Imunon, Inc. · NASDAQ:IMNN
Imunon — Investor Day (September 2023)
95 slides from Imunon's investor day presentation, Sep 14, 2023
Slide 1: Harnessing the Power of the Immune System: R&D Day
Harnessing the Power of R&D Day the Immune System September Nasdaq: IMNN 14, 2023 © 2023 IMUNON, Inc. PAGE 1
Slide 2: Corinne Le Goff, Pharm.D, M.B.A.
Corinne Le Goff, Pharm.D, M.B.A. President & CEO IMUNON © 2023 IMUNON, Inc. PAGE 2
Slide 3: Safe Harbor Statement
Safe Harbor Statement This presentation and any statements made during any presentation or meeting contain forward-looking statements related to Imunon, Inc. (“Imunon”) under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks an
Slide 4: Today's Agenda
Today’s Agenda Introduction Corinne Le Goff, Pharm.D, PhD 4:00 – 4:15pm President & CEO IMUNON The Vaccines of the Future Sallie Permar, MD, PhD 4:15 – 4:35pm Nancy C. Paduano Professor and Chair Weill Cornell Medicine IMNN-101 Development Plan Khursheed Anwer, PhD 4:35 – 4:45pm CSO Immuno-Oncology:
Slide 5: Transforming Medicine with Our Disruptive Non-Viral DNA Technology
Transforming Medicine with Our Disruptive Non-Viral DNA Technology Proprietary Synthetic Delivery and Facilitating System, that promotes DNA Protection, Uptake, Bioavailability and Enhanced Antigen Expression ra Th e P l a s Pl a C C i n e NEXT GEN NEXT GEN IMMUNO Gene Therapy MODULATION PROPHYLACTI
Slide 6: IMUNON Strategy to Build a Fully Integrated Biotech Company
IMUNON Strategy to Build a Fully Integrated Biotech Company FOCUS ON IMMUNO-ONCOLOGY GMP MANUFACTURING Cytokines Coding & Cancer Vaccines In-house Early Development Scale FOCUS ON INFECTIOUS DISEASES WORLD CLASS PARTNERS Pathogen Antigens Coding Vaccines To Expand our R&D Capabilities M&A POTENTIAL
Slide 7: IMUNON's Technology Advantages in Prophylactic Vaccines
IMUNON’s Technology Advantages in Prophylactic Vaccines Durability of Flexible Speed protection manufacturing Durable antigen expression Non-viral DNA is a platform Simple handling & distribution Induces robust immunological Ability to go from sequence Stability and long shelf-life at response to th
Slide 8: IMUNON's Technology Advantages in Cancer Vaccines
makes the assumption the immune system can see th IMUNON’s Technology Advantages in Cancer Vaccines Fully personalised vaccines based on individual patient’s cancer genotypes are feasible Several vaccine platforms have high antigen capacities and short timelines to manufacture. . Choices as to which
Slide 9: IMUNON's Pipeline of DNA-based Transformative Medicines
IMUNON’s Pipeline of DNA-based Transformative Medicines Modality Program Indication(s) Discovery IND Phase 1 Phase 2 Partnerships enabling Advanced Ovarian, IL-12 (OVATION) Fallopian Tube or Primary IMNN-001 (formerly GEN-1) Intraperitoneal (IP) Peritoneal Cancer TheraPlas IL-12 IP in Advanced Ovari
Slide 10: Financial Summary & Upcoming Key Milestones
Financial Summary & Upcoming Key Milestones: Robust Flow of Value Creating Activities Cash , Cash Equivalents & Investments IMNN-001 OVATION 2 IMNN-001 OVATION 2 Interim Data Topline Results $ $24.1M As of June 30, 2023 Interim Results IMNN-001 + bevacizumab Shares Outstanding IMNN-101 IMNN-102 SARS
Slide 11: Dr. Sallie Permar, MD, Ph.D.
Dr. Sallie Permar, MD, Ph.D. Nancy C. Paduano Professor and Chair Weill Cornell Medicine © 2023 IMUNON, Inc. PAGE 11
Slide 12: Dr. Khursheed Anwer, Ph.D.
Dr. Khursheed Anwer, Ph.D. CSO IMUNON © 2023 IMUNON, Inc. PAGE 12
Slide 13: Dr. Patrick Ott, MD, Ph.D.
