Transforming Immuno-Oncology (IO) - 1Q 2023 Corporate Overview
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Transforming Immuno-Oncology (IO)
Corporate Overview
1Q 2023
This presentation (“Presentation”) is for informational purposes only to assist interested parties in making their own evaluation with
respect to ImmunoGenesis, Inc. (“ImmunoGenesis” or the “Company”). The information contained herein does not purport to be
all-inclusive and none of the Company, its affiliates nor any of its or their control persons, officers, directors, employees or
representatives makes any representation or warranty, expressed or implied, as to the accuracy, completeness or reliability of the
information contained in this Presentation. You should consult your own counsel and tax and financial advisors as to legal and related
matters concerning the matters described herein, and, by accepting this presentation, you confirm that you are not relying upon the
information contained herein to make any decision.
Forward-Looking Statements
Certain statements in this presentation may be considered forward-looking statements. Forward-looking statements generally relate to
future events or the Company’s future financial or operating performance. In some cases, you can identify forward-looking statements
by terminology such as “may,” “should,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue,” or
the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks,
uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-
looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by
the Company and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not
possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include,
but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties
and factors. Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set
forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not
place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company does not undertake
any duty to update these forward-looking statements.
2
Company Summary
First-in-Class PD-L1/PD-L2 Dual-Specific Inhibitor
4
ImmunoGenesis Investment Thesis
• IMGS-001, lead product, is a first-in-class PD-L1/PD-L2 dual-specific inhibitor
with effector function
– Ready to enter the clinic – FDA ok to proceed
– Enhanced approach to proven biological pathway
– Can be foundational agent in >$50 B market segment
• Experienced team in place
• Scientific founder is a pioneer in modern IO; highly sought after for SAB roles
• Phase 2 asset in pipeline that is generating partnering interest
5
Series A Financing Leads to Value-Enhancing Milestones
Series A Financing
1H 2H 1H 2H 1H 2H
2023 2023 2024 2024 2025 2025
Phase 1A data Top-line data
IMGS-001 FDA Ok to in 18 patients Phase 1A/1B
PD-L1/L2 Dual- Proceed
Phase 1A data First 60 Pts
Specific w/Effector Initiate in 25 patients
Function Phase Top-line Data
1A/1B Trial Initiate Phase Phase 1A/1B
1B expansion 90 Pts
Initiate Data
IMGS-101 Phase 1/2 Phase 1 data Phase 1/2
in 12 patients 42 Pts
Evofosfamide Trial
Data in 10
IMGS-203 Manufacturing and other patients
STING pre-IND work
Phase 1 Trial
6
Founder: Michael A. Curran, PhD
Associate Professor of Immunology, MDACC
• Trained with Nobel Laureate Jim Allison
• Co-inventor on CTLA-4 patent; proposed, described, and drove early development
of YERVOY® + OPDIVO® , still most efficacious checkpoint combo
• More than 45 IO publications since 2012 and multiple awards, including the
Presidential Award from the Society for Immunotherapy of Cancer
• Extensive IO drug development experience, including co-scientific director of
the MDACC ORBIT platform (eg, GSK αOX-40 and clinical 8F4 programs); SAB
positions from small to large pharma
• Founded ImmunoGenesis in 2019 to develop therapies from his lab to address
the significant unmet need in cold tumors
7
ImmunoGenesis Team
MANAGEMENT
James A. Barlow, Jr. | CEO and President Freddi F. O’Brien | Chief Financial Officer
Jeremy Barton, MD | Acting Chief Medical Officer Scott Cullison | Acting Chief Business Officer
Federica Pericle, PhD | Chief Scientific Officer Matthew Hemberger, PhD | Senior Director, CMC & Quality
Charles Schweizer, PhD | SVP Clinical Development Amanda Sanders| Associate Director, Clinical Operations
SCIENTIFIC, CLINICAL, & BUSINESS ADVISORS
Michael A. Curran, PhD David Hong, MD Jacques Gaudreault Robert Stein, MD PhD
Founder and SAB Head Clinical Advisor Nonclinical Consultant Member, Board of Directors
8
Lead PoC Manufacturing
PROGRAM INDICATIONS Discovery
Optimization (in vivo) IND-Enabling Phase 1 Phase 2
Lead Program
IMGS-001
PD-L1/PD-L2 TNBC,
dual-specific Colorectal,
antibody with Ovarian
effector function
IMGS-101 (EVO)
Hypoxia-reversal Prostate,
agent in combination Pancreatic,
with checkpoint Head and Neck
inhibitors
Development Programs
IMGS-401 Cold Tumors
PD-L1/PD-L2 + 4-1BB
Tri-functional Bispecific Ab
IMGS-501
Cold Tumors
STING-ISAC with
PD-L1/PD-L2 dual-
specific Ab
Ab, antibody; ISAC, immune-stimulating antibody conjugate; STING, stimulator of interferon genes; TNBC, triple-negative breast cancer.
