One Target: Infinite Hope ™ … Corporate Presentation Q1 2018 TSX: MDNA OTCQX: MDNAF 1
Forward Looking Statements Certain statements in this presentation are “forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always using words or phrases such as “expect”, “seek”, “endeavour”, “anticipate”, “plan”, “estimate”, “believe”, “intend”, or stating that certain actions, events or results may, could, would, might or will occur or be taken, or achieved) are not statements of historical fact and may be “forward-looking statements”. Forward-looking statements are based on expectations, estimates and projections at the time the statements are made that involve a number of risks and uncertainties which would cause actual results or events to differ materially from those presently anticipated. Forward-looking statements are based on expectations, estimates and projections at the time the statements are made and involve significant known and unknown risks, uncertainties and assumptions. A number of factors could cause actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. These include, but are not limited to, the risk factors discussed in the public filings made by Medicenna with the applicable securities commissions in Canada, including the Annual Information Form dated June 15, 2017. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements could vary materially from those expressed or implied by the forward-looking statements contained in this document. These factors should be considered carefully and prospective investors should not place undue reliance on these forward-looking statements. Although the forward-looking statements contained in this document are based upon what Medicenna currently believes to be reasonable assumptions, Medicenna cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, Medicenna does not have any obligation to advise any person if it becomes aware of any inaccuracy in or omission from any forward-looking statement, nor does it intend, or assume any obligation, to update or revise these forward-looking statements to reflect new events or circumstances. One Target. Infinite Hope ™ … 2
Corporate Highlights Publicly listed (TSX: MDNA, OTCQX: MDNAF), clinical-stage, Immunotherapy company 1 Million cancer patients annually Exciting pre-clinical IL-2, IL-4 and IL-13 Superkine platform diagnosed with tumors with the Interleukin- 4 Receptor (IL4R) Technology platform protected by 13 patent families MDNA55: Compelling, Phase 1 and 2 clinical data (N=66) for recurrent glioblastoma (rGBM), the most common Lead program funded with $14M US non- and uniformly fatal form of brain cancer dilutive grant and $14M CAD Private Placement MDNA55 has Orphan Drug (FDA, EMA) & Fast Track Designations (FDA) cGMP compliant commercial scale manufacturing process established Currently enrolling in a Phase 2b recurrent GBM trial at 10 centers in the U.S. and Seasoned management, advisors and Europe directors One Target. Infinite Hope ™ … 3
Treatment Pathway for Glioblastoma (GBM) GBM is uniformly fatal; virtually all tumors will recur (rGBM) GBM Diagnosis Surgery Radiotherapy Chemotherapy (85-90%) + Chemotherapy 55% of GBM Chemo-Resistant* 25% 75% Relapse OPERABLE rGBM INOPERABLE rGBM MDNA55 Treatment Add’l Chemotherapy Surgery or Experimental Therapies (Direct infusion into tumor - CED) * Expression of the DNA repair protein O6-methylguanine-DNA methyltransferase (MGMT) is responsible for resistance to alkylating agents used in GBM treatment. One Target. Infinite Hope ™ … 4
MDNA55 Targeted Dual-Action Immunotherapeutic A Powerful Molecular Trojan Horse Tumor Targeting Domain Tumor Killing “Cytotoxic” Domain Circularly Permuted Catalytic domain of Pseudomonas Interleukin-4 (cpIL-4) Exotoxin A (PE) Ø Potently toxic to tumor cells with a wide therapeutic window Ø Bypass the Blood Brain Barrier through localized Convection Enhanced Delivery (CED) Ø Simultaneously purges the Tumor Microenvironment (TME) and un-blinds the immune system to cancer cells Ø Proven payload efficacy– identical to Medimmune’s anti-CD22 immunotoxin, Moxetumomab Pasudotox, currently in PhIII trial for Hairy Cell Leukemia One Target. Infinite Hope ™ … 5
