Curis, Inc. · NASDAQ:CRIS
Curis — Investor Presentation (May 2021)
34 slides from Curis's investor presentation, May 2021
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 Robust There are no drugs currently approved for IRAK4 inhibition in o
Slide 5: Evolution of Curis
Evolution of Curis Progressing through Clinical Studies on the Path to Potential Registration 2019 2020 2021 Initial Clinical Data Expand Clinical Opportunities Registrational Strategy Report initial Ph1 data for CA-4948 in Report expanded Ph1 data for CA-4948 study Initiate Combination Study
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: IRAK4 Targeted Program in AML/MDS
IRAK4 Targeted Program in AML/MDS CA-4948: In development for treatment of cancers driven by IRAK4-L 7
Slide 8: CA-4948: First-in-Class Inhibitor of IRAK4 in Oncology
CA-4948 Overview In Nov 2020, the NCI selected CA-4948, Curis’s First-in-Class Inhibitor of IRAK4 in Oncology first-in-class IRAK4 inhibitor, and entered into an agreement (“CRADA”) with Curis to conduct both clinical and non-clinical studies of CA-4948 Profile in oncology • First-in-class IRAK4 inh
Slide 9: IRAK4-L is a Novel Target in AML/MDS
CA-4948 in AML/MDS IRAK4-L is a Novel Target in AML/MDS Normal Malignant Haematopoietic Cell Haematopoietic Cell Spliceosome Spliceosome Mutation on U2AF1 specific genetic mutations (incl. U2AF1 and SF3B1) drive the expression of IRAK-L, the long isoform of IRAK4 Myddosome Myddosome MYD88 MYD88 IRAK
Slide 10: Targeting IRAK-L Demonstrates Anti-Cancer Activity in Preclinical Models
CA-4948 in AML/MDS Targeting IRAK-L Demonstrates Anti-Cancer Activity in Preclinical Models IRAK4-L is Oncogenic CA-4948 Targets IRAK4-L Specimen 001-7-3068 Blocking IRAK4-L CA-4948 reduces formation of treatment reduces leukemia colonies leukemic blasts in preclinical studies1 Specimen 001-7-3067 i
Slide 11: 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 % of Patient Disease Driver Population provided limited clinical benefit, especially in relapsed/refractory patients IRAK4-L > 50%1 FLT3 25-30%2 • Targeted therapies (e.g
Slide 12: Trial Design
CA-4948 in AML/MDS Trial Design Data cut-off: 23Nov2020 Study Objectives Overall Primary: Maximum tolerated dose and recommended Phase 2 dose Baseline Characteristics of Ph1 Patients (N=6) Secondary: Pharmacokinetic (PK) profile, preliminary anti-cancer activity Male (%) 5 (83%) Female (%) 1 (17%) S
Slide 13: Monotherapy Anti-Cancer Activity Observed in Early Ph1 Data
CA-4948 in AML/MDS Monotherapy Anti-Cancer Activity Observed in Early Ph1 Data 40% AML 35% hrMDS • 1st patient dosed in Q3 2020 30% • Consistent reduction of Marrow Blasts across population (6 patients) Bone Marrow Blast Percentage 300mg 25% 300mg • 2 patients have achieved Marrow CR 20% Blasts Blas
Slide 14: Identifying the patient population that may benefit from CA-4948
CA-4948 in AML/MDS Identifying the patient population that may benefit from treatment with CA-4948 (Feb 8 cutoff) Planned Study Expansion ASH ASH EHA Abstract 2019 2020 2021 Monotherapy – 4 cohorts: 1) hrMDS, R/R to HMA, w/spliceosome mut 2) hrMDS, R/R to HMA, w/o spliceosome mut 6 patients 15 patie
Slide 15: 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 15
Slide 16: Novel Mechanism of Action for Addressing NF-κB
CA-4948 Novel Mechanism of Action for Addressing NF-κB BCR and TLR are parallel pathways and primary independent activators of NF-κB BCR Pathway TLR Pathway B cell TLR1 TLR2 TLR4 TLR5 receptor TLR6 Pathway is Oncogenic Pathway is Oncogenic2,3,4 Endosome Pathway activates NF-κB TLR7 TLR8 TLR9 Pathway
Slide 17: Trial Design
CA-4948 in Lymphoma Trial Design Data cut-off: 23Nov2020 Overall Baseline Characteristics of Ph1 Patients (N=31) Male 26 (84%) Study Objectives Female 5 (16%) Primary: Safety and tolerability Secondary: Pharmacokinetic (PK) profile, preliminary anti-cancer activity Median Age 69yrs Histology Diffuse
