Spicona Inc. is focused on developing novel vaccines against SARS-CoV-2 (Covid-19). The company utilizes state-of-the-art recombinant vaccine platforms. The production of a recombinant vaccine involves the insertion of the DNA which encodes an antigen that stimulates an immune response into bacterial or mammalian cells. The expressed antigens are then purified and applied to the healthy people to build up immunity. Spicona’s approach is to optimize the antigen design utilizing the Covid-19 surface spike protein to ensure optimal immune response. Spicona’s proprietary technology is based on profound experience of its founders which have developed over 16 vaccines over the past decades. Our development approach is based on standards of the International council for harmonization of technical requirements for Pharmaceuticals for human use (ICH).
SCIENCE
SAB - Scientific Advisory Board
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Norbert Bischofberger, PhD
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Marcel Tanner, PhD, MPH, DSc and DVM h.c
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Wolfgang Klietmann, M.D.
Norbert joined Kronos Bio in 2018 as President and CEO. Prior to joining Kronos Bio, Norbert was the Executive Vice President, Research and Development and Chief Scientific Officer at Gilead Sciences. Norbert joined Gilead in 1990 as Director of Chemistry. During his 28-year tenure at Gilead, Norbert presided over the development and approval of more than 25 medicines for a range of serious conditions which led the transformation of the treatment of diseases such as HIV, HCV and lymphoma. Norbert was part of the core management team that grew Gilead from less than 50 employees with no revenues to 10,000 employees with $25B in revenue. In addition to Kronos Bio, Norbert serves on the Supervisory Board of Bayer AG and Board of Directors of Morphic Therapeutic.
Marcel was Director of the Swiss Tropical and Public Health Institute from 1997-2015. He acted as Professor and chair of Epidemiology/Public Health and Medical Parasitology at the Faculties of Science and Medicine of the University of Basel until his retirement in 2017. He is now President of the Swiss Academy of Arts and Sciences. He devoted his professional life to develop new drugs and vaccines for the eradication of malaria and other poverty-related diseases and to find new solutions to strengthen health systems in Africa and the Pacific region. As a leading expert on communicable diseases research and control, health systems strengthening and capacity building he is member and advisor of various national and international agencies/bodies and in boards/committees such as e.g. University Hospital Basel, WHO/SAG, Wellcome Trust, DNDi, FIND, INCLEN-Trust, Gebert-Rüf Foundation, Botnar Foundation and EDCPT. He is President of the Federal Commission for Sexual Health (CFIST) since 2017. Marcel Tanner was key in building up research and implementation institutions in Africa, namely the Ifakara Health Institute (IHI) in Tanzania and the Centre Suisse de Recherches Scientifiques (CSRS) in Côte d’Ivoire.
Wolfgang is a clinical pathologist and medical microbiologist, served on the faculty of Harvard Medical School, and was a staff member at the Department of Pathology at the Massachusetts General Hospital. Today, he heads an international healthcare consulting company with a focus on infectious diseases and epidemiology. Dr. Klietmann served as President of the Harvard Business School Health Industry Alumni Association and on the Board for 12 years and organized as chairman several major conferences held at Harvard.
Prior, Dr. Klietmann founded- and was President and CMO of a major institute of laboratory medicine in Germany, which he built into the leading private laboratory institution with highest scientific standing in innovation in viral diagnostics in Germany. For 12 years he was the lead investigator- and head of a scientific collaboration with the Insitut Mérieux in Lyon (France) on rabies vaccines involving the WHO. The Institute was bought out by Bioscientia, a subsidiary of the pharmaceutical company Boehringer-Ingelheim at the time.
Before, Dr. Klietmann headed a research group at the Max-Planck-Institute for Virus Research in Tübingen, Germany, as well as serving on the Medical Faculty of the University of Tübingen. Also, Dr. Klietmann was an Associate Scientist at the Wistar Institute at the University of Pennsylvania. His memberships in several scientific societies include a Fellow of the College of American Pathologists. He serves on the Board of the Swiss-American Chamber of Commerce in Boston. Academics: Dr. med. University of Freiburg, Germany; Diplôme University of Paris and Sorbonne. Habilitation University of Tübingen. Executive business education at Harvard Business School. Faculty of Harvard Medical School.
Board of Directors
Dr. Kaspar Bänziger
CEO & President
Dr. Bänziger has been in the Pharmaceutical industry for the past 30 years. Investment advisor to Financial Institutions and Banks with focus on Healthcare and macroeconomics buy side. Private medical consultant. Producer and founder of the PeakViews platform. Founding Managing Director NCCR, Nanosciences. Founder Nexatio Inc, an Oncology focused company. Previously with Lansdowne Partners, London, Geymonat SpA, Lombard Odier, Immunology Fund, Geneva and Nestle Inc. Academics, Dr. med. University Basel, MAS Int policy making Graduate Institute, Geneva.
