Biovaxys Technology Corp · CSE:BIOV
Biovaxys Technology — Investor Presentation (December 2021)
44 slides from Biovaxys Technology's investor presentation, December 2021
Slide 1: Waking up the Human Immune System
Waking up the Human Immune System Immunotherapeutic vaccine platforms and diagnostics harnessing the power of T-cells 1
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT The statements in this presentation are "forward-looking" statements that are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements involve significant risk
Slide 3: Haptenized Antigen Vaccine Platform
Haptenized Antigen Vaccine Platform ● Unique established approach “teaches” the patient's immune system to recognize and target viral or tumor antigens as foreign via process of haptenization ● Antigens modified w/ a chemical called a ‘hapten’ (Examples: dinitrophenyl/DNP, sulfanilic acid/SA); makes
Slide 4: The BioVaxys Difference
The BioVaxys Difference Derisked Development BIOVAXYS Technology Corp. (CSE:BIOV OTCQB:BVAXF FR:5LB ) ● BioVaxys LLC founded in 2018 to improve on the ‘first-generation’ of haptenized antigen vaccines & leverage previous vaccine development efforts by Dr David Berd while at Thomas Jefferson Universi
Slide 5: Product Portfolio
Product Portfolio PRODUCT INDICATION PRECLINICAL IND/PHASE I PHASE II/III Monovalent Sars-CoV-2 BVX-0320 Vaccine BVX-0204 HPV Viral Vaccine (Partnered in EU w/ ProCare Health) BVX-0918A (Partnered in EU w/ ProCare Health) Ovarian Cancer BVX-0918C (Partnered in EU w/ Cervical Cancer ProCare Health) P
Slide 6: Haptenized Tumor Antigen Vaccine Platform Ovarian Cancer
Haptenized Tumor Antigen Vaccine Platform Ovarian Cancer ● Lead target of Stage III/Stage IV ovarian cancer ➢ ~300 ,000 cases diagnosed worldwide per year 1 ➢ Most deadly gynecologic malignancy in developed countries 1 ➢ Majority of stage III or IV disease will ultimately have recurrent disease resi
Slide 7: Bihaptenized Autologous Ovarian Cancer Vaccine: BVX-0918
Bihaptenized (DNP +SA) Autologous Ovarian Cancer Vaccine: BVX-0918 ● Focus is on patients with advanced, platinum-resistant ovarian cancer ● Vaccine cells obtained from autologous tumor tissue ● Vaccine cells are modified with two haptens: DNP – modifies hydrophilic amino acids SA – modifies hydroph
Slide 8: Bi-haptenization: An advance over first generation single hapten vaccines
Bi-haptenization: An advance over first generation single hapten vaccines Bihaptenization SUPERIOR TO Anti-CTLA4 SINGLE Two haptens & Anti-PDA HAPTEN IN conjugated to Antibodies TUMOR the patients own tumor cell VACCINES • Early autologous haptenized vaccines based on single hapten (DNP) conjugated
Slide 9: Bihaptenized Autologous Cancer Vaccine + Checkpoint Antibody
Bihaptenized Autologous Cancer Vaccine + Checkpoint Antibody T regs downregulate immune Immunological Synergies Breaks Tolerance T reg response and lower the T cell cell response: the “brakes” of the immune system T helper cell Check Point T cells now attack Inhibitor Blocks T unmodified tumors Regs
Slide 10: Clinical Data on First Generation Haptenized Cancer Vaccines
Clinical Data on First Generation Haptenized Cancer Vaccines (D. Berd) Melanoma: Thomas Jefferson University DNP-modified, Stage IV: 97 DNP-modified, Stage III adjuvant: 214 DNP-modified, Other studies: 96 Bihaptenized, Stage IV 23 Previous Licensee Stage III + Stage IV 188 Total Melanoma 618 Ovaria
Slide 11: Results of a Trial of DNP-Modified Vaccine in Stage IV Melanoma
