ZUG, Switzerland, Aug. 19, 2015 /PRNewswire/ -- SELLAS Life Sciences Group (SELLAS), a development-stage biopharmaceutical company with its main focus on developing innovative products to treat cancers and central nervous system (CNS) diseases, today announced the appointments of Gregory M. Torre, Ph.D., J.D, as Chief Regulatory Officer and Vice President, Operations, and Martin G. Baum, as Senior Vice President, Commercial Strategy. The Company is expanding and strengthening its team as it prepares to launch multiple Phase 3 studies for its lead programs developing WT1 vaccine for cancer indications and a proprietary formulation of Zolpidem for basal ganglia disorders.
"We are delighted to welcome Greg and Martin, two accomplished industry professionals with proven track records in leading regulatory affairs, operations and development as well as commercial strategy for global pharmaceutical franchises, respectively," said Dr. Angelos M. Stergiou, MD, Chairman and Chief Executive Officer of SELLAS. "Their combined experience will be invaluable to SELLAS as we progress our lead programs into advanced clinical testing later this year and early next year."
SELLAS plans to initiate Phase 3 studies based on an extensive array of promising clinical results; including increased survival of patients with acute myeloid leukemia following treatment with the Company's WT1 cancer vaccine, improvements in motor functioning of a key subset of patients with progressive supranuclear palsy (PSP) and Parkinson's disease who were treated with high-dose use of Zolpidem, as well as initiating a Phase I trial next year with its proprietary transporter protein attached with a full-length p21 tumor suppressor protein for activating apoptosis and inhibiting tumor proliferation."
"SELLAS continues to make rapid progress in advancing products with well-characterized mechanisms and strong therapeutic rationale intended to meet substantial unmet needs in oncology and neurological diseases," stated Dr. Torre. "I look forward to working with SELLAS' world-class team as the Company's lead programs begin late stage registration studies designed for market authorization filing in the US and select overseas markets."
Mr. Baum commented, "I am very excited to join SELLAS at this pivotal moment in the Company's development. The Company's progress is testimony to the careful preparation and planning required to advance innovative products to the market that can transform patient therapy in hard-to-treat diseases."
Dr. Gregory M. Torre
Dr. Torre is a scientist-attorney with 35 years of hands-on international executive leadership experience in the pharmaceutical and biotech industries. Prior to joining SELLAS, Dr. Torre served as Vice President, Worldwide Regulatory Strategy – Global Established Products at Pfizer, Inc. Prior to this, he was Vice President of Drug Development at Elusys Therapeutics Inc., and served as Pharmaceutical Science and Legal Consultant at Axiom Law/The Torre Group. Previously, Dr. Torre held senior positions at Alvogen, including Vice President, Regulatory Affairs and Quality; Chief Compliance Officer, and Intellectual Property and Regulatory Council. Prior to joining Alvogen, Dr. Torre was the Senior Vice President for Regulatory Affairs, Quality and Technical Operations at NPS Pharmaceuticals, and he also held positions at MannKind. Prior to this, at Biovest, he was instrumental in developing FDA-acceptable surrogate markers and endpoints for an autologous vaccine to treat non-Hodgkin lymphoma. During his career, Dr. Torre also held leadership positions at Bristol-Myers Squibb, Sanofi, Sankyo and Novartis. Dr. Torre received his J.D. from Brooklyn Law School, and he is a member of the Bar in the State of New Jersey, the District of Columbia and the United States Supreme Court. He received his B.S. in Pharmacy from St. John's University, College of Pharmacy and Allied Health Professions and is a registered Pharmacist in the State of New York. He was also awarded an M.S. in Pharmacology/Toxicology and a Ph.D. in Pharmacology/Toxicology from the same institution.
Martin G. Baum
Mr. Baum brings to SELLAS over 25 years' experience building and leading global biopharmaceutical companies through continued growth. Most recently, he served as founding partner and Managing Director of Komedica, a healthcare consulting firm. Previously, Mr. Baum founded and served as President and Chief Executive Officer of Vestiq Pharmaceuticals, which was sold to a holding of Praelia Pharmaceuticals Inc. in 2013. Prior to this, Mr. Baum was the President and Chief Executive Officer of Turnberry Development and previously was Founder and Chief Executive Officer of TEAMM Pharma, a specialty pain company that he sold to Accentia Biopharma and took public in 2005. Prior to this, he held the position of Senior Vice President, Commercial Operations at DJ Pharmaceuticals, where he helped achieve profitability within two years and sold the Company to Biovail Corporation. He also was a founding member and served as Senior Vice President of Operations and BD at Skye Pharma PLC, an international company focused on generics and novel drug delivery technologies. He began his career with Merrell Dow Pharmaceuticals and GlaxoSmithKline Pharmaceuticals. Mr. Baum is a founding member of Health Scape Data and sits on the board of Inno BioPharma, an early stage oncology development company spun out of the University of Iowa. Mr. Baum graduated from the University of Toledo, with B.S. degrees in Human Life Sciences and Business Administration.
About SELLAS Life Sciences Group
SELLAS Life Sciences is a late-stage biopharmaceutical company focused on the development of novel cancer immunotherapies and therapeutics for a broad range of orphan indications, as well as drugs targeting high-value neurological indications with significant unmet medical need, as well as orphan indications.
SELLAS was founded in 2012 and is headquartered in Zug, Switzerland. With most of the Company's management team based in the US, SELLAS is in the process of establishing a second base in New York City.
