABIVAX
ABIVAX is an advanced clinical stage biotech company focused on becoming a global leader in the discovery, development and commercialization of anti-viral compounds and human vaccines to treat some of the world's most important infectious diseases, including HIV/AIDS and chronic Hepatitis B.
ABIVAX has 2 compounds in clinical stage research: ABX464 a novel small molecule against HIV with a number of important potential competitive advantages, and ABX203, a therapeutic vaccine candidate that could be a cure for chronic hepatitis B. The broader ABIVAX portfolio includes additional anti-viral compounds and vaccines that may enter the clinical stage in the coming 18 months.
ABX464 has been developed using ABIVAX' anti-viral platform that allows the Company to address a broad range of viral targets involved in the production and management of viral RNA within the host cell. ABIVAX also has access to a number of cutting edge technologies including complex molecular protein/RNA-pro interactions to discover and develop proprietary breakthrough therapies to help patients' clear important pathogenic viruses.
Headquartered in Paris, France, ABIVAX conducts its research and development in Évry (France) and Montpellier (France). In addition, ABIVAX benefits from long term partnerships with the Cuban Center for Genetic Engineering and Biotechnology (Havana, Cuba), The Finlay Institute (Havana, Cuba), the Molecular Genetics Institute of Montpellier (CNRS-Université de Montpellier, France), the Curie Institute (Paris, France), the Scripps Research Institute (La Jolla, CA, USA), the University of Chicago (Chicago, IL, USA), Brigham Young University (Provo, UT, USA), and the Institut Pasteur (Paris, France). ABIVAX intends to pursue further business development opportunities to access commercial products as part of its overall corporate strategy.
ABIVAX was founded by Dr. Philippe Pouletty, M.D. , managing partner at Truffle Capital, the cornerstone investor in ABIVAX since its creation.
For more information, please visit the company's website: http://www.ABIVAX.com Contacts ABIVAX
Prof. Hartmut J. Ehrlich, CEO Press Relations Citigate Dewe Rogerson
David Dible [email protected]
+44(0)20-7282-2949 作者: StephenW 时间: 2015-2-27 04:45
Type text or a website address or translate a document.
ABIVAX新兵首先患者处于举足轻重的IIb期/ III与ABX203,新型免疫疗法对慢性乙型肝炎的临床试验
The previous studies of ABX203 have provided clinical proof of the concept of therapeutic vaccination in chronic hepatitis B. Its unique sustained effect, in addition to a shorter duration of administration, means that ABX203 could deliver important therapeutic advantages over standard treatments for patients suffering from chronic hepatitis B.
目标定的很谨慎啊,比现有的治疗方案好点就行。我一直以为免疫疫苗类的治疗方法,都是一次治愈呢。这个药没听过呢,能有谁说说它的来龙去脉吗,可以谈谈个人意见,觉得忽悠的还是真的呢?作者: StephenW 时间: 2015-2-27 09:52
是古巴治疗疫苗
They were licensed in 2013 from the Center for Genetic Engineering and Biotechnology (CIGB, Havana, Cuba) following the completion of successful phase I, I/II and III clinical trials run by CIGB in Cuba and Bangladesh.作者: 战天斗hbv 时间: 2015-2-27 15:00
下面是Gerardo教授本人的回复与我各人的翻译,不当之处敬请指正。
For us is nice to hear that our vaccine candidateconstitute a hope for many CHB patients around the world. Thanks for yourinterest.
对我们而言,很高兴得知我们的候选疫苗使世界范围内的慢性乙肝患者看到了希望。感谢您的关注。
Regarding your questions, so far, the clinical trialsalready finished with HeberNasvac show that this vaccine is safe and induce asustained reduction of the viral load below 250 copies/mlin a high percent of treated patients. The normalization of the transaminaseswas obtained for the 100% of the patients, and also in a group of patients theHBeAg elimination and seroconversion was achieved. In addition, in a clinicaltrial comparing HeberNasvac againstthe PEG-IFNwe obtained better results for HeberNasvac's treatment group.