Dr. Patrick Ott, MD, Ph.D. Associate Professor, Medicine Harvard Medical School Clinical Director, Melanoma Center Dana-Farber Cancer Institute © 2023 IMUNON, Inc. PAGE 13
Slide 14: Dr. Khursheed Anwer, Ph.D.
Dr. Khursheed Anwer, Ph.D. CSO IMUNON © 2023 IMUNON, Inc. PAGE 14
Slide 15: © 2023 IMUNON, Inc. PAGE
SIMUNON | © 2023 IMUNON, Inc.
Slide 16: Vaccines of the Future
Vaccines of the Future Sallie Permar, MD, PhD Nancy C. Paduano Professor and Chair, Weill Cornell Medicine Pediatrician-in-Chief, NewYork-Presbyterian/Weill Cornell Medical Center @salliepermar
Slide 17: Dr. Permar is a consultant for Pfizer, Merck, Moderna, GSK
Dr. Permar is a consultant for Pfizer, Merck, Moderna, GSK, Hoopika, and Dynavax CMV vaccine programs
Slide 18: Highly successful SARS-CoV-2 mRNA/LNP vaccine developed in warp speed
Highly successful SARS-CoV-2 mRNA/LNP vaccine developed in “warp speed”
Slide 19: Congenital Cytomegalovirus (CMV)
Congenital Cytomegalovirus (CMV) • Most common congenital infection and cause of birth defects worldwide – 1/200 (0.5%) live-born infants globally – 40,000 cases annually in US, ~5,000 have permanent sequelae – 4 billion cost annually in US • Leading cause of pediatric neurologic deficits – Up to 25
Slide 20: 50+ years of CMV vaccine development, yet no approved vaccine
50+ years of CMV vaccine development, yet we still await an approved vaccine Vaccine Platform Phase Efficacy 1972 Live attenuated Phase I,II Reduction of disease in renal tx Live viral vectors Phase I - gB subunit Phase I,II 50% eVLP Phase I - Single round DISC Phase I,II 42% vectors PC subunit/MVA
Slide 21: The rate of pandemics is increasing
The rate of pandemics is increasing
Slide 22: Deadly endemic infections still require novel vaccine efforts
Yet, deadly endemic infections still require novel vaccine efforts
Slide 23: Populations vulnerable to infectious diseases are increasing
Populations vulnerable to infectious diseases are increasing: elderly and immunocompromised
Slide 24: Pregnant women and children frequently more vulnerable to pandemic variants
Pregnant women and children frequently more vulnerable to pandemic variants • Pregnant/lactating women and children left out of early phase vaccine development • Prevents innovations from reaching these groups https://www.aamc.org/news-insights/are-covid-19-vaccines-safe- • Children require specific
Slide 25: Ideal Immunity: Vaccination in infancy for life-long prevention
Ideal Immunity: Vaccination in infancy for life-long prevention Hepatitis B vaccine • 1st dose: Birth • 2nd dose: 1-2 months • 3rd dose: 6-18 months High risk newborn: • HIBIg + HepB vaccine (passive + active)
Slide 26: Leverage rapidly designed DNA vaccine platforms to protect the next generation
Leverage rapidly designed/produced DNA vaccine platforms to design vaccines to protect the next gen Two Novel Approaches: 1. Reverse vaccinology: Isolation of potent mAbs from pre- screened, infected patients, use to design antigens that will elicit potent, protective responses 2. Protective Transfe
Slide 27: New Era of Vaccines: Pandemic Readiness via Reverse Vaccinology
New Era of Vaccines: Pandemic Readiness via Reverse Vaccinology
Slide 28: Challenging Vaccines: Where natural immunity is not protective
