Sellas Life Sciences Group, Inc. · NASDAQ:SLS
Sellas Life Sciences — 30th Annual ROTH Conference 2018
23 slides from Sellas Life Sciences's conference presentation, Mar 12, 2018
Slide 1: SELLAS Life Sciences Group, Inc. Company Overview
SELLAS LIFE SCIENCES GROUP, INC. COMPANY OVERVIEW NASDAQ: SLS MARCH 2018
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation may include forward-looking statements about strategy, future operations, future financial position, prospects, plans and objectives of SELLAS Life Sciences Group, Inc. (“SELLAS”). Examples of such statements include, but are not limited to, SELLAS’ abili
Slide 3: Investment Highlights: Late-Stage Immunotherapy Company
INVESTMENT HIGHLIGHTS: LATE-STAGE IMMUNOTHERAPY COMPANY • Lead asset, galinpepimut-S (GPS): numerous potential indications in a multibillion dollar cancer immunotherapy market with a strong intellectual property platform • Targets an NCI top ranked antigen, Wilms Tumor 1 (WT1) • Highly differentiate
Slide 4: GPS: Highly Innovative and Differentiated Immunotherapy
GPS: HIGHLY INNOVATIVE AND DIFFERENTIATED IMMUNOTHERAPY Heteroclitic peptide increases Multivalent 4 peptide immune response and mitigates chains (25 epitopes) tolerance, while maintaining antigenicity profile • Also strengthens MHC class I and II binding for optimal recognition of the corresponding
Slide 5: GPS: Immunogenicity Improved by Creating Synthetic Heteroclitic Peptides
GPS: IMMUNOGENICITY IMPROVED BY CREATING SYNTHETIC HETEROCLITIC PEPTIDES Peptide Sequences Computationally Predicted Immune Response (Position) Binding to HLA WT1-A1: *YMFPNAPYL A0201, A0301, A2402, B1501, B3901 CD8+ CTLs (126-134) 427 long: RSDELVRHHNMHQRNMTKL CD4+ T cells (427-445) B1501, B3901, B
Slide 6: WT1: A Top Ranked Cancer Antigen by the NCI
WT1: A TOP RANKED CANCER ANTIGEN BY THE NATIONAL CANCER INSTITUTE (NCI)* (Positive samples / Total samples) 28/28 33/34 54/56 23/25 41/46 • Potential to treat 20 or more cancer types • Expressed broadly in hematological malignancies and solid tumors Tumor types pursued by SELLAS’ clinical program to
Slide 7: GPS Clinical Overview
GPS CLINICAL OVERVIEW • Well tolerated with compelling efficacy profile in completed Phase 2 trials - Acute myeloid leukemia (AML): In older population (>60 years), 35.3 months median overall survival, longer than expected with SOC (~ 1 year); 67.6 median overall survival across all ages - Malignant
Slide 8: Development Pipeline
DEVELOPMENT PIPELINE PROGRAM PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Galinpepimut-S Phase 3 Protocol reviewed/approved by FDA; Phase 3 PLANNED* H2 ‘18 Acute Myeloid Leukemia (AML)** > 100 sites pre-screened Malignant Plural Mesothelioma (MPM)** Phase 3 Protocol reviewed/approved by FDA Phase 3 PLANNED*
Slide 9: Anticipated Milestones
ANTICIPATED MILESTONES Program Milestone Projected Date* Galinpepimut-S Updated data from Phase 2 multiple myeloma trial H1 2018 Galinpepimut-S Interim data from nivolumab combination trial in ovarian cancer H1 2018 NeuVax Interim data analysis: HER2 1+/2+ patients; combination trial with H1 2018 (n
Slide 10: Phase 2 Clinical Program in Acute Myeloid Leukemia
PHASE 2 CLINICAL PROGRAMS IN ACUTE MYELOID LEUKEMIA • Phase 2 study: primary endpoint met • Primary objective of 3-year OS > 34% was met: 47.3% • Prolonged median overall survival: 67.6 months (all ages) • Aggregate population of patients > 60 years (Phase 3 Population): median overall survival (mOS
Slide 11: Phase 2 Trial in AML: Patients >60 Years (in CR1)
