SELLAS Life Sciences Group (SELLAS), a Swiss based, development-stage biopharmaceutical company with its main focus in developing innovative products for the treatment of various indications in Oncology and the Central Nervous System, today announced that it has signed an exclusive global collaboration and license agreement with TrojanTec Ltd, (TrojanTec), a UK-based Discovery Research and Development Company affiliated with Imperial College London, UK, for the development, marketing and commercialization of the innovative and proprietary TR-1 cancer therapeutic technology and drug.
TR-1 is a potent and specific 'replacement therapy' of wild type p53/p21, a tumor suppressor protein that has been long referred to as "the guardian of the genome." P53/p21 represents one of the most sought after oncology drug targets by clinical oncologists due to its central role in preventing the initiation and progression of most haematological and solid tumors. TR-1 is the first clinical drug candidate that 'replaces' dysfunctional p53/p21 suppressor proteins, in contrast to other p53-targeting small molecule drugs in clinical development that only inhibit MDM2.
"This upcoming Phase 1 study represents an ambitious and highly exciting undertaking for SELLAS and TrojanTec. The ultimate goal of this study is to demonstrate our ability to safely and effectively engage one of the most important drug targets in all of oncology, p53/p21, and further establish the druggability of transcription factors that have been shown to be some of the most important, but difficult-to-target oncogenic drivers. This Phase 1 study will demonstrate the first systemic administration of a cell-penetrating peptide delivering another therapeutic peptide, p21, to the nucleus of cells and will further establish the potential of this new class of medicines for a wide range of therapeutic areas. With the Phase 1 study soon to be underway, we would expect to have a steady flow of important insights into the safety and activity of TR-1 in patients," said Prof. Agamemnon A. Epenetos, PhD, FRCP, Chairman and Chief Executive Officer of TrojanTec and Visting Professor at Imperial College.
"It is thought that p53 signalling is inactivated in virtually all human cancers. Our ability to directly 'replace and repair' dysfunctional p53/p21, could have unprecedented impact, not only in treating a broad range of haematological and solid tumors that test positive for p53, but TR-1 could also expand the efficacy of many current therapies that rely on a functional p53 pathway," said Dr. Christina A. Kousparou, BSc, DIC, PhD, Chief Scientific Officer of TrojanTec.
Under this license agreement, TrojanTec shall receive an upfront payment from SELLAS, as well as additional milestone payments upon achieving certain clinical, regulatory and commercial milestones, including royalty payments associated with product sales of the TR-1 technology and drug across all indications.
"We are particularly excited entering into this agreement with TrojanTec, which is a leader in discovery for innovative cancer treatments, and we are eager to make the potential of TR-1 becoming first-in-class a reality. The studies and results demonstrated by this technology thus far are truly exciting and very promising. SELLAS is committed, as we have shown by integrating the WT-1 cancer vaccine into our pipeline, to becoming a leader in developing highly innovative and promising drugs for major unmet medical needs. We will initiate the Phase I study of TR-1 around Q4 of this year or early Q1 of next year, with emphasis in ovarian, breast and colon cancers," said Dr. Angelos M. Stergiou, MD, Chairman and Chief Executive Officer of SELLAS. "We are convinced that the addition of TR-1 puts SELLAS into a prominent position in this fast-evolving field; combating cancer at its root with TR-1 and allowing patients to remain in remission with our WT-1 cancer vaccine."