CRO PPD, Sellas Partner On Zolpidem And WT1 Cancer Vaccine

Sellas Life Sciences Group announced in a press release that it has partnered with Pharmaceutical Product Development (PPD), a contract research organization (CRO), to develop Sellas’ Zolpidem for central nervous indications and its WT1 cancer vaccine.

Dr. Angelos M. Stergiou, CEO and Chairman of Sellas, said of the new arrangement with PPD, “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 and SELLAS Partnership

SELLAS sought the partnership with PPD in order to advance its assets through the clinical and regulatory life cycles. PPD will advance Zolpidem for Parkinson's disease (PD) and Progressive Supranuclear Palsy (PSD) and the WT1 vaccine for Acute Myeloid Leukemia (AML), Mesothelioma, and Multiple Myeloma (MM). In later stages, PPD will help Sellas with WTI for ovarian cancer, lung cancer, prostate cancer, and colon cancer. Dr. Stergiou lauded PPD’s track record and also stated that PPD showed a willingness to customize its financial terms.

WT1 Cancer Vaccine

The National Cancer Institute has ranked WT1 first as a promising cancer immunotherapy. Wilms' tumor protein 1 (WT1) is over-expressed in many human cancers including blood cancer, mesothelioma, and cancer of the ovary, lung, gastrointestinal tract, breast, and prostate. MSK researchers have conducted several clinical trials that have shown the efficacy and safety of the WT1 vaccine to immunize patients against the WT1 antigen.

Recently, in September, Sellas was in the news for its partnership with Memorial Sloan Kettering Cancer Center (MSK) to develop and commercialize the WT1 cancer vaccine. The company extended an exclusive global collaboration and license agreement to MSK to develop and market the vaccine. 

Zolpidem

Zolpidem is a GABA agonist that diminishes symptoms in Parkinson's disease and Progressive Supranuclear Palsy, including motor and cognitive deficiencies. Sellas hopes to prove efficacy in other basal ganglia disorders — diseases in the deep brain structures that start and control movement.

Zolpidem (brand name Ambien) is approved to treat insomnia. In July 2014, the Food and Drug Administration (FDA) updated the label to include a driving and drowsiness warning, recommending that patients halve or adjust the dose at night due to the risk of driving in the morning while under the influence. The FDA states in its guidance, “FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose. FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).”