Curis, Inc. · NASDAQ:CRIS
Curis — Investor Presentation (November 2020)
28 slides from Curis's investor presentation, November 2020
Slide 1: Corporate Presentation
Corporate Presentation NASDAQ: CRIS
Slide 2: Cautionary Note Regarding Forward Looking Statements
Cautionary Note Regarding 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),” “believe(s),” “will,”
Slide 3: Curis Mission & Strategy
Curis Mission & Strategy Developing the New Generation of Targeted Cancer Drugs Innovation Execution Mission Strategy Work relentlessly to develop Select the right targets innovative and differentiated Design the right drugs therapeutics that improve the lives Study the right patients of cancer pati
Slide 4: Company Overview
Company Overview Investment Curis seeks to develop novel, first-in-class, cancer therapeutics Thesis that we believe have significant potential in areas of unmet patient need CA-4948: first-in-class inhibitor of IRAK4 in oncology There are no drugs currently approved for IRAK4 inhibition in oncology
Slide 5: Evolution of Curis
Evolution of Curis Progressing through Clinical Studies on the Path to Potential Registration 2018 2019 2020 Target Discovery Initial Clinical Data Define Registration Path ✓ Work with investigators and FDA to ✓ Report preliminary efficacy data for • Determine R2PD of CA-4948 in NHL and CA-4948 Ph1
Slide 6: Pipeline
Pipeline All Curis programs are novel, first-in-class PRE-CLINICAL CLINICAL MARKETED Dose Clinical Indication Proof of Principle Safety Pivotal Commercial Optimization Activity Heme Malignancies CA-4948* MYD88/TLR-altered IRAK4 Lymphoma (NHL) CA-4948* IRAK4L-expressing IRAK4 Leukemia (AML/MDS) Fimep
Slide 7: Targeted Programs in Heme Malignancies: CA-4948
Targeted Programs in Heme Malignancies CA-4948: In development for treatment of TLR-altered cancers 7
Slide 8: CA-4948 Overview
CA-4948 Overview First-in-Class Inhibitor of IRAK4 in Oncology Affinity Profile Kinase Kd (nM) Designed to be best-in-class IRAK4 23 IRAK4 inhibitor1 IRAK1 12,000 • First-in-class IRAK4 inhibitor in cancer IRAK2 >20,000 • Specific malignancies in Lymphoma are characterized by overactivity of the IRA
Slide 9: CA-4948 Mechanism of Action
CA-4948 Mechanism of Action The TLR Pathway is a primary and independent activator of NF-kB and is oncogenic in both Lymphoma and Leukemia BTK Pathway TLR Pathway B cell TLR1 TLR2 TLR4 TLR5 receptor TLR6 Oncogenic Oncogenic − Dysregulation drives excessive B Cell proliferation − Dysregulation drives
Slide 10: CA-4948 in Lymphoma
CA-4948 in Lymphoma Preliminary Phase 1 Data Demonstrate Tolerability, PK, PD, and Anti-Cancer Activity Patient Population • Patients with R/R Lymphoma (incl DLBCL, WM, 50mg BID and patients with MYD88-altered disease) n=3 [+3] 50mg QD 100mg BID 200mg BID Higher Doses Continue dose escalation Treatm
Slide 11: CA-4948 in Lymphoma: Single Agent Dose Response
CA-4948 in Lymphoma Single Agent Dose Response Observed as Phase 1 Study Advances to Therapeutic Dose Levels Change in Tumor Burden Change in Tumor Burden 14 Evaluable Patients at Sub-Therapeutic Dose Levels 50mg - 100mg 60% 50mg QD – 100mg BID (qd & bid) 40% Best Response 20% -20% -40% Dose Respons
Slide 12: CA-4948 in Lymphoma
CA-4948 in Lymphoma Single Agent Dose Response Observed as Phase 1 Study Advances to Therapeutic Dose Levels Dose Response Observed Increased tumor reduction observed as patient increased dose 12
Slide 13: CA-4948 in Lymphoma: Combination with BTKi
CA-4948 in Lymphoma Combination with BTKi leads to Potent Anti-Cancer Activity in MYD88-altered DLBCL Models Preclinical Anti-Cancer Activity Preclinical Anti-Cancer Activity in MYD88-altered DLBCL1 (OCI-Ly10) Potent as Single Agent vehicle • Anti-cancer activity demonstrated in MYD88-altered DLBCL
Slide 14: CA-4948 in AML/MDS
CA-4948 in AML/MDS Additional Regulatory Path Identified in AML/MDS Specific Genetic Mutations Lead to Expression of the Long Isoform of IRAK4 (IRAK4-L) Oncogenic IRAK4-L, which is driven by spliceosome mutations (incl. SF3B1 and U2AF1), is preferentially expressed >50% of AML/MDS patients IRAK4-L i
Slide 15: CA-4948 in AML/MDS: Preclinical Data