Challenging Vaccines: Where natural immunity is not protective Reverse Engineering 2.0 Strategy: Identify immunogens that can select for B cells with key mutations required for neutralizing IgG development (Kwong, Mascola, 2018) (Haynes, et al. 2012)
Slide 29: Improbable B cell mutations prevent development of potent antibodies
Improbable B cell mutations prevent development of potent antibodies after vaccination Problem: Improbable B cell mutations may impose a bottleneck on B cell lineage maturation M utational Probability Solution: Rapidly iterative 20-100% 10-20% 2-10% vaccine design for engaging 1-2% 0.1-1% 0.01-0.1%
Slide 30: Protective Transfer: Design protective antibodies for delivery
Protective Transfer: Design protective antibodies for delivery to specific sites of virus acquisition Abs at the maternal/fetal interface Maternal Vaccine or Vectored Immunoprophylaxis IgM Antibody products have a good safety profile and precedent in pregnancy • Rh factor incompatibility • Varicella
Slide 31: Vertical transmission of Zika Virus
Vertical transmission of Zika Virus • 1 in 10 pregnant women with a confirmed Zika infection had a baby with congenital Zika syndrome (US population, CDC) – >11,000 cases of microcephaly in 2015-16 epidemic http://www.bbc.com/news/world-latin-america-37112639 • Congenital ZIKV symptoms: – Microcepha
Slide 32: Ultrapotent ZIKV-neutralizing IgM mAb DH1017.IgM
Ultrapotent ZIKV-neutralizing IgM mAb DH1017.IgM Z IK V B in d in g Z IK V N e u tr a liz a tio n 2 .0 R e la tiv e In fe c tio n (% ) Z IK V B in d in g (O D 4 50 ) D H 1 0 1 7 .Ig M 100 1 1 9 -4 -D 6 1 .5 1 1 9 -1 -D 7 1 .0 1 1 9 -5 -C 5 50 1 2 3 -3 -G 2 0 .5 1 2 4 -1 -C 2 1 2 4 -4 -C 8 0 .0 0 1 2
Slide 33: Maternal potent IgM as Zika post or pre-exposure prophylaxis
Maternal potent IgM as Zika post or pre- exposure prophylaxis that does not cross the placenta Potential uses of a ZIKV immunoprophylaxis: Option #1 Option #2 Pre-exposure Post-exposure Virion Image: Sirohi et al., 2016; Google Images
Slide 34: Protective Transfer: maternal dIgA into breast milk
Protective Transfer: maternal dIgA for transfer into breast milk to protect against neonatal enteric pathogens
Slide 35: Design of a maternally administered dIgA to block rotavirus
Design of a maternally administered dIgA to traffic to breast milk and block rotavirus transmission to the infant mAb#41 • Isolated from IgA+ antibody secreting cells in the intestine • VP4-specific • Neutralizing in vitro and in vivo Nair et al., 2017 Produce as a dimeric IgA Dimeric IgA Tetrameric
Slide 36: Systemically administered maternal dIgA protect against rotavirus challenge
Systemically administered maternal dIgA protect against rotavirus challenge Pup stomach content 5 mg/kg mAb41 5 mg/kg tail vein mAb41 tailinfusion vein 1 day post dam injection infusion 150000 100000 106 FFU RV 24 hours ng/ml 50000 Euthanize/ 6 hours post dam injection necropsy 0 15 mg/kg 5 mg/kg Pr
Slide 37: Leveraging DNA vaccine platform for vaccines of the future
Leveraging rapidly designed/produced DNA vaccine platform for vaccines of the future Reverse vaccinology: Isolation of potent mAbs from pre- screened, infected patients, use to design antigens that will elicit potent, protective responses • DNA vaccines could be rapidly and iteratively developed for
