Marker Therapeutics, Inc. · NASDAQ:MRKR
Marker Therapeutics — Investor Presentation (March 2021)
38 slides from Marker Therapeutics's investor presentation, Mar 16, 2021
Slide 1: Corporate Presentation March 2021
CORPORATE PRESENTATION March 2021
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS Certain statements contained herein are forward - looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as
Slide 3: Now is the Time for a Breakthrough in Cell Therapy
3 Now is the Time for a Breakthrough in Cell Therapy CAR - T, TCR and NK therapies have made headway in treating cancer, but data underscores the many hazards and limitations Clinical Impact Limited durability of response Limitations in solid tumors Limitations of Single Antigen Targeting Treatment
Slide 4: Marker – Non-engineered, Multi Tumor Associated Antigen T cells
4 Marker – Non - engineered, Multi Tumor Associated Antigen T cells Marker has strong clinical data and potentially addresses limitations of other cell therapies DC Overlapping Peptide pools PBMCs MTAA T cell TCR TRAIL FASL Tumor cell Apoptosis PRAME Survivin NY - ESO - 1 WT1 MultiTAA - specific T c
Slide 5: Marker Therapeutics Management Team and Scientific Advisory Board
Marker Therapeutics Management Team Scientific Advisory Board James P. Allison, Ph.D. Chair, Department of Immunology The University of Texas MD Anderson Cancer Center C liona M. Rooney, Ph.D. Professor of Pediatrics & Molecular Virology and Microbiology, and Immunology Baylor College of Medicine Ma
Slide 6: About MultiTAA
ABOUT MultiTAA
Slide 7: Targeting Multiple Antigens for Improved Outcomes
Targeting Multiple Antigens for Improved Outcomes In contrast to mono - specific T cells, MultiTAA T cells recognize up to 5 antigens for a potentially more potent, durable anti - tumor response. Unique Benefits of MultiTAA T Cell Therapy 7 Targets Multiple Antigens Target expression of multiple tum
Slide 8: Favorable Safety Profile and Administration
Favorable Safety Profile and Administration 8 • Administration & dose • 10 min infusion at clinic without need for hospitalization or ICU stay • Administered in various tumor types, typically 20 x 10 6 /m 2 with 3 infusions over 2 - 4 week intervals • Safety profile in over 150 patients treated to d
Slide 9: MultiTAA Platform Leading with AML
MultiTAA Platform Leading with AML Preclinical Ph. I & Ph. I/II Ph. II Ph. III Acute Myeloid Leukemia Breast Cancer Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Lymphoma Multiple Myeloma Pancreatic Cancer Sarcoma 9 BCM studies demonstrate potential of MultiTAA T cell therapy Investigator spon
Slide 10: Leveraging the Accomplishments at Baylor and Advancing our Programs at Marker
10 Leveraging the Accomplishments at Baylor and Advancing our Programs at Marker Where We’ve Been Where We’re Going • Technology founded at the Baylor College of Medicine in 2012 • Seven Phase I/II clinical trials: » AML, Lymphoma, ALL, Multiple Myeloma » Pancreas, Breast, Sarcomas • Largest data se
Slide 11: MultiTAA in Blood Cancers
MultiTAA IN BLOOD CANCERS
Slide 12: Active Lymphoma Clinical Trial Outcomes
Active Lymphoma Clinical Trial Outcomes Months ID Age/G Prior Therapies 2 4 6 8 10 12 14 16 18 20 22 BOR (Time to Relapse) 1* 31/F 9 SD (1.4 mo ) 2* 55/F 3 CR (3.2mo) Died of unrelated p neumonia 4* 38/M 7 CR (60.8 mo ) 5* 44/F 4 SD (2.5 mo ) 9 46/M 4 CR (59.4 mo ) 10 46/F 3 CR (48.7 mo ) 11 31/F 9
Slide 13: Adjuvant Lymphoma Clinical Trial Outcomes