CA-4948 in AML/MDS Preclinical data supporting opportunity in AML/MDS Xenografts Treated with CA-4948 Treatment with CA-4948 Cell lines Overexpressing IRAK4-L Maintained Normal Spleen Size Prevented Leukemic Engraftment Are More Sensitive to CA-4948 (surrogate for leukemic burden) in Almost All Xeno
Slide 16: CA-4948 in AML/MDS: Phase 1 Study Design
CA-4948 in AML/MDS Phase 1 Study Design Upcoming Milestones FDA supports study initiation ✓ Initiated Ph1 study in Q2 2020 at therapeutic dosing level (200mg BID) • Report initial data by end of 2020 Patient Population • Patients with R/R AML and High Risk MDS Treatment 200mg BID Higher Doses Contin
Slide 17: Monoclonal Antibody Immune Checkpoint Inhibitor CI-8993
Monoclonal Antibody Immune Checkpoint Inhibitor CI-8993: In development for treatment of VISTA-expressing cancers 17
Slide 18: CI-8993 Overview
CI-8993 Overview In Development for VISTA Expressing and Infiltrated Cancers Curis is the first to advance an oral small molecule checkpoint inhibitor into the clinic Profile • First-in-class monoclonal antibody antagonist of VISTA Value Proposition • No anti-VISTA drugs currently in the clinic • Co
Slide 19: CI-8993 Target Background
CI-8993 Target Background VISTA is a Major Checkpoint Regulator • CTLA-4, PD-1, and VISTA are the three main players in controlling checkpoint blockade • VISTA controls early T cell activation events • Blockade of VISTA will allow for an expanded T cell response against tumors Eltanbouly et al. Scie
Slide 20: Role of VISTA in Immune Suppression in the TME
CI-8993 Target Background Role of VISTA in Immune Suppression in the Tumor Microenvironment (TME) Blocking PD-1 VISTA Blocking VISTA activates T cells re-suppresses T cells1 re-activates T cells2 ❶ ❷ ❸ ❹ Normal Immune Suppression Temporary Immune Activation VISTA-mediated Immune Suppression Alleviat
Slide 21: CI-8993 Preclinical Data
CI-8993 Preclinical Data Preclinical efficacy demonstrated in both monotherapy & combination therapy Monotherapy Combination Therapy Anti-VISTA inhibits tumor growth Anti-VISTA inhibits xenograft growth in B16ova melanoma model1 in checkpoint resistant CT26 model2 Control n=14 100% Day 0 Day 2 Day 4
Slide 22: CI-8993 Clinical Plan
CI-8993 Clinical Plan Phase 1 dose escalation study to begin in 2H 2020 Patient Population • Patients with advanced refractory solid tumors Curis Design for Ph1 Dose Escalation Study (includes mesothelioma, melanoma, NSCLC, TNBC) Treatment 0.15mg/kg Level 2 Level 3 Higher Doses Continue dose escalat
Slide 23: Targeted Programs in Heme Malignancies: Fimepinostat
Targeted Programs in Heme Malignancies Fimepinostat: In development for treatment of MYC-altered cancers 23
Slide 24: Fimepinostat Overview
Fimepinostat Overview In Development for Patients with MYC-Altered Cancers PI3Ki Profile Mechanism #1 HDACi Mechanism #2 The HDAC component The PI3K component Suppresses Enhances • First-in-class drug candidate with demonstrated anti-cancer activity as a MYC transcription2 MYC destruction2 Value Pro
Slide 25: Fimepinostat Clinical Data in MYC-Altered Lymphoma
Fimepinostat Clinical Data Provides Strong Rationale For Development in MYC-Altered Lymphoma Deep Responses in MYC-altered subset of patients (49 evaluable patients; 60 ITT patients) Monotherapy Anti-Cancer Activity CR/PR Deep responses SD/PD • 8 complete responses (CR); 6 partial responses (PR) MY
Slide 26: Company Summary
Company Summary Investment Curis seeks to develop novel, first-in-class, cancer therapeutics Thesis that we believe have significant potential in areas of unmet patient need CA-4948: first-in-class inhibitor of IRAK4 in oncology There are no drugs currently approved for IRAK4 inhibition in oncology
Slide 27: Leadership Team
Curis Leadership Team Rachel Blasbalg James Dentzer Christine Guertin Robert Martell Head, Human Resources President & CEO Head, Regulatory Head, R&D Mark Noel Reinhard von Roemeling Raul Soikes Nancy Soohoo William Steinkrauss Head, Intellectual Property Head, Clinical Development Head, Portfolio M
Slide 28: End of Corporate Presentation
End of Corporate Presentation NASDAQ: CRIS