SELLAS Life Sciences Appoints Acclaimed Cancer Researchers Drs. Larry W. Kwak and Jedd D. Wolchok to Its Scientific Advisory Board

ZUG, Switzerland and NEW YORK, Nov. 11, 2015 /PRNewswire/ -- SELLAS Life Sciences Group (SELLAS), a development-stage biopharmaceutical company focused on innovative products to treat cancers and central nervous system (CNS) diseases, today announced that it has appointed to its Scientific Advisory Board ("SAB") Larry W. Kwak, MD, PhD, of the City of Hope National Medical Center, and Jedd D. Wolchok, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSK). Drs. Kwak and Wolchok join existing members of SELLAS's SAB, including: David A. Scheinberg, MD, PhD, of MSK; Prof. Agamemnon A. Epenetos, MB, ChB, PhD, FRCP, of Trojantec Limited; Sattva Neelapu, MD, PhD, of the University of Texas M.D. Anderson; Prof. Dr. Gunter U. Hoglinger, MD, PhD, of the German Center for Neurodegenerative Diseases (DZNE), and Prof. Antonio Daniele, MD, PhD, of Catholic University.

"We are delighted to welcome Larry and Jedd to our SAB.  Each brings acclaimed experience in developing novel approaches to cancer treatment, Dr. Kwak having pioneered the use of patient-specific cancer vaccines to treat lymphoma and Dr. Wolchok playing a key role in the development of checkpoint inhibitor ipilimumab for advanced melanoma," said Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS. "They join a distinguished roster of clinicians and researchers on our SAB, and Dr. Kwak's and Wolchok's combined experience will be invaluable to SELLAS as we further advance our lead cancer immunotherapy program, SELLAS's WT1 cancer vaccine, which is entering Phase 3 pivotal testing next year, as well as our earlier-stage cancer therapeutic, TR1, which is expected to commence Phase 1 testing in 2Q 2016."

Dr. Kwak stated, "I am excited to join the SELLAS SAB and to contribute to the advancement of a promising vaccine with potential application across diverse cancers. The WT1 antigen is one of the most widely expressed cancer antigens, ranked by the NCI as the Number 1 target for cancer immunotherapy. In particular, SELLAS is pursuing an approach that has promise in targeting certain cancer stem cells, which may aid in the goal of destroying residual tumor cells of cancers in remission and providing ongoing immune surveillance for recurrent tumors.  I look forward to the progress of the WT1 program, as well as their TR1 program."

Dr. Wolchok stated, "MSK has been a proud collaborator with SELLAS, in our work on the WT1 vaccine based on the promising results achieved by research teams at MSK. These researchers have demonstrated the potential of the WT1 vaccine to safely immunize patients against the WT1 antigen in several clinical trials, and we expect that SELLAS will build on these efforts in the pivotal program they intend to commence next year."

SELLAS's SAB Members

Larry W. Kwak, MD, PhD is Cancer Center Associate Director, Translational Research & Developmental Therapeutics for the City of Hope National Medical Center, Director of the Toni Stephenson Lymphoma Center within the Hematologic Malignancies and Stem Cell Transplantation Institute, and is endowed with the title of the Dr. Michael Friedman Professor in Translational Medicine. From 2004 to 2014, Dr. Kwak served as Chairman of the Department of Lymphoma and Myeloma and Co-Director of the Center for Cancer Immunology Research at the University of Texas, M.D. Anderson Cancer Center in Houston, Texas, where he also held the Jane and John Justin Distinguished Chair in Leukemia Research. Prior to his role at M.D. Anderson, Dr. Kwak served as Head of the Vaccine Biology Section, Experimental Transplantation and Immunology Branch, at the National Cancer Institute for 12 years. His laboratory at the NCI was credited with the bench-to-clinic development of a therapeutic cancer vaccine for B-cell malignancies. In 2010, Kwak was named to TIME Magazine's TIME100 as one of the world's 100 most influential people for his 20-year commitment to the science of cancer vaccines, specifically a personalized therapy for follicular lymphoma. Dr. Kwak received his medical degree from Northwestern University Medical School and earned his Ph.D. in tumor cell biology there in 1984. He also completed a residency in internal medicine and a fellowship in medical oncology at Stanford University Medical Center in California.