Slide 38: IMNN-101 Development Plan
IMNN-101 Development Plan Dr. Khursheed Anwer, PhD, MBA CSO IMUNON © 2023 IMUNON, Inc. PAGE 1
Slide 39: IMNN-101 – The Lead PlaCCine Product
IMNN-101– The Lead PlaCCine Product Next-Generation Covid-19 DNA Vaccine Antigen DNA Plasmid Addressing the limitations of Omicron XBB1.5 Spike Antigen current vaccines Key Distinguishing Attributes Synthetic DNA Delivery System Durable Ag expression Safe & efficient delivery Stable at working temp
Slide 40: IMNN-101 – Evidence of Robust Immunogenicity in a Mouse Model
IMNN-101– Evidence of Robust Immunogenicity in a Mouse Model Prime & Boost Day 14 Day 28 23-032 IgG ✱ 105 10 5 IgG 5 5 nAbs ns Titer Titer 4 Endpoint Titer 4 104 10 4 Endpoint Titer IC50 3 3 Log IC50 103 10 3 2 Log 2 102 10 2 1 1 41039.5 56623.4 21558.3 56623.4 11324.7 21558.3 2264.9 1641.6 2264.9 3
Slide 41: Over 90% Protection From Live Viral Challenge in Mice
Over 90% Protection From Live Viral Challenge in Mice IMNN-101 Prototypes – Early Spike Variants TCID50 Tissue Culture Infection Dose 10 7 10 7 D614G Challenge ( 2.5 x 105) ) Delta Challenge (7 x 104) 10 6 TCID50/gm of lung 10 6 TCID50/gm of lung 10 5 10 5 10 4 10 4 LOD LOD 10 3 10 3 Placebo pVac16
Slide 42: Complete & Comparable Viral Clearance to mRNA Vaccine in Monkeys
4 4 4 Log copies/m 4 Log copies/m Log copies Logcopies/m Log copies/m Log copies Log copies/ Log copies/ Log copi Log copi Log copie 4 Log copie 4 Log copies/ Log copies/ copies/ 44 4 4 4 4 4 3 3 3 3 3 3 3 3 3 Complete & Comparable Viral Clearance to mRNA Vaccine in Monkeys 33 3 3 3 Log 3 2 2 2 2 2
Slide 43: IMNN-101 – Development Status
IMNN-101– Development Status Preclinical Proof of Concept IND-Enabling Studies Safety Tox 4Q 2023 Biodistribution 4Q 2023 Clinical Lot 1Q 2024 IND Filing 1Q 2024 Phase 1 April 2024 Phase 2 June 2024 © 2023 IMUNON, Inc. PAGE 6
Slide 44: IMNN-101 – FDA-Reviewed Clinical Development Plan
IMNN-101– FDA-Reviewed Clinical Development Plan Phase 1/2 Trial in Healthy Subjects: Single Dose, Placebo Controlled Rapid Dose Escalation Followed by Expanded Phase 2 Approach for Speedy Completion DNA Dose Escalation (mg) 0.5 1.0 2.0 Placebo (n = 8 each) Vaccine -30 Days Day-1 Day-7 Day-28 Day-90
Slide 45: Plug & Play Allows for Rapid Response to New & Urgent Vaccines
Plug & Play Allows for Rapid Response to New & Urgent Vaccines Proof of Concept Against Multiple Pathogens • Flu • LASSA C AA • Marburg TTG • Monkeypox CAG Antigen Coding Cassettes SARS-CoV2 Variants Active Vaccine Partnerships • NIAID/NIH – LASSA • Wistar Institute – Flu, Marburg © 2023 IMUNON, Inc
Slide 46: Personal(ized) Immunotherapy
Personal(ized) Immunotherapy Patrick A Ott, MD, PhD Clinical Director, Melanoma Center Dana Farber Cancer Institute Associate Professor of Medicine Harvard Medical School
Slide 47: Disclosures
Disclosures Advisory Role: Alexion, Array, Bristol-Myers Squibb, Celldex, CytomX, Genentech, Merck, Neon Therapeutics, Novartis, Pfizer, TRM Oncology, Evaxion, Immunetune, Imunon, Servier Grants to institution: Armo Biosciences, AstraZeneca/MedImmune, Bristol-Myers Squibb, Celldex, CytomX, Genentech
Slide 48: What is personalized Immunotherapy, really?
What is personalized Immunotherapy, really?
