Immunology Meets Engineering Biology

Microbial Cancer Immunotherapy and Targeted Vaccines

Technology

Using our expertise in engineering biology and immunology, we apply our platform to prevent infectious diseases (Vaxonella®) and to treat solid tumours (Onconella™).

Vaxonella®

Bacteria are ingested, pass through the stomach and then traverse the lining of the small intestine via microfold cells (M cells) into lymphatic nodules called Peyer’s patches. There they are phagocytosed by antigen-presenting cells (APCs) such as macrophages and express the antigen genes. The antigens are processed and presented by the APCs to stimulate cellular and humoral immune responses, including mucosal responses.

Onconella™

In this adaption of our platform technologies, we leverage proprietary genetic engineering interventions to build on the natural ability of our bacterial strains to seek out and colonise solid tumours. We have developed attenuated strains capable of targeting tumours without causing pathology in normal tissues. These Onconella™ strains are also capable of delivering specific immunostimulatory cargo aimed at activating the patient’s immune system to destroy tumours.

Team

Ted Fjällman

CEO

Ted took over as Prokarium’s CEO in March 2014 after serving as Development Director since December 2011. Prior to joining Prokarium, he has held positions in clinical research at Sahlgrenska University Hospital and in strategy consulting at Sweden’s Royal Academy of Engineering Sciences, where he coordinated the country’s national innovation strategy. Ted holds a PhD from the University of Guelph, Canada, and has been recognised as a leader in biotechnology under the Sloan Foundation funded Synthetic Biology Leadership Accelerator Program (LEAP). He is a member of the international Bacterial Vaccines Network (BactiVac) management board, as well as an active member of the UK BioIndustry Association (BIA).

Kristen Albright

VP BD & Translational Research

Kristen Albright joined Prokarium in 2018 as the VP, Business Development and Translational Research. Prior to joining Prokarium, Kristen was a Life Science Investor at Osage University Partners, a Philadelphia-based venture capital fund focused on academic spinouts from leading research universities. At Osage, Kristen completed multiple deals in the immunology, oncology and rare disease spaces ranging from target validation to clinical-stage companies. Earlier in her career, Kristen worked within Business Development at multiple mid-size companies including Emergent BioSolutions and Cangene Corporation, where she specialized in asset licensing and M&A. In the latter she was involved in the acquisition, integration and regulatory approval of a haemophilia programme. Kristen earned her Doctorate of Pharmacy from the University of the Sciences in Philadelphia and is a licensed pharmacist. She also holds an MBA from Saint Joseph’s University.

Livija Deban

VP Immunology & Oncology

Livija joined Prokarium in 2018 as the VP Immunology and Oncology. She is leading the strategic and operational development of Prokarium’s immuno-oncology portfolio. As an immunologist Livija specializes in mucosal and tumour immunology, immunological assay development and immuno-oncology. Prior to joining Prokarium, Livija headed the lead selection and immuno-oncology R&D at Oxford BioTherapeutics where she focused on the target discovery and the development of immunomodulatory antibodies for cancer treatment. She has a MA in Medical Biotechnology and holds a PhD in Basic and Applied Immunology. Livija conducted her research at Cancer Research UK and King’s College London before joining the biotech industry.

Mike Darsley

Head of Clinical Development

Mike is Prokarium’s Head of Clinical Development and brings over 25 years of experience in biopharmaceutial development from the US, UK and Denmark. He was VP bacterial vaccine research at Acambis UK, Chief Development Officer at ACE Biosciences and TD Vaccines in Denmark and has provided independent product development consultancy to pharma, biotech and academic clients. He has a BA in biochemistry and a D.Phil in molecular immunology from the University of Oxford and was a Fogarty International Postdoctoral Fellow at the US National Cancer Institute, NIH. Mike has been involved in the development of a number of vaccines against diarrhoeal diseases and continues to be consulted as Key Opinion Leader by various organisations in the enteric diseases field.

Paola Salerno

Head of Molecular Biology

Paola is Prokarium’s Head of Molecular Biology. She joined Prokarium in 2013 as Principal Scientist, following on two years as Senior Scientist at Cobra Biologics within the molecular biology group, where she was involved as lead scientist in a number of collaborative research and development projects. Paola has a PhD in microbial molecular genetics from the University of Palermo, Italy and has worked as postdoctoral researcher at the Institute for Experimental Treatment of Cystic Fibrosis in Milan (Italy), the School of Biology of Lund University (Sweden) and the Institute for Life Science of Swansea University (UK). Her research activity has focused mainly on microbiology and microbial molecular genetics.