关于您的提问,迄今为止,已经完成的关于HeberNasvac的临床试验表明在高比例的接受治疗的人群中,疫苗是安全的,并能引起病毒载量持续性的降低(低于250拷贝/每毫升,译者注:国际标准单位IU/ml与copies/ml的换算关系为1UI/ml≈5.6copies/ml,因此大家常用的小于103应该是5600 copies/ml,译者的数学不好,欢迎大家批评指正。如果译者理解正确,那么,这种疫苗可以大概可以让DNA低于50 IU/ml)。全部接受治疗的病人的转氨酶均变得正常(我不明白为什么是normalization,这个词更像是个统计学术语“正态化”,译者认为Gerardo教授想表达的应该是“正常了”,欢迎有医学背景的各位指正我的翻译),一组病人也实现了e抗原的消除及血清转换。此外,对比临床试验表明HeberNasvac与长效干扰素相比疗效更佳。
About your second question, an Asian multicenter clinicaltrial is ongoing right now with HeberNasvac in combination with antivirals (incollaboration with the French Company ABIVAX), depending on the results comingfrom this trial we could obtain the registration of the product in differentcountries of Asia.On the other hand, in Bangladesh and Cuba theregistration process is more advanced and the vaccine could reach the market in2016. In China we should follow the National regulations (SFDA), probably wewill need to start from Phase I clinical trial to be able to register thevaccine. We area talking with companies in china for the introduction of thevaccine, but it will be needed several years for clinical trials to be able toregister the product.
关于您的第二个问题,一个HeberNasvac联合抗病毒药的亚洲的多中心临床试验(与法国公司ABIVAX合作)目前正在进行中,HeberNasvac是否能获得在亚洲不同国家的药剂制品注册取决于该试验的结果。另一方面,在孟加拉国(译者注:好近,如果可以,应该不用横渡太平洋了)和古巴,HeberNasvac的注册进程更快,疫苗可能会在2016年上市。在中国,我们必须遵循国家食品药品监督管理局(药监局)的相关规定,可能需要从临床一期试验开始以便能获得HeberNasvac在中国的注册。我们目前正在与中国的公司进行交流以引入HeberNasvac,但这可能需要一些时间(译者注:原文是说很多年)来进行临床试验以便能获得产品的注册。
ABIVAX Strengthens Its Senior Leadership Team by Appointing Dr. Jean-Marc Steens, M.D. as the Company’s Chief Medical Officer
September 23, 2015 01:17 PM Eastern Daylight Time
PARIS--(BUSINESS WIRE)--Regulatory News:
“I am looking forward to applying my experience and learnings to the development of ABIVAX’s ground-breaking therapies, which I am confident will have a substantial effect on the lives of many patients worldwide currently suffering from chronic Hepatitis B and HIV.”
ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a publicly traded, clinical stage biotech company developing and commercializing anti-viral drugs and therapeutic vaccines, today announced the appointment of Dr. Jean-Marc Steens, M.D. as its Chief Medical Officer.
Dr. Steens joins ABIVAX with almost three decades of experience in the biopharmaceutical industry. During these years, he held critical leadership roles with a focus on viral diseases (especially HIV/AIDS, but also hepatitis B) in both global clinical development and medical affairs. Furthermore, he has lived and worked in Europe and in the Unites States, and has had roles whose scope also included developing markets.
Prof. Hartmut Ehrlich M.D., CEO of ABIVAX, stated: “I am delighted to welcome Jean Marc to ABIVAX’s senior leadership team. His broad experience in the field of anti-viral drugs and vaccines, developed through decades of international leadership roles at GSK and ViiV, will be invaluable for the ongoing development of ABIVAX’s first-in-class clinical-stage product candidates ABX464 (HIV/AIDS) and ABX 203 (chronic hepatitis B), and to our pipeline of pre-clinical anti-viral compounds.”
Dr. Steens completed his medical education as well as a post-doctoral degree in Public Health at the Catholic University of Louvain in Belgium. He began his career at Sandoz in Belgium and subsequently joined Glaxo where he stayed for more than 20 years and carried extensive responsibilities for the global clinical development, medical affairs and access programs for novel therapies and vaccines for HIV and other infectious diseases.
In 2009, Dr. Steens was appointed to the post of Vice President and International Medical Director of ViiV Healthcare, with responsibility for establishing and managing medical departments across Eastern Europe, Asia and Latin America. In this capacity, he was ViiV Healthcare’s appointed liaison with guideline bodies including the WHO and the Medical Research Council (UK).
Since 2013, Dr. Steens has consulted to various Biopharmaceutical companies, including Novartis. Also, Dr. Steens is a member of the HIV advisory boards and steering committees of several global and national healthcare organizations such as the WHO and the National Institutes of Health (US). 作者: StephenW 时间: 2015-9-24 14:46
IMOJEV is a monovalent, live attenuated viral vaccine. The virus was obtained via recombinant DNA technology. It is based on the 17D-204 yellow fever vaccine virus in which two genes have been replaced by the corresponding genes from Japanese encephalitis (JE) virus. These are the premembrane (prM) and envelope (E) coding sequences of the SA14-14-2 live attenuated JE
vaccine virus. The immunising antigens are the prM and E proteins from the SA14-14-2 vaccine
virus.
DNA vaccination is a technique for protecting an animal against disease by injecting it with genetically engineered DNA so cells directly produce an antigen, resulting in a protective immunological response. Several DNA vaccines have been released for veterinary use, and there has been promising research using the vaccines for viral, bacterial and parasitic diseases, as well as to several tumour types. Although only one DNA vaccine has been approved for human use, DNA vaccines may have a number of potential advantages over conventional vaccines, including the ability to induce a wider range of immune response types.
ABIVAX Completes Recruitment in Its Phase IIb/III Pivotal Study with ABX203, First-in-Class Therapeutic Vaccine Against Chronic Hepatitis B
September 24, 2015 12:51 PM Eastern Daylight Time
PARIS--(BUSINESS WIRE)--Regulatory News:
“We are very pleased with this important clinical development milestone that demonstrates the efficiency of the relationship between ABIVAX and the CIGB”
ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), a leading clinical stage biotech company developing and commercializing therapeutic anti-viral drugs and vaccines, today announced that it has completed enrollment of all 266 subjects into its pivotal Phase IIb/III clinical trial of ABX203, aimed at demonstrating the safety and efficacy of ABX203, a therapeutic vaccine candidate for the treatment of patients with chronic hepatitis B disease. This is a significant milestone for the company, which recently conducted an IPO on the regulated market of Euronext Paris and set a record among biotechnology companies in France in terms of the amount of funds raised.
“We are delighted to announce that ABIVAX has successfully and rapidly fully enrolled 266 patients for this essential study. The enthusiasm of the physicians and investigators involved in the study is evident. This not only highlights the interest in our innovative therapeutic vaccine, but also underlines the medical need for immunotherapy in this indication. This is an important milestone for ABIVAX that should enable us to generate the first study results in Q4/2016,” said Prof. Hartmut J. Ehrlich, M.D., CEO of ABIVAX.
“We are very pleased with this important clinical development milestone that demonstrates the efficiency of the relationship between ABIVAX and the CIGB,” added Luis Herrera Martinez, CEO of the Cuban Center for Genetic Engineering and Biotechnology (CIGB), and Gerardo Guillén Nieto, Director of Biomedical Investigation at the CIGB.
Chronic Hepatitis B (CHB) virus infection is a very severe disease that often leads to life-threatening complications such as cirrhosis and liver cancer. There are approximately 350 million chronic carriers of Hepatitis B virus (HBV) worldwide, and between 1.0 and 1.5 million people die each year from these complications. CHB is present worldwide but its prevalence is highest in Sub-Saharan Africa and in East Asia.
The ABX203 phase IIb/III study is an open-label, randomized, comparative study designed to assess the efficacy of ABX203 to maintain control of Hepatitis B disease after cessation of nucleotide analogs, in particular in controlling viral load for a much longer period of time when compared to current treatment options. This study is ongoing in seven Asian/Pacific countries (Taiwan, Hong-Kong, Thailand, Singapore, South Korea, Australia and New-Zealand). In this large scale controlled and randomized study, one group of patients will receive ABX203 for 24 weeks, in addition to the current standard of care (nucleoside analogues, NUCs, along with alpha interferon); therapy will be stopped after 24 weeks. These patients will be evaluated against a control group receiving NUCs only. The study’s primary efficacy endpoint is the percentage of subjects with viral load <40 IU/mL at week 48, i.e 24 weeks after the treatment with ABX203 has been completed. Study results are expected in the fourth quarter of 2016.
ABX203 is a therapeutic vaccine composed of 2 recombinant proteins from HBV, the surface antigen (HBsAg) and the nucleocapsid (core) structure (HBcAg). It has been designed to induce the production of neutralizing serum antibodies to HBsAg and the induction of strong cellular responses, which are usually weak or undetectable in patients with CHB. These immune responses are similar to those that occur in patients with a self-resolving acute HBV infection. ABX203 is formulated as a nasal spray solution and as a solution for sub-cutaneous injection.
ABIVAX owns the development and distribution rights for ABX203 for more than 80 territories in Asia, Europe and Africa. These rights were licensed in 2013 from the Center for Genetic Engineering and Biotechnology (CIGB, Havana, Cuba) following the completion of successful phase I, I/II and III clinical trials run by the CIGB. These studies showed that ABX203 was well tolerated and had an antiviral effect similar to that of PEG-IFNα but that this effect on HBV viral load was, in contrast with PEG-IFNα, sustained for at least 6 months after treatment cessation. This unique sustained effect, in addition to a shorter duration of administration, means that ABX203 may offer important therapeutic advantages over standard treatments for CHB.
