Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Day (June 2021)
89 slides from Pds Biotechnology's investor day presentation, Jun 16, 2021
Slide 1: 2021 Oncology R&D Day
2021 Oncology R&D Day JUNE 16, 2021 A new generation of multi-functional cancer immunotherapies and infectious disease vaccines
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements about PDS Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development activi
Slide 3: Welcome and Agenda
Welcome and Agenda
Slide 4: Today's Agenda
Today’s Agenda Welcome and Introductions Deanne Randolph Versamune®: A New Generation of Cancer Immunotherapies Dr. Frank Bedu-Addo Development of PDS0101 for HPV16-associated cancers Dr. Lauren V. Wood Dr. Jeff Schlom Dr. Caroline Jochems Dr. Julius Strauss Development of PDS0102 for TARP-related c
Slide 5: Versamune: A New Generation of Cancer Immunotherapies
® Versamune : A New Generation of Cancer Immunotherapies
Slide 6: A significant barrier to effective immunotherapy
PDS Biotech’s Versamune®-based A significant barrier to immunotherapies are designed to effective immunotherapy promote a powerful in vivo tumor-specific CD8+ killer T-cell response has been the inability to promote adequate CD8+ Versamune®-based therapies also show promising potential to: killer T-
Slide 7: Current state of cancer immunotherapy
Current state of cancer immunotherapy • Cancers evade immunosurveillance and suppress T-cell attack by several immune suppressive and evasive mechanisms - several immunotherapies target such mechanisms – Checkpoint inhibitors – Inhibitors of LAG-3 – TGF-β TRAP • Technologies that can overcome immune
Slide 8: Versamune-induced killer T-cells may eradicate HPV-positive tumors after a single dose
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies 500 Polyfunctional
Slide 9: PDS0101 Phase 1 study showed strong induction of HPV16 T-cell responses
PDS0101 Phase 1 clinical study demonstrated strong in vivo induction of circulating HPV16 T-cell responses Responses were evaluated on Days 14-19 after SC injection Predominant CD8+ T-cell responses confirmed by Granzyme-b ELISPOT HPV-specific HPV-specific 2000 250 T-cell Response T-cell Response IF
Slide 10: Introduction to the Versamune Platform
Introduction to the ® Versamune Platform
Slide 11: Versamune is a proprietary T-cell activating platform
Versamune® is a proprietary T-cell activating platform engineered to induce a robust, targeted anti-tumor response in vivo ▪ Versamune® is based on proprietary, positively charged and immune activating lipids that form spherical nanoparticles in aqueous media ▪ The nanoparticles are sized to mimic v
Slide 12: Enantiomeric specificity in immunological activation
Versamune® provides the first demonstration of enantiomeric specificity pertaining to immunological activation R-DOTAP provides superior CD8+ and CD4+ T-cell induction vs. S-DOTAP Immune responses to S-DOTAP are further weakened in the presence of a tumor Enantiomeric specificity Nasdaq: PDSB Refere
Slide 13: Versamune Mechanism of Action
Versamune® Mechanism of Action
Slide 14: Versamune designed to induce robust targeted anti-tumor response in vivo
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered with a tumor-associated antigen Versamune® + Tumor- associated proteins (antigens) Promotes uptake of vaccine Promotes antigen processing Activates Type I Interferon or immunotherapy and and presenta
Slide 15: Uptake of the Versamune-Based Immunotherapy
® Uptake of the Versamune - Based Immunotherapy
Slide 16: Sub-cutaneous injection initiates cascade of immunological events
Versamune® sub-cutaneous injection initiates a powerful and targeted cascade of critical immunological events First demonstration of lipid enantiomeric specificity on immune activation Versamune® (R-DOTAP) nanoparticles S-DOTAP nanoparticles SC injection of the active enantiomer (R-DOTAP) SC injecti
