Cullinan Therapeutics, Inc. · NASDAQ:CGEM
Cullinan Therapeutics — Corporate Update (April 2024)
25 slides from Cullinan Therapeutics's corporate update, Apr 16, 2024
Slide 1: Cullinan Therapeutics: Autoimmune Disease Strategy
Cullinan Therapeutics Autoimmune Disease Strategy April 16, 2024 © CULLINAN THERAPEUTICS, INC. ALL RIGHTS RESERVED.
Slide 2: Important Notice and Disclaimers
Important Notice and Disclaimers This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including statements regarding our strategy, fut
Slide 3: On Today's Call
CULLINAN THERAPEUTICS On Today’s Call Nadim Ahmed Chief Executive Officer Jeff Jones, MD, MPH, MBA Chief Medical Officer Patrick Baeuerle, PhD Chief Scientific Advisor © CULLINAN THERAPEUTICS, © CULLINAN INC. ALL THERAPEUTICS, RIGHTS RESERVED. INC. ALL RIGHTS RESERVED.
Slide 4: Announcing Cullinan Therapeutics
Announcing Cullinan Therapeutics • New Company name, Cullinan Therapeutics, reflects expansion of portfolio into autoimmune diseases. • CLN-978 to be developed exclusively in autoimmune diseases, with system lupus erythematosus (SLE) as a first indication. • New observations from the B-NHL study sho
Slide 5: CLN-978 Opportunity in Autoimmune Diseases
CLN-978 Opportunity in Autoimmune Diseases CLN-978 CLN-978 program update CD19 x CD3 T Cell Engager Development of CD19xCD3 T cell engager in autoimmune diseases ➢ IND submission planned for SLE in 3Q 2024 ➢ Planning for other autoimmune disease indications 𝛼-HSA 𝛼-CD19 𝛼-CD3 ➢ Enrollment in…
Slide 6: Cullinan Oncology Pipeline Remains on Track
Cullinan Oncology Pipeline Remains on Track Program IND- Geographic Phase 1 Phase 2 Phase 3 Status Modality/MOA Enabling Rights Initial combo data and CLN-619 Pan-cancer monotherapy update in Anti-MICA/B antibody 2Q24; Disease specific or its subsidiary owns worldwide rights expansion data in 1H25 C
Slide 7: CLN-978: Clinical Observations and Development Plans in Autoimmune Diseases
CLN-978: Clinical Observations and Development Plans in Autoimmune Diseases © CULLINAN THERAPEUTICS, INC. ALL RIGHTS RESERVED.
Slide 8: CD19 CAR-T generated immune system reset and durable remissions
CD19 CAR-T cell therapy generated immune system reset and durable, treatment-free remissions in autoimmune patients Immune system reset: selected SLE PD data Observations • Mueller et al. (2024) treated 15 autoimmune patients (SLE, IIM, & SSc)1 with autologous CD19 CAR T • SLE and IIM patients had c
Slide 9: CD19 CAR T generally well tolerated; infectious complications frequent
CD19 CAR T was generally well tolerated across autoimmune indications studied; however infectious complications were frequent Class Specific Adverse Events Grade 1 Grade 2+ ICANS 1/15 0/15 CRS* 10/15 1/15 *6/15 patient received tocilizumab • Safety profile generally favorable versus observed safety
Slide 10: CAR T cell therapy: Promising outcomes but multiple challenges
CAR T cell therapy: Promising outcomes but multiple challenges may limit broad uptake in autoimmune diseases Cell therapy limitations • Available cellular therapies all require lymphodepleting chemotherapy, which has been associated with increased risk for infection, infertility, and secondary malig
Slide 11: TCE and CAR-T cells have comparable efficacy in similar NHL patients
TCE and CAR-T cells have comparable efficacy in similar NHL patient populations* YESCARTA1 KYMRIAH2 LUNSUMIO3 Axi-cel Tisa-cel Mosunetuzumab Target/Modality CD19 CAR T CD19 CAR T CD20 TCE (IV) ZUMA-5 Phase 2 ELARA Phase 3 GO29781 Phase 2 Study / pt pop R/R FL 3L+ R/R FL 3L+ R/R FL 3L+ ORR / CR (%) 9
Slide 12: CLN-978: A novel CD19 T cell engager
CLN-978: A novel CD19 T cell engager designed to deliver T cell directed potency with off-the-shelf convenience CLN-978 3 2 4 1 CLN-978 potently triggers redirected lysis of CD19-expressing target cells in vitro and in vivo 𝛼-CD3 𝛼-CD19 𝛼-HSA (scFv) (scFv) (VHH) 2 Engineered to achieve very high…
Slide 13: Targeting CD19 achieves broader coverage of B cell compartment
Targeting CD19 achieves broader coverage of the B cell compartment compared to CD20 or BCMA Stem cell Pro-B cell Pre-B cell Immature B cell Mature B cell Memory B Cell Plasmablast Plasma cell CD19 CD20 BCMA ➢ CD19 directed therapies afford significant potential for deep and broad B cell depletion as
Slide 14: Attractive Opportunity for CLN-978 Amongst Autoimmune Therapies