PHASE 2 TRIAL IN AML: AML PATIENTS > 60 YEAR (IN CR1) STUDY RESULTS VS. HISTORICAL COMPARATORS PHASE 2 SURVIVAL WITH GPS IN THE POPULATION TARGETED BY SELLAS’ PHASE 3 TRIAL EXCEEDS THAT SEEN WITH HISTORICAL COMPARATORS, EVEN ALLOGENEIC STEM CELL TRANSPLANT 35.3 61% ADDITIONAL COMPARISONS FOR LANDMAR
Slide 12: 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 13: Phase 2 Randomized Trial in Malignant Pleural Mesothelioma
PHASE 2 RANDOMIZED TRIAL IN MALIGNANT PLEURAL MESOTHELIOMA CLINICALLY MEANINGFUL SURVIVAL BENEFIT IN A SOLID TUMOR INDICATION • Controlled, randomized blinded Phase 2 study with GPS after upfront surgery and other treatment (n=41) • GPS increased overall survival (OS) vs. control group • Median over
Slide 14: Ongoing Phase 2 Trial in Multiple Myeloma
ONGOING PHASE 2 TRIAL IN MULTIPLE MYELOMA (MM) • Patients were treated for up to 9 months (12 GPS administrations) post stem cell transplant (SCT) • 15/18 patients had high-risk cytogenetics at baseline; all patients remained at least MRD(+) after SCT • Interim results substantially exceeded standar
Slide 15: Ovarian Cancer Trial: Galinpepimut-S + Opdivo
OVARIAN CANCER TRIAL: GALINPEPIMUT-S + OPDIVO • Open-label phase 1/2 trial; N = 10 • Recurrent WT1+ ovarian cancer in 2nd or greater clinical remission after salvage chemotherapy • Therapy initiation within 4 months of completion of last chemotherapy Treatment Schedule Galinpepimut-S • Initial regim
Slide 16: Planned Phase 3 Study in AML
PLANNED PHASE 3 STUDY IN AML • Successful End-of-Phase 2 Meeting with FDA • Agreed upon development, study design, endpoints, statistical analysis and CMC • Primary endpoint is overall survival; secondary endpoints include LFS, safety/MRD, immune response • 180 sites in North America, Europe, Austra
Slide 17: Planned Galinpepimut-S + Pembrolizumab Phase 2a Study (Merck Collaboration)
PLANNED GALINPEPIMUT-S + PEMBROLIZUMAB – PHASE 2A STUDY (MERCK COLLABORATION) Open label, multicenter, multi-arm combination trial; N = 90 N = 10-20 Schema CRC^ 3/4L • Adult patients (>18 yrs) E N = 10-20 Galinpepimut-S with confirmed WT1 N OvC 2/3L (200 µg/ peptide x 4 800 µg/dose) expression (by
Slide 18: Partnerships & Collaborations
PARTNERSHIPS & COLLABORATIONS 18
Slide 19: Manufacturing Relationships and Readiness
MANUFACTURING RELATIONSHIPS AND READINESS Active Pharmaceutical Ingredient Drug Product Manufacturing Manufacturing • Plant in Torrance, CA • Plant in Caponago, Italy • Solid State Peptide Synthesis of peptides • Sterile fill & finish emulsion manufacturing • Successful Regulatory Site Inspections •
Slide 20: Management Team
MANAGEMENT TEAM NAME POSITION PRIOR EXPERIENCE / AFFILIATIONS Angelos Stergiou, M.D., ScD h.c. Chief Executive Officer Nicholas J. Sarlis, M.D., Ph.D., Chief Medical Officer FACP Chief Financial Officer Aleksey Krylov, CFA (Interim) Chief Regulatory Officer Gregory M. Torre, Ph.D., J.D. SVP, Technic
Slide 21: 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 22: Scientific Advisory Board
SCIENTIFIC ADVISORY BOARD NAME POSITION Chief, Melanoma & Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center Jedd D. Wolchok, M.D., Ph.D. (MSKCC) Deputy Director of the Perlmutter Cancer Center, Co-director of the Melanoma Research Program Jeffrey Weber, M.D., Ph.D. at the New York
Slide 23: SELLAS Life Sciences Group, Inc. Company Overview
SELLAS LIFE SCIENCES GROUP, INC. COMPANY OVERVIEW NASDAQ: SLS MARCH 2018
SELLAS Life Sciences Group — 30th Annual ROTH Conference 2018 on 6ix