Peter McGowan

CFO

Peter McGowan joined Prokarium as CFO in 2019. He brings a wealth of international experience and expertise gained over 25 years in the healthcare industry, including having served most recently as SVP of Finance at Mundipharma. While at Mundipharma, he held various senior finance leadership roles and was integral in its establishment as a fully integrated global pharmaceutical business. Peter also worked at PPD, a contract research organisation. He honed his analytical skills in numerous positions in banking and finance both in Sydney and London. Peter is a fellow of the Association of Certified Chartered Accountants (ACCA) and has a degree in Business.

Steve Chatfield

Chairman of the board

Steve is Chairman of the Board of Prokarium and brings more than 30 years of experience in the biopharmaceutical industry, developing vaccines in small and large businesses, most recently as Executive Vice President, Strategic Investments at Emergent BioSolutions. Steve has also served as Executive Director of the UK Health Protection Agency (now Public Health England) and has held posts at Medeva and the Wellcome Foundation. In his career he has focused on the development of products to prevent and treat infectious disease and is internationally recognized as an opinion leader in the vaccines field with more than 100 scientific papers.

Carl-Johan Spak

Director

Carl-Johan represents Flerie Invest on the board of Prokarium and was its first CEO until Ted Fjällman took over in 2014. He graduated with a doctorate in dental surgery in 1980 and a PhD in pharmacology from the Karolinska institute in 1984. He has since held a number of positions in medical and pharma companies and currently serves as director of several technology development companies. Carl-Johan is Executive VP Development & Technology at Recipharm AB and Executive Director of Cobra Biologics Ltd.

Allan P. Jarvis

Director

Allan brings more than 40 years of experience in vaccines and biotechnology, most recently as VP Corp Dev at Sanofi Pasteur and VP BD and Strategy at Wyeth. Allan has built several smaller biotech companies as well: In 1980, Allan co-founded Damon Biotech, where he held diverse positions of increasing responsibility from Manager, Molecular Biology to VP Research and VP BD. From 1990 to 1992 he worked at Abbott Labs, as Director of Bus Dev. In 1992 he joined Repligen Corp. in the dual role of VP Business Planning for the parent company and SVP Commercial Development for its wholly owned subsidiary, Amira, Inc. Allan holds a PhD in Molecular Genetics from UC Davis.

Khalid Al-Saleh

Director

Khalid is the CEO of Riyadh Valley Company (RVC) and joined the Prokarium board after investment in Prokarium in January 2018. He is also an Associate Professor in Industrial Engineering at King Saud University (KSU), has conducted consultancy work for the Saudi Ministry of Higher Education, on e.g. IP regulations, and continues to serve as the Director of the IP and Technology Licensing Programme at KSU. He has published numerous papers in the field of Industrial Engineering, is a founding-member of the Saudi Inventors Society and is a member of the Association of University Technology Managers (AUTM) amongst others. Khalid holds a B.S. in Industrial Engineering from King Saud University and a Ph.D. in Industrial Engineering from Birmingham University.

Sangwoo Lee

Director

Sangwoo is a Managing Director and Head of Korea Investment Partners’ (KIP’s) US office based in Silicon Valley and joined the Prokarium board after investment in Prokarium in February 2018. He is responsible for the global expansion of Korea Investment Partners and actively explores cross-border investments. Sangwoo currently manages over 10 companies in his investment portfolio and participates on more than 5 boards. His portfolio companies range from biotech/healthcare companies such as Elastagen, Auris Surgical Robotics and KAHR to IT/Fintech companies such as SoFi and Le Tote. Sangwoo has started and grown two startups; Neomtel and Polidigm. Neomtel’s technology became a de-facto standard in Korea in the early 2000s and the company went IPO in 2007. Sangwoo received his B.S. and M.S. in Control and Instrumentation Engineering from Seoul National University.

Ted Fjällman

CEO

Ted took over as Prokarium’s CEO in March 2014 after serving as Development Director since the start in December 2011. Prior to joining Prokarium, he has held positions in clinical research at Sahlgrenska University Hospital and in strategy consulting at Sweden’s Royal Academy of Engineering Sciences, where he coordinated the country’s national innovation strategy. Ted holds a PhD from the University of Guelph, Canada, and has been recognised as a leader in biotechnology under the Sloan Foundation funded Synthetic Biology Leadership Accelerator Program (LEAP). He is a member of the international Bacterial Vaccines Network (BactiVac) management board, as well as an active member of the UK BioIndustry Association (BIA).