Adjuvant Lymphoma Clinical Trial Outcomes Months ID Age/G Prior Therapies 4 8 12 16 20 24 28 32 36 40 BOR (Time to Relapse) 3* 39/M 3 CCR (47 mo ) 6* 78/F 2 CCR (R after 8.6 mo ) 7* 21/M 4 CCR (62 mo ) 8* 34/M 4 CCR (R after 12 mo ) 12 78/F 4 CCR (39.6 mo ) 17 73/F 4 CCR (29.9 mo ) 18 32/F 5 CCR (25
Slide 14: Case Study: Response in Lymphoma Trial of Patient
14 Case Study: Response in Lymphoma Trial of Patient 10 Marker T cell expansion changes over time to match antigen expression on tumor
Slide 15: AML Unmet Medical Need
AML Unmet Medical Need • In 2016, there were an estimated 61,048 people living with AML in the U.S. Prevalence Acute myeloid leukemia (AML) is the most common acute leukemia in adults and progresses rapidly without treatment. It can spread from the blood to the lymph nodes, liver, spleen, brain and
Slide 16: Therapeutic Pathway for an AML Patient
THERAPEUTIC PATHWAY FOR AN AML PATIENT Adverse Risk/ Relapsed All Other A AML 7438 AMC Therapies p ~26,000/yr HDACx4 cr Cured Comolex cytogenetics Te
Slide 17: Outcomes of AML/MDS Patients Post Allo-HSCT
ee OUTCOMES OF AML/MDS PATIENTS POST ALLO-HSCT Dead - 54% TRM: 25%, AML Relapse 75% 0% 50% 100% Outcome at 5 years Overall survival after relapse: 4.5 months
Slide 18: Marker Lead Clinical Trial: Post-Transplant AML Positive Phase 1 Data
Marker Lead Clinical Trial: Post - Transplant AML Positive Phase 1 Data • Demonstrated anti - tumor effect, as well as significant in vivo expansion of T cells • Well tolerated, with no incidence of cytokine release syndrome, neurotoxicity or Gr3 - 4 GvHD Unmet Need for Effective Therapies in Post -
Slide 19: Adjuvant AML / MDS Clinical Trial Outcomes
Adjuvant AML / MDS Clinical Trial Outcomes 19 0 1 2 3 4 5 9 6 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 Adjuvant in CR post HSCT Years post infusion Complete response Relapse Pt. ID * * * * *
Slide 20: Active AML / MDS Clinical Trial Outcomes
Active AML / MDS Clinical Trial Outcomes 20 A2 A1 A3 A4 A5 A5 A6 A6 Active AML at time of infusion Years post infusion Stable disease Partial response Complete response Next line of therapy Second HCT 1 1.5 0 0.5 Relapse * * * * Pt. ID
Slide 21: Clinical Course of Patient (Group B: Active Disease)
Clinical Course of Patient 1 (Group B: Active Disease) 57 - year - old female with AML post multiple courses of chemoRx and allo - HSCT. First Rx with MultiTAA T cells during remission. Elevated AST was Rx’d with prednisone, causing relapse that resolved once prednisone was DC’d . Rx with decitabine
Slide 22: Phase 2 Study Design for AML with Safety Lead-in
Phase 2 Study Design for AML with Safety Lead - in Primary objectives are to evaluate: • Relapse - free survival (RFS) (Group 1) • Complete remission (CR), duration of CR (DOCR) (Group 2) Main entry criteria: • Patients with AML after allogeneic HSCT (HLA - matched related donor, matched unrelated d
Slide 23: MultiTAA in Solid Tumors
<> MARKER THERAPEUTICS MultiTAA IN SOLID TUMORS
Slide 24: Pancreatic Cancer – Difficult to Treat
Pancreatic Cancer – Difficult to Treat Pancreatic cancer is the seventh leading cause of global cancer deaths and the third leading cause of cancer death in the U.S. • In 2017, there were an estimated 78,969 people living with pancreatic cancer in the U.S. • Estimated new cases in 2020: 57,600 • Est
Slide 25: Pancreatic Cancer: Synergy Between Chemotherapy and MultiTAA T cells
25 Pancreatic Cancer: Synergy Between Chemotherapy and MultiTAA T cells Courtesy of Walter Mejia