The PD-1 Pathway : Classical Model
Problem: Cancers evade immune recognition by
engaging the PD-1 molecule to turn off the protective
function of T cells
Partial solution: Antibody blocking of PD-1 or PD-L1
restores immune function. However, targeting this
inhibitory pathway by blocking PD-1 benefits only a
minority of patients with immune-flamed tumors
Opportunity: No FDA approved drugs that block both
PD-L1 and PD-L2 binding to PD-1 and eliminate PD-
L+ expressing cells via ADCC and ADCP mechanisms,
allowing patients with immune-excluded tumors to
benefit
10IMGS-001: PD-L1/PD-L2 Dual-Specific Inhibitor with
Effector Function
PD-L1
• Fully human IgG1 monoclonal antibody
ADCC+
• Binds both PD-L1 and PD-L2 and (FcγRllla)
I332E PD-L2
blocks their interaction with PD-1 S239D
– Also blocks interaction of PD-L1 with B7.1
• Fc engineered with 3 mutations to
G236A
induce ADCC, ADCP activity ADCP+ PD-L1
(FcγRlla)
Human IgG1
PD-L2
11Immune Excluded Tumors Represent a Significant
Unmet Need
Melanoma Lung TNBC Bladder Gastric Ovarian CRC PDAC
CRC 12% 63% 25%
Incidence
NSCLC 31% 44% 25%
mUC 26% 47% 27%
TNBC 36% 47% 17%
Source: Roche ASCO Presentation 2020.
CRC, colorectal cancer; NSCLC, non-small cell lung cancer; mUC, metastatic urothelial carcinoma; TNBC, triple-negative breast cancer;
CIT: cancer immunotherapy; PDAC, pancreatic ductal adenocarcinoma.
12Curing Checkpoint Fatigue
New Paradigm of PD-1 Pathway Blockade—First to Target PD-L2
IMGS-001
2025 estimated revenue
for these drugs is $50B* Re-envision and reset
the starting point for
cold tumor efficacy
>$50B market
All Other
Tumors Cold, Immune-
45% Excluded
Tumors
55%
*GlobalData estimates. 13IMGS-001 Takes Out Immune Suppression at the Source
Robust killing function of immunosuppressive cells expressing PD-L1 and/or PD-L2.
CAFs
M2 Macrophages
TGF-β
Arginase
MDSCs IDO
Cold Tumor
Microenvironment
Adenosine IMGS-001
Tumor Cells
CAF, cancer-associated fibroblast; IDO, indoleamine 2, 3-dioxygenase; MDSC, myeloid-derived suppressor cell; TGF-β, transforming growth factor beta. 14Enhanced Cold Tumor Efficacy for Final Clinical Lead
5 x 104 B16-F10-PDL2 Treat on days Treatment with IMGS-001 resulted in a 50% survival
right flank 3, 6, 9, 12, 15, 18
rate while anti-PD-1 showed no survival benefit
100 1500
Tumor Volume (mm3)
75 1200
% survival
900
50 IMGS-001
*** 600
anti-PD-1
Negative Control (mouse Keytruda)
25
anti-PD-1 300 Negative Control
(mouse Keytruda)
0
IMGS-001
0
0 20 40 60 0 5 10 15 20 25
days (post tumor implant) days (post tumor implant)
Log-rank (Mantel-Cox) test: ***p < 0.001
15IMGS-001^ Increases CD8+ and CD4+ T cell Proliferation
B16-PDL2 Model: IMGS-001 drives increased
proliferation of T cells^^
* p=0.05
** p=0.01
^ Previous IMGS-001 lead molecule; further refinements were made to final lead that went to manufacture *** p=0.001
^^ Analysis of tumor draining lymph node after five doses of IMGS-001 **** p=0.0001 16IMGS-001^ Expands Dendritic Cells
B16-PDL2 Model: IMGS-001 expands innate immune
DCs^^
* p=0.05
** p=0.01
^ Previous IMGS-001 lead molecule; further refinements were made to final lead that went to manufacture *** p=0.001
^^ Analysis of tumor draining lymph node after five doses of IMGS-001 **** p=0.0001 17IMGS-001^ Depletes Key Immunosuppressive Cells
B16-PDL2 Model: IMGS-001 depletes suppressive
MDSC and MACs^^
* p=0.05
** p=0.01
^ Previous IMGS-001 lead molecule; further refinements were made to final lead that went to manufacture *** p=0.001
