SELLAS Life Sciences to Present Phase 2 Clinical Results for WT1 Cancer Vaccine at the 2016 ASCO Annual Meeting and the 13th International Conference of the International Mesothelioma Interest Group (iMig)

ZUG, Switzerland and NEW YORK, April 1, 2016 /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 that results from a Phase 2 trial of the Company's WT1 cancer vaccine in patients with AML have been selected for an oral presentation during the Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago, IL, June 3-7, 2016. In addition, Phase 2 results of the WT1 cancer vaccine in patients with malignant pleural mesothelioma (MPM) have been selected for an oral presentation at the iMig 2016 Conference, being held in Birmingham, UK, May 1-4, 2016 as well as a poster presentation at the ASCO Conference.

SELLAS's WT1 vaccine (galinpepimut-S) is a late clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including MPM, acute myeloid leukemia (AML), multiple myeloma, ovarian cancer, and multiple other cancers. Based on the results of its mid-stage clinical program, SELLAS is preparing to initiate a pivotal Phase 3 trial of its WT1 vaccine in AML patients by the second quarter of 2016 and a pivotal Phase 2b/3 trial in patients with MPM by the third quarter of this year.

"We are very pleased that the most advanced clinical findings for our WT1 vaccine have been selected for presentations at ASCO and the upcoming iMig conference," said Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS. "In addition to our anticipated Phase 3 pivotal trials, SELLAS also plans to launch a broad program in additional solid tumors and hematological malignancies, including multiple Phase 2 studies we expect to commence later this year. Based on this progress, we anticipate a steady flow of clinical trial readouts over the next two years."

Additional Presentation Details:

2016 ASCO Annual Meeting

iMig 2016 Conference

About the Phase 2 Trial in Mesothelioma

The double-blind, randomized (1:1) study compared the WT-1 analog peptides vaccine in combination with Montanide-adjuvant + Granulocyte-macrophage colony-stimulating factor (GM-CSF), versus Montanide-adjuvant + GM-CSF in patients with MPM who had previously completed combined modality therapy. Thirty-nine patients were to be enrolled in each arm at two centers, Memorial Sloan Kettering Cancer Center and M.D. Anderson Cancer Center. However, in May 2015, the trial's independent Data Monitoring Committee requested discontinuation of the control arm due to futility in the placebo arm while leaving open the WT1 cancer vaccine arm. This change led to unblinding the study earlier than planned; total enrollment has reached 40 patients, with 19 patients in the WT1 cancer vaccine arm and 21 in the control arm.

About the Phase 1 and 2 Trials in AML

Phase 1 and Phase 2 trials studied the WT1 analog peptide vaccine in combination with Montanide-adjuvant + 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 at Memorial Sloan Kettering Cancer Center.  The WT1 vaccine was also provided to the Moffitt Cancer Center for an independent Phase 2 study in AML and MDS  patients (N=10) in second remission (CR2).

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 (MPM), 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 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 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. The company recently received orphan drug designations by the US FDA for its WT1 cancer vaccine in Acute Myeloid Leukemia and Malignant Pleural Mesothelioma which will enter into pivotal clinical trials in 2016.

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 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 by early 2017.

SELLAS was founded in 2012 and is headquartered in Zug, Switzerland, with additional offices in New York, USA.

Contact:

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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