Curis, Inc. · NASDAQ:CRIS
Curis — Investor Presentation (August 2017)
26 slides from Curis's investor presentation, Aug 3, 2017
Slide 1: Corporate Presentation August 2017
Corporate Presentation August 2017 Exhibit 99.2
Slide 2: Forward-looking statements
This presentation contains certain forward-looking statements about Curis, Inc. (“we,” “us,” or the “Company”) within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “expect(s),” “feel(s),” “believe(s),” “will,” “may,” “anticipate(s)” and similar expres
Slide 3: Mission: Innovative Medicines to Treat Cancer Effectively
Mission: Innovative Medicines to Treat Cancer Effectively Precision Oncology Oncology-Focused Biotech Pipeline of differentiated small molecule cancer drug candidates Developing and intend to commercialize oncology drugs Partnerships: Aurigene, Genentech/Roche Immuno-oncology
Slide 4: Pipeline: Immuno-oncology and Precision Oncology
Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL MYC-Driven Solid Tumors CA-170 * PD-L1 / VISTA Solid Tumors & Lymphomas CA-327 * PD-L1 / TIM3 Cancers CA-4948 * IRAK4 Hematologic malignancies Erivedge® ** Smoothened Advanced
Slide 5: CUDC-907 has the potential to become a treatment for MYC-altered cancers
CUDC-907 has the potential to become a treatment for MYC-altered cancers CUDC-907 Phase 2 drug candidate to treat MYC-driven cancers Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL MYC-Driven Solid Tumors
Slide 6: CUDC-907: oral inhibitor of HDAC and PI3K enzymes
HDACi PI3Ki CUDC-907 Oral, small molecule inhibitor of HDAC & PI3K enzymes Down-regulates MYC mRNA and protein levels Phase 1 heme study completed (88 patients) – relapsed/ refractory (R/R) lymphoma or multiple myeloma Favorable safety and tolerability observed Objective responses (CRs and PRs) in p
Slide 7: CUDC-907 Phase 1 and Phase 2 Trial Parameters
CUDC-907 Phase 1 and Phase 2 Trial Parameters Study Population Relapsed or refractory lymphoma or multiple myeloma after ≥2 prior regimens Total of 88 patients enrolled Objectives Primary: MTD, recommended Phase 2 dose (RP2D) Secondary: Safety and tolerability, pharmacokinetics, biomarkers, anti-can
Slide 8: CUDC-907 Phase 1 and Phase 2 Interim Trial Results
CUDC-907 Phase 1 and Phase 2 Interim Trial Results Monotherapy in relapsed/refractory DLBCL Favorable safety and tolerability observed to date Durable responses, including a number of CRs observed Responses predominately observed in patients with MYC-altered disease status Phase 1 Trial (Interim) Ph
Slide 9: CUDC-907 Phase 2 Trial Status
CUDC-907 Phase 2 Trial Status Monotherapy in MYC-altered relapsed/refractory DLBCL Open label study to evaluate the efficacy and safety of CUDC-907 monotherapy in patients with relapsed/refractory (R/R) DLBCL – after 2 prior treatments Study Status Interim analysis conducted following enrollment of
Slide 10: CA-170 is a first-in-class oral small molecule immune checkpoint inhibitor
CA-170 is a first-in-class oral small molecule immune checkpoint inhibitor In Phase 1 clinical development CA-170 Oral, small molecule checkpoint inhibitor – PDL1 and VISTA Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CA-170 PD-L1 / VISTA Solid Tumors & Lympho
Slide 11: Small Molecule Checkpoint Inhibitors
Small Molecule Checkpoint Inhibitors Oral, small molecules designed to bind inhibitory checkpoints Common folding structure in the extracellular domain PD-L1Expressed on immune and tumor cells VISTAExpressed on myeloid cells, including MDSCs TIM3Co-expressed with PD-1 on highly exhausted CD8+ T cell
Slide 12: CA-170 is a Checkpoint inhibitor
CA-170 Concentration (log nM) Activation (%) CA-170 is a Checkpoint inhibitor Ex-vivo and in vivo T cell activation and anti-tumor activity Increase in Activated CD8+ T cells In vivo Activation of PDL1 or VISTA-inhibited T cells Activation (%) CA-170 Concentration (log nM) Anti-Tumor Activity In viv
Slide 13: CA-170 Phase 1 Trial: dose escalation stage