^^ Analysis of tumor draining lymph node after five doses of IMGS-001 **** p=0.0001 18IMGS-001 is Ready to Enter Clinic in Q1 2023
Good Manufacturability Profile Regulatory
• WuXi Biologics completed GMP manufacturing at • FDA Ok to Proceed; FPI in Q1 2023
2,000 L scale in March 2022 – robust titer of ~6 g/L • Robust IP protection – IMGS-001 COM out to
• Product vialed and IND documentation complete 2043
Initial Demonstration of Clean Tox Profile Phase 1A/1B Trial Design in Place
• Non-GLP mouse study: no overt tox • Optimizing clinical trial design
• Non-GLP cyno PK/PD study: no overt tox even at • Robust biomarker opportunities/strategy; assays
10X clinical dose will be finalized in Q1 2023
• GLP Tox in cynos: no overt tox even at 5X and
10X clinical dose
19IMGS-001: Phase 1A/1B Clinical Trial Plan
PART 2
Tumor Specific
Cohorts
Study Objectives (PD-L1 >5%) Study Objectives
Assess safety of Single Agent Efficacy
PART 1 IMGS-001 Ovarian (ORR, CBR, PFS)
Dose Escalation chemorefractory
Investigate correlation between
Assess preliminary
Colorectal 9p24.1 amplification, PD-L1,
signs of efficacy
chemorefractory PD-L2 expression
PK analysis and clinical response
PHASE 1A
Solid Tumors
Breast (TNBC) Explore biomarkers of
Explore biomarkers of response or target
IC resistant/refractory
response or target engagement (via tissue
engagement (via tissue Gastric/Esophageal* biopsies and serum
biopsies and serum IC resistant/refractory plasma)
plasma)
*Potential5 dose cohorts *NSCLC, Bladder and HNSCC also under consideration.
20
(.3 to 15 mg/kg) Qx2w.Phase 1A/B Clinical Trial - Multiple Opportunities to
Show Clinical Differentiation
Biomarker Strategy: Can differentiate across:
1) Leverage single cell RNA data to identify 1) Checkpoint naïve patients
tumor types with advantageous (i.e. Ovarian and Colorectal)
expression of PD-L1/L2
2) Checkpoint experienced
2) Prospectively test for PD-L1 >5% patients (i.e. Bladder,
• Select away from immune desert patients TNBC, Gastroesophageal)
• High concordance with PD-L2 expression 3) Biomarker-driven population
3) Retrospectively test for: • PD-L1/L2 overexpressers
• PD-L2 • 9p24.1 amplified
• 9p24.1amplification
21Cutting Edge Bioinformatics to Guide Indication Selection
22Lead PoC Manufacturing
PROGRAM INDICATIONS Discovery
Optimization (in vivo) IND-Enabling Phase 1 Phase 2
Lead Program
IMGS-001
PD-L1/PD-L2 TNBC,
dual-specific Colorectal,
antibody with Ovarian
effector function
IMGS-101 (EVO)
Hypoxia-reversal Prostate,
agent in combination Pancreatic,
with checkpoint Head and Neck
inhibitors
Development Programs
IMGS-401 Cold Tumors
PD-L1/PD-L2 + 4-1BB
Tri-functional Bispecific Ab
IMGS-501
Cold Tumors
STING-ISAC with
PD-L1/PD-L2 dual-
specific Ab
Ab, antibody; ISAC, immune-stimulating antibody conjugate; STING, stimulator of interferon genes; TNBC, triple-negative breast cancer.IMGS-101 (EVO) Conditions Cold Cancers to Respond
and is IND ready for Phase 2
• ImmunoGenesis is developing Evofosfamide (Evo) as a hypoxia-reversal agent
(HRA), which can be combined with IO to drive efficacy
• Completed a successful phase 1/2 with Evo + anti-CTLA4 (initial proof of concept)
• Initiating a targeted phase 2 with EVO + anti-CTLA-4 and anti-PD-1 (ASAP 2023)
• Goal is to confirm proof-of-biology for Evo as a conditioning agent; opportunity to
add Evo to our other products as an adjunctive agent
• Plan to partner this molecule for more advanced combination studies with
checkpoint inhibitors and/or cell therapies
