SELLAS Life Sciences Announces Preliminary Positive WT1 Cancer Vaccine Clinical Results in Multiple Myeloma Patients

ZUG, Switzerland and NEW YORK, Jan. 12, 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 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.

Contacts:
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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