Slide 17: Efficient and exclusive uptake by dendritic cells
Early clinical studies with Versamune® demonstrate efficient and exclusive uptake by dendritic cells Positively-charged particles are designed to be spherical and sized similarly to viruses for optimal uptake VLP nanoparticle sizing Dendritic cells or epithelial cell line incubated with DQ-OVA alone
Slide 18: Versamune induces activation/maturation of dendritic cells
Versamune® induces activation/maturation of dendritic cells Dendritic cell Versamune® uptake & T-cell activation Mature dendritic cells: • migrate into lymph donor#1 nodes 100 • express costimulatory GeoMean molecules 80 • facilitate the 60 interaction with T-cells 40 • take up VersamuneⓇ 20 within
Slide 19: Versamune Promotes Antigen Cross-Presentation
® Versamune Promotes Antigen Cross-Presentation
Slide 20: Superior antigen processing and endosomal accumulation
Versamune® may promote superior antigen processing and endosomal accumulation (in vitro) – Facilitates access to MHC Class I Pathway The positive charge of the liposome destabilizes the endosomes allowing the antigen to enter the cytoplasm of the dendritic cells and facilitates cross-presentation to
Slide 21: Antigen presentation to CD8+ killer and CD4+ helper T-cells
Preclinical studies show that Versamune® demonstrates effective antigen presentation to both CD8+ killer and CD4+ helper T-cells Effective presentation of peptides via both the major histocompatibility complex (MHC) Class I pathway to CD8+ killer T-cells and via the MHC Class II pathway to CD4+ help
Slide 22: Versamune Promotes Up-Regulation of Type I Interferons
® Versamune Promotes Up- Regulation of Type I Interferons
Slide 23: Type I interferons lead to sustained recruitment of T-cells
Induction of Type I interferons and associated chemokines in the lymph nodes leads to powerful and sustained recruitment of T-cells Elevated T-cell levels persist in lymph nodes for over 7 days after 1 Versamune® dose Localization of cytokines & chemokines promotes a strong safety profile Localized
Slide 24: Type I interferons upregulated via Myd88 pathway
Specificity of the Versamune® effect: Type I interferons are upregulated via activation of the Myd88 pathway Versamune® mediates its CTL-inducing effects by activating type I interferons in a Myd88-dependent manner Type I IFN / Myd88 specificity Versamune® Versamune® The T-cell responses were elimin
Slide 25: Localized cytokine induction may minimize systemic toxicity
The localized and sustained cytokine induction in the lymph nodes of Versamune® has the potential to minimize the risk of systemic toxicity Negligible systemic inflammation MCP-1 (CCL2) IP-10 pg/ml pg/ml R-DOTAP® Versamune TLR-Adjuvant Low PDS0101 High PDS0101 Versamune® alone +ve Ctrl R-DOTAP alone
Slide 26: PDS0101 induces high quantity and quality of CD8+ T-cells
PDS0101: Versamune® induces high quantity and quality of CD8+ killer T-cells and alters the tumor micro-environment to increase efficacy Minimizes the presence of immune suppressive regulatory T-cells (Treg) within the tumor microenvironment Antigen-specific T-cells infiltrate tumor A-antigen, R-Ver
Slide 27: Versamune-induced killer T-cells may eradicate HPV-positive tumors
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies 500 Polyfunctional
Slide 28: Versamune Is Effective Against Non-Viral Tumors
® Versamune Is Effective Against Non-Viral Tumors
Slide 29: Versamune-induced T-cells may enhance checkpoint inhibitors in B16 melanoma
Versamune®-induced T-cells may enhance efficacy of checkpoint inhibitors – Study in immune suppressive B16 melanoma Versamune works with multiple tumor antigens Enhanced anti-tumor activity in combination 1.2 among all cells in the tumor mass Percentage of CD4+ and CD8+ 0.8 0.4 0 75nmol TRP2 75nmol
Slide 30: TRP2-specific CD8+ T-cells break immune tolerance in B16 melanoma