24IMGS-101 (Evo) + Ipilimumab Phase 1/2 Compelling
Efficacy
Phase 1 Dose Escalation – Ipilimumab/Evofosfamide
100
• Heavily pretreated patients across prostate,
% Change – Best Response
400 mg/m2
pancreatic, and HNSCC: ≤6 months survival 50 480 mg/m2
SD
• Across 4 doses and 4 indications, the ORR was 0
560 mg/m2
17% and DCR was 83%; every patient re-treated PR
640 mg/m2
with Evo/Ipi responded with tumor regression -50
and/or ≥4 months progression-free survival (PFS) -100
• Objective responses in prostate cancer patients
would qualify as breakthrough and for FDA
Fast Track
• Breakthrough and FDA Fast Track would also
apply to HNSCC and pancreatic if response noted
• Clear biomarker signal emerged; will be validated
in phase 2
Ipilimumab
Evofosfamide
25EVO-011 Phase 1/2 Clinical Trial
• Histologically confirmed locally advanced/metastatic prostate, pancreatic, and HPV (-) head and neck
• Patients refractory to standard of care lines of therapy
Phase 2
~62
Tumor Subjects
Phase 1 BOIN Design ~12
Cohorts Key Endpoints
Dose Escalation Subjects
• Objective Response Rate and PFS
Dose Evo AGEN1884 AGEN2034 Head/Neck (n=16) • Safety and tolerability
• Pharmacokinetics
2
1 480 mg/m 1 mg/kg 3 mg/ kg
RP2D • Exploratory biomarkers via serum, blood,
2 Pancreatic (n=16) and tissue (Pre/Post Tx biopsies)
2 560 mg/m 1 mg/kg 3 mg/ kg
• Sub-study PET-CT using [18F]FAZA
Prostate (n=16) (n=14)
Prostate: Simon 2 stage
(1st stage ≥ 2 of 16 ORR)
*FDA Clearance to Proceed Received June 2022 26Pipeline and Financing
Series A Financing
• IMGS-001
– Finish Phase 1A for IMGS-001 (data in 25 patients)
• IMGS-101 (EVO)
– 12 patients of data for IMGS-101 (EVO)
• Drives to key data inflection point in mid-2024
28Series A Financing Leads to Value-Enhancing Milestones
Series A Financing
1H 2H 1H 2H 1H 2H
2023 2023 2024 2024 2025 2025
Phase 1A data Top-line data
IMGS-001 FDA Ok to in 18 patients Phase 1A/1B
PD-L1/L2 Dual- Proceed
Phase 1A data First 60 Pts
Specific w/Effector Initiate in 25 patients
Function Phase Top-line Data
1A/1B Trial Initiate Phase Phase 1A/1B
1B expansion 90 Pts
Initiate Data
IMGS-101 Phase 1/2 Phase 1 data Phase 1/2
in 12 patients 42 Pts
Evofosfamide Trial
Data in 10
IMGS-203 Manufacturing and other patients
STING pre-IND work
Phase 1 Trial
29ImmunoGenesis Investment Thesis
• Developing transformational agents that will represent the next major
advancement in Immuno-Oncology
• Lead product, IMGS-001, is a disruptive technology that can become a
foundational agent in a >$50B market
• Phase 2 asset with significant potential as tumor conditioning agent
• Founder and management team have proven track records and the
experience to drive this transformation
• This financing will enable the demonstration of efficacy across tumor types
with high unmet need, driving value for shareholders and creating hope for
patients
30Backup Slides
Why Target PD-L2 in Addition to PD-L1? T 1) PD-L2 is widely expressed in the stroma, tumor, and endothelium of many cancers 2) PD-L2 binds to PD-1 with 5X the affinity of PD-L1; often more predictive of response to PD-1 inhibition 3) Normal tissues express less PD-L2 than PD-L1 (i.e., less toxicity) 4) PD-L2 uniquely expressed on certain immunosuppressive cells such as a subtype of CAFs PD-L2 expression in stromal (includes immune cell infiltrate), tumor, and endothelial cells of various tumor types. Presence (≥1) or absence (
PD-L2 Is More Tumor Selective Than PD-L1
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