Hyam Levitsky

Immunotherapy Advisor

Hyam joined Prokarium in 2019 as advisor in immunology, immunotherapy of cancer and research strategy. Currently, he is President of Research and Development at Century Therapeutics. He was previously Executive Vice President and Chief Scientific Officer at Juno Therapeutics in Seattle, and before that, Head of Cancer Immunotherapy Experimental Medicine at Roche Pharma Research and Early Development in Switzerland. He received an MD from Johns Hopkins University School of Medicine in 1984, followed by training in internal medicine and medical oncology. He joined the Johns Hopkins faculty in 1991, rising to Professor of Oncology, Medicine and Urology in 2001 while working at the Sidney Kimmel Comprehensive Cancer Center where he served as Scientific Director of the George Santos Bone Marrow Transplant Program. Upon joining industry, he has held an adjunct professorship since 2011. His research has focused on tumour immunology, cancer vaccines, and adoptive T cell therapy. He is a Leukemia and Lymphoma Society Stohlman Scholar, a Member of theAmerican Society for Clinical Investigation, and is a founding member of the Cancer Immunotherapy Consortium of the Cancer Research Institute.

David Holden

Salmonella Advisor

David joined Prokarium in 2019 as advisor in Salmonella biology and engineering strategy. He is Professor of Molecular Microbiology in the Department of Infectious Disease at Imperial College London since 1995. David was Director of the Centre for Molecular Bacteriology and Infection (MRC CMBI),between 2012 and 2019. In 2016, he was appointed as the first Regius Professor of Infectious Disease in the UK and he is a fellow of the Royal Society, the American Academy of Microbiology, the Academy of Medical Sciences (UK), and an EMBO Member. David was co-founder of the biotech company Microscience that developed the Salmonella strain ZH9. He is best known for inventing a technique called signature-tagged mutagenesis (also termed barcoding) for identification of mutants with altered growth in mixed populations. Using STM his group has identified numerous genes of Streptococcus, Staphylococcus and Salmonella that are required for virulence.

Geoff Kitson

Medical Advisor

Nigel Woods

CMC Advisor

Nigel has been working with Prokarium since September 2019 supporting their CMC activities. He has over thirty years’ experience in the process development, scale-up and manufacture of human therapeutics, including live microbial products/vaccines. Nigel has been working as an independent CMC consultant supporting small and medium sized companies with their CMC activities for the last 14 years. Prior to that he worked in a number of roles both within biopharma companies (British Biotech and Oxxon Therapeutics) and for contract manufacturing organisations (Accentus Biologics and Cobra Biologics). Nigel has a BSc in microbiology from the University of East Anglia and a PhD in industrial microbiology from the University of Warwick.

Pipeline

Bladder Cancer

NMIBC Therapeutic

Bladder cancer represents 5% of all new cancer cases in the US and accounts for 550,000 new cases yearly worldwide. The clinical staging is determined by the depth of invasion into the bladder wall and more than 70% of cases are diagnosed at an early-stage, also known as Non Muscle Invasive Bladder Cancer (NMIBC). Despite the early diagnosis, the only approved therapies are Bacillus Calmette–Guérin (BCG), which often faces shortages, and chemotherapy, both delivered intravescically. Because of its high incidence and the low number of treatment options, a huge unmet medical need remains in NMIBC.

Solid Tumours

Undisclosed

Prokarium is investigating the use of engineered bacteria as immunotherapy to treat solid tumours. Onconella has the ability to sense and kill tumour cells and, in addition, to boost the natural anti-tumoral activity of the immune system.

Entervax

S. Typhi and S. Paratyphi A
Vaccine

FIH Phase 1
1Q2020

Enteric fever, a preventable illness caused by Salmonella enterica serovars Typhi and Paratyphi A, is the most common bacterial bloodstream infection in South Asia. It has been estimated to cause >15 million illnesses and nearly 153,000 deaths worldwide annually.

Entervax™, a novel, oral bivalent vaccine against enteric fever, is based on the Vaxonella® platform and is the combination of our proprietary strain ZH9 (Salmonella enterica serovar Typhi ZH9), plus a novel strain modified to express antigens specific to S. Paratyphi A.

Chlamydia

Chlamydia trachomatis
Vaccine

Chlamydia trachomatis is one of the most common sexually transmitted infections (STIs) that occurs in humans. There were 203,000 diagnoses of Chlamydia related STI in 2017 in England (PHE) and 131 million new cases worldwide.

Many infections are asymptomatic so a large proportion of cases remain undiagnosed. Infection with C. trachomatis can lead to long-term health problems, such as pelvic inflammatory disease (PID) that can cause permanent damage to the female reproductive system.

Prokarium aims to be the first to develop an effective Chlamydia vaccine that could prevent PID and infertility and at the same time reduce antibiotic use and save on costs for national healthcare systems.

Coronavirus