Sellas Life Sciences Group, Inc. · NASDAQ:SLS
Sellas Life Sciences — 2019 BIO CEO & Investor Conference
22 slides from Sellas Life Sciences's conference presentation, Feb 12, 2019
Slide 1: Company Overview
Company Overview NASDAQ: SLS February 2019
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements. You can identify such forward-looking statements by the use of the words “expect,” “believe,” “will,” “anticipate,” “estimate,” “plan,” “project” and other words of similar import. The forward-looking statements in thi
Slide 3: Late-Stage Cancer Immunotherapy Company
LATE-STAGE CANCER IMMUNOTHERAPY COMPANY Pivotal Phase 3 • Galinpepimut-S (GPS) WT1 peptide vaccine • Acute myeloid leukemia (AML) with orphan drug designation (ODD) and fast track status Development • Nelipepimut-S (NeuVax, NPS) HER-2 peptide vaccine Programs • Combination NPS + trastuzumab in tripl
Slide 4: Management Team
MANAGEMENT TEAM NAME POSITION PRIOR EXPERIENCE / AFFILIATIONS President, Chief Angelos Stergiou, M.D., ScD h.c. Executive Officer EVP, Chief Nicholas J. Sarlis, M.D., Ph.D., FACP Medical Officer EVP, General Counsel & Barbara Wood, J.D. Corporate Secretary VP, Finance & John T. Burns, CPA Corporate
Slide 5: Clinical Program Overview
CLINICAL PROGRAM OVERVIEW Galinpepimut-S (GPS): WT1 peptide vaccine • Acute myeloid leukemia (AML): In an open-label Phase 2 study with older patients (≥60 years; historical control ~12 months) median overall survival reached 35.3 months and 67.6 months across all ages; pivotal Phase 3 study planned
Slide 6: Development Pipeline
DEVELOPMENT PIPELINE PROGRAM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Galinpepimut-S – Multiple Indications Acute Myeloid Leukemia (AML) Malignant Plural Mesothelioma (MPM) Multiple Myeloma (MM) Immune Combo (w/Pembrolizumab) - MRK Ovarian (combo w/Nivolumab) - BMS Nelipepimut-S – Breast Cancer Developme
Slide 7: Anticipated Near-Term Milestones
ANTICIPATED NEAR-TERM MILESTONES Program Milestone Projected Date NPS Regulatory guidance from FDA and EMA on further development Q1 2019 GPS Start AML Phase 3 randomized trial Q2 2019 Interim analysis of Phase 1/2 combination trial with PD-1 inhibitor GPS Q4 2019 (pembrolizumab) GPS First Interim a
Slide 8: GPS Clinical Program
GPS CLINICAL PROGRAM ¢eLLAS (i Vike SCIENCES GROUP
Slide 9: GPS: Novel Peptide Engineered for Differentiated Immunotherapy
GPS: NOVEL PEPTIDE ENGINEERED FOR DIFFERENTIATED IMMUNOTHERAPY Heteroclitic peptide increases Multivalent 4 peptide immune response and mitigates chains (25 epitopes) tolerance, while maintaining antigenicity profile GPS Peptide sequences (position) WT1-A1: *YMFPNAPYL (126–134) 9-mer Spurs multi-epi
Slide 10: Positive Phase 2 Clinical Results in Acute Myeloid Leukemia
POSITIVE PHASE 2 CLINICAL RESULTS IN ACUTE MYELOID LEUKEMIA • Primary endpoint of 3-year OS > 34% was met: 47.4% • Prolonged median overall survival: 67.6 months (all ages) • Aggregate population of patients > 60 years (Phase 3 population): median overall survival (mOS) = 35.3 months in Phase 2 (vs.
Slide 11: Independent Trial in AML Patients in CR2 at Moffitt Cancer Center
INDEPENDENT TRIAL IN AML PATIENTS IN CR2 AT MOFFITT CANCER CENTER (MCC) OVERALL SURVIVAL RELAPSE-FREE SURVIVAL ---- Control ---- Control ---- Galinpepimut-S Patients ---- Galinpepimut-S N = 10 N = 10 N = 15 N = 15 • AML patients receiving > 2 administrations of GPS (n=10) compared to group of paired
Slide 12: Ovarian Cancer Trial: GPS + Nivolumab
OVARIAN CANCER TRIAL: GPS + Nivolumab • Patient Characteristics: WT1-specific IgG over time • N = 11 (open label) • 7 pts were in second remission and 4 pts were in third remission • Recurrent WT1+ ovarian cancer in 2nd (n=7) or greater (n=4) clinical remission after salvage chemotherapy • Clinical
Slide 13: Planned Phase 3 Study in AML
PLANNED PHASE 3 STUDY IN AML • Successful End-of-Phase 2 Meeting with FDA • Agreed: study design, endpoints, statistical analysis and CMC • Primary endpoint is overall survival; secondary endpoints include LFS, safety, rate of achievement of MRD negativity, antigen-specific T-cell immune response dy
Slide 14: Phase 2a Study of GPS + Pembrolizumab: Merck Collaboration
PHASE 2A STUDY OF GPS + PEMBROLIZUMAB (KEYTRUDA): MERCK COLLABORATION – PATIENT ENROLLMENT INITIATED SCHEMA N = 10-20 CRC^ 3/4L • Adult patients (>18 yrs) with confirmed WT1 Galinpepimut-S ENROLLMENT N = 10-20 OvC 2/3L (200 µg/ peptide x 4 → 800 µg/dose) expression (by IHC) →Administered SC • Presen
Slide 15: NPS Clinical Program
NPS CLINICAL PROGRAM ¢eLLAS (i Vike SCIENCES GROUP
Slide 16: Phase 2b NPS + Herceptin Combination Trial Results
PHASE 2B NPS + HERCEPTIN COMBINATION TRIAL RESULTS • Phase 2b: N = 275 patients TNBC COHORT (36% of ITT) – DFS • Two primary study target patient populations Final Analysis • Lymph node-positive and triple-negative breast cancer • Pre-specified interim analysis by independent DSMB 92.6% • Clinically
Slide 17: Folate Binding Protein-Derived E39 Peptide Vaccine
Folate Binding Protein-Derived E39 Peptide Vaccine 17
Slide 18: Folate Binding Protein-Derived E39 Peptide Vaccine
FOLATE BINDING PROTEIN-DERIVED E39 PEPTIDE VACCINE • Novel peptide vaccine approach targeting the folate binding protein (FBP) • Incorporates peptide E39 of FBP along with its attenuated version E39’ (J65) • Induces immunogenicity and decreases the potential for immune tolerance • Clinical activity
Slide 19: Corporate
CORPORATE ¢eLLAS (i Vike SCIENCES GROUP
Slide 20: Board of Directors
BOARD OF DIRECTORS NAME POSITION PRIOR EXPERIENCE / AFFILIATIONS Board Chair, Nominating and Jane Wasman Governance Committee Chair Angelos Stergiou, MD, ScD h.c. Chief Executive Officer John Varian Audit Committee Chair Compensation Robert Van Nostrand Committee Chair Science Committee Dr. David Sc
Slide 21: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD NAME POSITION Deputy Director of the Perlmutter Cancer Center, Co-director of the Melanoma Research Program Jeffrey Weber, M.D., Ph.D. - Chair at the New York University (NYU)-Langone Cancer Center Chief, Melanoma & Immunotherapeutics Service at Memorial Sloan Kettering Can
Slide 22: Thank you
¥cLLAS CD Wire SCIENCES GROUP Thank you
SELLAS Life Sciences Group — 2019 BIO CEO & Investor Conference on 6ix