SELLAS Life Sciences Announces Orphan Drug Designation for WT1 Cancer Vaccine in Patients with Acute Myeloid Leukemia (AML)

SELLAS to Initiate Pivotal Phase 3 Study of WT1 Vaccine in AML Patients in Early 2016

Jan 11, 2016, 08:00 ET from SELLAS Life Sciences Group

ZUG, Switzerland and NEW YORK, Jan. 11, 2016 /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 the U.S. Food and Drug Administration (FDA) granted orphan drug designation for the Company's WT1 cancer vaccine for the treatment of patients with AML. Recent presentations at the International WT1 Conference highlighted positive efficacy results, including clinically meaningful prolonged survival, and safety data from the Phase 1 and Phase 2 trials of the WT1 vaccine in AML patients. Based on these promising findings, SELLAS intends to initiate a pivotal Phase 3 trial of this product candidate in AML patients early this year.

"We are pleased to have received this orphan designation in the U.S., which we believe recognizes the substantial need in treating patients with AML," said Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS. "To date, we have seen compelling clinical data in this patient population, and we plan to commence shortly our first pivotal study, which will assess efficacy and safety of our WT1 vaccine in AML patients. This is a momentous step forward for the Company into late-stage, registration studies, and we are thrilled with this progress."

The FDA Office of Orphan Products Development grants orphan designation to drugs and biologics intended for treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits to sponsors planning to test a product for use in a rare disease or condition. These benefits include tax credits for qualified clinical trials costs, and exemption from FDA user fees, and upon approval, the product may qualify for seven years of market exclusivity.

WT1 Cancer Vaccine Clinical Program in AML

SELLAS's anticipated Phase 3 study of the WT1 vaccine in AML patients is designed as a double-blind, placebo-controlled, multi-center, and multinational trial to assess efficacy and safety of the vaccine in this patient population. The Company's clinical program builds on previous data in the treatment of AML, as presented most recently at the International WT1 Conference held in Kyoto, Japan, in November 2015. These findings showed that SELLAS's WT1 vaccine resulted clinically meaningful prolonged survival in AML patients in both Phase 1 and Phase 2 trials.

A median overall survival of around 4 years was achieved in a Phase 2 trial of the WT1 vaccine in adult patients with AML. Similarly, in a previous Phase 1 AML study, the WT1 vaccine resulted in a median overall survival of more than 3 years. When combined, the results from the Phase 1 and Phase 2 studies demonstrated a 2-year overall survival in adult AML patients of 79%. Historical 2-year overall survival results in similar patient populations range from 30% to 45%. In both studies, SELLAS's WT1 vaccine also demonstrated a favorable safety and tolerability profile. The Phase 1 and Phase 2 trials studied the WT1 analog peptide vaccine in combination with Montanide-adjuvant plus GM-CSF in patients with AML who were in first complete response and completed any planned post-remission therapy. Altogether, 31 patients were enrolled in the two studies, which were conducted at Memorial Sloan Kettering Cancer Center (MSK).

About SELLAS Life Sciences Group

SELLAS to present at the 34th Annual J.P. Morgan Healthcare Conference on January 12th, 2016, at 3:30pm PST at the Westin St. Francis Hotel in San Francisco, CA

SELLAS Life Sciences is a development-stage biopharmaceutical company focused on innovative products to treat cancer and central nervous system (CNS) diseases. SELLAS has two Phase 2b- and 3-ready products poised to enter trials in Europe and the US in 2016, across multiple indications in cancer and CNS diseases, as well as an earlier-stage highly innovative cancer therapeutic.

SELLAS's WT1 vaccine, licensed from Memorial Sloan Kettering Cancer Center, is a cancer immunotherapeutic agent targeting a broad spectrum of hematologic cancers and solid tumor indications. This program will advance into Phase 3 trials in 2016 in AML and MPM as well as other indications in various development phases, including ovarian cancer, glioblastoma multiforme, and others with WT1 vaccine alone or in combination with other immunooncology agents.  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. Zolpidem's mechanism of action and therapeutic effects in such CNS-related diseases have been demonstrated in several studies. SELLAS expects to initiate a Phase 2b/3 study of high-dose Zolpidem for PSP in 1H 2016. A third program is focused on SELLAS's TR1 product candidate, a novel fusion protein that supplies the normal wild type p53/p21 protein to cancer cells to trigger innate cell death mechanisms (apoptosis). 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 was founded in 2012 and is headquartered in Zug, Switzerland, with additional offices in New York, USA.

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SOURCE SELLAS Life Sciences Group