Jedd D. Wolchok, MD, PhD is Chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center, an associate director of the Ludwig Center for Cancer Immunotherapy at MSK, an associate member of Ludwig Cancer Research, and the Lloyd J. Old/Virginia and Daniel K. Ludwig Chair in Clinical Investigation at MSK. He is also director of the CRI/Ludwig Cancer Vaccine Collaborative Trials Network, and is an associate director of the CRI Scientific Advisory Council. Further, he is the co-director of the Swim Across America laboratory at MSK, one of the foremost immunotherapy and melanoma research groups in the country. Dr. Wolchok was instrumental in the clinical development leading to the approval of ipilimumab for advanced melanoma, and he is Principal Investigator of numerous ongoing clinical trials at MSK in the area of immunotherapy. He is also Associate Professor in the Immunology and Microbial Pathogenesis Program at Weill Cornell Graduate School of Medical Sciences of Cornell University and an Associate Professor of Medicine at Weill Cornell Medical College. Dr. Wolchok received his undergraduate degree from Princeton University and his master's, medical, and doctorate degrees from New York University. He completed his internship and residency at the New York University Medical Center/Bellevue Hospital and his fellowship at MSKCC, where he was named Chief Fellow in Medical Oncology-Hematology.

About SELLAS's WT1 Cancer Vaccine

SELLAS' WT1 vaccine is a late clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including acute myeloid leukemia (AML), mesothelioma, multiple myeloma, ovarian cancer, and multiple other cancers. The WT1 antigen is a transcription factor that is not generally expressed in normal adult cells, but appears in a large number of cancers, as well as in certain cancer stem cells. WT1 has been ranked by the National Cancer Institute (NCI) as the Number 1 target for cancer immunotherapy. While WT1 has not been druggable by traditional approaches, it can be targeted by the immune system. Specifically, a number of different peptide sequences from the WT1 antigen have been identified as immunogenic and capable of stimulating cytotoxic T-cells that can target and kill WT1-expressing cancer cells. Studies also have shown that WT1 does not provoke tolerization, and that patients' T-cells can remain reactive to the antigen over time.

The WT1 vaccine, originally developed by Memorial Sloan Kettering Cancer Center (MSK) and licensed to SELLAS, comprises four modified peptide chains that induce a strong innate immune response (CD4+/CD8+ T-cells) against the WT1 antigen. The WT1 vaccine is administered in combination with an adjuvant and an immune modulator to improve the immune response to the target. Based on its mechanism and the accumulating evidence of activity in mid-stage trials, the WT1 vaccine may have the potential to complement currently available therapies by destroying residual tumor cells of cancers in remission and providing ongoing immune surveillance for recurrent tumors. Overall, SELLAS' WT1 vaccine is expected to target over 20 cancers that over-express WT1, many of which are associated with relapse rates of up to 80% or more, as seen in patients with AML and malignant pleural mesothelioma (MPM). This program is expected to advance into Phase 3 trials in AML and MPM in 2016.

About SELLAS's TR1

SELLAS' second lead oncology product candidate, TR1, is a fusion protein designed to eradicate cancer stem cells (CSCs) to prevent tumor recurrence and metastasis. SELLAS' TR1 therapeutic specifically targets tumor cells with mutations of the p53/p21 gene that have resulted in the loss of apoptotic function. 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 mechanisms (apoptosis).  P53/p21 is known to be inactivated in most human cancers.

TR1 has been designed to deliver the functioning p53/p21 protein into tumor cells by utilizing a patented transporter protein technology based on the Antennapedia protein (ANTP). ANTP mediates transmembrane transport and is able to "carry" its fusion partner, p53/p21, across cell membranes, including cells lining the blood-brain-barrier, and into the nucleus. Once inserted, p53/p21 restores the ability for cancer cells to trigger apoptosis. There are no adverse effects on normal cells, which are already regulated by their own p21.

Preclinical in vivo research has shown that restoring the function and activity of p21 within CSCs can suppress tumor development by inducing apoptosis. A Phase 1 study of TR1 is anticipated in 2Q 2016.

About SELLAS Life Sciences Group

SELLAS Life Sciences is a development-stage biopharmaceutical company focused on innovative products to treat cancer and central nervous system (CNS) diseases. SELLAS's lead oncology candidates are the WT1 vaccine, a cancer immunotherapeutic agent that is expected to enter Phase 3 testing in AML and MPM in 2016, and TR1, a novel fusion protein supplying normal wild type p53/p21, which is anticipated to enter Phase 1 testing in 2016 and report initial data in 2017. SELLAS is also advancing a proprietary formulation of high-dose Zolpidem under the 505(b)(2) pathway to treat basal ganglia disorders, including Parkinson's disease and Progressive Supranuclear Palsy (PSP), which is the lead orphan indication. SELLAS expects to initiate a Phase 2b/3 study of high-dose Zolpidem for PSP in 1H 2016.

Founded in 2012, SELLAS is headquartered in Zug, Switzerland, and has recently opened a second headquarters in New York, NY.

Contacts:

For Investors:

Ami Bavishi, Burns McClellan, +1 (212) 213-0006, [email protected]

For Media:

David Moser, J.D., +1 (813) 864-2571, [email protected]

Justin Jackson, Burns McClellan, +1 (212) 213-0006, [email protected]

SOURCE SELLAS Life Sciences Group

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