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– GRAd-VOC2 code for sarS-CoV-2 full-length coronavirus protein
– healthy volunteers of two old cohorts (18-55 and 65-85 years old) to recruit in two clinical centers in Italy
– The phase 1 trial is being conducted through the Lazzaro Spallanzani National Institute of Infectious Diseases with the sponsorship of ReiThera
– The phase 1 trial and the manufacture of the clinical apparatus required for it are financed through the Ministry of Scientific Research of Italy and the Region of Lazio (Rome).
– A foreign Phase 2/3 trial is expected in countries with the highest rates of coronavirus infection to begin by the end of 2020, ending the initial effects of Phase 1.
ROME, August 24, 2020 / PRNewswire / – ReiThera Srl, a biotechnology company committed to technological development, the production of BPF and the clinical translation of genetic vaccines and drugs for complex therapies, announced that the first healthy volunteer has been dosed in a Phase 1 test of the Company’s candidate (GRAd-COV2) opposed to the new coronavirus (SARS-CoV-2). The Phase 1 exam is being carried out in Italy at the Lazzaro Spallanzani National Institute of Infectious Diseases (INMI) in Rome and at GB Rossi University Hospital in Verona.
ReiThera’s GRAd-VOC2 candidate vaccine encodes the full-length complex protein of SARS-CoV-2 coronavirus. Vaccine generation is based on a new patented vector of defective gorilla adenovirus for replication (GRAd), which has induced a strong cellular and fun immune reaction in preclinical studies and has demonstrated an intelligent protection profile. GRAd-VOC2 is expected to induce strong immune reactions over the low immunity of the pre-existing vector in humans.
Vaccines discovered in adenoviral vectors of similar apes, such as adenviral chimpanzee vectors (ChAd), have been evaluated in phase 1 and 2 clinical trials in other infectious diseases and have been found to be immunogenic with a single-dose vaccine.
The Phase 1 clinical trial evaluates the protection and immunogenicity of GRAd-VOC2 in 90 healthy volunteers divided similarly into two age cohorts: 18-55 years and 65-85 years. Each cohort will be divided into 3 arms of 15 volunteers who will get one of the 3 doses of GRAd-COV22 expansion. Participants will be followed for a period of 24 weeks.
The main objective of the study is to evaluate the protection and tolerance of GRAd-VOC2, and a dose of vaccine for further research in a phase 2/3 trial. The secondary goal is to evaluate the vaccine’s ability to induce immune responses (antibodies and T cells) opposed to the new SARS-CoV-2 coronavirus in volunteers. Provisional research on protection and immunogenicity is expected until the mid-2020 T4, which will serve as an ion dose consultant for phase 2/3 studies.
A larger phase 2/3 foreign trial is expected in countries where SARS-CoV-2 is still very active is still very active to begin until the end of 2020, ending the intermediate protection and immunogenicity effects of the Phase 1 trial.
THE PHASE 1 GRAd-VOC2 trial is funded by the Italian Ministry of Scientific Research and the Lazio region. The examination is carried out jointly through ReiThera and Lazzaro Spallanzani INMI, the initial vaccine apparatus manufactured at ReiThera’s cGMP facility in Rome.
At the same time, ReiThera is working with LEUKOCARE in Germany to expand the formulas of a grAd-COV2 thermostable vaccine and with Univercells in Belgium to expand a bespoke production procedure for the immediate and large-scale production of the vaccine.
“This test is the first vital step in the clinical progression of our new GRAd-VOC2 vaccine opposite COVID-19,” said Stefano Colloca, Chief Technology Officer of ReiThera. “We are proud to adopt this trial in Italy, where the effect of COVID-19 has been felt. The cutting-edge science behind our technique is backed by many years of pioneering studies on adenoviral vector technologies with preclinical and clinical results data generated with a single-dose vaccine in other serious infectious diseases demonstrating resistant cellular and fun immune responses. This feature makes our generation platform suitable for an epidemic scenario like COVID-19 and has apparent production and compliance advantages.”
“The launch of this Phase 1 trial demonstrates ReiThera’s experience and what can be done when stakeholders combine to achieve a common goal,” said Antonella Folgori, ReiThera’s executive director. We thank Lazzaro Spallanzani INMI for their continued collaboration and the Ministry of Scientific Research of Italy and the Lazio region for investing in the initial testing and manufacture of the GRAd-COV2 candidate vaccine. We look forward to providing updates on the protection and immunogenicity of our candidate vaccine over the coming months, and potentially moving on to the 2/3 phase of foreign testing later in the year. “
About GRAd-COV2
GRAd-VOC2, the candidate vaccine opposed to SARS-CoV-2 recently developed through ReiThera, is found in a new adenoviral vector of defective ape (gorilla) for replication (called GRAd) that encodes the complex full-length coronavirus protein (GRAd-VOC2). Complex protein allows coronaviruses to enter human cells.
Adenovirial vectors of apes (SAd) have been widely used as agents for genetic vaccine applicants who oppose multiple infectious diseases, adding Ebola and RSV (respiratory syncytial virus), in other populations, with more than 5,000 people, adding elderly and babies, recruited early and late. clinical trials to date. Preclinical and clinical evidence has shown that the generation of ReiThera vaccines is and induces physically powerful cellular and funny immune responses.
ReiThera’s new GRAd vector belongs to the adenovirus of species C, which is the highest potency vaccine vector and has a low seroprevalence in humans. This means that the immunogenicity of the GRAd vaccine is not hindered by pre-existing human anti-adenovirus antibodies.
About ReiThera Srl
ReiThera Srl is a biogeneration company committed to technological development, GMP production and clinical translation of genetic vaccines and drugs for complex therapies. The company’s control and clinical groups have developed a state-of-the-art generation platform for adenovectorial adenovectorial ape vaccines that oppose various infectious diseases, such as RSV and Ebola.
ReiThera is led through an experienced control team that has worked in combination for many years in past successful companies, adding Okairos (acquired through GSK), and has long experience in scalable processes for the manufacture of viral vectors, backed through a cGMP facility adding filling room and quality laboratories. ReiThera is also part of a pan-European consortium aimed at the large-scale progression and manufacture of an adenoviral vector vaccine opposite COVID-19.
ReiThera is headquartered, its progression laboratories and its GMP services in Rome, Italy.
For information, see: www.reithera.com
Media Contacts:
ReiThera SrlAntonella Folgori, Director géné[email protected]
Citigate Dewe Rogerson – Sylvie Berrebi International Press, Mark Swallow PhD – (0) 7714306525 /'(0) [email protected]
GPG Associati – Italian Press Maria Alessio Ruffo [email protected] Cell. 3357450537
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SOURCE ReiThera Srl