Slide 49: Personalized Immunotherapy in the neoadjuvant setting
Personalized Immunotherapy in the neoadjuvant setting: Use of biomarkers to adapt therapy Baseline biomarker On treatment Pathologic response • response biomarkers for • prognosticator • toxicity early Tx adjustment • +/- adj therapy Biomarker for combination vs monotherapies Adapted from Blank, ASC
Slide 50: Personalized Immunotherapy in the neoadjuvant setting
Personalized Immunotherapy in the neoadjuvant setting: Use of biomarkers to adapt therapy Baseline biomarker On treatment Pathologic response • response biomarkers for • prognosticator • toxicity early Tx adjustment • +/- adj therapy Biomarker for combination vs Extent of Adjuvant therapy monotherap
Slide 51: "Stratified" vs. "Personalized Therapy"
“Stratified” vs. “Personalized Therapy” Stratified Personalized – the drug is custom-made for each patient • Tebentafusp – HLA-A2 • Personalized Vaccines • BRAF/MEKi – BRAFV600 • Adoptive T cell Therapy • EGFR/ALK/METi
Slide 52: "Stratified" vs. "Personalized Therapy"
“Stratified” vs. “Personalized Therapy” Stratified Personalized – the drug is custom-made for each patient • Tebentafusp – HLA-A2 • Personalized Vaccines • BRAF/MEKi – BRAFV600 • Adoptive T cell Therapy
Slide 53: Neoantigens as Cancer Immunotherapy Targets: A paradigm shift
Neoantigens as Cancer Immunotherapy Targets: A paradigm shift A Personal Approach Ott Hematol Oncol Clin N Am 2018
Slide 54: Generation of a personalized neoantigen vaccine
Generation of a personalized neoantigen vaccine Hacohen Cancer Immunol Res 2013
Slide 55: How can Neoantigens be Targeted Therapeutically?
How can Neoantigens be Targeted Therapeutically?
Slide 56: Vaccines and Adoptive Cell Transfer
VACCINES Adoptive Cell Transfer Peptide TIL RNA/DNA Effector Phase: Priming Phase: neoTCR Effector Phase: Tumor DC Lymph nodes Tumor Viral etc. Adapted from Gupta RG Cancer Discov 2021
Slide 57: TILs
TILs Lifileucel Sarnaik SITC 2022
Slide 58: TILs
TILs neoTCR T cells derived from TILs neoTCR T cells derived from autologous PBMC Lybaert Trends in Cancer 2023
Slide 59: Prophylactic vaccines and cancer therapeutic vaccines
SARS-CoV-2 Pathgens Prophylactic vaccines Antibody generation ? T cell responses Cancer Therapeutic vaccines Hu Ott Wu Nature Reviews Immunology 2018
Slide 60: Therapeutic Cancer Vaccines: Considerations
Therapeutic Cancer Vaccines: Considerations Blass, Ott Nature Rev Clin Oncol, 2021
Slide 61: NeoVax in High risk melanoma patients: Study Design
NeoVax in High risk melanoma patients: Study Design Ott et al. Nature 2017
Slide 62: Neoantigen-specific T cell responses
Neoantigen-specific T cell responses Ex vivo * * * ** * * ** * CD4 CD8 ex vivo 18% 0% 1 stimulation 60% 16% © American Association for Cancer Research Ott et al. Nature 2017
Slide 63: Vaccine-induced T cell responses
Vaccine-induced T cell responses: 1) Specific for the mutant epitope 2) Reactive against autologous tumor 4) Broaden after PD-1 inhibition 4) CR after Vax + anti-PD-1 © American Association for Cancer Research Ott et al Nature 2017
Slide 64: Transcriptional profile of neoantigen-specific T cells over the course of vaccination
Transcriptional profile of neoantigen-specific T cells over the course of vaccination v Hu Z & Leet DE Nat. Med., 2021
Slide 65: Transcriptional profile of neoantigen-specific T cells over the course of vaccination
Transcriptional profile of neoantigen-specific T cells over the course of vaccination v Hu Z & Leet DE Nat. Med., 2021
Slide 66: Transcriptional profile of neoantigen-specific T cells over the course of vaccination
Transcriptional profile of neoantigen-specific T cells over the course of vaccination v v Hu Z & Leet DE Nat. Med., 2021
Slide 67: The TCR repertoire diversifies over time after vaccination
