Therapy Areas: AIDS & HIV
Clover Biopharmaceuticals Initiates Phase 1 Clinical Trial for COVID-19 Vaccine Candidate
19 June 2020 - - The first participants have been dosed in the Phase 1 first-in-human study evaluating Australia-based Clover Biopharmaceuticals' COVID-19 S-Trimer subunit vaccine candidate (SCB-2019), which is based on Clover's proprietary Trimer-Tag vaccine technology platform, the company said.

Preliminary safety and immunogenicity results for this Phase 1 study are expected in August 2020. In parallel, the planning for a global Phase 2b/3 vaccine efficacy trial has begun, with initiation targeted by year-end 2020.

The Phase I study will evaluate two adjuvant systems GSK's (London Stock Exchange) pandemic adjuvant system as well as Dynavax's (NASDAQ: DVAX) CpG 1018 adjuvant combined with alum. Clover has previously announced research collaborations with both GSK and Dynavax respectively.

An adjuvant is added to some vaccines to enhance the immune response, thereby creating a stronger and longer lasting immunity against infections than the vaccine alone.

The use of an adjuvant is of particular importance in a pandemic situation since it can reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and made available to more people.

Based on preclinical results demonstrating the ability of adjuvanted SCB-2019 to elicit neutralizing antibodies in multiple animal species, the collaborations with GSK and Dynavax have been expanded to include clinical supply of the adjuvants to Clover.

The Phase I clinical trial is a randomized, double-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels.

Each SCB-2019 dose level will be evaluated with and without adjuvant.

The study is being conducted at Linear Clinical Research in Perth, Australia and will enroll approximately 90 healthy adult participants and 60 healthy elderly participants.

The trial and Clover's COVID-19 vaccine program is being supported by the funding and collaboration with the Coalition for Epidemic Preparedness Innovations.

In early-2020, upon knowing the genomic DNA sequence of the newly identified SARS-CoV-2 virus, which causes a disease named COVID-19, Clover scientists started designing the viral spike (S)-protein construct and completed its gene synthesis.

Utilising its patented Trimer-Tag technology, Clover has produced a COVID-19 S-Trimer subunit vaccine candidate that resembles the native trimeric viral spike via a rapid mammalian cell-culture based expression system.

Having one of the largest in-house, commercial-scale cGMP biomanufacturing capabilities in China, Clover could potentially rapidly scale-up and produce large-quantities of a new coronavirus vaccine.

Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercialising transformative biologic therapies, with a focus on oncology and autoimmune diseases, as well as viral vaccines.

Having raised more than USD 200m in total capital since 2016, Clover is utilising its proprietary Trimer-Tag technology platform to develop novel biologics targeting trimerization-dependent pathways.

Additionally, Clover is leveraging its in-house GMP biomanufacturing capabilities to support large-scale production of its biologic therapies.

Trimer-Tag is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins.

Many major disease targets are trimerization-dependent such as the tumor necrosis factor superfamily (involved in extrinsic apoptosis, immune co-stimulation and inflammation) as well as enveloped RNA virus antigens responsible for entry into host cells.

Clover is using its Trimer-Tag technology with global IP position to develop recombinant trimerized fusion proteins that are able to effectively target these previously undruggable pathways.

Utilizing Clover's proprietary Trimer-Tag technology, S-Trimer is a trimeric SARS-CoV-2 spike (S)-protein subunit vaccine candidate.

Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope.

The trimeric S protein of SARS-CoV-2 is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry, making it the primary target antigen for vaccine development.

S-Trimer resembles the native trimeric viral spike protein and is produced via a rapid mammalian cell-culture based expression system.