ReiThera宣称在Phase I临床实验中GRAd-COV2 COVID-19候选疫苗在18-55岁的健康受试者中具有良好的耐受性并诱导明显的免疫应答,有助于推进到65-85岁的老年受试者
2020-11-27

ReiThera宣称在Phase I临床实验中GRAd-COV2 COVID-19候选疫苗在18-55岁的健康受试者中具有良好的耐受性并诱导明显的免疫应答,有助于推进到65-85岁的老年受试者

【意大利,罗马,20201124日】——ReiThera Srl是一家致力于基因疫苗和先进治疗药物的技术开发、GMP生产和临床转化的生物技术公司。今天提供了新型冠状病毒(SARS-CoV-2)的候选疫苗(GRAd-COV2)Phase I临床实验的最新进展。这项研究是与位于罗马(意大利)LazzaroSpallanzani国家传染病研究所(INMI)设计和共同运行的,并得到了意大利科学研究部和拉齐奥地区(罗马)的财政支持。

该公司报告说,试验正在按计划进行,对第一批健康志愿者(18-55)的剂量和初步评估已经完成。来自这组研究的初步结果显示,在所有三种剂量的测试中,GRAd-COV2具有良好的耐受性和产生的spike结合抗体和T细胞反应。

该试验目前正在推进对第二组三批健康老年人(年龄在65-85岁之间)GRAd-COV2研究。该试验的结果有望在Phase 2/3临床实验中为进一步研究选择疫苗剂量提供依据。

我们在GRAd-COV2的第一阶段试验中取得了很大进展,并按计划完成了研究的第一部分。最初的研究结果表明,候选疫苗对年轻受试者具有良好的耐受性和抗SARS-CoV-2的免疫原性,这使该研究能够进入下一个阶段的老年受试者,”ReiThera的首席执行官Antonella Folgori说。老年志愿者的登记工作也进行得很顺利,我们期待在年底左右报告整体研究的初步结果,以及我们更大规模的国际研究计划。

Folgori博士补充道:“感谢罗马的Lazzaro Spallanzani和维罗纳的GB Rossi大学医院的试验伙伴,也感谢前来参与这项研究的大量志愿者。这确实是一个有共同目标的合作努力的成果。

ReiThera公司利用其在意大利的GMP生产技术和能力生产了用于本次试验的疫苗材料。与此同时,该公司正在与德国的LEUKOCARE公司合作开发SARS-CoV-2疫苗的热稳定配方,并与比利时的Univercells公司合作开发定制生产流程,以实现疫苗的快速、大规模生产。

关于GRAd-COV2候选疫苗

SARS-CoV2是由ReiThera公司开发的抗SARS-CoV-2的候选疫苗,它基于一种新的、专有的复制缺陷猿类(大猩猩gorilla)腺病毒载体(称为GRAd),编码全长冠状病毒刺突蛋白(GRAd-COV2)。刺突蛋白使冠状病毒能够进入人类细胞。

猿猴腺病毒(SAd)载体被广泛用作针对多种传染病的候选基因疫苗的传递剂,包括埃博拉和呼吸道合胞病毒(RSV,呼吸道合胞病毒);应用在不同的人群中,包括迄今已参加早期和晚期临床试验的老年人和婴儿。临床前和临床证据表明,ReiThera的疫苗技术是安全的,并诱导强大的细胞和体液免疫反应。

ReiThera的新型GRAd载体属于C种腺病毒,被认为是最有效的疫苗载体,在人类中血清亲和力较低。这意味着,GRAd疫苗的免疫原性不受已有的抗人腺病毒抗体的影响。

关于GRAd-COV2候选疫苗的PhaseI临床实验

正在进行的一期临床试验是在90名健康志愿者中评估GRAd-COV2的安全性和免疫原性,这些志愿者平均分为两个年龄组:18-55岁和65-85岁。每个年龄组被分成三个研究小组,由15名志愿者组成,他们接受三种不断增加的GRAd-COV2剂量中的一种。参与者将接受为期24周的监测。

