Full Press Release Details
Phase 1 Trial in Pancreatic
Adenocarcinoma (TACTOPS) JUNE 1, 2020
FORWARD LOOKING STATEMENTS
This presentation includes forward-looking statements. All statements contained in this presentation other than statements of
historical facts, including statements regarding future results of operations and financial position of Marker Therapeutics, Inc.
("Marker," "we," "us," "our" or the "Company"), our business strategy
and plans, our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen
specific T cell therapies, the effectiveness of these programs or the possible range of application and potential curative effects
and safety in the treatment of diseases and the timing and success of our clinical trials, as well as clinical trials conducted
by our collaborators, are forward-looking statements. The words "anticipate," believe," "continue,"
"estimate," "expect," "intend," "may," "will" and similar expressions
are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations
and projections about future events and financial trends that we believe may affect our financial condition, results of operations,
business strategy, clinical development, short-term and long-term business operations and objectives and financial needs. These
forward-looking statements are subject to a number of risks, uncertainties and assumptions. Risks regarding our business are described
in detail in our Securities and Exchange Commission filings, including in our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time.
It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the
extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any
forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed
in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied
in the forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable,
we cannot guarantee future results, levels of activity, performance, achievements or events and circumstances reflected in the
forward-looking statements will occur. We are under no duty to update any of these forward-looking statements after the date of
this presentation to conform these statements to actual results or revised expectations, except as required by law. You should,
therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this
presentation. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and
completeness of the forward-looking statements contained in this presentation. 2
Pancreatic Cancer Overview
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 - Estimated deaths in 2020: 47,050 Prevalence - Local (pancreas): Accounts for 10% of cases; 5-year survival
rate is 37% - Regional (lymph nodes): 29% of cases; 5-year survival rate is 12% - Distant (Stage IV or metastatic):
More than half of all cases (53%) are diagnosed at the distant stage; 5-year survival rate is 3% - Overall 5-year survival
rate = 10% Survival Rates Sources: National Cancer Institute, National Institutes of Health, American Cancer Society, Pancreatic
Cancer Action Network - SOC for front-line unresectable pancreatic cancer: Chemotherapy (FOLFIRINOX or Gemcitabine/nab-paclitaxel)
- Less than 20% of patients are candidates for surgery (resectable) because cancer has usually spread by the time of diagnosis
Combination Treatment 3
Expected PFS in Phase
1 Pancreatic Study at Baylor College of Medicine (BCM) We commissioned an outside statistician to analyze the expected PFS for
patients consistent with the eligibility of BCM Ph1 TACTOPS study by removing patients who progressed during the first 3 months
of chemotherapy alone mPFS = 6.4 months modified mPFS = 8 months FOLFIRINOX (ACCORD study) Nab-Paclitaxel-Gemcitabine (MPACT study)
mPFS = 5.5 months modified mPFS = 6.8 months Expected PFS based on Baylor Ph1 Eligibility 4
MultiTAA-Specific T Cell
Therapy in First-Line Setting 5 Demonstrates benefit on top of standard-of-care chemotherapy in patients with advanced and metastatic
pancreatic cancer ASCO 2020 Presentation MultiTAA-specific T cells was well tolerated when administered to patients with
advanced pancreatic cancer, along with SOC chemotherapy In some patients, addition of T cells extended duration of first-line