CA-170 Phase 1 Trial Dose escalation stage Patient Population Patients with advanced solid tumors or lymphoma Study sites in US, EU, and Asia Objectives Safety/Tolerability, PK, PD, Recommended Phase 2 Dose (RP2D), anti-cancer activity Treatment Oral, once daily, dosing in continuous 21-day cycles D
Slide 14: CA-170 Oral Exposure in Patients
CA-170 Oral Exposure in Patients 50mg – 800mg dose – continuous once daily dosing PK profile in patients was similar to PK observed in non-clinical models Cmax and AUC at 50mg starting dose in patients was similar to 10mg/kg dose in mouse (active dose) Dose proportional increase in exposure with inc
Slide 15: CA-170 is a Checkpoint Inhibitor in Patients
CA-170 is a Checkpoint Inhibitor in Patients Increase in T cells in Tumor Increase in CD8+ T cells in patient tumor biopsies after CA-170 treatment Assessed after first cycle of CA-170 treatment at 600mg dose (21 days) Patient with colorectal cancer, 5 prior treatments; immunotherapy treatment-naïve
Slide 16: CA-170 Phase 1b Trial: dose expansion design and plans
CA-170 Phase 1b Trial Dose expansion design and plans Melanoma NSCLC RCC HL TNBC HNSCC CRC Bladder Gastric + Etc CA-170 Treatment Clinical Parameters Tumor and Immune Profile Parameters Tumor shrinkage Duration on treatment AE / irAE profile Tumor infiltrate profile Gene expression profile Expressio
Slide 17: CA-327 is an oral, small molecule immune checkpoint inhibitor
CA-327 is an oral, small molecule immune checkpoint inhibitor IND filing expected in Q1 2018 CA-327 Oral, small molecule checkpoint inhibitor – PDL1 and TIM3 Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CA-327 PD-L1 / TIM3 Cancers
Slide 18: CA-327 Is a Checkpoint Inhibitor
CA-327 Is a Checkpoint Inhibitor Selectively targets PDL1 and TIM3 CA-327 Vehicle Blood CD8+/CD69+ T cells Vehicle Control Anti-PD1 Antibody 1mg/kg CA-327 Tumor CD8+/CD69+ T cells Vehicle Control Anti-PD1 Antibody 1mg/kg CA-327 Tumor Model Treatment % TGI at Dose (mg/kg) 1 3 10 B16F10 melanoma CA-32
Slide 19: CA-4948 is an oral, small molecule inhibitor of IRAK4
CA-4948 is an oral, small molecule inhibitor of IRAK4 IND filing expected in 3Q 2017 (Phase 1 trial in Non-Hodgkin’s Lymphoma) CA-4948 Oral, small molecule inhibitor of IRAK4 Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CA-4948 IRAK4 Heme malignancies
Slide 20: IRAK4 kinase in TLR and IL-1R signaling pathways
IRAK4 kinase is a critical component of toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways – implicated in certain cancers IRAK4 kinase, through IRAK1 is critical for NF-kB activation for cytokine secretion & cell survival Recruitment of IRAK4 to TLR/ IL-1R mediated by my
Slide 21: Prevalence of Oncogenic MYD88 Mutations
Prevalence of Oncogenic MYD88 Mutations Non-Hodgkin lymphomas Indication MYD88-L265P Diffuse Large B-cell Lymphoma (ABC-DLBCL) 15-29% Immune-privileged DLBCL (IP-DLBCL) 50-80% Waldenstrom’s Macroglobulinemia (WM) 95-97% Lymphoplasmacytic Lymphoma (LPL) 79% Splenic Marginal Zone Lymphoma (SMZL) 6-10%
Slide 22: CA-4948 Exhibited Significant In vivo Activity
CA-4948 Exhibited Significant In vivo Activity MYD88-mutant DLBCL tumor models CA-4948 is a potent and selective IRAK4 inhibitor In vivo anti-tumor activity in multiple MYD88-mutant (L265P) vs. MYD88-wt DLBCL tumor models
Slide 23: Pipeline summary
Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL MYC-Driven Solid Tumors CA-170 * PD-L1 / VISTA Solid Tumors & Lymphomas CA-327 * PD-L1 / TIM3 Cancers CA-4948 * IRAK4 Hematologic malignancies Erivedge® ** Smoothened Advanced
Slide 24: 2017 Projected Milestones
CA-170 Phase 1 initial data, Clinical profilen Q3 2017ESMO n Q4 2017SITC CA-4948 IND filing n Q3 2017 CA-327 IND filing n Q1 2018 2017 Projected Milestones
Slide 25: Summary of Financials As of June 30, 2017
$51.0MCash & Marketable Securities 143.9MShares Outstanding - Basic 162.5MShares Outstanding - Fully Diluted* *Diluted Shares = 143.9M basic shares + 18.6M options Summary of Financials As of June 30, 2017
Slide 26: END
END