ZUG, Switzerland and NEW YORK -- SELLAS Life Sciences Group (SELLAS), a Swiss-based development-stage biopharmaceutical company, today announced that it has signed a definitive master service agreement with Pharmaceutical Product Development (PPD), a leading global contract research organization (CRO), to advance and expand clinical and regulatory development across Sellas' portfolio of drugs and biologics.
"We are very excited having selected PPD, one of the world's leading contract research organizations, to be our strategic clinical development partner in advancing our assets through the clinical and regulatory life cycles leading toward approval, which is a key milestone for us," states Dr. Angelos M. Stergiou, CEO & chairman of Sellas. "The assets we currently hold, mainly Zolpidem for central nervous indications and the WT1 cancer vaccine, initially will be used across five late-stage indications: Zolpidem for Parkinson's Disease and Progressive Supranuclear Palsy, and WT1 for Acute Myeloid Leukemia, Mesothelioma, Multiple Myeloma and subsequently ovarian cancer, lung cancer, prostate cancer and colon cancer. PPD brings its strong track record in successfully helping pharmaceutical and biotechnology clients develop innovative therapies. This strategic partnership, customized to address these specific opportunities, will ensure a robust clinical development plan with appropriate clinical and regulatory strategies across all major markets globally. PPD's willingness to offer commercial terms tailored to our specific needs will help focus the clinical development teams on expeditious delivery of clinical data and will serve to align partnership goals."
Sellas has an exclusive global collaboration and license agreement with Memorial Sloan Kettering Cancer Center (MSK) for the development, marketing and commercialization of MSK's proprietary WT1 cancer vaccine. WT1 is over-expressed in many human cancers, including most blood cancers and many solid tumors, including mesothelioma, and cancers of the ovary, lung, gastrointestinal tract, breast and prostate. The National Cancer Institute recently ranked WT1 as the top target for cancer immunotherapy. MSK researchers have already shown the potential of this vaccine to safely and efficaciously immunize patients against the WT1 antigen in several clinical trials. Sellas also holds global rights of Zolpidem, a highly specific GABA agonist, in the indications of Parkinson's Disease (PD) and Progressive Supranuclear Palsy (PSP), as well as other basal ganglia disorders, and studies suggest that Zolpidem may significantly ameliorate motor and cognitive symptoms in patients with Parkinson's Disease and Progressive Supranuclear Palsy.
"We are pleased that Sellas has chosen us as its CRO partner of choice," said Paul Colvin, PPD's executive vice president of global clinical development. "PPD's deep capabilities and consultative approach are instrumental in helping the emerging biotech industry deliver on its pipeline promise. We offer clients proven expertise in neuroscience , oncology and other therapeutic areas. PPD's resources and experience in pharmaceutical development allow us to provide needed support for Sellas' clinical and regulatory activities at each stage of the development of Sellas' two promising assets."
Dr. Miltiadis Sougioultzoglou, executive vice president of Sellas, said: "We strive for strong and effective collaborations and currently have disruptive technologies in our portfolio in blockbuster markets and continue to seek innovative product candidates and technologies that will complement and strengthen our product portfolio."
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, Switzerland. Being a healthcare-oriented global group of companies, SELLAS has embraced all major aspects of the healthcare industry. Our core team is highly experienced in developing drugs and 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.
Presently, there are two phase 2 products to enter clinical trials in Europe and the USA in 2014 and 2015 across five indications in cancer and CNS; i) The WT1 vaccine for hematological malignancies and solid tumors, in-licensed from Memorial Sloan Kettering; and ii)Zolpidem 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 phase 2 program will be initiated around Q4 2014 for the orphan indication PSP and followed thereafter for PD. Due to high efficacy doses, SELLAS will implement a REMS (Risk Mitigation Safety) program. 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. More detailed descriptions of these two clinical development products follows.
WT1 Vaccine: WT1 protein is a transcription factor that is not generally expressed in adult tissues, but reappears in a large number of cancers, as well as in certain cancer stem cells. The WT1 protein is not drugable by traditional approaches, but it can be targeted by the immune system, in particular by CD4 T cells and CD8 T cells. A number of different peptide sequences from the WT1 protein have been identified as being immunogenic and capable of stimulating cytotoxic T cells that will kill WT1 expressing cancer cells. The WT1 vaccine was assembled from a set of immunogenic peptides that are capable of stimulating both CD4 and CD8 T cells. In addition, key amino acids from some of these peptides have been modified to improve their immunogenicity. The WT1 peptides in the vaccine are administered in combination with an immunologic adjuvant and an immune stimulant to improve the immune response to the target. Initial studies with the vaccine were conducted in patients with myeloid leukemias and thoracic cancers, such as lung cancer and mesothelioma. Based on encouraging results in these initial studies, additional phase 2 trials were launched in hematopoietic cancers and solid tumors. Results of these initial studies have shown the vaccine is well-tolerated and capable of inducing an immune response to the peptide. Patients enrolled in the acute myeloid leukemia trials have shown prolonged survival following vaccination.
Zolpidem: Parkinson's Disease is a progressive, neurodegenerative disease that belongs to the group of conditions called motor system disorders. Parkinson's Disease cannot yet be cured and sufferers get worse over time as the normal bodily functions, including breathing, balance, movement, and heart function worsen. It is estimated that approximately 4 million people have Parkinson's Disease globally. About 1.3 million people have been diagnosed in Europe and 1.5 million in the US. The amount of people having Parkinson's Disease in Europe is forecasted to double until 2030. The economic impact of the disease is enormous. The estimated annual European cost of Parkinson's Disease is €13.9 billion.
Progressive Supranuclear Palsy (PSP) is a neurodegenerative brain disease that has no known cause, treatment or cure. It affects nerve cells that control walking, balance, mobility, vision, speech, and swallowing. Five to six people per 100,000 will develop PSP and although it is a rare disease, the annual cost in the 27-country European Union sums up to €1.2–2.7 billion.
Zolpidem has shown extremely promising data in clinical efficacy and safety studies across Progressive Supranucelar Palsy and Parkinson's Disease and may be used as a mono-therapy or combination therapy.
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratoryservices. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and approximately 13,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
Media Contacts for SELLAS:
Mrs. Maria Katsori: [email protected]
David Moser, J.D., Director of Legal Affairs: +1 813-864-2571
Contacts for PPD:
+1 919 456 5350
+1 910 558 7585