SELLAS has two late-stage, Phase 3-ready products poised to enter trials in Europe and the US in 2015/2016 across at least five indications in cancer and CNS diseases as well as an earlier stage highly innovative cancer therapeutic. The Company's WT1 vaccine for hematological malignancies and solid tumors has improved survival in patients with acute myeloid leukemia and shown additional clinical benefits in multiple myeloma and mesothelioma. SELLAS also is advancing a proprietary formulation of Zolpidem for basal ganglia disorders, including Parkinson's disease and the orphan indication PSP, and its TR1 product candidate, a novel fusion protein to induce apoptosis in cancer cells. The Company's management team has a proven track record of developing drugs and cancer vaccines throughout all stages of the product's life cycle, and the team has played key roles in bringing companies public, successfully out-licensing drug candidates, forming R&D partnerships with big pharma, and creating multiple alliances with centers of excellence. For more information on SELLAS's programs and leadership, please visit http://sellaslifesciences.com/.
About the WT1 Therapeutic Cancer Vaccine
The WT1 vaccine, licensed from Memorial Sloan Kettering Cancer Center, is a late-stage cancer immunotherapy targeting a broad spectrum of hematologic cancers and solid tumor indications including acute myeloid leukemia, mesothelioma, multiple myeloma, ovarian cancer, and multiple other cancers. The WT1 vaccine is comprised of four modified peptide chains that induce a strong innate immune response (CD4+/CD8+) against the WT1 antigen which is over-expressed in multiple malignancies. The WT1 antigen was recently identified as the top potential immunotherapy cancer target by the National Cancer Institute.
SELLAS' WT1 vaccine was assembled from a set of immunogenic synthetic peptides, also using heteroclitic sequences that are capable of stimulating both CD4 and CD8 T cells. Initial studies with the vaccine have been conducted in patients with myeloid leukemias and thoracic cancers, such as lung cancer and mesothelioma. The Company's ongoing Phase 2 trial in acute myeloid leukemia (AML) has yet to reach median survival, which has surpassed 52 months; the standard survival is approximately 12 months for patients at the stage of disease as enrolled in the study. Based on encouraging results in SELLAS' initial studies, the Company expects to initiate in the first quarter of 2016 a Phase 3 trial of its WT1 vaccine in patients with AML and a Phase 2 study in multiple myeloma. SELLAS also anticipates data either later this year or in 2016 from an ongoing Phase 2 study of the WT1 vaccine in mesothelioma patients.
SELLAS' TR1 product candidate is a novel fusion protein that supplies the normal wild type p53/p21 protein to cancer cells to trigger innate cell death mechanisms (apoptosis). P53/p21 is known as "the guardian of the genome" because it is the body's cellular first line of defense enabling 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. In SELLAS' TR1 candidate, full-length p53/p21 is fused with the transporter protein Antennapedia (ANTP) to enhance the penetration of peptides through the blood-brain barrier.
TR1 is designed to be given in conjunction with conventional chemotherapy, acting in synergy with no added toxicity and without inconveniencing the patient. The Company also expects TR1 to be synergistic with radiotherapy and other biotherapies (such as monoclonal antibodies) because of its mode of action of switching on the apoptotic pathway in p53-mutated tumors. The Company is advancing its TR1 program toward IND-enabling studies, with the goal of commencing Phase 1 testing in 2016 and reporting initial data in 2017.
SELLAS is currently developing a proprietary formulation of high-dose Zolpidem, under the 505(b)(2) pathway for PSP. Zolpidem's mechanism of action and therapeutic effects in CNS-related diseases, including PSP and Parkinson's, has been demonstrated in several studies. SELLAS expects to initiate a Phase 2b/3 study of high-dose Zolpidem for PSP in 1H 2016, with completion anticipated by 2H 2017. High-dose Zolpidem is eligible for Orphan Designation, Fast-Track Designation and Accelerated Approval for PSP. Method-of-use and formulation patents for high-dose Zolpidem extend out to 2026.
Zolpidem, in high doses of 25mg – 75 mg per day, is a selective agonist of GABA-A-BZ1 receptor that mediates anti-Parkinsonian effects in patients suffering from Parkinson's disease and related diseases. These receptors are upregulated in areas of the brain (such as the globus pallidus and substantia nigra) that are known to be abnormally overactive in PSP and Parkinson's patients, resulting in reduced activity of motor cortical areas. Zolpidem selectively inhibits these receptors in the affected areas resulting in improved activity of motor cortical areas.
Clinical studies report that high-dose Zolpidem has demonstrated statistically significant improvement in UPDRS motor score and improvement in voluntary saccadic eye movement for PSP patients. Additional beneficial effects included improvement in speech and vocalization, swallowing, vertical gaze and ocular pursuit, facial expression, speed of movement, bradykinesia, akinesia, limb and axial rigidity/extensor dystonia, PSP rating scale and Berg Balance score, dysphagia, drooling, agitation and aggressiveness.
SELLAS has an exclusive development and licensing agreement with Catalent Pharma Solutions to support the development and formulation of high-dose Zolpidem. SELLAS will utilize Catalent's proprietary OptiDose technology, which allows for sustained-release and combination dose forms, as well as administration as a monotherapy or combination therapy with three sustained-release reservoir compartments per tablet to cover 12 – 24 hour symptom relief.
Ami Bavishi, Burns McClellan, (212) 213-0006, firstname.lastname@example.org
SOURCE SELLAS Life Sciences Group