Results of a Trial of DNP-Modified Vaccine in Patients with Stage IV Melanoma - I ▪ 83 patients with stage IV, surgically-incurable melanoma ▪ Received multiple injection of autologous, DNP-vaccine with BCG adjuvant ▪ Tumor regression assessed by standard criteria ▪ 11 anti-tumor responses – 2 CR, 4
Slide 12: Complete Regression of Melanoma Lung Metastases After DNP-Modified Vaccine
Complete Regression of Melanoma Lung Metastases After DNP-Modified Vaccine Pre-Vaccine 4 Months Post-Vaccine 12
Slide 13: T Lymphocyte Infiltration of Metastatic Tumors After DNP-Modified Vaccine
T Lymphocyte Infiltration of Metastatic Tumors After DNP-Modified Vaccine (-) CD3+ T H and Control Cells E CD8+ T CD4+ T Cells Cells 13
Slide 14: Phase I Trial of Bihaptenized Vaccine in Stage IV Melanoma
Results of a Phase I Trial of Bihaptenized Vaccine in Patients with Stage IV Melanoma ▪ Autologous melanoma cells were extracted from excised metastatic tumors. ▪ Half the cells modified with dinitrophenyl (DNP) and half with sulfanilic acid (SA). ▪ DNP- and SA-modified cells were combined, fixed in
Slide 15: Phase I-II Trial of DNP-Modified Vaccine in Advanced Ovarian Cancer - I
Results of a Phase I-II Trial of DNP-Modified Vaccine in Patients with Advanced Ovarian Cancer - I Efficacy: 26 evaluable patients with advanced, chemotherapy-resistant ovarian cancer Received multiple injection of autologous, DNP-vaccine with BCG adjuvant Median survival: 25.4 months with >20% 5-ye
Slide 16: Phase I-II Trial of DNP-Modified Vaccine in Advanced Ovarian Cancer - II
Results of a Phase I-II Trial of DNP-Modified Vaccine in Patients with Advanced Ovarian Cancer - II Vaccine No Vaccine (Month s) Overall survival of patients who received vaccine (25.4 months) vs patients who had vaccine prepared but did not receive vaccine (6.5 months); p=0.001 16
Slide 17: Single Hapten Phase I/II Clinical Results
Single Hapten Phase I/II Clinical Results Stage III-IV Platinum-Resistant Ovarian Cancer Median Survival Ovarian Cancer (Platinum Resistant) Competitive Comparison 25 22.68 20 OVAX plus 1 cyclophosphamide 15 16.6 AVASTIN (bevacizumab) + Chemo 12.9 Chemotherapy 10 5 0 17
Slide 18: Abstract: Single Hapten Vaccine in Recurrent Ovarian Cancer (2013)
Abstract: Single Hapten (First Generation) Vaccine in Recurrent Ovarian Cancer (2013) ● Objectives: Recurrent ovarian cancer is ultimately chemotherapy resistant. We investigated an alternative treatment using a human cancer vaccine consisting of autologous tumor cells modified with the hapten, dini
Slide 19: Co-Development, Joint Commercialization and Marketing Collaboration
CO-DEVELOPMENT, JOINT COMMERCIALIZATION AND MARKETING COLLABORATION GYNECOLOGICAL CANCER & HPV VACCINES ○ P&G spin-off (2012) focused on Women’s Health ○ Fully integrated EU pharmaco w/ established KOL relationships, marketing & sales presence in the EU ○ BioVaxys+Procare Agreement (2/2021): ○ USD$9
Slide 20: BVX-0918A Phase I Study
BVX-0918A Phase I Study of a Bihaptenized Autologous Ovarian Tumor Cell Vaccine in Ovarian Cancer Patients After Relapse ● Determine toxicity & safety in late-stage ovarian cancer after relapse ● Phase I, single-arm (n=30), multi-center study in Spain (3-5 centers) ● Treatment-emergent and related a
Slide 21: Papilocare
Papilocare® HPV INFECTION: 528,000 CASES OF CERVICAL CANCER AND 266,000 CERVICAL CANCER DEATHS EACH YEAR1 ● 1st and only product for treatment and prevention HPV-dependent cervical lesions ● Marketed in EU as a Class IIa medical device (€ for 28 European countries) ● Est. $49.0M US OTC / $294.0M US
Slide 22: T cell Immunity: The Key to Combating the Pandemic