Versatility of Versamune®: Potent TRP2-specific CD8+ killer T-cells break immune tolerance in difficult-to-treat B16 melanoma Potent activity with different tumor antigens Healthy animals 14 days after single injection treatment Versamune® Formulation 1 Versamune® Formulation 2 Black stains Negative
Slide 31: PDS0101 proprietary formulation: peptide micelles with Versamune
PDS0101 Proprietary formulation: Mixture of peptide micelles with Versamune® promotes superior CD8+ killer T-cell response Comparison of Micellar vs. Traditional Encapsulation Methods - IFN ELISPOT Shows Superior Potency of the PDS Biotech Micellar Approach – EU Patent Received 1200 Micellar antige
Slide 32: Development of PDS0101 for HPV16-associated cancers
Development of PDS0101 for HPV16-associated cancers
Slide 33: PDS0101 designed to treat HPV16-associated cancers
PDS0101 is designed to treat cancers caused by human papillomavirus (HPV)-16, which represents 70-80% of the HPV-associated cancers US annual HPV-associated cancer incidence1 • Approximately 43,000 patients are Females (24,391) Males (18,280) diagnosed with HPV-associated cancers annually in the US1
Slide 34: Clinical strategy: PDS0101 in combination with established therapies
Clinical strategy: Develop PDS0101 in combination with established therapies for rapid proof-of-concept and risk mitigation Combinations of PDS0101 with FDA-approved Novel combinations of PDS0101 with promising, standard of care investigational immunotherapeutic agents − Combination with KEYTRUDA® −
Slide 35: PDS0101 engineered for simplicity and ease of administration
PDS0101: Versamune® plus a proprietary mix of HPV16 antigens is engineered for simplicity and ease of administration Delivered SC – no need for intratumoral or intranodal delivery Vial #1 of Versamune® (L) and PDS0101 formulation Delivered via Vial #2 of HPV16 mix (R) is mixed before injection* subc
Slide 36: Phase 2 NCI-led trial of triple combination
Phase 2 NCI-led clinical trial evaluating the triple combination of PDS0101, Bintrafusp alfa and M9241 in advanced HPV-associated cancer Indication Patients with advanced HPV-associated cancer who have failed prior treatment Bintrafusp alfa: Bifunctional “trap” fusion protein Clinical Agents M9241:
Slide 37: Preclinical triple combination demonstrated higher targeted T-cell response
Preclinical study: Triple combination of PDS0101, Bintrafusp alfa (M7824) and M9241 (NHS-IL12) demonstrated higher targeted T-cell response Combination of PDS0101 with Bintrafusp alfa or M9241 generated superior targeted T-cell response; triple combination demonstrated superior efficacy Bintrafusp a
Slide 38: A Multifaceted Approach to Cancer Immunotherapy
“A Multifaceted Approach to Cancer Immunotherapy” Jeffrey Schlom, PhD Chief, Laboratory of Tumor Immunology and Biology Center for Cancer Research National Cancer Institute, NIH
Slide 39: PD(L)-1 Inhibitors and HPV-associated Cancers
PD(L)-1 Inhibitors and HPV-associated Cancers ▪ Cervical, SCCHN, rectal, vaginal, vulvar > 30,000 new cases in the U.S. annually > 630,000 annually worldwide ▪ Nivolumab and Pembrolizumab approved for SCCHN ▪ Pembrolizumab approved for PD-L1+ cervical cancer ▪ ORR ranged from 13–24% 39
Slide 40: Schlom and Gulley. JAMA 2018
Schlom and Gulley. JAMA 2018 40
Slide 41: A Multifaceted Approach to Cancer Immunotherapy
A Multifaceted Approach to Cancer Immunotherapy ▪ Activation of a T-cell immune response to a tumor-associated/specific antigen ▪ Potentiation of the immune response - systemic - in the tumor microenvironment (TME) ▪ Reduction of immunosuppressive cells ▪ Alteration of the tumor phenotype to render
Slide 42: A Multifaceted Approach to Cancer Immunotherapy
A Multifaceted Approach to Cancer Immunotherapy ▪ Activation of a T-cell immune response to a tumor-associated/specific antigen HPV therapeutic vaccine (PDS0101) ▪ Potentiation of the immune response - systemic - in the tumor microenvironment (TME) NHS-IL12 immunocytokine ▪ Reduction of immunosuppre
