Oloker Therapeutics is a biotechnology start-up committed to discovery, development and commercialization of cellular therapies for the treatment of cardiovascular disease. Our mission is to bring to light new innovative cellular therapies for unmet clinical needs that can improve patients’ prognosis and quality of life through extensive scientific research and in-depth knowledge of cardiovascular diseases.
Translating science from the Lab to the Clinic
Company Overview
Cardiac-derived progenitor cell
Oloker is developing proprietary cardiac-derived progenitor cell products with the aim to find a cure for various cardiovascular diseases. Basic and preclinical research studies in ischaemia models have shown that its proprietary cardiac cell product is salutary for the treatment of heart conditions that require new blood vessels.
An innovative technology
Our innovative technology originates from the close collaboration between scientists and physicians with an integrated bench-to-bedside approach.
Giulio Pompilio is Scientific Director, Head of Vascular Biology and Regenerative Medicine Unit, and Senior Staff Surgeon at Centro Cardiologico Monzino IRCCS. He is appointed as Associate Professor of Cardiac Surgery at University of Milano. Prof. Pompilio has a long-lasting experience in cardiovascular clinical and surgical research. He is pioneer in Italy of cardiovascular gene and stem cell therapy and an international opinion leader of CV regenerative medicine. He currently serves as Chair-elect of the ESC Working Group on Cardiovascular Regenerative and Reparative Medicine. He was Principal/Co-principal Investigator in phase I-III studies of regenerative CV medicine.
Dr. Gambini has 16-year experience in cardiac stem cell biology. Her translational expertise ranges from stem cell basic science to preclinical models of cardiovascular stem cell therapy. She has served as staff scientists at Centro Cardiologico Monzino IRCCS from 2004 to 2020. Dr. Gambini boasts experience in GMP-grade translation of cell products to the clinic and in IMPD finalization for Phase I-II cardiac cell therapy regulatory authorization.
Dr. Gambini has 16-year experience in cardiac stem cell biology. Her translational expertise ranges from stem cell basic science to preclinical models of cardiovascular stem cell therapy. She has served as staff scientists at Centro Cardiologico Monzino IRCCS from 2004 to 2020. Dr. Gambini boasts experience in GMP-grade translation of cell products to the clinic and in IMPD finalization for Phase I-II cardiac cell therapy regulatory authorization.
Giulio Pompilio is Scientific Director, Head of Vascular Biology and Regenerative Medicine Unit, and Senior Staff Surgeon at Centro Cardiologico Monzino IRCCS. He is appointed as Associate Professor of Cardiac Surgery at University of Milano. Prof. Pompilio has a long-lasting experience in cardiovascular clinical and surgical research. He is pioneer in Italy of cardiovascular gene and stem cell therapy and an international opinion leader of CV regenerative medicine. He currently serves as Chair-elect of the ESC Working Group on Cardiovascular Regenerative and Reparative Medicine. He was Principal/Co-principal Investigator in phase I-III studies of regenerative CV medicine.
Dr. Philippe Menasché is professor in the UAB Department of Biomedical Engineering. He also serves as clinical cardiac surgeon at the Hôpital Européen Georges Pompidou, Professor of Thoracic and Cardiovascular Surgery at the University of Paris Descartes, and leader of an INSERM team devoted to cell therapy of cardiovascular diseases.
He is the founder and Director of the Cardiology Stem Cell Centre in the Heart Centre at Rigshospitalet, at the University Hospital of Copenhagen. JK is one of the original inventors of the technology behind Cell2Cure. He is the primary investigator and currently heading three ongoing clinical trials with C2C-ASC.
Research
The invention, christened CPCPlus, is a product-by-process intended to comply, according to EMA guidelines and EU legislation, with the ATMP classification. CPCPlus therapy is conceived as a novel cost-effective cardiac ATMP directly delivered through specific catheters into the ischemic heart. The product exerts a potent angiogenic effect into the ischemic myocardium. From a clinical standpoint, the technology is aimed to cover the lack of therapy for patients dealing with refractory angina, a no-option heart condition due to inadequate oxygen supply to the cardiac muscle.
The key aspects of CPCPlus are summarized below:
Product Pipeline
The Oloker Therapeutics core technology, christened CPCPlus, is proprietary product-by-process platform including: 1) a method for cardiac-derived cell selection and expansion and 2) a newly discovered subpopulation of stromal-derived cardiac cells. We have developed a proprietary fully GMP-compliant manufacturing process that enables a high-efficient and cost-effective scalable expansion of our human cardiac progenitor cells (hCmPC), while maintaining their ability to produce key molecules associated with neovascularization, immunomodulation and tissue repair. Our cell product can be exploited both in autologous and “off-the-shelf” allogenic setting. Our technology enables to release a cell product with consistent, well-defined therapeutic properties, batch release criteria and potency assays, all with economy of scale criteria.
“METHOD FOR THE ISOLATION OF SUBPOPULATIONS OF CARDIAC PROGENITOR CELLS AND RELATED USES IN THE MEDICAL FIELD”
- Italian: 102017000062176 – Priority: June 7 2017 – Granted September 30 2019.
- International: PCT/IB2018/054057, Publication WO 2018/224983 A1.
In December 2019, we entered the national/regional phase including Europe, USA, Canada, Australia, China, Hong Kong, Japan, South Korea, India, Israel, Singapore.
Product Pipeline
Registered office
Piazza Giuseppe Massari 19 – 70122 Bari (Italy) – c/o Siryo S.p.A.
P.Iva 08507120726
Codice Destinatario: M5UXCR1
PEC: oloker@pec.it
Operational headquarters
c/o Centro Cardiologico Monzino,
Via Carlo Parea 4,
20138 Milano (Italy)
Investors