这项研究正在意大利罗马的Lazzaro Spallanzani国家传染病研究所(INMI)和维罗纳的GB罗西大学医院进行,由意大利科学研究部和拉齐奥地区(罗马)提供资金。

该研究的主要目的是评估GRAd-COV2的安全性和耐受性,并选择疫苗剂量进行2/3期试验的进一步研究。第二目标是评估疫苗在志愿者体内诱导免疫反应(抗体和T细胞)对抗新型SARS-CoV-2冠状病毒的能力。

一个更大的国际Phase 2/3期试验计划在未来几个月开始,等待第一阶段试验的初步安全性和免疫原性的阳性结果。

关于ReiThera Srl

ReiTheraSrl是一家致力于基因疫苗和先进治疗药物的技术开发、GMP生产和临床转化的生物技术公司。该公司的管理和科学团队已经开发了一个高度创新的技术平台,该平台基于针对RSV和埃博拉等多种传染病的猿猴腺载体疫苗。ReiThera由一个经验丰富的管理团队领导;他们在以前的成功企业,如Okairos(GSK收购)中合作多年,并在含有灌装设备和质量控制实验室的cGMP设施中,拥有可扩展的病毒载体制造流程方面的长期生产经验。ReiThera也是一个泛欧联盟的成员,该联盟致力于开发和大规模生产一种针对COVID-19的腺病毒载体疫苗。

ReiThera在意大利罗马设有总部、研发实验室和GMP设施。


参考链接:

https://www.reithera.com/2020/11/24/reithera-announces-its-grad-cov2-covid-19-vaccine-candidate-is-well-tolerated-and-induces-clear-immune-responses-in-healthy-subjects-aged-18-55-years-phase-1-trial-to-advance-into-elderly-subjects-age/?fbclid=IwAR3JihZnebNgd76K8Ny67vfwiZEkvoe9ggbGxXpnmvcREvWue9DRyFxdzU4


ReiThera Announces its GRAd-COV2COVID-19 Vaccine Candidate is Well Tolerated and Induces Clear Immune Responsesin Healthy Subjects Aged 18-55 Years Phase 1 Trial to Advance into ElderlySubjects Aged 65-85 Years

ROME, Italy, November 24th, 2020 – ReiTheraSrl, a biotech company dedicated to the technology development, GMPmanufacturing and clinical translation of genetic vaccines and medicinalproducts for advanced therapies, today provides an update on the ongoing Phase1 study of its vaccine candidate (GRAd-COV2) against the novel coronavirus(SARS-CoV-2). The study has been designed and is run jointly with the LazzaroSpallanzani National Institute for Infectious Diseases (INMI) in Rome (Italy)and received financial support from the Italian Ministry of Scientific Researchand the Lazio Region (Rome).

The Company reports that the trial isadvancing on schedule and that dosing and initial evaluation on the firstcohort of healthy volunteers (aged 18-55 years) have been completed.Preliminary results from this cohort, which was divided into three study armsof 15 subjects, have shown that GRAd-COV2 was well-tolerated and generatedspike-binding antibodies and T-cell responses at all three doses tested.

The trial is now advancing to investigateGRAd-COV2 in the second set of three cohorts of healthy, elderly subjects (aged65-85 years). Results from the trial are expected to enable the selection of avaccine dose for further investigation in a Phase 2/3 trial.

“We are making great progress with thePhase 1 trial of GRAd-COV2 and have completed the first part of the study asplanned. The initial findings have shown that the vaccine candidate is welltolerated and immunogenic against SARS-CoV-2 in younger subjects, enabling thestudy to advance into the next phase in elderly subjects,” said ReiThera’sChief Executive Officer, Antonella Folgori. “Enrolment of elderly volunteers isalso proceeding well, and we look forward to reporting initial results from theoverall study around year end along with our plans for larger internationalstudies.”