The TCR repertoire diversifies over time after vaccination Time Hu Z & Leet DE Nat. Med., 2021
Slide 68: Clinical Course of Patients with High Risk Melanoma (Long-term)
Clinical Course of Patients with High Risk Melanoma (Long-term) Hu Z & Leet DE Nat. Med., 2021
Slide 69: Vaccine-induced neoantigen specific T cells persist over several years
Vaccine-induced neoantigen specific T cells persist over several years Hu Z & Leet DE Nat. Med., 2021
Slide 70: Vaccine-induced neoantigen specific T cells persist over several years
Vaccine-induced neoantigen specific T cells persist over several years Hu Z & Leet DE Nat. Med., 2021
Slide 71: NT-001: Personalized peptide vaccine plus Nivolumab in metastatic patients
NT-001: Personalized peptide vaccine (PV-01) + Nivolumab in metastatic patients (melanoma, NSCLC, and urothelial cancer) NEO-PV-01 + nivolumab in αPD-1/PD-L1 naïve subjects Objectives: safety, clinical efficacy (response rate and durability) and immune responses Ott et al. Cell 2020
Slide 72: NT-001: Personalized peptide vaccine plus Nivolumab in metastatic patients
NT-001: Personalized peptide vaccine (PV-01) + Nivolumab in metastatic patients (melanoma, NSCLC, and urothelial cancer) NEO-PV-01 + nivolumab in αPD-1/PD-L1 naïve subjects Immune Monitoring: (NCT02897765) Ott et al. Cell 2020
Slide 73: NEO-PV-01 + Nivolumab Induces Neoantigen-Specific Immune Responses
NEO-PV-01 + Nivolumab Induces Neoantigen-Specific Immune Responses Ott et al. Cell 2020
Slide 74: Anti-tumor activity
Anti-tumor activity Ott et al. Cell 2020
Slide 75: Epitope spreading correlates with durable progression-free survival
Epitope spreading correlates with durable progression-free survival Ott et al. Cell 2020
Slide 76: Pathologic response post vaccine is associated with clinical benefit
Pathologic response post vaccine is associated with clinical benefit Ott et al. Cell 2020
Slide 77: Pathologic response post vaccine is associated with clinical benefit
Pathologic response post vaccine is associated with clinical benefit Ott et al. Cell 2020
Slide 78: Pathologic response post vaccine is associated with clinical benefit
Pathologic response post vaccine is associated with clinical benefit %PFS Ott et al. Cell 2020
Slide 79: Encouraging signals for efficacy, however no definitive data until recently
Encouraging signals for efficacy, however no definitive data … until recently CRs with α-PD-1 post long Epitope Spreading post long-peptide Path CR post long-peptide Vax peptide Vax in Melanoma Vax in mel, NSCLC, bladder Ca in melanoma Ott & Hu, Nature 2017 Ott, Cell 2020 Ott, Cell 2020 Decreased Re
Slide 80: Personalized Neoantigen RNA vaccine autogene cevumeran in resectable PDAC
Personalized Neoantigen RNA vaccine autogene cevumeran in patients with resectable pancreatic ductal carcinoma (PDAC) Balachandran et al, ASCO Annual Meeting, 2022
Slide 81: T cell immunity induced with a Personalized RNA vaccine correlates with delayed recurrence
T cell immunity induced with a Personalized RNA vaccine + Atezolizumab + mFOLFORINOX correlates with delayed recurrence Rojas LA, Nature, 2023
Slide 82: Randomized Phase 2 trial: mRNA-4157 (V940) + pembrolizumab vs. pembrolizumab
And now a randomized Phase 2 trial: mRNA-4157 (V940) + pembrolizumab vs. Pembrolizumab alone Combination treatment arm: mRNA-4157 (V940) + pembrolizumab Up to 1 year of pembrolizumab treatment Primary endpoint: Key eligibility criteria mRNA-4157 (V940) 1 mg IM Q3W for up to 9 doses + RFSc,d • Stage
Slide 83: mRNA-4157 (V940) and pembrolizumab demonstrated RFS improvement
mRNA-4157 (V940) and pembrolizumab combination treatment demonstrated a statistically significant and clinically meaningful RFS improvement 100 + + 12-month RFS 18-month RFS + + 90 + 83.4 + Censored ++ + % +++++ 78.6 80 + +++++++ %++ +++++ + +++++++ + +++ + ++ 70 77.1 +++++ + + % + +++ + ++++ ++ 60