Slide 18: Treatment Emerging Adverse Events
Treatment Emerging Adverse Events Most AEs have been Grade 1-2, manageable, and reversible 200 mg BID 300 mg BID 400 mg BID All General (n=5); (%) (n=6); (%) (n=8); (%) (n=30); (%) Adverse Reaction • No Grade 5 toxicity All Grade All Grade All Grade All Grades 3 or 4 Grades 3 or 4 Grades 3 or 4 Grad
Slide 19: Two Potential Biomarkers Identified
CA-4948 in Lymphoma Two Potential Biomarkers Identified ❷ Is NF-κB activity driven by the TLR/myddosomal axis? BCR Pathway TLR Pathway MYD88 Mutation B cell TLR1 TLR2 Genetic alteration of MYD88 at baseline TLR4 TLR5 receptor TLR6 causes constitutive activation of the myddosome and is a driver of NF
Slide 20: Early Biomarker Data from Phase 1 Patients
CA-4948 in Lymphoma Early Biomarker Data from Phase 1 patients This clinical study is ongoing, more data are needed to confirm these potential biomarkers p-p50 Biomarker May Support Patient Selection NF-κB phospho-p50 NF-κB phospho-p50 protein expression at baseline • Patients whose tumors do not ex
Slide 21: Anti-Cancer Activity and Dose Response in a Patient with WM
CA-4948 in Lymphoma Anti-Cancer Activity and Dose Response in a Patient with Waldenströms Macroglobulinemia (WM) Data cut-off: 23Nov2020 Note: This WM patient is one of the two patients in the Ph1 study who tested positive for MYD88 Demonstrated Anti-Cancer Activity Objective Response observed at 30
Slide 22: 300mg BID (RP2D) Offered Best Balance of Tolerability and Activity
CA-4948 in Lymphoma In Updated Ph1 Data, 300mg BID (RP2D) Offered Best Balance of Tolerability and Anti-Cancer Activity Change in Tumor Burden for 13 Evaluable Patients (200mg BID+) • Clear Single Agent Anti-Cancer Activity at RP2D 50% Tumor reduction 6 of 7 pts in a heavily pretreated population (4
Slide 23: 300mg BID (RP2D) Offered Best Balance of Tolerability and Activity
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 • Clear Single Agent Anti-Cancer Activity at RP2D (300mg BID) Tumor reduction 6 of 7 pts in a heavily pretreated population (4 prior lines of
Slide 24: 2021 Plan: Initiate Clinical Study in Combination Therapy
CA-4948 in Lymphoma 2021 Plan: Initiate Clinical Study in Combination Therapy (CA-4948 + ibrutinib) Anti-Cancer Activity in Monotherapy and Combination Therapy in MYD88-altered DLBCL preclinical model (OCI-Ly10) 1500 vehicle Mechanism of Action Supports Combination 1200 • CA-4948 potentially offers
Slide 25: CA-4948 in Lymphoma Combination Study Trial Design
CA-4948 in Lymphoma (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 B-c
Slide 26: 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 26
Slide 27: 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 • Composition-of-matter IP extends into 2034 • Pat
Slide 28: 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.
Slide 29: 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 30: CI-8993 Preclinical Data
CI-8993 Preclinical Data Preclinical anti-cancer activity demonstrated in both monotherapy & combination therapy Monotherapy Combination Therapy Anti-VISTA inhibited tumor growth Anti-VISTA inhibited xenograft growth in B16ova melanoma model1 in checkpoint resistant CT26 model2 Control n=14 100% Day
Slide 31: CI-8993 Clinical Plan
CI-8993 Clinical Plan Phase 1 dose escalation study design 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 escalation • Bi-week
Slide 32: 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 Robust There are no drugs currently approved for IRAK4 inhibition in on
Slide 33: 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 34: End of Corporate Presentation
End of Corporate Presentation NASDAQ: CRIS