GRAd-COV2 / ReiThera, Leukocare, Univercells - LARVOL DELTA

Enhanced thermostability of a gorilla-derived adenoviral (GRAd) vector via E4 region chimerism (ESGCT 2024) - "ReiThera has developed a COVID-19 vaccine based on a gorilla adenoviral vector (GRAd-COV2)...In addition, the backbone b2 provide a more thermostable product, a property linked to the possibility of storing formulated vaccine lots at 2-8°C, which is extremely beneficial for transport and storage in different countries worldwide. These important characteristics support the use of this backbone for the Phase I clinical trial for GRAdHIVNE1."

Infectious Disease • Novel Coronavirus Disease

GRAd as vaccine platform for COVID-19, HIV, and global health (ESGCT 2024) - "GRAd-COV2, a GRAd-based COVID-19 vaccine, has been the first product based on this platform technology, tested in humans and demonstrated to induce a potent and broad CD8+ and Th1-skewed CD4+ response, associated to a good safety profile and elevated productivity...This innovative approach underscores GRAd’s potential as a versatile and potent vaccine platform for addressing global health challenges. This work has been funded by the Bill and Melinda Gates Foundation (ReiThera grants INV-031044, INV-059646; Ragon Institute grant INV-008696)."

Clinical • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8

Enhanced Thermostability of a Gorilla-derived Adenoviral (GRAd) vector via E4 region chimerism (ASGCT 2025) - "ReiThera has developed a COVID-19 vaccine based on a gorilla adenoviral vector (GRAd-COV2)...These important characteristics support the use of this backbone for the Phase I clinical trial for GRAdHIVNE1. Disease Focus of Abstract:None"

Infectious Disease • Novel Coronavirus Disease

GRAd as Vaccine Platform for COVID-19 and HIV (ASGCT 2025) - "GRAd-COV2, a GRAd-based COVID-19 vaccine, has been the first product based on this platform technology, tested in humans and demonstrated to induce a potent and broad CD8 and Th1-skewed CD4 response, associated to a good safety profile and elevated productivity...This innovative approach underscores GRAd's potential as a versatile and potent vaccine platform for addressing global health challenges. Disease Focus of Abstract:HIV"

Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8

GRAd-COV2 vaccine provides potent and durable humoral and cellular immunity to SARS-CoV-2 in randomized placebo-controlled phase 2 trial. (PubMed, Cell Rep Med) - P2/3 | "T cells maintain immediate effector functions and high proliferative potential over time. Thus, GRAd vector is a valuable platform for genetic vaccine development, especially when robust CD8 response is needed."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD8

Intensified Production Process for Gorilla Adenoviral Vector GRAd: Yield, Purity, Potency and Stability Results (ASGCT 2023) - "Adenoviral vectors derived from simian adenovirus and more specifically from great apes have been studied in millions of human subjects using vaccine vectors encoding different antigens (relevant to Ebola, malaria, hepatitis C, human immunodeficiency virus [HIV], respiratory syncytial virus [RSV] and COVID-19) have shown that this vaccine platforms are safe and can generate potent, durable, and high-quality T cell and antibody (Ab) responses.Reithera has developed a COVID-19 vaccine using a novel gorilla adenovirus classified into species C. This adenovirus isolated from a captive animal was converted into a replication-defective adenoviral vector generating GRAd-COV2 vaccine...In addition, the final product was demonstrated to be stable at +2-8°C for more than one year. In conclusion, this novel GRAd vector is an attractive vaccine platform suitable for development and production of high-throughput vaccines against pathogens or diseases requiring the generation of..."

Viral vector • Hepatitis C • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Malaria • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

COVITAR: Study of GRAd-COV2 for the Prevention of COVID-19 in Adults (clinicaltrials.gov) - P2/3 | N=10300 | Completed | Sponsor: ReiThera Srl | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Safety and immune response kinetics of GRAd-COV2 vaccine: phase 1 clinical trial results. (PubMed, NPJ Vaccines) - "No major differences in immune response to GRAd-COV2 vaccination were observed in the two age cohorts. In light of its favorable safety and immunogenicity, GRAd-COV2 is a valuable candidate for further clinical development and potential addition to the COVID-19 vaccine toolbox to help fighting SARS-CoV-2 pandemic."

Journal • P1 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Strong immunogenicity of heterologous prime-boost immunizations with the experimental vaccine GRAd-COV2 and BNT162b2 or ChAdOx1-nCOV19. (PubMed, NPJ Vaccines) - "We observed a clear boost of both binding/neutralizing antibodies as well as T-cell responses upon receipt of the heterologous BNT162b2 or ChAdOx1-nCOV19 vaccines. These results, despite the limitation of the small sample size, support the concept that a single dose of an adenoviral vaccine may represent an ideal tool to effectively prime a balanced immune response, which can be boosted to high levels by a single dose of a different vaccine platform."

