Curis, Inc. · NASDAQ:CRIS
Curis — Investor Presentation (November 2017)
28 slides from Curis's investor presentation, Nov 13, 2017
Slide 1: Corporate Presentation
Corporate Presentation © Curis, Inc. 2017 – All Rights Reserved Exhibit 99.1
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 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 HDAC and PI3K inhibitor
HDACi PI3Ki CUDC-907 Oral, small molecule inhibitor of HDAC & PI3K enzymes1 Down-regulates MYC mRNA and protein levels2 Phase 1 study completed (88 patients) – relapsed/ refractory (R/R) lymphoma or multiple myeloma3 Favorable safety and tolerability observed Objective responses (CRs and PRs) in pat
Slide 7: DLBCL and MYC
DLBCL and MYC 35% of newly diagnosed DLBCL patients have MYC alterations1 Newly-Diagnosed DLBCL Patient Population MYC+ by IHC 30% Double-Expressor 25% overexpression of MYC and BCL2, assessed by IHC MYC+ by FISH 12% Double-Hit 8% rearrangements of MYC and BCL2/BCL6, assessed by FISH 1. Curr Hematol
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 Interim Trial Results
CUDC-907 Phase 1 and Phase 2 Interim Trial Results Monotherapy in relapsed/refractory DLBCL Durable responses, including Complete Responses 7 durable CRs observed (Phase 1 & 2 combined) Responses observed predominantly in patients with MYC-altered disease status 22.2% ORR in MYC+(Phase 1 & 2 combine
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 interim Phase 2 trial results Durable CRs and PRs observed preferentially in patients with MYC-altered DLBCL Clinical benefit in patients with MYC+ relapsed/refractory DLBC
Slide 11: CA-170 first-in-class oral 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 PDL1 / VISTA Solid Tumors & Lymphom
Slide 12: CA-170 is a Checkpoint inhibitor
CA-170 is a Checkpoint inhibitor Ex-vivo and in vivo T cell activation and anti-tumor activity * Ref: Powderly etc, ESMO, 2017 * Rationally designed, orally bioavailable small molecule Targets 2 non-redundant immune checkpoints: PDL1 and VISTA
Slide 13: CA-170 Phase 1 Trial
CA-170 Phase 1 Trial Dose escalation stage Objectives Primary: Recommended Phase 2 Dose (RP2D), Safety Secondary: PK, PD, anti-cancer activity Patient Population Patients with advanced solid tumors or lymphoma Study sites in South Korea, US, Spain, UK Treatment Oral, once daily, dosing in continuous
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 dose in patients was similar to 10mg/kg dose in mouse (active dose) Dose proportional increase in exposure with increasing d
Slide 15: CA-170 Anti-tumor Activity
CA-170 Anti-tumor Activity IO treatment-naïve patients treated during dose escalation *ongoing patients
Slide 16: CA-170 Anti-tumor Activity – Duration on Rx
CA-170 Anti-tumor Activity – Duration on Rx All patients treated during dose escalation
Slide 17: CA-170 Tumor Pharmacodynamics
CA-170 Tumor Pharmacodynamics Post-treatment increase in cytotoxic T cells in tumors GROUP 1 - naïve to ICI therapy - approved PD(L)1 tumor type GROUP 2 - naïve to ICI therapy - not approved PD(L)1 tumor type -17.24 49.09 22.25 9.52 0.94 0 -14.03 19.05 0 -0.73 % Change RECIST/Cheson * * * * * Ongoin
Slide 18: CA-170 Development Path
CA-170 Development Path Expansion in key cancer types and profiling of patient tumors 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 G
Slide 19: CA-327 oral small molecule immune checkpoint inhibitor
CA-327 is an oral, small molecule immune checkpoint inhibitor IND filing expected in 1H 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 Active and Combines with CA-170
CA-327 Is Active and Combines with CA-170 Selectively targets PDL1 and TIM3 CA-327 (50) CA-170 (100) Combo. (100+50) Anti-PD-1 Isotype Ctrl. Vehicle Days post randomization
Slide 21: CA-4948 oral small molecule inhibitor of IRAK4
CA-4948 is an oral, small molecule inhibitor of IRAK4 Patient enrollment expected in 4Q 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 Lymp
Slide 22: CA-4948 and IRAK4
Inhibition of B cell receptor signaling provides clinical efficiency in MCL, WM, MZL and other lymphomas Overactive Toll-like receptor (TLR) pathway is another hallmark of some B cell lymphomas MYD88 mutations constitutively activate the TLR pathway CA-4948 is a small-molecule inhibitor of interleuk
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: 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 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: Projected Milestones
CUDC-907 Updated regulatory path n Q1 2018 CA-170 Phase 1 dose escalationn Ongoing Phase 2 expansion trial n Q4 2017 – in India CA-4948 Phase 1 dose escalation n Q4 2017 CA-327 IND filing n 1H 2018 Projected Milestones
Slide 27: Summary of Financials
Summary of Financials As of September 30, 2017 as of Sept 30 Cash & Marketable Securities $69.2M Basic Shares Outstanding164.0M Fully Diluted Shares Outstanding 181.0M Note: Fully Diluted Shares = 164.0M basic shares + 17.0M options
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