Slide 84: Challenges/opportunities
Challenges/opportunities • Time and Cost • Magnitude and Quality of Vaccine-induced Immune responses • Improve vaccine formulation/immune adjuvant • Enhance T cell priming
Slide 85: Challenges/opportunities
Challenges/opportunities • Time and Cost • Magnitude and Quality of Vaccine-induced Immune responses • Improve vaccine formulation/immune adjuvant • Enhance T cell priming • “Manage” the TME
Slide 86: Challenges/opportunities
Challenges/opportunities • Time and Cost • Magnitude and Quality of Immune responses • Improve vaccine formulation • Enhance T cell priming • Identify best immune adjuvant • “Manage” the tumor microenvironment • Neoantigen discovery HLAthena • What are the most immunogenic tumor neoantigens? 9-38%in
Slide 87: Challenges/opportunities
Challenges/opportunities • Time and Cost • Magnitude and Quality of Immune responses • Improve vaccine formulation • Enhance T cell priming • Identify best immune adjuvant • “Manage” the tumor microenvironment • Neoantigen discovery • What are the most immunogenic tumor neoantigens? • Can we increas
Slide 88: Catherine Wu lab acknowledgments
Catherine Wu lab DFCI Department of Cancer Immunology and Zhuting Hu Virology Donna Leet Ed Fritsch Kai Wucherpfennig Giacomo Olivera Adrienne Luoma Sachet Shukla Jason Pyrdol Jing Sun Wandi Zhang DFCI Center for Immuno- Pavan Bachireddy Oncology Satyen Gohil Scott Rodig Patrick Lee Zoe Ciantra Moha
Slide 89: Immuno-Oncology & Cancer Vaccine Programs
Immuno-Oncology & Cancer Vaccine Programs Dr. Khursheed Anwer, PhD, MBA CSO IMUNON © 2023 IMUNON, Inc. PAGE 1
Slide 90: IMUNON's Immuno-Oncology & Cancer Vaccine Programs
IMUNON’s Immuno-Oncology & Cancer Vaccine Programs DNA-based Technology Independent of Viruses or Devices for Delivery TheraPlas FixPlas IndiPlas Immune Modulation by Tumor-Associated Antigen Neoantigens Cytokine Therapy Vaccines (personalized vaccines) IMNN-001 IMNN-001 Normal Cell Tumor Cell Self
Slide 91: IMNN-001 – Persistent Local Delivery of IL-12 with Formulated Plasmid
IMNN-001 – Persistent Local Delivery of IL-12 with Formulated Plasmid First Target: Epithelial Ovarian Cancer • Insidious disease – late-stage diagnosis • High recurrence rate – poor survival • Novel approaches warranted IMNN-001 • A gene therapy product for safe and effective delivery of IL-12 • IL
Slide 92: FixPlas: Cancer Vaccines Targeting Tumor-Associated Antigens
FixPlas: Cancer Vaccines Targeting Tumor-Associated Antigens (TAAs) – Monovalent and Bivalent DNA Vaccines Preclinical Proof-of-Concept Studies (bivalent vaccine) Mouse TAA Antigens Melanoma • NYESO-1 & Trp-2 Strong Cellular Responses (Advantage over protein/mRNA) Prophylactic Completed Well Suited
Slide 93: FixPlas Prophylactic: Tumor Inhibition & Survival Improvement
FixPlas Prophylactic- Tumor Inhibition & Survival Improvement – Trp2/NYESO1, B16F10 Melanoma Monovalent Trp2 Vaccine Bivalent Trp2 + NYESO1 Vaccine Monovalent & Bivalent (Formulated Trp2 plasmid) (Formulated Trp2 + NYESO1 plasmid) (Formulated plasmid) Bivalent Trp2 - NYESO Vaccine 23-018 IFNγ T cell
Slide 94: FixPlas Therapeutic: Tumor Inhibition & Survival Improvement
FixPlas Therapeutic- Tumor Inhibition & Survival Improvement Bivalent Trp2 + NYESO1 Vaccine Formulation 3000 Mock 100 Mock Tumor volume (mm3) control-CP+STIN control-CP+STINGa Percent Survival Ga (1×104cells) (1×104cells) 2000 NYESO1+Trp2 NYESO1+Trp2 CP-STINGa 50 CP-STINGa (1×104cells) 1000 (1×104ce
Slide 95: FixPlas Development Plan
FixPlas Development Plan Preliminary Studies Warrant a Product Development Plan • Selection of the disease target • Selection of the antigen target(s) • Optimization of the antigen • Demonstration of robust anticancer activity • IND-enabling studies • Phase 1 clinical trial © 2023 IMUNON, Inc. PAGE