Slide 26: Pancreatic Phase 1/2 Trial Results
Pancreatic Phase 1/2 Trial Results Three months of 1 st line chemotherapy regimen Observe to progression Continued same 1 st line chemotherapy + Monthly T cells up to 6x • All patients had stable disease after receiving chemotherapy alone • 4 confirmed objective responses (OR): - 1 complete response
Slide 27: MultiTAA T Cells + Chemo Summary
27 MultiTAA T Cells + Chemo Summary gemcitabine + nabpaclitaxel FOLFIRINOX Presented at American Society of Clinical Oncology (ASCO) May 2020
Slide 28: Aggregate Tumor Measurements
0 1 2 3 4 5 6 7 8 Tumor Size (cm) Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 7 Patient 8 Patient 9 Patient 10 Patient 11 Patient 12 Patient 13 3 mths ChemoTx Post #3 infusion Post #6 infusion 3 mths Post T cells 6 mths Post T cells Baseline Start T cells 1 Year Therapy 28 Ag
Slide 29: Manufacturing
Manufacturing
Slide 30: Introduction to MT-401 manufacturing
Introduction to MT - 401 Indications: • AML • ALL 30 Indications: • Lymphoma • MM • Solid Tumors MultiTAA T Cell Infusion Wash & Freeze PBMCs APC + pepmix +cytokines 10+ Days MultiTAA T Cells Blood Draw/ Apheresis LAPP WT1 PRAME Survivin NY - ESO - 1 MAPP PRAME MAGEA4 SSX2 Survivin NY - ESO - 1 Allo
Slide 31: Simplified manufacture process yields T cells with better phenotype
31 Simplified manufacture process yield T cells with better phenotype Marker Process BCM Process Marker Process BCM Process Marker Process BCM Process C
Slide 32: Simplified manufacture process yields T cells with better target recognition
32 BCM process Marker process Donor #1 Donor #2 Donor #3 Simplified manufacture process yield T cells with better target recognition BCM process Marker process BCM process Marker process
Slide 33: Company Infrastructure
Marker Therapeutics, Inc. Company Infrastructure 33 Houston,TX Marker GMP facility (anticipated supply for phase 2 clinical studies) BCM GMP (phase 1 clinical) Process Development and Immunomonitoring Laboratory • Clinical operations • regulatory team Houston Medical Center
Slide 34: GMP Manufacturing Facility (Houston, Texas)
GMP Manufacturing Facility (Houston, Texas) ANALYTICAL LAB Gowning GMP Manufacturing Analytical Lab GMP Storage Micro Lab PCR Lab Storage QA/QC GMP expansion Quality assurance 34 PCR GMP expansion GMP expansion GMP expansion GMP expansion GMP expansion GMP Manufacturing Quality control
Slide 35: Process Development & Immunomonitoring Laboratory
Process Development & Immunomonitoring laboratory Storage Room Flow Cold Storage Office Cell culture Molecular Biology • Epitope spreading • T cell persistence • Process improvements CRF CRF Mechanical room Conference Future expansion 35
Slide 36: Upcoming Milestones
Upcoming Milestones 36 AML trial clinical milestones • Treat first patient in the AML trial with MT - 401 in Q1 2021 • Complete safety lead - in (6 patients) in Q2 2021 • Initiate main portion of phase 2 trial in Q3 2021 • Complete enrollment of 20 patients in main portion of phase 2 in Q4 2021 • To
Slide 37: Company Overview
Company Overview We are advancing novel T cell immunotherapies for the treatment of blood cancers and solid tumors • Lead program uses non - genetically engineered T cells designed to recognize and kill multiple tumor targets for broad anti - cancer activity. Unique potential benefits include: - Eas
Slide 38: > MARKER
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