Slide 43: Triple therapy of HPV-associated malignancies with PDS0101, bintrafusp alfa, and NHS-IL12
Triple therapy of HPV-associated malignancies with PDS0101, bintrafusp alfa, and NHS-IL12 Caroline Jochems, M.D., Ph.D. PDS Oncology R&D Day, June 16, 2021 43
Slide 44: HPV-associated malignancies
HPV-associated malignancies Human Papilloma Virus: dsDNA virus, > 200 strains VH VL VH VL 13 “high risk” strains, HPV16 and HPV18 CH CH1 CL 1 CL Prevalence of high-risk HPV: Men: 25% Bintrafusp alfa / M7824 CH2 CH2 Women 20% CH3 CH3 Linker Linker > 630,000 new cases worldwide annually EMD Serono TGF
Slide 45: Publications: Bintrafusp alfa / M7824
Publications: Bintrafusp alfa / M7824 Analysis of the tumor microenvironment and anti-tumor efficacy of subcutaneous vs systemic delivery of the bifunctional agent bintrafusp alfa. Ozawa Y, Schlom J, Gameiro SR. Oncoimmunology. 2021 May 3;10(1):1915561. Improving the Odds in Advanced Breast Cancer W
Slide 46: Publications: NHS-IL12 / M9241
Publications: NHS-IL12 / M9241 Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. Smalley Rumfield C, Pellom ST, Morillon Ii YM, Schlom J, Jochems C.J Immunother Cancer. 2020 Jun;8(1):e000612. Efficient Tumor Clearance and Diversified Immunity through Neoepitope Vaccines and Com
Slide 47: Tumor model TC-1
Tumor model TC-1 TC-1: syngeneic lung carcinoma cell line transformed with HPV16 E6/E7 TC Wu, Baltimore Mice treated with: • PDS0101 s.c, weekly, days 7, 14, and 21 • M7824 250 µg i.p, days 7, 9, and 11 • NHS-IL12 50 µg s.c, day 7 0 7 14 21 28 Tumor implantation End of Study 47
Slide 48: Combination reduced tumor volume in TC-1 bearing mice
The combination of PDS0101, bintrafusp alfa, and NHS-IL12 reduced tumor volume in TC-1 bearing mice 48
Slide 49: Combination increased TCR clonality
The combination of PDS0101, bintrafusp alfa, and NHS-IL12 increased TCR clonality Tumor infiltrating lymphocytes (TILs) were purified from whole tumor. DNA isolated from TILs was analyzed by Adaptive Biotechnology for TCR repertoire. 49
Slide 50: Conclusions
Conclusions These studies provide a preclinical rationale for the on-going Phase I/II study run by Dr. Julius Strauss 50
Slide 51: Phase II evaluation of triple combination in HPV16 positive malignancies
PHASE II EVALUATION OF THE TRIPLE COMBINATION OF PDS0101, M9241, AND BINTRAFUSP ALFA IN PATIENTS WITH HPV 16 POSITIVE MALIGNANCIES Julius Strauss1, Charalampos S. Floudas2, Houssein Abdul Sater2, Michell Manu3, Elizabeth Lamping2, Deneise C Francis2, Lisa M Cordes2, Jenn Marte2, Renee N Donahue1, Ca
Slide 52: Study Design
Study Design • Patients with advanced HPV-related cancers received the combination of bintrafusp alfa at 1200 mg flat dose i.v. q 2wks, M9241 at 16.8 mcg/kg s.c. q 4 wks and PDS0101 given as two separate 0.5 ml s.c. injections q 4 wks [NCT04287868] • Dose reductions of M9241 to 8 mcg/kg were allowed
Slide 53: Results: baseline characteristics
Results All patients N=25 Key baseline patient and disease Age, median (range), years 50 (37-80) characteristics Female, n (%) 17 (68) Tumor type, n (%) • As of 01 MAR 2021, 25 patients had received the Cervical 10 (40) triple combination of PDS0101, M9241 & Anal 6 (24) bintrafusp alfa Head & Neck S
Slide 54: Results: safety summary
Results All patients Safety summary N=25 Grade ≥2 • Grade 3 TRAEs occurred in 10 (40%) patients Treatment-related adverse events (TRAEs) 23 (92) TRAEs leading to discontinuation of ≥ 1 drug(s) 5 (20) • anemia due to hematuria (n=4), AST/ALT elevation (n=2); flu like symptoms (n=1), Treatment-related
Slide 55: Results: patient outcomes
J Clin Oncol 2019;37:1470–8 J Clin Oncol 2019;37:1470–8 J Clin Oncol 2019;37:1470–8 Results Patient Outcomes All HPV HPV 16+ • ORR 55.6% (tumor reduction 66.7%) in HPV 16+ disease 16+ patient HPV 16+ CPI CPI s N=18 Refractory N=25 Naïve N=12 • ORR 83.3% in CPI naïve HPV 16+ disease N=6 BOR, n (%) •
