Policy & Regulation
Clover Biopharmaceuticals Forms Global Scientific Advisory Board for its COVID-19 Vaccine Programme
25 September 2020 - - China-based clinical-stage biotechnology company Clover Biopharmaceuticals has formed a scientific advisory board comprised of internationally-renowned experts in the vaccine industry, public health and policy making, the company said.

The SAB will provide strategic oversight and guidance to the global development of Clover's protein-based COVID-19 S-Trimer vaccine programs.

Clover's COVID-19 S-Trimer vaccine was developed by combining the trimeric SARS-CoV-2 spike (S)-protein with the company's proprietary Trimer-Tag technology.

In preclinical studies, S-Trimer induced strong humoral and Th1-biased cell-mediated immune responses in multiple animal models and protects monkeys from SARS-CoV-2 challenge.

Clover's ongoing Phase 1 clinical trial is a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the COVID-19 S-Trimer vaccine at multiple dose levels.

The study has completed enrollment of 150 adult and elderly participants, and will enroll an additional 200 participants at the selected dose in a Phase 1 dose-expansion study.

Clover intends to initiate a global Phase 2/3 vaccine efficacy study before the end of 2020. Clover's COVID-19 vaccine program is being supported by funding and collaboration with the Coalition for Epidemic Preparedness Innovations.

Clover's SAB includes Ralf Clemens, M.D., Ph.D., chairman of the SAB, former senior vice president / Global Head of Vaccine Development at Takeda, Novartis Vaccines and GSK; former Member board of Trustees, International Vaccine Institute.

Donna Ambrosino, M.D., Research Advisor, former chief executive officer, Nosocomian Vaccine Corp; former chief executive officer, MassBiologics and Professor of Pediatrics, University of Massachusetts Medical School.

Sue Ann Costa Clemens, M.D., Ph.D., Clinical Development Advisor, Visiting Professor of Global Health, Oxford University; director Vaccine Group Oxford-Brazil; Professor and Head of Institute for Global Health, Universita di Siena; former vice president of Vaccine Development (Latin America), GSK.
Pierre Desmons, Ph.D., CMC Advisor, former vice president, Head of R and D China and Head of Asia Strategic Partnerships, GSK.

Sam Liao, Business Development and Strategy Advisor, former Head of Business Development and Licensing, Novartis Vaccines; former director of Corporate Development, Sanofi.

Michael Pfleiderer, Ph.D., Regulatory Affairs Advisor, Principal Consultant, Biopharma Excellence; former Head of Viral Vaccines Section, Paul-Enrlich-Institut ; former chair of Pandemic Task Force (2009/10), European Medicines Agency.

Peter Richmond, MBBS MCRP(UK) FRACP, Medical Advisor, Head of Division of Paediatrics (Faculty of Health and Medical Sciences), The University of Western Australia; Head of Vaccine Trials Group, Telethon Kids Institute.

Antoinette Quinsaat, Project Management Advisor, former Head of Clinical Operations (International), GSK Biologicals and Novartis Vaccines; former Head of Study Management (Asia Pacific), Sanofi.
Frank Rockhold, Ph.D., Biostatistics Advisor, Professor of Biostatistics and Bioinformatics, Duke University Medical Center; Managing Partner, HunterRockhold Inc; former senior vice president and Chief Safety officer, GSK.

David Salisbury, Public Health Advisor, former director of Immunization, Department of Health (London); former chair of Strategic Advisory Group on Immunization, World Health Organization; former Co-chair of Pandemic Influenza Group, G7 Global Health Initiative.

George Siber, M.D., Research Advisor, Co-founder, Affinivax; former executive vice president and chief scientific officer, Wyeth Vaccines; former Associate Professor of Medicine, Infectious Diseases, Harvard Medical School.

Nelson Teich, M.D.,MSc, Public Health Advisor, former Minister of Health, Brazil; Founder and former president, Integrated Clinical Oncology Group and COI Management, Education and Research Institute.

Anh Wartel, M.D., Clinical Development Advisor, Associate director General, International Vaccine Institute; former Senior director of Clinical R and D, Regional Medical Expert, and Country Medical Head (Vietnam/Cambodia), Sanofi.

Nicholas Jackson, Ph.D., SAB Observer, Head of Programs and Innovation, CEPI; former vice president and Head of Global Research, Sanofi.

Clover Biopharmaceuticals is a global, clinical-stage, research-based biotechnology company focused on discovering, developing and commercializing 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 utilizing 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.

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.

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.


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