T cell Immunity: The Key to Combating the Pandemic “This study aimed to explore the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific humoral responses and T-cell responses in patients who have recovered from coronavirus disease 2019 (COVID-19) to understand the natural protectiv
Slide 23: BVX-0320
BVX-0320 Haptenized recombinant SARS-CoV-2 s-protein Emerging Profile Second generation SARS-CoV-2 vaccine with robust antibody response, superior T cell activation, superior tolerability & safety to mRNA and adenovirus vector vaccines, and broad pan- sarbecovirus (β CoV B) coverage ● 96.4% positive
Slide 24: DNP-Modified Covid-19 Vaccine: BVX-0320 Murine Proof of Concept
DNP-Modified Covid-19 Vaccine: BVX-0320 Murine Proof of Concept Model ● The S1 subunit of the spike protein of SARS-Cov-2 was modified with DNP by reacting with dinitrobenzene sulfonic acid. ● BVX-0320 was mixed with the adjuvant QS21 10ug before sc injection. ● Male CF-1 mice (7 per group) were ass
Slide 25: Haptenized Covid-19 Vaccine - Results
Haptenized Covid-19 Vaccine - Results Two injections of BVX-0320 + adjuvant induced: ● 96.4% positive antibody response detected at week 6 ● T cell response as indicated by λ interferon production after secondary stimulation with S1 peptides ● T cell response as indicated by induction of activation
Slide 26: Haptenized Covid-19 Vaccine – Antibody Response
Haptenized Covid-19 Vaccine – Antibody Response *Titer 1:120,00 0.3ug group vs. 3ug group, p=.002 1ug group vs. 3ug group, p=.041 3ug group vs. 10ug group, p=.522 26
Slide 27: Haptenized Covid-19 Vaccine – T Cell Response Activation – CD4+CD25+
Haptenized Covid-19 Vaccine – T Cell Response Activation – CD4+CD25+ CD4+CD25+ Dose: 10ug p=.005, 3 ug p=.016 5.0% 3.0% 1.0% Unstim Peptide 27
Slide 28: Haptenized Covid-19 Vaccine – T Cell Response Activation – CD8+CD25+
Haptenized Covid-19 Vaccine – T Cell Response Activation – CD4+CD25+ CD8+CD25+ Dose: 10ug p=.012, 3 ug p=.038 0.75% 0.50% 0.25% 0.00% Unstim Peptide 28
Slide 29: A Pan-CoV Vaccine is a Pan-Sarbecovirus Vaccine
A “Pan-CoV” Vaccine is a Pan-Sarbecovirus Vaccine ● Sarbecovirus (β CoV B) includes SARS1 and Coronaviradae Family SARS2, and many zoonotic CoV’s---the next pandemic? ● Sarbecoviruses all bind to the ACE2 receptor---makes them highly transmissible ● Published studies support achievement of protectiv
Slide 30: SARS-CoV-2 Platform Development
SARS-CoV-2 Platform Development ● In vivo preclinical to meet FDA CBER guidance (complete) ● CHO cell line / expression system and GLP s-protein bioproduction (complete) ● ACE2 protein/protein assay (12/2021) ● OSU+BIOV collaboration on pan-sarbecovirus (β Cov B) vaccine (12/2021-1Q2022) ● GLP SARS-
Slide 31: CoviDTH: Filling an Urgent Need
CoviDTH™: Filling an Urgent Need ● Most tests of immunity to SARS-CoV-2 detect antibody response. ● T cell-mediated immunity is equally or more important. ● T cell-mediated immunity may persist for years while antibody response wanes in months. ● Commercially available tests for T cell immunity to S
Slide 32: DTH: History and Development
DTH: History and Development ● DTH is the oldest test of human T cell function ● Discovered by Robert Koch: The injection of killed Mycobacterium tuberculosis induced a cutaneous inflammatory response in patients who had previously been exposed to the organism. ● Landsteiner and others showed that D
Slide 33: DTH: Anatomy and Histology
DTH: Anatomy and Histology ● The hallmark of a DTH reaction is the development of induration and erythema 24-72 hours after intradermal injection of antigen ● Histology: Perivascular accumulation of T lymphocytes with a CD4+/CD8+ ratio of about 2:1 ● T cells become progressively activated, as shown