Slide 56: Results
Results • Responses in HPV 16+ disease occurred irrespective of tumor type 56 J. Strauss
Slide 57: Results
Results Primary Refractory: Prior PD or SD < 6 months • Overwhelming majority of HPV 16+ CPI naive pts had a Secondary Refractory: Prior PR or SD > 6 months response 57 • Majority of HPV 16+ CPI refractory pts had tumor shrinkage J. Strauss
Slide 58: Conclusions
Conclusions • Triple combination of PDS0101, M9241 and bintrafusp alfa appears to have a manageable safety profile along with early evidence of notable clinical activity for pts with advanced HPV 16+ malignancies • Clinical activity noted irrespective of tumor type or CPI status • ORR was 55.6% (tum
Slide 59: Clinical strategy: PDS0101 in combination with established therapies
Clinical strategy: Develop PDS0101 in combination with established therapies for rapid proof-of-concept and risk mitigation Combinations of PDS0101 with FDA-approved Novel combinations of PDS0101 with promising, standard of care investigational immunotherapeutic agents − Combination with KEYTRUDA®
Slide 60: VERSATILE-002: PDS0101 and KEYTRUDA in head and neck cancer
PDS Biotech-sponsored phase 2 trial evaluating the combination of PDS0101 and KEYTRUDA for first-line treatment of HPV-associated metastatic/recurrent head and neck cancer (VERSATILE-002) Indication First line treatment of patients with HPV-associated head and neck cancer whose cancer has spread or
Slide 61: IMMUNOCERV: PDS0101 with chemoradiation in cervical cancer
A Phase 2, investigator-initiated clinical trial evaluating PDS0101 in combination with chemoradiation therapy in patients with locally advanced cervical cancer (IMMUNOCERV) Indication Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA Clinical Chemoradiotherapy (CRT – Stan
Slide 62: Projected PDS0101 milestones through 2022
Projected PDS0101 milestones through 2022* 1Q21 2Q21 3Q21 4Q21 1Q22 2Q22 3Q22 4Q22 Preliminary efficacy Data from advanced HPV-associated cancer trial (NCI) Interim data from HPV- associated Cancer trial (NCI) expected PDS0101 Expected completion of accrual HPV-associated cancer trial (NCI) Potentia
Slide 63: Questions?
Questions?
Slide 64: Development of PDS0102 for TARP-related cancers
Development of PDS0102 for TARP-related cancers
Slide 65: PDS0102 designed to treat TARP-related cancers
PDS0102 is designed to treat cancers caused by T-cell receptor gamma alternate reading frame protein (TARP), including AML, prostate and breast cancers Approximately 470,000 patients are diagnosed annually with AML, prostate or breast cancer, most of which are associated with target T-cell receptor
Slide 66: TARP antigen validated for cancer immunotherapy
The TARP antigen used in PDS0102 has been validated for use in cancer immunotherapy Patients with Stage D0 prostate cancer vaccinated with TARP showed a significant decrease in tumor growth rate based on PSA levels* Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8) 66
Slide 67: PDS0102 may provide superior induction of TARP-specific CD8+ T-cells
PDS0102 may provide superior induction of TARP-specific tumor attacking CD8+ killer T-cells PRE-CLINICAL OPTIMIZATION STUDIES: TARP-Specific T-cell Induction after 2 injections of PDS0102 Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8) CFA – Complete Freund’s Adjuvant a highly potent immu
Slide 68: Clinical strategy: PDS0102 monotherapy and combinations in prostate cancer
Clinical strategy: Develop PDS0102 both as monotherapy and in combination with established therapies in prostate cancer, then expand Early Disease Advanced Disease Confirm PDS0102 immunogenicity and tumor Explore PDS0102 safety and immunogenicity in infiltration as monotherapy and in combination: co
Slide 69: Questions?
Questions?