Dr Folgori added: “We are grateful to ourtrial partners at the Lazzaro Spallanzani in Rome and the GB Rossi UniversityHospital in Verona, and also to the volunteers who have come forward in greatnumbers to participate in the study. It truly is a collaborative effort with ashared goal.”

ReiThera produced the vaccine material forthis trial using its in–house GMP manufacturing expertise and capabilities inItaly. In parallel, the Company is working with LEUKOCARE in Germany to developa thermostable formulation of the GRAd-COV2 vaccine and with Univercells inBelgium to develop a bespoke manufacturing process to enable rapid, large-scaleproduction of the vaccine.

About GRAd-COV2

GRAd-COV2, the candidate vaccine againstSARS-CoV-2 recently developed by ReiThera, is based on a novel and proprietaryreplication-defective simian (gorilla) adenoviral vector (called GRAd) encodingthe full-length coronavirus spike protein (GRAd-COV2). The spike proteinenables the coronavirus to enter human cells.

Simian adenoviral (SAd) vectors have beenextensively used as delivery agents for genetic vaccine candidates againstmultiple infectious diseases, including Ebola and RSV (Respiratory SyncytialVirus), in different populations, including elderly and infants enrolled inearly and late stage clinical trials to date. Preclinical and clinical evidencehave demonstrated that ReiThera’s vaccine technology is safe and induces robustcellular and humoral immune responses.

ReiThera’s novel GRAd vector belongs tospecies C adenovirus that are considered the most potent vaccine carriers andhas low seroprevalence in humans. This means that GRAd vaccine immunogenicityis not hampered by pre-existing anti-human adenovirus antibodies.

About the Phase 1 trial of GRAd-COV2

The Phase 1 clinical trial underway isevaluating the safety and immunogenicity of GRAd-COV2 in 90 healthy volunteersdivided equally into two age cohorts: 18-55 years and 65-85 years. Each cohortis divided into three study arms of 15 volunteers who receive one of threeescalating doses of GRAd-COV2. Participants will be monitored over a 24-weekperiod.

The study is being conducted in Italy atthe Lazzaro Spallanzani National Institute for Infectious Diseases (INMI) inRome and at the GB Rossi University Hospital in Verona, with funding providedby the Italian Ministry of Scientific Research and the Lazio Region (Rome).

The primary objective of the study is toevaluate the safety and tolerability of GRAd-COV2, and to select a vaccine dosefor further investigation in a Phase 2/3 trial. The secondary objective is toevaluate the vaccine’s ability to induce immune responses (antibodies and Tcells) against the novel SARS-CoV-2 coronavirus in volunteers.

A larger international Phase 2/3 trial isplanned to commence in the coming months, pending positiveinterim safety andimmunogenicity results of the Phase 1 trial.

About ReiThera Srl

ReiThera Srl is a biotech company dedicatedto the technology development, GMP manufacturing and clinical translation ofgenetic vaccines and medicinal products for advanced therapies. The company’smanagement and scientific teams have developed a highly innovativetechnological platform based on simian adeno-vectored vaccines against severalinfectious diseases, such as RSV and Ebola.

ReiThera is led by an experiencedmanagement team that has worked together for many years in previous successfulenterprises, including Okairos (acquired by GSK), and has a long-standingexpertise in scalable processes for viral vector manufacturing, supported by acGMP facility inclusive of filling suite and quality control laboratories.ReiThera is also part of a pan-European consortium focused on the development andlarge-scale manufacture of an adeno-viral vector vaccine against COVID-19.

ReiThera has its headquarters, R&Dlaboratories and GMP facilities in Rome, Italy.

For further information see:www.reithera.com

Media Contacts:

ReiThera Srl

Antonella Folgori, Chief Executive Officer

media@reithera.com

Citigate Dewe Rogerson - InternationalPress

Sylvie Berrebi, Mark Swallow PhD

+44 (0) 7714306525 / +44 (0) 7903737703

reithera@citigatedewerogerson.com

Comin & Partners – Italian Press

Giorgia Bazurli

+39 349 2840676

giorgia.bazurli@cominandpartners.com

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