• Recent Previous Reports Showed Positive Findings for WT1 Cancer Vaccine in Mesothelioma and Acute Myeloid Leukemia (AML) Patients
• SELLAS to Present at the Annual JP Morgan Healthcare Conference on January 12th at 3:30pm PST

Zug, Switzerland, and New York (Press Release) – SELLAS Life Sciences Group (SELLAS), a devel­op­ment-stage bio­pharma­ceu­tical com­pany focused on inno­va­tive prod­ucts to treat cancers and central nervous system (CNS) diseases, today reported positive results from the Company's Phase 1/2 clin­i­cal study of its WT1 cancer vaccine in patients with multiple myeloma (MM) fol­low­ing au­tol­o­gous stem cell trans­plan­ta­tion. Initial results from the study, which commenced in June 2014 and enrolled a total of 15 patients, have dem­onstrated positive immune response data and safety findings as well as early efficacy data. Three patients with high-risk cytogenetics achieved an immune response against WT1 peptides encoded in the vaccine, and two of these patients con­tinued in remission at the time of last follow-up at one year; the third patient was in remission as of the first, three-month follow-up and will con­tinue to be followed through one year. Additional clin­i­cal results will be reported in 2016 in the appro­pri­ate peer-reviewed forum once all of the 15 patients have com­pleted the vaccinations and immune responses have been analyzed. Based on these promising data, SELLAS intends to assess the efficacy of the WT1 cancer vaccine in MM in a larger Phase II/III trial in­­clud­ing patients with standard risk disease fol­low­ing induction chemo­ther­apy in 2016.

Guenther Koehne, M.D., Ph.D., Attending Physician, Adult Bone Marrow Transplantation Service, at Memorial Sloan Kettering Cancer Center (MSKCC), Associate Professor of Medicine, Weill Cornell Medical College and Principal Investigator of the Phase I/II trial, commented, "I am excited by the prospect of this WT1 cancer vaccine in treating multiple myeloma, as it has dem­onstrated strong safety findings and impressive immune response data. While these results are pre­lim­i­nary, it appears patients with high-risk cytogenetics may ex­peri­ence a benefit of pro­gres­sion-free survival with the WT1 vaccine, and we will con­tinue to track closely each patient's progress as we com­plete the follow-up."

"Over the past few months, our WT1 vaccine has dem­onstrated positive results in treating diverse cancers, in­­clud­ing mesothelioma and acute myeloid leukemia (AML), and now multiple myeloma. In the latter, we are seeing promising responses in high-risk patients, which are very exciting given that these patients typically relapse in less than one year," said Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS. "We are thrilled to have seen compelling clin­i­cal data in all of the patient pop­u­la­tions studied to date and ex­pec­t to ini­ti­ate two pivotal trials of the WT1 vaccine, in AML and mesothelioma, this year, with the AML pivotal study ex­pec­ted to commence in this quarter. Further­more, we plan on opening up a basket-trial with our WT1 cancer vaccine across various indi­ca­tions with our vaccine alone, as well as in com­bi­na­tion with other immuno-oncology agents as we are further ad­vanc­ing our highly inno­va­tive and lead asset."

WT1 Cancer Vaccine Clinical Program in Multiple Myeloma

SELLAS's Phase 1/2 Multiple Myeloma clin­i­cal trial of its WT1 vaccine enrolled a total of 15 patients, each patient receiving chemo­ther­apy and stem cell trans­plan­ta­tion and followed by 1-2 cycles (6 vaccines per cycle) of the Company's WT1 cancer vaccine. Of the patients enrolled, 60% were found to have high risk cytogenetics at diag­nosis (9/15), in­­clud­ing del p53; this is the most dif­fi­cult pop­u­la­tion to maintain in long-lasting remission. Initial data have shown positive safety findings and that treat­ment with the WT1 vaccine was well-tolerated. Immune responses, as well as efficacy and safety, are being further eval­u­ated. To date, com­plete immune response data have been determined in three high-risk patients, two of whom have finished the one-year study follow-up.

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 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 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 could 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 MPM.

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.

Source: SELLAS Life Sciences Group