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news.SELLAS Life Sciences Group, a Swiss-based development-stage biopharmaceutical company, 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.
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"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."