Mechanism of Action of MDNA55 MDNA55 Efficient intracellular delivery of Toxin Payload Endocytosis ADP Ribosylation Inhibits Protein NUCLEUS Synthesis - Apoptosis One Target. Infinite Hope ™ … 6
Compelling Efficacy in Non-Resected rGBM (n=25) High Objective Response Rate Pre-treatment Pre-treatment Week 26 9 months Partial Response Complete Response (PR): 9/25 (CR): 5/25 Kawakami, et al (2003) Interleukin-4-Pseudomonas exotoxin chimeric fusion protein One Target. Infinite Hope ™ … for malignant glioma therapy Journal of Neuro-Oncology Vol 65 p 15-25 7
MDNA55 Survival Results Consistent with Immunotherapy Benefits Non-Resectable Recurrent GBM: MDNA55 Overall Survival in Survival of Responders vs Non Responders Non-Resectable (Phase 1 - Blue) and Resectable (Phase 2 - Red) rGBM Responders (CR +PR): MS= 100 379 days(n=14) Percent Survival Non-Responders (SD +PD) MS =98 days(n=11) 50 0 0 300 600 900 1200 1500 Days SD –Stable disease Log-Rank test p-value is 0.9430 (N=57) PD –Progressive disease Investigators Brochure (page 82) One Target. Infinite Hope ™ … 8
Real-Time Monitoring 2nd Generation Infusion of Drug Distribution Will Improve Outcomes 1 st Generation CED: Past Studies Ø Inaccurate catheter placement Ø Drug leakage due to backflow Ø Inadequate tumor coverage Saito and Tominaga (2012), Neurol Med Chir (Tokyo) 52, 531 2 nd Generation CED: Future Studies Ø Image-guided catheter placement Ø New catheters prevent backflow Ø Real-time monitoring ensures tumor coverage Images courtesy of John Sampson, Duke University Sampson et al, Congress for Neurosurgery, Oct 9-11, 2017 One Target. Infinite Hope ™ … 9
US Sites Participating in the Study OSU (Columbus, OH) Cleveland Clinic (Cleveland, OH) Weill Cornell + UCSF MSKCC (San Francisco, CA) (New York, NY) JWCI (Santa Monica, CA) Duke (Durham, NC) UT Southwestern (Dallas, TX) Marcus UT San Antonio (San Antonio, Neuroscience TX) Institute ( Boca Raton, FL) One Target. Infinite Hope ™ … 10
MDNA55 Brain Cancer Market Opportunity Annual Incidence Projected Market Tumor Type Recurrent Glioblastoma 33,300 $650M (rGBM) Metastatic Brain Cancer 91,500 $1.30B Pediatric Glioma 3,800 $50M TOTAL 133,500 $2.0B One Target. Infinite Hope ™ … 11
Future Indications: 1 Million IL4R Cancers Annually >2000 Patient Biopsies Analyzed Consistently Show IL4R Over-Expression Hodgkins Biliary Tract Bladder B-Cell CLL Lymphoma 73% 56% 78% 67% Head and Neck Breast Colorectal NSCLC 89% 75% 79% 82% Mesothelioma Ovarian Anaplastic Thyroid Pancreatic 91% 96% 60% 60% One Target. Infinite Hope ™ … 12
Product Pipeline DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PIVOTAL CANDIDATE INDICATIONS MDNA55 Recurrent GBM Brain Metastasis Newly Diagnosed GBM (MGMT + VE) Diffuse Intrinsic Pontine Glioma Cancer MDNA109 Immunotherapies Autoimmne MDNA209 diseases Atopic Dermatitis, MDNA413 Asthma, Fibrosis, Solid Tumors Solid Tumors: MDNA132 IL13Ralpha2 CAR-T 2018 2019 Development Plans One Target. Infinite Hope ™ … 13
Deep Early Stage Pipeline Targets Validated by Multiple Big Pharma Transactions Recent Transactions Target and Potential Candidate Deal Size Mechanism Indications Solid Tumors, IL4/13 Dual MDNA413 $2 Billion Respiratory, Super- with $60M Fibrotic and Antagonist Upfront Atopic Diseases IL2 Super- Cancer MDNA109 Undisclosed Agonist Immunotherapy Undisclosed $775M with IL2 Super- Autoimmune $300M MDNA209 Upfront Antagonist Diseases $400M with $150M Upfront One Target. Infinite Hope ™ … 14
MDNA109 Synergizes With Anti-PD-1 Immunotherapy Combination Therapy Produces Robust Responses Ø MDNA109 and anti-PD-1 produce limited efficacy alone Ø Combination treatment sufficient to cure most mice without increased toxicities One Target. Infinite Hope ™ … 15
Multiple Near Term Value Inflection Milestones Pursue Accelerated Approval for rGBM in 2019 Milestone Estimated Timing ü Commenced Enrollment in Phase 2b rGBM Trial First Patient In - Phase 2b rGBM Trial ü H1/2018 Commence Phase 2a Trial in other types of Brain Cancer Complete Enrollment in Phase 2b rGBM Trial H1/2018 H2/2018 Report rGBM Phase 2b Interim Top-Line Results End of Phase 2 Meeting with FDA H2/2018 H2/2018 Commence IND Enabling Studies with MDNA109 Pursue Accelerated Approval for rGBM H1/2019 H1/2019 Report Interim Top-Line Results from P2 Brain Cancer Trial One Target. Infinite Hope ™ … 16
Recommend
More recommend
