Type: Vaccine based on a novel and proprietary replication-defective simian (gorilla) adenoviral vector called GRAd, which encodes the full-length coronavirus spike protein. The GRAd vector belongs to the species C adenovirus, and has low seroprevalence in humans. As a result, ReiThera said, GRAd vaccine immunogenicity is not hampered by pre-existing anti-human adenovirus antibodies.
Status: ReiThera said August 24 that the first first healthy volunteer had been dosed in a Phase I study of GRAd-COV2 being conducted in Italy at the Lazzaro Spallanzani National Institute for Infectious Diseases (INMI) in Rome and at the GB Rossi University Hospital in Verona.
The Phase 1 trial is designed to assess the safety and immunogenicity of GRAd-COV2 in 90 healthy volunteers divided equally into two age cohorts: 18-55 years and 65-85 years. Each cohort will be divided into three study arms of 15 volunteers which will be administered one of three escalating doses of GRAd-COV2. Participants will be monitored over a 24-week period, ReiThera said.
The trial’s primary objectives are to evaluate the safety and tolerability of GRAd-COV2, and to select a vaccine dose for further investigation in a Phase II/III trial. Mexican Foreign Minister Marcelo Ebrard said August 25 his country would participate in later-stage trials—but did not specifiy if that would be in Phase II or Phase III.
ReiThera also aims to evaluate the vaccine’s ability to induce immune responses (antibodies and T cells) against the SARS-CoV-2 in volunteers. The company said interim safety and immunogenicity analysis are expected by mid Q4 2020.
A larger international Phase II/III trial in “countries where SARS-CoV-2 is still very active” is planned to commence by the end of 2020, pending positive interim safety and immunogenicity results of the Phase I trial, ReiThera added.
The Phase I trial of GRAd-COV2 is being funded by the Italian Ministry of Scientific Research and the Lazio Region. The study is being run jointly by ReiThera and Lazzaro Spallanzani INMI using initial vaccine material manufactured at ReiThera’s cGMP facility in Rome.
ReiThera added that was working with LEUKOCARE in Germany to develop a thermostable GRAd-COV2 vaccine formulation, and with Univercells in Belgium to develop a manufacturing process designed to enable rapid, large-scale production of the vaccine.
In June, Reithera selected contract research organization SGS to accelerate development and production of GRAd-COV2. ReiThera plans to tap into SGS’s team of virology and molecular biology experts to conduct microbiological biosafety and identity release testing at each key stage of the vaccine candidate’s production, the companies said. All testing will be undertaken from SGS’ recently-expanded Biosafety Center of Excellence in Glasgow, Scotland.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: