Curis, Inc. · NASDAQ:CRIS
Curis — Investor Presentation (December 2020)
34 slides from Curis's investor presentation, Dec 8, 2020
Slide 1: Corporate Presentation
Corporate Presentation NASDAQ: CRIS Exhibit 99.1
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 Translational Biology Clinical Development Mission Work relentlessly to develop innovative and differentiated therapeutics that improve the lives of cancer patients Strategy Selectthe right targets Designthe right drugs
Slide 4: Company Overview Investment Thesis
Company Overview Investment Thesis Curis seeks to develop novel, first-in-class, cancer therapeutics that we believe have significant potential in areas of unmet patient need Robust Pipeline CA-4948:first-in-class inhibitor of IRAK4 in oncology There are no drugs currently approved for IRAK4 inhibit
Slide 5: Evolution of Curis
Evolution of Curis Progressing through Clinical Studies on the Path to Potential Registration Registrational Strategy Initiate Combination Study of CA-4948 and ibrutinib in NHL and evaluate potential paths for registration Report expanded Ph1 data for CA-4948 study in AML/MDS and identify Recommende
Slide 6: Pipeline
Indication Proof of Principle Safety Dose Optimization Clinical Activity Pivotal Commercial Heme Malignancies CA-4948* IRAK4 MYD88/TLR-altered Lymphoma (NHL) CA-4948* IRAK4 IRAK4L-expressing Leukemia (AML/MDS) Fimepinostat HDAC/PI3K MYC-altered Cancers Immune Checkpoint Inhibitors CI-8993** VISTA VI
Slide 7: IRAK4 Targeted Program in NHL
IRAK4 Targeted Program in NHL CA-4948: In development for treatment of cancers driven by NF-kB and the TLR/Myddosome
Slide 8: CA-4948 Overview
CA-4948 Overview Data from Curis preclinical study Booher et al. AACR 2017 (poster #1168) Smith et al. Nat Cell Biol 2019 Profile Value Proposition First-in-class IRAK4 inhibitor in cancer Specific malignancies in Lymphoma are characterized by overactivity of NF-kB and the TLR/myddosome (which is de
Slide 9: Novel Mechanism of Action for Addressing NF-κB
CA-4948 Novel Mechanism of Action for Addressing NF-κB Pathway is Oncogenic Pathway activates NF-κB Pathway is dependent upon BTK Pathway is Oncogenic2,3,4 Pathway activates NF-κB Pathway is dependent upon IRAK4 Signaling requires myddosome, which requires IRAK4 IMBRUVICA Package Insert. Rev 08/2018
Slide 10: CA-4948 in Lymphoma Trial Design
CA-4948 in Lymphoma Trial Design Study Objectives Primary: Safety and tolerability Secondary:Pharmacokinetic (PK) profile, preliminary anti-cancer activity Study Population Relapsed/Refractory disease Histopathologically confirmed B-cell NHL, including WM/LPL Age ≥ 18 years ECOG performance status o
Slide 11: Two Potential Biomarkers Identified
CA-4948 in Lymphoma Two Potential Biomarkers Identified NF-κB phospho-p50 Positive expression of NF-κB phospho-p50 indicates that the NF-κB complex is active MYD88 Mutation Genetic alteration of MYD88 at baseline causes constitutive activation of the myddosome and is a driver of NF-κB activity ❷ Is
Slide 12: Early Biomarker Data from Phase 1 Patients
CA-4948 in Lymphoma Early Biomarker Data from Phase 1 patients Patient Best Response 12-1002 +86% PD 018-2004 +156% PD 001-4002 +7% PD 002-4004 +75% PD 012-4004 +125% PD 012-5006 +190% PD 013-6001 +98% PD NEGATIVE at baseline NFκB phospho-p50 expression before treatment with CA-4948 Patient Best Res
Slide 13: Demonstrated Anti-Cancer Activity
Demonstrated Anti-Cancer Activity Objective Response observed at 300mg BID (RP2D) Demonstrated Dose Response Tumor burden decreased with each increase in dose CA-4948 in Lymphoma Anti-Cancer Activity and Dose Response in a Patient with Waldenströms Macroglobulinemia (WM) Note: This WM patient is one
Slide 14: 300mg BID (RP2D) Offered Best Balance
CA-4948 in Lymphoma In Updated Ph1 Data, 300mg BID (RP2D) Offered Best Balance of Tolerability and Anti-Cancer Activity 200mg BID or 400mg BID 300mg BID (RP2D) Clear Single Agent Anti-Cancer Activity at RP2D Tumor reduction 6 of 7 pts in a heavily pretreated population (4 prior lines of therapy) Dur
Slide 15: Patients Dosed at Recommended Ph2 Dose
CA-4948 in Lymphoma In Updated Ph1 Data, 300mg BID (RP2D) Offered Best Balance of Tolerability and Anti-Cancer Activity Patients Dosed at Recommended Ph2 Dose (300mg BID) Days on Study (dotted line indicates ongoing treatment) Data cut-off: 23Nov2020 Clear Single Agent Anti-Cancer Activity at RP2D T
Slide 16: 2021 Plan: Combination Therapy with ibrutinib
CA-4948 in Lymphoma 2021 Plan: Initiate Clinical Study in Combination Therapy (CA-4948 + ibrutinib) Days of Treatment vehicle ibrutinib Combination Therapy (CA-4948 + ibrutinib) CA-4948 Monotherapy 0 5 10 15 20 25 30 0 300 600 900 1200 1500 Mean Tumor Volume (mm3) ± SEM Anti-Cancer Activity in Monot
Slide 17: Planned Combination Study Trial Design
CA-4948 in Lymphoma (planned combination study) Trial Design Study Objectives Primary: Safety and tolerability of CA-4948 in combination with ibrutinib Secondary:Pharmacokinetic (PK) profile, preliminary anti-cancer activity Study Population Relapsed/Refractory disease Histopathologically confirmed