Attractive Opportunity for CLN-978 Amongst Autoimmune Therapies Targeting B Cells Select assets with disclosed BCMA-CD19-cCAR (iCell Gene Tx) IMPT-514 (ImmPACT) GC012F (AZ/Gracell) AID plans or current use AUTO8 (Autolus) CAR T\\NK ~15-20 other programs DESCARTES-08/-15 LMY-920 ADI-001 from companie
Slide 15: CLN-978 pre-clinical: SC dosing achieved deep B cell depletion in NHPs
CLN-978 pre-clinical highlights: Subcutaneous dosing achieved rapid, deep and sustained B cell depletion with attenuated cytokine release in NHPs Deep, sustained peripheral B cell Subcutaneous dosing attenuated cytokine release in NHPs depletion after a single dose in NHPs IL-6 TNFα 2.5 IV SC Absolu
Slide 16: Deep B cell depletion in tissues following SC CLN-978 in monkeys
Deep B cell depletion in bone marrow, spleen and lymphoid tissues following SC administration of CLN-978 in cynomolgus monkeys Bone Marrow Spleen Lymphoid Tissues Bone marrow Spleen Lymphoid tissue 80 80 80 80 15 15 15 15 60 60 60 60 cells Percent CD20+ cells Percent CD20+ cells Vehicle Percent CD20
Slide 17: CLN-978 in B-NHL: Clinically active at starting dose with favorable safety
CLN-978 in B-NHL: Clinically active at starting dose with favorable safety Clinical observations from B-NHL study (as of 5 April 2024) Disease Characteristics and Efficacy Observations Treatment Emergent Adverse Events1 Prior Duration of Best ID Diagnosis Response Non-Hematological Hematological CRS
Slide 18: Subject #3 case study: mantle cell lymphoma
Subject #3 case study: 68-year-old patient with mantle cell lymphoma Baseline PET-CT After 7 doses of CLN-978 ▪ 7.4 x 1.7 cm mass in left mandible and adjacent musculature was palpable on physical exam at baseline ▪ Investigator reported mass was no longer appreciated on exam 96 hours following the
Slide 19: Rapid, deep and sustained B cell depletion in B-NHL patients
Rapid, deep and sustained B cell depletion was demonstrated in B-NHL patients following CLN-978 dosing Peripheral blood TBNK flow assay Data cut-off 20 March 2024 Last dose CLN978 Subject 1 ▪ Rapid, deep and sustained B cell depletion was demonstrated in 2 of 2 subjects with measurable B cells at ba
Slide 20: CLN-978-SLE-001 planned study design
CLN-978-SLE-001 planned study design PA R T A : D O S E E S C A L AT I O N PAR T B : D O S E E X PAN S I O N Study Population PLANNED DESIGN FEATURES PLANNED DESIGN FEATURES Objectives 1. SLE patients • Step-wise escalation to determine target • Exploration of 2 or more dosing schedules Primary Obje
Slide 21: SLE: High Unmet Need Creates a Compelling Market Opportunity
Systemic Lupus Erythematosus (SLE)1: High Unmet Need Creates a Compelling Market Opportunity High Unmet Need U.S. SLE Market Opportunity – 2024 Estimate ▪ Systemic disease characterized by 163,000 Diagnosed patients (18-70 y/o) autoantibodies produced by B cells, leading to multiple affected organ s
Slide 22: Opportunity for CLN-978 across a range of outcomes in SLE
Due to CAR T cell therapy limitations, opportunity exists for CLN-978 across a range of outcomes in SLE Anti-malarials Corticosteroids NSAIDs Immunosuppressives Opportunity Gap Immunomodulatory BLyS CD19 Therapy Anti-IFN-1 CAR T Current Standards of Care Lower efficacy Higher efficacy Need for conti
Slide 23: Substantial number of addressable autoimmune diseases
Substantial number of addressable autoimmune diseases Opportunity to Address Multiple B Cell Mediated Autoimmune Diseases <50,000+ U.S. Patients 50,000 - 500,000 U.S. Patients 500,000+ U.S. Patients NMOSD SLE Multiple Sclerosis Pemphigus vulgaris Myasthenia gravis Rheumatoid arthritis Autoimmune hem
Slide 24: CLN-978 program: Summary and next steps
CLN-978 program: Summary and next steps ▪ CLN-978 development refocused exclusively on autoimmune diseases ▪ CD19 is the optimal target for autoimmune diseases • CLN-978 represents a potential first in class opportunity with the following differentiated benefits: • Off-the-shelf convenience and subc
Slide 25: Q&A
CULLINAN THERAPEUTICS Q&A Nadim Ahmed Chief Executive Officer Jeff Jones, MD, MPH, MBA Chief Medical Officer Patrick Baeuerle, PhD Chief Scientific Advisor © CULLINAN THERAPEUTICS, © CULLINAN INC. ALL THERAPEUTICS, RIGHTS RESERVED. INC. ALL RIGHTS RESERVED.
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