SELLAS Life Sciences Group, Inc. · NASDAQ:SLS
SELLAS Life Sciences — ASCO 2016
15 slides from SELLAS Life Sciences's conference presentation, 2016
Slide 1: Phase II trial of WT1 Analog Peptide Vaccine in adults with AML in First CR
Phase II trial of WT1 Analog Peptide Vaccine in adults with Acute Myeloid Leukemia (AML) in First Complete Remission (CR) Maslak P, Dao T, Bernal Y, Chanel S, Zhang R, Frattini M, Rosenblat T, Jurcic J, Brentjens R, Rampal R, Park J, Douer D, Katz L*, Gutierrez A*, Tallman M, Scheinberg DA. *Sellas
Slide 2: Background- WT1 as a Immunologic Target
Background- WT1 as a Immunologic Target • Wilms’ tumor 1 (WT1) gene is a transcription factor with limited expression in normal tissues. • WT1 is over-expressed in AML,CML, ALL and several solid tumors including mesothelioma, lung, breast, prostate and ovarian cancers. • WT1 is found in early leukem
Slide 3: Galinpepimut-S: peptide sequences used in the trial
Galinpepimut-S : peptide sequences used in the trial Sequences (position) Binding to HLA & length of peptide WT1-A : RMFPNAPYL (126- 134) A0201 (9 aa) WT1-A1: YMFPNAPYL (126-134) A0201 (9 aa) Vaccine Peptide 427 long: RSDELVRHHNMHQRNMTKL HLA-DR.B1 (19 aa) (427-445) Vaccine Peptide 331 long: PGCNKRYF
Slide 4: Phase II galinpepimut-S (GPS) Trial Design
Phase II galinpepimut-S (GPS) Trial Design • Eligibility: • Monitoring – Age > 18 yrs – Immune response (after 6 /12 vaccines) – Completed all planned chemotherapy • HLA-A02: CD8+ response – WT1 + pcr – IFN-γ ELISPOT – CR1- documentation of prior AML – WT1-A / Ao2o1 tetramer diagnosis • CD4+ respons
Slide 5: Study Patient Characteristics
Study Patient Characteristics (N=22) Median Age, y (range) 63 (23-75) Male (%) 32 Median KPS 90 (80-100) HLA-A0201 9 Risk Status (LeukemiaNet), n (%) Favorable 8 (36.4) Intermediate 1 7 (31.8) Intermediate 2 3 (13.6) Adverse 3 (13.6) Undetermined 1 (4.5) Prior Therapies Ara-C + Anthracycline : 95% P
Slide 6: Clinical outcomes
Clinical outcomes • Completed vaccinations • 12 Alive – 64% : 6 – 9 in 1st CR – 45% : 12 – 3 post- HSCT (11,19 &31 mos) • 15 patients relapsed • 10 Dead – 10 while receiving GPS • 4 after 1 vaccine – 9 relapsed disease • 5 received salvage HSCT – 1 infection post-HSCT • Median DFS: 23.75 mos • Media
Slide 7: Common Adverse Events
Common Adverse Events Toxicity Grade N (%) Injection site reaction 1-2 10 (45.5) Skin induration 1-2 7 (31.8) Pain / Pain in extremity 1 6 (27.3) Pruritus (local) 1-2 6 (27.3) Decreased WBC (transient) 3-4 6 (27.3) Decreased Plts (transient) 3-4 4 (18.2) Erythema Multiforme 1 3 (13.6) Flushing 1-3 3
Slide 8: GPS induces immunologic responses
GPS induces immunologic responses • Immunologic correlative data available in 14 of 22 (64%) of patients • CD4+ Response : ‒ Four of 9 patients (44%) had a + proliferation ‒ No clear correlation with HLA-DR type • CD8+ Response : – Testing restricted to HLA- A02 patients • Six of 7 patients (86%) ha
Slide 9: Example: GPS induces CD4+ proliferation
Example: GPS induces CD4+ proliferation Time 0 incorporation (cpm) 3H-Thymidine Vaccine 6 Vaccine 12 Pt#4
Slide 10: GPS induces CD8+ INF-γ secretion
GPS induces CD8+ INF – ϒ secretion Elispot 180 160 140 Spots/10^5 cells 120 CD14 T cells stimulated 100 WT1-A with WT1A 80 WT1-A1 60 EW (Time after vaccine) 40 20 0 Time 0 Time 6 Time 12 Vaccination Native and heteroclitic peptides are 400 T cells stimulated 350 cross-reactive with WT1A1 300 Spots/1
Slide 11: GPS induces CD8/WT1A/HLA-A02 Tetramers
GPS induces CD8/ WT1A/HLA-Ao2 Tetramers WT1-A WT1-A1 0.15 - 0.42 + 0.75 + 0.17 - 0.17 + 1.24 + Pt#1-T0 0.11 2.50 2.98 1.28 1.86 3.12 Pt#1-T6 CD8 0.12 1.95 1.84 0.12 1.70 1.84 Pt#1-T12
Slide 12: Immune response (IR) after WT1 vaccination
Immune response (IR) after WT1 vaccination Survival in months: median (range) Status DFS OS Negative IR n= 5 15 (8.5-38.1) 50.5 (15-62.5) Positive IR (CD4 or CD8) n= 9 Not reached (9-78.8) Not reached (15-78.5) DFS OS P=NS P=NS
Slide 13: Conclusions
Conclusions • Serial vaccination with galinpepimut-S can be accomplished in the post-remission setting with acceptable toxicity • Immune responses can be elicited after 6 vaccinations – CD4+ responses seen across HLA-Class II subtypes – Specific CD8+ responses seen in patients with HLA-A0201 • Prolo
Slide 14: Acknowlegements
Acknowlegements • MSKCC Leukemia Service • Scheinberg Lab ‒ O. Abdel-Wahab ‒ T. Dao ‒ E. Berman ‒ T Korontsvit ‒ R Brentjens ‒ S Chung ‒ V Zakhaleva ‒ D Douer • Molecular Pathology ‒ V Klimek ‒ R Levine – M Arcila ‒ M Mauro – C Hedvat ‒ J Park ‒ R Rampal • Sellas Life Sciences ‒ D Scheinberg – A Gut
Slide 15: COLUMBIA
ZZ Lc 00162 COLUMBIA esp THE VACCINES