Slide 18: IRAK4 Targeted Program in AML/MDS
IRAK4 Targeted Program in AML/MDS CA-4948: In development for treatment of cancers driven by IRAK4-L
Slide 19: Landscape of Disease Targets in AML/MDS
CA-4948 in AML/MDS Landscape of Disease Targets in AML/MDS Non-targeted therapies administered in monotherapy have historically provided limited clinical benefit, especially in relapsed/refractory patients Targeted therapies (e.g., FLT3, IDH) have been limited by the size of their respective target
Slide 20: IRAK4-L Genetic Link to Oncogenic Signaling
IRAK4-L provides a genetic link to oncogenic immune signaling in AML/MDS CA-4948 in AML/MDS IRAK4-L is a Novel Target in AML/MDS Specific Genetic Mutations Drive the Expression of the Long Isoform of IRAK4 (IRAK4-L) Oncogenic IRAK4-L, which is driven by spliceosome mutations (incl. SF3B1 and U2AF1),
Slide 21: CA-4948 in AML/MDS Trial Design
CA-4948 in AML/MDS Trial Design Study Objectives Primary: Maximum tolerated dose and recommended Phase 2 dose Secondary:Pharmacokinetic (PK) profile, preliminary anti-cancer activity Study Population Relapsed/Refractory disease Histopathologically confirmed AML or High-Risk MDS Age ≥ 18 years ECOG p
Slide 22: Monotherapy Anti-Cancer Activity in Early Ph1 Data
CA-4948 in AML/MDS Monotherapy Anti-Cancer Activity Observed in Early Ph1 Data Blasts Baseline Blasts Best Resp Change AML 005-2003 32% 26% -19% AML 005-2002 39% 25% -36% AML 003-1002 24% 9% -63% hrMDS 003-1003 4% 2% -50% hrMDS 003-1001 11% 2% -82% Marrow CR AML 005-2001 23% 1% -96% Marrow CR 1st pa
Slide 23: VISTA Targeted Program in Solid Tumors
VISTA Targeted Program in Solid Tumors CI-8993: In development for treatment of cancers driven by VISTA-mediated Immune Suppression
Slide 24: CI-8993 Overview
CI-8993 Overview In Development for VISTA Expressing and Infiltrated Cancers Profile Value Proposition First-in-class monoclonal antibody antagonist of VISTA Composition-of-matter IP extends into 2034 Target Patient Population Patients with VISTA-expressing cancers (incl. Mesothelioma, NSCLC, and TN
Slide 25: VISTA is an Important Checkpoint Regulator
CI-8993 Target Background VISTA is an Important 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. Scien
Slide 26: Role of VISTA in Immune Suppression in the TME
CI-8993 Target Background Role of VISTA in Immune Suppression in the Tumor Microenvironment (TME) Temporary Immune Activation ❷ MDSC T cells Activated after PD1 Treatment Y Normal Immune Suppression ❶ T Cell Exhausted MDSC Alleviation of Immune Suppression ❹ Y Y Y Y Y Y MDSC Y Y Y T cells Re-Activat
Slide 27: CI-8993 Preclinical Data
αPD1 + αCTLA4 + αVISTA αPD1 + αCTLA4 + isotype CI-8993 Preclinical Data Preclinical anti-cancer activity demonstrated in both monotherapy & combination therapy 1 Le Mercier et al. Cancer Res. 2014 Apr 1 Anti-VISTA inhibited tumor growth in B16ova melanoma model1 Anti-VISTA inhibited xenograft growth
Slide 28: CI-8993 Clinical Plan
CI-8993 Clinical Plan Phase 1 dose escalation study design Patient Population Patients with advanced refractory solid tumors (includes mesothelioma, melanoma, NSCLC, TNBC) Treatment Bi-weekly dosing Mitigate potential toxicities by desensitization, premedication, dosing interval and duration Objecti
Slide 29: Targeted Programs in Heme Malignancies
Targeted Programs in Heme Malignancies Fimepinostat: In development for treatment of MYC-altered cancers
Slide 30: Fimepinostat Overview
Fimepinostat Overview In Development for Patients with MYC-Altered Cancers Qian et.al. Clin Cancer Res. 2012. 18: 4104 Sun et.al. Mol Cancer Ther. 2017. 6: 285 Chen et al. Nature. 2018 Feb 23. 3:5 Profile Value Proposition First-in-class drug candidate with demonstrated anti-cancer activity as a sin
Slide 31: Clinical Anti-Cancer Activity in MYC-Altered Cancers
Fimepinostat Overview Clinical Anti-Cancer Activity in Patients with MYC-Altered Cancers in Ph1 and Ph2 Studies Deep Responses 8 complete responses (CR); 6 partial responses (PR) 2 patients able to proceed to transplant Durable Responses Median duration = 13.6 months Fast Track designation received
Slide 32: Company Summary Investment Thesis
Company Summary Investment Thesis Curis seeks to develop novel, first-in-class, cancer therapeutics that we believe have significant potential in areas of unmet patient need Robust Pipeline CA-4948:first-in-class inhibitor of IRAK4 in oncology There are no drugs currently approved for IRAK4 inhibiti
Slide 33: Curis Leadership Team
Curis Leadership Team Reinhard von Roemeling Head, Clinical Development Raul Soikes Head, Portfolio Management Nancy Soohoo General Counsel William Steinkrauss Chief Financial Officer Mark Noel Head, Intellectual Property Rachel Blasbalg Head, Human Resources James Dentzer President & CEO Christine
Slide 34: End of Presentation
End of Corporate Presentation NASDAQ: CRIS