Slide 70: Development of PDS0103 for MUC1-related cancers
Development of PDS0103 for MUC1-related cancers
Slide 71: PDS0103 designed to treat MUC1-related cancers
PDS0103 is designed to treat cancers caused by mucin-1 (MUC1), which is highly expressed in solid tumors and is associated with poor prognosis Clinical trial design will seek to evaluate PDS0103 in tumor types with the highest expression of MUC1 and the greatest differences in MUC1 expression betwee
Slide 72: Versamune-induced CD8+ T-cells may eradicate MUC1-positive tumors
Greater quantity and quality of Versamune®-induced CD8+ killer T-cells may result in unique ability to eradicate MUC1-positive tumors Induced a >10-fold number of polyfunctional MUC1 specific CD8+ T-cells 500 Polyfunctional T-cells # of Antigen-Recognizing CD8+ T-Cells 450 IFN-γ Spot Forming Cells/1
Slide 73: MUC1 agonist epitopes for therapeutic cancer vaccine development
MUC1 agonist epitopes for therapeutic cancer vaccine development Caroline Jochems, M.D., Ph.D. PDS Oncology R&D Day, June 16, 2021 73
Slide 74: MUC1
MUC1 • Expressed in >90% of all carcinomas • Aberrantly expressed in cancer • N-terminus of MUC1: extracellular, shed • C-terminus of MUC1: • Transmembrane and intracellular parts • Oncogene • Drives lineage plasticity by inducing EMT (Epithelial to Mesenchymal Transition) • Associated with more mal
Slide 75: MUC1 epitope designations and locations
MUC1 epitope designations and locations 75
Slide 76: Agonist epitopes
Agonist epitopes Change individual amino acids Better MHC binding Better presentation Better T-cell stimulation 76
Slide 77: IFN production by native and agonist specific T cell lines
Production of IFN by native and agonist specific T cell lines stimulated with the native and agonist HLA-A2 epitopes 77
Slide 78: MUC1 epitope-specific T cell lines lyse tumor cell lines
MUC1 native and agonist epitope-specific T cell lines lyse tumor cell lines expressing MUC1 and HLA-A2 T cell line E:T ratio MCF-7 SK-Mel MUC1+ HLA-A2+ MUC1- HLA-A2+ T-1-C1 50:1 26.4 8.0 25:1 3.9 - T-1-C1A 50:1 40.7 0 25:1 25.5 - T-1-C2 50:1 53.6 4.6 HLA-A2 blocking 25:1 38.5 - T-1-C2A 50:1 54.4 0 2
Slide 79: Functional assays with MUC1 agonist peptides vs native peptides
Functional assays with MUC1 agonist peptides compared to native peptides Agonist vs. Agonist vs. Agonist Agonist HLA Native Native Lysis of IFNγ MUC1 Region allele Designation Tumor Lysis IFNγ Tumor Production N-non-VNTR A2 P93L + + + + VNTR A2 V1 NA* NA* + + VNTR A2 V2 NA* NA* + + C domain A2 C1 +
Slide 80: Conclusions
Conclusions 1. 10 agonist epitopes have been identified for MUC1 - 7 are in the oncogenic C-terminus 2. Compared to T-cells generated with the native epitopes, T-cells generated with the agonists show greater lysis of tumor cells expressing native MUC1 3. All 10 agonist epitopes are included in PDS0
Slide 81: PDS0103 demonstrates potent induction of MUC1-specific T cells
PDS0103 (MUC1) demonstrates potent induction of MUC1-specifc T cells across multiple epitopes IFN- Spot forming cells /106spleen cells 4096 • PDS0103 formulation EN10 was 2048 tested in HLA-A2 transgenic mice. 1024 • Vaccine immunogenicity was assessed using HLA-A2 specific 512 epitopes V1A, V2A,C1
Slide 82: Clinical strategy: PDS0103 in a basket trial of MUC1-associated cancers
Clinical strategy: Develop PDS0103 in a basket trial of MUC1-associated cancers in combination with established and investigational therapies Combinations of PDS0103 with FDA-approved Novel combinations of PDS0103 with promising, standard of care investigational immunotherapeutic agents − Treatment
Slide 83: Clinical disease indications for Versamune-based platforms
Clinical disease indications that could potentially be targeted by dual Versamune®-based platforms PDS0101 (HPV16mix) PDS0102 (TARP) PDS0103 (MUC1) Anal AML Breast Cervical Prostate Colorectal HNC Breast Lung Penile Ovarian Vaginal / Vulvar Cervix HNC PDS0101 / PDS0103 PDS0102 / PDS0103 Cervical Bre
Slide 84: Questions?
Questions?
Slide 85: Next Steps and Opportunities
Next Steps and Opportunities
Slide 86: PDS Biotech seeks to validate Versamune platform across multiple antigens
PDS Biotech seeks to validate the efficacy and safety of the Versamune® platform across multiple tumor-targeting antigens Nasdaq: PDSB
Slide 87: Versamune compatible with a wide array of tumor antigens
Versamune® has demonstrated the potential for immunological compatibility with a wide array of tumor antigens • Versamune®’s unique flexibility means it may work well with a wide range of targets • 4 tumor antigens are currently being utilized with the Versamune® platform • The company is seeking co
Slide 88: Exploring research collaborations and partnerships over next 18 months
Over the next 18 months PDS Biotech will be exploring research collaborations and partnerships to progress the pipeline PDS Biotech Asset Research Objectives PDS0101 • Document tumor infiltration of PDS0101-induced HPV16-targeted T-cells PDS0102 • Establish safety, immunogenicity and pathologic resp
Slide 89: A new generation of multi-functional cancer immunotherapies
A new generation of multi-functional cancer immunotherapies