Journal • Infectious Disease • Novel Coronavirus Disease

GRAd-COV2, a gorilla adenovirus-based candidate vaccine against COVID-19, is safe and immunogenic in younger and older adults. (PubMed, Sci Transl Med) - "[Figure: see text]."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease

"Mexico in talks to produce Italy's GRAd-COV2 COVID-19 vaccine https://t.co/F2UErQXWXA" (@Reuters)

Clinical • Infectious Disease • Novel Coronavirus Disease

GRAd-COV2 Vaccine Against COVID-19 (clinicaltrials.gov) - P1; N=90; Completed; Sponsor: ReiThera Srl; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease

COVITAR: Study of GRAd-COV2 for the Prevention of COVID-19 in Adults (clinicaltrials.gov) - P2/3; N=10300; Active, not recruiting; Sponsor: ReiThera Srl; Trial primary completion date: May 2021 ➔ Oct 2021

Clinical • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Immunogenicity of a new gorilla adenovirus vaccine candidate for COVID-19. (PubMed, Mol Ther) - P1 | "To face the unprecedented need for vaccine manufacturing at massive scale, different GRAd genome deletions were compared to select the vector backbone showing the highest productivity in stirred tank bioreactors. This preliminary dataset identified GRAd-COV2 as a potential COVID-19 vaccine candidate, supporting the translation of GRAd-COV2 vaccine in a currently ongoing Phase I clinical trial (NCT04528641)."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVITAR: Study of GRAd-COV2 for the Prevention of COVID-19 in Adults (clinicaltrials.gov) - P2/3; N=10300; Active, not recruiting; Sponsor: ReiThera Srl; Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

GRAd-COV2 Vaccine Against COVID-19 (clinicaltrials.gov) - P1; N=90; Active, not recruiting; Sponsor: ReiThera Srl; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

ReiThera’s COVID-19 Vaccine Candidate Enters Phase 2/3 Clinical Study (PharmiWeb) - P1, N=90; NCT04528641; Sponsor: ReiThera Srl; "ReiThera Srl...today announces the start of its Phase 2/3 clinical study of GRAd-COV2, its vaccine candidate against the novel coronavirus (SARS-CoV-2). The study...will assess the safety, immunogenicity and efficacy of GRAd-COV2 vaccine...In the Phase 1 trial, a single inoculation with GRAd-COV2 was well-tolerated and generated spike-binding and neutralizing antibodies and T-cell responses at all three doses tested, with similar results in both cohorts of healthy volunteers tested..."

P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

COVITAR: Study of GRAd-COV2 for the Prevention of COVID-19 in Adults (clinicaltrials.gov) - P2/3; N=10300; Not yet recruiting; Sponsor: ReiThera Srl

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease

A Clinical Study with GRAd-COV2 Vaccine for the Prevention of COVID-19 in Adults Studio clinico con vaccino GRAd-COV2 per la prevenzione di COVID-19 negli adulti (clinicaltrialsregister.eu) - P2/3; N=10000; Ongoing; Sponsor: REITHERA SRL

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Italy to invest in biotech ReiThera to support COVID-19 vaccine development (Reuters) - P1, N=90; NCT04528641; Sponsor: ReiThera Srl; "Government called results of a Phase 1 trial encouraging....None of them showed serious side effects in the 28 days after the vaccination...'Some 92.5% of volunteers had detectable levels of neutralizing antibodies,' he said, adding that trials were scheduled to conclude by the summer...Government would invest in ReiThera to support the research and eventually provide Italy with some independence in vaccine procurement."

Financing • P1 data • Infectious Disease • Novel Coronavirus Disease

ReiThera’s COVID-19 Vaccine Candidate Enters Phase 1 Clinical Study with First Healthy Volunteer Dosed in Italy (PRNewswire) - "ReiThera Srl...today announces that the first healthy volunteer has been dosed in a Phase 1 study of the Company's vaccine candidate (GRAd-COV2)....The primary objective of the study is to evaluate the safety and tolerability of GRAd-COV2, and to select a vaccine dose for further investigation in a Phase 2/3 trial....Interim safety and immunogenicity analysis are expected by mid Q4 2020....A larger international Phase 2/3 trial in countries where SARS-CoV-2 is still very active is planned to commence by the end of 2020..."

New P2/3 trial • P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

GRAd-COV2 Vaccine Against COVID-19 (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: ReiThera Srl

New P1 trial • Infectious Disease • Novel Coronavirus Disease

Brazil University in Talks to Test Italian Coronavirus Vaccine (The New York Times) - "The Federal University of Sao Paulo (Unifesp) is in talks to test a potential coronavirus vaccine developed by Italian researchers....Francesco Vaia...said the institute had agreed to do Phase II and III trials in Sao Paulo, once it completes the first phase which is expected to start in Italy in the first half of July. The candidate vaccine is produced by Italy's ReiThera....Unifesp began clinical trials of a vaccine developed by Oxford University....Brazil's government is nearing an agreement to eventually produce that vaccine....Trial of the Oxford vaccine will involved 2,000 people in Sao Paulo, and preliminary results may be available within six months."

Clinical data • Licensing / partnership • New P1 trial • Infectious Disease • Novel Coronavirus Disease