Curis, Inc. · NASDAQ:CRIS
Curis — Investor Presentation (September 2017)
28 slides from Curis's investor presentation, Sep 13, 2017
Slide 1: Corporate Presentation September 2017
Corporate Presentation September 2017 Exhibit 99.1 © Curis, Inc. 2017 - All Rights Reserved
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 program overview
Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL CA-170 * PD-L1 / VISTA Solid Tumors & Lymphomas CA-4948 * IRAK4 Non-Hodgkin’s Lymphoma CA-327 * PDL1 / TIM3 Cancers Erivedge® ** Smoothened Advanced Basal Cell Carcinoma Immuno
Slide 5: CUDC-907 potential treatment for MYC-altered DLBCL
CUDC-907 has the potential to become a treatment for MYC-altered DLBCL CUDC-907 Phase 2 drug candidate to treat MYC-driven DLBCL Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL
Slide 6: CUDC-907: oral inhibitor of HDAC and PI3K
HDACi PI3Ki CUDC-907 Oral, small molecule inhibitor of HDAC & PI3K enzymes1 Down-regulates MYC mRNA and protein levels2 Phase 1 heme study completed (88 patients) – relapsed/ refractory (R/R) lymphoma or multiple myeloma3 Favorable safety and tolerability observed Objective responses (CRs and PRs) i
Slide 7: DLBCL and MYC
DLBCL and MYC 35% of newly diagnosed DLBCL patients have MYC alterations1 Double-Hit Lymphoma:rearrangements of MYC and BCL2 and/or BCL6 genes, assessed by FISH Double-Expressor Lymphoma:overexpression of MYC and BCL2 proteins, assessed by IHC Newly-Diagnosed DLBCL Patient Population MYC IHC+ 30% Do
Slide 8: CUDC-907 Phase 1 and Phase 2 Trials in DLBCL
CUDC-907 Phase 1 and Phase 2 Trials in DLBCL Study population Relapsed or refractory DLBCL after ≥2 prior regimens Total of 105 patients enrolled in Phase 1 (37) and Phase 2 (68) Treatment: oral, once daily dosing – RP2D 5/2 (5 days on, 2 days off): 60mg continuous dosing Safety and tolerability No
Slide 9: 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 Durable responses, including a number of CRs observed Combined 7 durable CRs observed between Phase 1 and Phase 2 trials Responses predominantly observed in patients with MYC-altered disease status Combined r
Slide 10: CUDC-907 Development Status
CUDC-907 Development Status Safety and tolerability observed to date at recommended dose and schedule No new safety findings in Phase 2 trial Durable CRs and PRs observed preferentially in patients with MYC-altered DLBCL Interim results show clinical benefit predominantly observed in patients with M
Slide 11: CA-170 first-in-class oral 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 12: 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 13: 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 14: CA-170 Phase 1 Trial dose escalation
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 15: 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 16: CA-170 is a Checkpoint Inhibitor in Patients
CA-170 is a Checkpoint Inhibitor in Patients Observed increase in T cells in Tumor Observed 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; immunothera
Slide 17: CA-170 biomarker signals and tumor shrinkage
CA-170 is a Checkpoint Inhibitor in Patients Preliminary data demonstrate compelling biomarker signals and evidence of tumor shrinkage Tumor Change by Cycle Presented at the European Society for Medical Oncology (ESMO) 2017 Congress Initial Clinical Data consistent with Pre-Clinical Data Appears saf
Slide 18: CA-170 Phase 1b Trial dose expansion
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 19: CA-327 oral small molecule 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 20: 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 21: CA-4948 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 Non-Hodgkin’s Lymphoma
Slide 22: IRAK4 kinase in TLR and IL-1R signaling
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 23: 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 24: 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 25: Pipeline program overview
Program Indication Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Marketed CUDC-907 HDAC / PI3K MYC-Altered DLBCL CA-170 * PD-L1 / VISTA Solid Tumors & Lymphomas CA-4948 * IRAK4 Non-Hodgkin’s Lymphoma CA-327 * PDL1 / TIM3 Cancers Erivedge® ** Smoothened Advanced Basal Cell Carcinoma Immuno
Slide 26: 2017 Projected Milestones
CA-170 Phase 1 initial data, Clinical profilen Q4 2017 SITC CA-4948 IND filing n Q3 2017 CA-327 IND filing n Q1 2018 2017 Projected Milestones
Slide 27: Summary of Financials
$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
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