Unique delivery vehicle to be developed across p53 mutated solid tumors by delivering wild type p21
Phase I study to be initiated in Europe around Q4 2015 with emphasis on colon, breast and ovarian cancers
NEW YORK and ZUG, Switzerland, April 15, 2015 /PRNewswire/ -- 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."
P53/p21 is known as "the guardian of the genome" because it is the body's cellular first line of defense that enables the repair of damaged DNA or, if unsuccessful, triggers cell death. It is one of the most studied and pursued tumor suppressor proteins, as it is known to be inactivated in virtually all human cancers. TrojanTec's novel fusion protein TR-1 can selectively 'replace' normal p53/p21 function and the cancer cell's ability to trigger its innate cell death mechanism. Antennapedia-based cell penetrating peptides are an emerging class of drugs that engage intracellular and extra-cellular targets and can also cross the blood-brain barrier. This novel class of drugs represents a fundamentally new therapeutic approach to modulate signalling pathways to treat human disease.
About SELLAS Life Sciences Group
SELLAS Life Sciences is a Swiss-based development-stage biopharmaceutical company that acquires and develops innovative products for the treatment of various indications in cancer and the central nervous system (CNS), including orphan indications. The headquarters of the company are located near Zurich (Zug), Switzerland. Being a healthcare-oriented global group of companies, SELLAS has embraced all major aspects of the biopharmaceutical industry. Our core team is highly experienced in developing drugs and cancer vaccines throughout all stages of the product's life cycle to the point of approval, marketing, and commercialization, pricing, and reimbursement, as well as third party out-licensing deals.
Our management team has a proven track record of drug discovery and development, and successful clinical trial coordination. In addition, the team has been involved in bringing previous companies to the German DAX and US NASDAQ stock markets, successful out-licensing of drug candidates, co-development, R&D partnership with big pharma, and creating multiple alliances with centers of excellence to accelerate drug discovery and development. The management team has also developed cost-effective and time efficient ways of developing drug candidates to value inflection points.
Presently, there are two phase 3 products to enter clinical trials in Europe and the USA in 2015 across five indications in cancer and CNS.
Next to the WT1 vaccine for hematological malignancies and solid tumors, in-licensed by Memorial Sloan Kettering, which has shown exceptional survival benefit in Phase I & II studies in patients with Acute Myeloid Leukemia as well as other indications such as Multiple Myeloma and Mesothelioma. SELLAS also holds the zolpidem asset for various CNS basal ganglia disorders, including Parkinson's Disease (PD) and the orphan indication Progressive Supranuclear Palsy (PSP), which SELLAS intends to develop via the expedited 505 (b)(II) regulatory path and as a fast-track product. The CNS program will be initiated around Q4 2015 for the orphan indication Progressive Supranuclear Palsy (PSP) and followed thereafter for Parkinsons Disease (PD). Numerous peer-reviewed journals have already published data supporting that the use of this drug is indeed highly effective and safe in patients with PD as well as with PSP.
About TrojanTec Ltd.
TrojanTec is a discovery and clinical stage biopharmaceutical company that is developing first-in-class therapeutics based on its proprietary Antennapedia peptide drug platform. TrojanTec's lead drug candidate is TR-1, a p53/p21 re-activator for the treatment of cancer, and will be entering clinical testing by around Q42015.
As an industry leader in cell penetrating peptides, TrojanTec aims to dramatically improve the treatment of a wide range of diseases including cancer, endocrine/metabolic disorders and infectious diseases. For more information, please visit: www.trojantec.com
SOURCE SELLAS Life Sciences Group
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