Sydys Corp is a globally active biotechnology company developing immuno-oncology products including an autologous dendritic cell immunotherapy that recently completed Phase II trials for ovarian cancer generating clinically meaningful progression free survival (PFS) and overall survival (OS) data.
Immunotherapy and immuno-oncology are currently growth areas in the field of cancer. Our product is an active form of therapy that boosts a patient’s own immune system to recognise and respond to tumors. Opportunity exists to manufacture and market our therapy as a standalone product for the treatment of ovarian as well as other epithelial cancers but also to couple it with other forms of therapy such as immune checkpoint inhibitors or antiangiogenesis agents to create a synergistic effect.
Our product was granted “Orphan Medicinal Product Designation” and “Small and Medium Sized Enterprise” status by the European Medicines Agency (EMA) for Europe in June 2010 and was also granted “Orphan Drug Designation” by the U.S. Food and Drug Administration (FDA) in May 2014. Fast Track designation with the FDA was also granted in May 2014. As such, market exclusivity periods of ten years will be afforded in Europe and seven years of Orphan Drug Exclusivity will be granted in the U.S.A. There is also the potential for 12 years of exclusivity from biosimilars under U.S. legislation. Moreover, a long-term driver of our value has been the development of a robust global supply, logistics, and manufacturing platform.
A maintenance-style immunotherapy like our product would be the first of its type in the market for ovarian cancer and could generate $1 billion+ in sales in the developed world. We intent to complete a Phase III clinical trial in ovarian cancer and initiate a Phase II trial in triple negative breast cancer (TNBC) and colorectal cancer.
OUR ADVANCED IMMUNOTHERAPY TECHNOLOGY:
Our lead product has completed Phase II clinical trials for late stage epithelial ovarian cancer patients in clinical remission after first or second line standard treatments. Our product is an active form of therapy that is comprised of a patients’ own dendritic cells that have been obtained by mononuclear cell (MNC) collection and treated with a proprietary sequence of mucin 1 with mannan as an adjuvant, which is commonly found and highly expressed in epithelial derived adenocarcinomas (>80% in ovarian and pancreatic cancers) compared with normal cells.
The manufacturing process takes 6 days and results in the production of enough cryopreserved product for up to a year of treatment. The final formulation can then be thawed and reinjected intradermally into the patient to boost the patient’s own immune system through the stimulation of T-cells that then recognize and respond to mucin 1-overexpressing tumors.
It is important to note that our product may be considered a platform technology as different antigens may be used for different applications such as pancreatic, breast, and lung cancers. Moreover, opportunity exists to manufacture and market our product as a stand-alone therapy for the treatment of ovarian as well as other epithelial cancers but also to couple our product with other forms of therapy such as immune checkpoint inhibitors or anti-angiogenesis agents to create a synergistic effect.
Learn more about the technology.