Prof. Reinhard Glück (i.m.)
Board
Prof. Glück has been a leader in vaccine research-, development- and manufacturing for the past 40 years and has developed over 16 vaccines. Prof. Glück is the co-founder of VaxBio Ltd, UK. Previously, Prof. Glück was CSO of Vaccines, Cadila Healthcare (Zydus), VP R&D, Vaccine Discovery Crucell and CSO Berna Biotech. He has been a member of numerous international commissions focused on vaccines and epidemiology, including the international association of biological standardization, commission of experts of the W.H.O. for rabies, measles, mumps, rubella etc. Also the European commission for coordination of vaccine research- and vaccine manufacturers and member of board of global alliance for vaccines and immunization. Furthermore, he was on the Board of International Society for Influenza and other Respiratory Virus Diseases (ISIRV). Scientific Board for INB, USA. Chairman, European Malaria Vaccine Development Association (EMVDA. Co-Founder and Board of Directors for Nexatio AG, Basel.
President of Etna Biotech Srl, Catania. Over 200 peer reviewed publications and 9 patents.
Academics, PhD in microbiology, University Bern.
NEWS
Catalent Partners with Spicona to Develop COVID-19 Vaccine Candidate
NEW YORK and SOMERSET, N.J. – June 10, 2020 — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it has signed an agreement with Spicona, Inc. to develop a virus-like protein (VLP)-based vaccine against COVID-19. Under the terms of the agreement, Catalent will use its proprietary GPEx® cell line development technology to develop a cell line expressing the recombinant VLP at its Madison, Wisconsin facility.
Spicona is focused on research and development in the field of immunology and vaccinology. Its pipeline is being built around novel compounds for the prevention and treatment of infectious diseases, with an immediate focus on the development of a novel, safe and protective COVID-19 vaccine. Spicona is led by a team of experienced vaccine experts headed by Dr. Kaspar Bänziger, Dr. Reinhard Glück, and Dr. Gaurav Gupta, together with a prestigious international advisory board, whose members have been involved in the development of several vaccines, including the severe acute respiratory syndrome (SARS) vaccine in 2003. Today, millions of children and adults are safely immunized with vaccines developed and brought to market by the experts who make up the Spicona team.
Catalent’s GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies to clinical manufacturing, through to commercial-scale production. GPEx technology is used with therapeutic candidates in more than 120 ongoing clinical trials.
“We feel privileged to start this collaboration with Catalent, which we consider the best partner for the development of a novel COVID-19 vaccine candidate,” commented Kaspar Bänziger, CEO, President, Spicona, Inc. “Together, our two experienced teams will work toward finding a safe and efficacious solution to prevent COVID-19 as soon as possible.”
“Catalent’s GPEx technology and the Madison facility provide proven technology and expertise that are a perfect fit for Spicona’s unique vaccine approach to address COVID-19.” commented Mike Riley, Region President, Catalent Biologics, North America. He added, “We are pleased to be working with Spicona and other partners on all major classes of COVID-19 vaccines in development.”
Catalent’s Madison facility provides mammalian cell line development, process development, process validation, formulation development and drug substance manufacturing ranging from pre-clinical to commercial stage. The site recently commenced an expansion to provide additional clinical and commercial production capacity at the 2,000 or 4,000-liter batch scale.
About Spicona
Spicona is focused on research and development in the field of immunology and vaccinology and is currently building a pipeline of novel compounds for the prevention and treatment of infectious diseases. The company is led by a team of experienced vaccine experts headed by Dr. Kaspar Bänziger, Dr. Reinhard Glück and Dr. Gaurav Gupta, who have developed several new vaccines, including a SARS vaccine in 2003, and brought multiple successfully to the market. Today, millions of children and adults are immunized with these vaccines. Spicona’s immediate focus is the research and development of a novel, safe and protective COVID-19 vaccine. Spicona is headquartered in New York City, NY. For more information, visit www.spicona.com.
ABOUT CATALENT BIOLOGICS
Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured 35+ commercially approved products. Catalent has recently acquired MaSTherCell, a technology-focused cell therapy development and manufacturing partner with expertise in autologous and allogeneic cell therapy that complements Catalent’s industry-leading expertise and commercial success in gene therapy development, manufacturing and adeno-associated virus (AAV) vector production. Together, Paragon Gene Therapy and MaSTherCell have produced over 100 GMP batches across 60+ clinical and commercial programs. For more information on Catalent Biologics, visit www.catalent.com/biologics
ABOUT CATALENT
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
https://www.catalent.com/catalent-news/catalent-partners-with-spicona-to-develop-covid-19-vaccine-candidate-using-gpex-cell-line-development-platform/