Slide 34: CoviDTH: The First Low-Cost, Disposable, PoC Test for T Cell Response
CoviDTH® : The First Low-Cost, Disposable, PoC Test for a T Cell Response to SARS-CoV-2 ● Recombinant S1 subunit of the SARS-Cov-2 spike protein administered as a solution in phosphate buffered saline for intradermal injection ● Identify individuals with an adaptive T-cell immune response to SARS-Co
Slide 35: Human Studies of DTH Testing to SARS-CoV-2 Protein
Human Studies of DTH Testing to SARS-CoV-2 Protein ● Barrios et al: Vaccines 9:575, 2021 ○ DTH testing to RBD of SARS-Cov-2 spike protein was performed in 28 subjects – 14 days post- vaccine ○ All 28 subjects had (+) DTH reaction ○ Mean diameter of induration: 14mm when measured at 48 hours ● Barrio
Slide 36: CoviDTH Development Plan
CoviDTH™ Development Plan Completed Milestones Upcoming Milestones US/CAN/EU ✓ EUA request filed (2/2021) and FDA CBER Assignment (3/2021) ❑ Bioproduction of clinical supply SARS-CoV-2 ✓ Submission of Pre-IND Meeting Request and protein (12/2021-2Q2022) Briefing Document (4/2021) ❑ Submission of IND
Slide 37: Immuno-Products Pipeline Expansion
Immuno-Products Pipeline Expansion HAPTENIZED PROTEIN VACCINE PLATFORM EXPANSION ○ Pan Sarbecovirus (β CoV B) Vaccine Combination ○ HPV, VZV, other CoV’s, MERS, other viruses ○ Phase I/II programs in cervical cancer, colon, melanoma and/or other cancers COVIDTH® ○ Expansion of diagnostic range to in
Slide 38: Investment Opportunity
Investment Opportunity ● Highly experienced team with Avax pedigree, oncology and antivirals experience ● Innovative, potentially life saving therapy for cancers and viruses ● Benefit of >$120M prior R&D investment ● Compelling cancer vaccine clinical data in over 600 subjects and record of safety f
Slide 39: Contact
Contact James Passin, CEO BioVaxys Technology Corp. Email: [email protected] Cell: +1 917 215 6659 www.biovaxys.com 39
Slide 40: Founders & Senior Management Team
Founders & Senior Management Team JAMES PASSIN: Founder & Chief Executive Officer ●Former Fund Manager at FG2 Advisors, LLC, an affiliate of New York-based Firebird Management LLC. ●He has 20 years of experience as a professional investor, with a deep experience of financing and developing venture-s
Slide 41: Advisors
Advisors CHARLES J. DUNTON, MD Dr. Dunton is a gynecologist/oncologist in Indiana. He received his medical degree from Jefferson Medical College and has been in practice for 30+ years. Dr. Dunton has been Chief, Division of Gynecologic Oncology Department of Obstetrics and Gynecology, Main Line Heal
Slide 42: Advisors
Advisors ADAM COUTTS, PHD Dr. Coutts is a Senior Research Fellow at Magdalene College, University of Cambridge, and a Research Associate in the Department of Sociology, University of Cambridge. Dr. Coutts' research focuses on the social and political determinants of health looking at how non-health
Slide 43: Advisors
Advisors YVELISE BARRIOS, MD Dr. Barrios is a specialist in Clinical Immunology at Hospital Universitario de Canarias, Tenerife, Spain, with a clinical focus on histocompatibility, autoimmune diseases and allergy, and is senior Immunology consultant for primary immunodeficiency diseases. Her lab is
Slide 44: Appendix A: IP Portfolio
Appendix A: IP Portfolio BIOVAXYS-OWNED ●US Patent Application HAPTENIZED CORONAVIRUS SPIKED PROTEINS, #62/992,722 (Filed 3/20/2020), PCT Application (filed 3/2021) ●US (March 2021) and International (September 2021) trademark applications filed for CoviDTH® ●US Patent Application BIHAPTENIZED AUTOL
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