ReiThera Srl, a biotech company dedicated to the technology development, GMP manufacturing and clinical translation of genetic vaccines and medicinal products for advanced therapies, today provides an update on the ongoing Phase 1 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 Lazzaro Spallanzani National Institute for Infectious Diseases (INMI) in Rome (Italy) and received financial support from the Italian Ministry of Scientific Research and the Lazio Region (Rome).
The Company reports that the trial is advancing on schedule and that dosing and initial evaluation on the first cohort of healthy volunteers (aged 18-55 years) have been completed. Preliminary results from this cohort, which was divided into three study arms of 15 subjects, have shown that GRAd-COV2 was well-tolerated and generated spike-binding antibodies and T-cell responses at all three doses tested.
The trial is now advancing to investigate GRAd-COV2 in the second set of three cohorts of healthy, elderly subjects (aged 65-85 years). Results from the trial are expected to enable the selection of a vaccine dose for further investigation in a Phase 2/3 trial.
“We are making great progress with the Phase 1 trial of GRAd-COV2 and have completed the first part of the study as planned. The initial findings have shown that the vaccine candidate is well tolerated and immunogenic against SARS-CoV-2 in younger subjects, enabling the study to advance into the next phase in elderly subjects,” said ReiThera’s Chief Executive Officer, Antonella Folgori. “Enrolment of elderly volunteers is also proceeding well, and we look forward to reporting initial results from the overall study around year end along with our plans for larger international studies.”
Dr Folgori added: “We are grateful to our trial partners at the Lazzaro Spallanzani in Rome and the GB Rossi University Hospital in Verona, and also to the volunteers who have come forward in great numbers to participate in the study. It truly is a collaborative effort with a shared goal.”
ReiThera produced the vaccine material for this trial using its in–house GMP manufacturing expertise and capabilities in Italy. In parallel, the Company is working with LEUKOCARE in Germany to develop a thermostable formulation of the GRAd-COV2 vaccine and with Univercells in Belgium to develop a bespoke manufacturing process to enable rapid, large-scale production of the vaccine.
More info: 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/