古巴疫苗ABX203For us is nice to hear that our vaccine candidateconstitute a hope for many CHB patients around the world. Thanks for yourinterest.
对我们而言,很高兴得知我们的候选疫苗使世界范围内的慢性乙肝患者看到了希望。感谢您的关注。
Regarding your questions, so far, the clinical trialsalready finished with HeberNasvac show that this vaccine is safe and induce asustained reduction of the viral load below 250 copies/mlin a high percent of treated patients. The normalization of the transaminaseswas obtained for the 100% of the patients, and also in a group of patients theHBeAg elimination and seroconversion was achieved. In addition, in a clinicaltrial comparing HeberNasvac againstthe PEG-IFNwe obtained better results for HeberNasvac's treatment group.
关于您的提问,迄今为止,已经完成的关于HeberNasvac的临床试验表明在高比例的接受治疗的人群中,疫苗是安全的,并能引起病毒载量持续性的降低(低于250拷贝/每毫升,译者注:国际标准单位IU/ml与copies/ml的换算关系为1UI/ml≈5.6copies/ml,因此大家常用的小于103应该是5600 copies/ml,译者的数学不好,欢迎大家批评指正。如果译者理解正确,那么,这种疫苗可以大概可以让DNA低于50 IU/ml)。全部接受治疗的病人的转氨酶均变得正常(我不明白为什么是normalization,这个词更像是个统计学术语“正态化”,译者认为Gerardo教授想表达的应该是“正常了”,欢迎有医学背景的各位指正我的翻译),一组病人也实现了e抗原的消除及血清转换。此外,对比临床试验表明HeberNasvac与长效干扰素相比疗效更佳。
About your second question, an Asian multicenter clinicaltrial is ongoing right now with HeberNasvac in combination with antivirals (incollaboration with the French Company ABIVAX), depending on the results comingfrom this trial we could obtain the registration of the product in differentcountries of Asia.On the other hand, in Bangladesh and Cuba theregistration process is more advanced and the vaccine could reach the market in2016. In China we should follow the National regulations (SFDA), probably wewill need to start from Phase I clinical trial to be able to register thevaccine. We area talking with companies in china for the introduction of thevaccine, but it will be needed several years for clinical trials to be able toregister the product.
关于您的第二个问题,一个HeberNasvac联合抗病毒药的亚洲的多中心临床试验(与法国公司ABIVAX合作)目前正在进行中,HeberNasvac是否能获得在亚洲不同国家的药剂制品注册取决于该试验的结果。另一方面,在孟加拉国(译者注:好近,如果可以,应该不用横渡太平洋了)和古巴,HeberNasvac的注册进程更快,疫苗可能会在2016年上市。在中国,我们必须遵循国家食品药品监督管理局(药监局)的相关规定,可能需要从临床一期试验开始以便能获得HeberNasvac在中国的注册。我们目前正在与中国的公司进行交流以引入HeberNasvac,但这可能需要一些时间(译者注:原文是说很多年)来进行临床试验以便能获得产品的注册。作者: 齐欢畅2 时间: 2015-10-22 22:13
Cuban HB vaccine undergoes clinical trials in 8 countries
English.news.cn 2015-10-23 17:23:42 [More]
HAVANA, Oct. 23 (Xinhua) -- A new Cuban vaccine for hepatitis B is undergoing clinical trials in seven Asian countries apart from Cuba, the Contemporanea newspaper reported Thursday.
The seven countries are Australia, New Zealand, South Korea, Singapore, China, the Philippines and Thailand, said Iris Lugo, a specialist from the Center for Genetic Engineering and Biotechnology (CIGB), which developed the vaccine.
The vaccine, HeberNasvac, prevents the progression of the disease or keeps it under control for a longer time, causes fewer adverse reactions, according to the CIGB. The treatment period is shorter, not exceeding 20 weeks.
Moreover, clinical trials have shown that the vaccine has greater antiviral efficacy than other applied conventional drugs.
Within a few months, Lugo said, the drug is expected to obtain the sanitary registration granted by the Center for State Control of Drugs and Medical Devices, allowing it to be used in Cuba in 2016.
The scientist added that some foreign companies have shown interest in its marketing, including French company Abivax, which has involved with the development of the new vaccine.
According to the World Health Organization, about 1 million people die each year from diseases related to the hepatitis B virus, which also continues to be the main risk factor for liver cancer and other serious complications, including esophageal varices.
Editor: Tian Shaohui