therapy, controlled cancer and induced additional tumor responses Clinical benefit correlated with detection of tumor-reactive
T cells in patient peripheral blood T cells exhibited activity against targeted antigens and non-targeted TAAs, indicating
induction of antigen/epitope spreading No infusion-related systemic- or neuro-toxicity "A phase I trial targeting
advanced or metastatic pancreatic cancer using a combination of standard chemotherapy and adoptively transferred nonengineered,
multiantigen specific T cells in the first-line setting (TACTOPS)" Observations
Brandon G. Smaglo, M.D.,
FACP Associate Professor, Department of Gastrointestinal (GI) Medical Oncology, Division of Cancer Medicine, The University of
Texas MD Anderson Cancer Center, Houston, TX 6 TACTOPS study conducted by Baylor College of Medicine
A Phase I Trial Targeting
Advanced or Metastatic Pancreatic Cancer using a Combination of Standard Chemotherapy and Adoptively Transferred Nonengineered,
Multiantigen Specific T Cells in the First-Line Setting (TACTOPS) Brandon G Smaglo, MD, FACP 7
Pancreatic Cancer Mortality
American Cancer Society Fact & Figures 2018 Trends in Age-adjusted Cancer Death Rates, Females, US, 1930-2015 Trends in Age-adjusted
Cancer Death Rates, Males, US, 1930-2015 Colon & rectum Uterus Stomach Breast Lung & bronchus Rate per 100,000
male population 100 80 60 40 20 0 1930 1935 1940 1945 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 Rate
per 100,000 female population 100 80 60 40 20 0 1930 1935 1940 1945 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005
2010 2015 Pancreas Pancreas Liver Prostate Colon & rectum Liver Stomach Lung & bronchus 8
ACCORD-11:FOLFIRINOX -
First line option for metastatic disease - Toxic - Not all patients can tolerate - Cannot continue indefinitely
- mOS 11.1 months - mPFS 6.4 months Conroy T, et al. N Engl J Med 364:1817; 2011. 9
MPACT:gemcitabine/nabpaclitaxel
- First line option for metastatic disease - Thought of as less toxic - mOS 8.5 months - mPFS 5.5 months Von
Hoff DD, et al. N Engl J Med 369:1691;2013. 10
Pancreatic Cancer: Treatment
- Combination chemotherapy (FFX or G/A) - Non-chemotherapy options very limited - Side effects - Cumulative:
fatigue, neuropathy, cytopenias - Repetitive: nausea, vomiting, diarrhea - Distressing: alopecia, cold-hypersensitivity
- T cell therapy options attractive for exploration 11
Patient Adoptive T cell
transfer Infusion Tumor-specific T cells Antigen Specificity Blood draw PBMCs 12
T cell therapy for pancreatic
Challenge: Tumor heterogeneity
target multiple TAAs - Target multiple epitopes (CD4 and CD8) within each antigen - T cells with native T cell receptor
specificity (non-engineered) Our approach 16
MultiTAA T cells MultiTAA
T cell therapy for PDAC MAGEA4 PRAME Survivin NYESO1 SSX2 17
TAA Expression in PDAC
TAA Expression in PDAC Survivin >75%1-2 SSX family 3-30%3-5 MAGE-A family 20-86%3, 5-8 PRAME >30%9 NY-ESO-1 2-10%3,5 1 Koido
et al, Clin Dev Immunol. 2011, 2 Dodson et al, Immunotherapy 2011, 3 Kubuschok et al, In.t J. Cancer 2004, 4 Abate- Daga et al,
PLoS One. 2014, 5 Schmitz-Winnenthal et al, Cancer Letters 2007, 6 Kim et al, Int. J. Cancer 2006, 7 Cogdill et al, Surgery. 2012,
8 Hansel et al, Int J Gastrointest Cancer. 2003, 9 The Human Protein Atlas, www.proteinatlas.org 18
MultiTAA-T Cell Generation
Activation DC Overlapping pepmixes PBMCs MultiTAA T cells Expansion 19
-10% 0% 10% 20% 30% 40%
50% Profile of MultiTAA-T cells Phenotype Safety % specific lysis 0 20 40 60 80 100 CD3 CD4 CD8 CD3- CD16+ CD56+ CD3- HLADR+ CD83+
TCM TEM % expression n=54 E:T 20:1 20
0 50 100 150 200 250 Targeted
antigens control Survivin NY-ESO-1 MAGE-A4 SSX2 PRAME no pepmix MultiTAA T cell specificity SFC/2x105 Specificity n=54 21
Clinical Trial: TACTOPS
- 6 Infusions, fixed cell dose (1x107/m2) - no lymphodepletion - Receive 3months chemotherapy - Procurement performed
and T cells generated - If cancer controlled after 3 months, start receiving monthly T cell infusions along with ongoing
Clinical Trial: TACTOPS
- Primary endpoints - safety, feasibility - Exploratory - efficacy - 13 patients infused - Sufficient
cells generated for all 6 infusions for 12 patients - 2 doses generated for the remaining patient 23