Actinium Pharmaceuticals, Inc. (delaware) · AMEX:ATNM
Actinium Pharmaceuticals, Inc. (delaware) — Actinium Pharmaceuticals — Corporate Update (October 2018)
37 slides from Actinium Pharmaceuticals, Inc. (delaware)'s corporate update, Oct 26, 2018
Slide 1: Actinium Pharmaceuticals, Inc.: Best in Class CD33 Program
Actinium Pharmaceuticals, Inc. Leveraging the strengths of Antibody Radiation Conjugates to build the Best in Class CD33 Program 1
Slide 2: Disclaimer and Safe Harbor
Disclaimer and Safe Harbor Some of the information presented herein may contain projections or other forward-looking statements regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management’s
Slide 3: Today's Featured Speakers
Today’s Featured Speakers Dr. Gary Schiller Dr. Hagop Kantarjian Dr. Tapan M. Kadia Professor, Hematology-Oncology Professor & Chair Assistant Professor Director, Hematologic Malignancy/Stem Cell Department of Leukemia Department of Leukemia Transplant Program Sandesh Seth Dr. Mark Berger Chairman &
Slide 4: Progressing and Expanding Actimab CD33 Program
Progressing and Expanding Actimab CD33 Program ♦ Only multi-disease, multi-indication CD33 program - 5 trials in 3 diseases with Ac-225 - Lintuzumab ♦ Expansion enabled by highly differentiated Antibody Radiation Conjugate (ARC) technology ♦ Broadening of program driven by interest from and in colla
Slide 5: Continued Momentum to Advance Actimab CD33 Footprint
Continued Momentum to Advance Actimab CD33 Footprint Latest initiative leverages targeted radiation via a potentially highly synergistic combination for patients with high unmet needs ♦ Continued expansion driven by strong investigator interest ♦ Builds on cornerstone combination strategy Actimab-A
Slide 6: II. CD33 Program Update
II. CD33 Program Update Actinium 6 Pharmaceuticals
Slide 7: Actimab CD33 Program – Key Learnings
Actimab CD33 Program – Key Learnings Significant clinical experience informs novel CD33 program strategy with several first in class trials and indications that build on strengths of ARC modality CD33 Program 4 100+ Therapeutic Effects Clinical Experience Clinical Trials Patients at Multiple Doses ♦
Slide 8: AWE Technology Powers CD33 Program
AWE Technology Powers CD33 Program Mechanistic benefits of Antibody Radiation Conjugate enables a broader development approach with multiple trials in targeted conditioning and therapeutic indications ARC Alpha Particles High Dose - Targeted Conditioning Actinium-225 Range: .06 mm1 Energy: 6 MeV1 ♦
Slide 9: Clinical Evidence Supporting Actimab-MDS Trial
Clinical Evidence Supporting Actimab-MDS Trial Clinical data demonstrating combination of broad myelosuppression coupled with low extramedullary toxicity supports development as a safer targeted conditioning agent prior to a bone marrow transplant Patients with prior Extramedullary Dose Myelosuppres
Slide 10: Value Proposition of the Actimab-MDS Trial
Value Proposition of the Actimab-MDS Trial Actimab-MDS trial combines Ac-225-Lintuzumab with Reduced Intensity Conditioning to achieve safer, more effective myeloablation with potentially superior outcomes ♦ Dr. Roboz (Cornell) conceptualized Actimab-MDS trial based on clinical experience with Actim
Slide 11: Actimab-MDS Development Pathway Proposed to FDA
Actimab-MDS Development Pathway Proposed to FDA Targeted Conditioning PoC Trial for High-Risk MDS Patients with TP53 Mutation Gail J. Roboz, M.D Principal Investigator Phase 2 MDS Trial Consortium Proposed Development Pathway: ♦ Phase 2, Open-label, 60-80 Patients ♦ Pivotal trial to follow Phase 2 P
Slide 12: Actimab-MDS Regulatory and Clinical Update
Actimab-MDS Regulatory and Clinical Update Positive FDA interactions have yielded an accelerated pathway to a pivotal trial in a larger addressable patient population Accelerated pathway to pivotal trial - Small phase 1 dose finding trial needed before moving to pivotal trial Initial Regulatory Path
Slide 13: Actimab-A Clinical Update
Actimab-A Clinical Update Full Phase 2 data to be presented at ASH 2018 Annual Meeting ♦ Difficult to treat patient population with poor prognoses − Age 60+ who are unfit for intensive chemotherapy − Median age of 75 years old − Initial data presented at ASH 2017, 6 (67%) patients had prior hematolo
Slide 14: III. Actimab-A in Combination with Venetoclax
III. Actimab-A in Combination with Venetoclax Actinium 14 Pharmaceuticals
Slide 15: Dr. Gary Schiller
Dr. Gary Schiller ♦ Professor, Hematology – Oncology at UCLA ♦ Director, Hematologic Malignancy/Stem Cell Transplant Program ♦ Over 20 years of clinical experience ♦ Over 85 peer-reviewed publications ♦ Research efforts focused on clinical trials of new drugs, therapies and bone marrow transplant fo
Slide 16: Dismal Prognosis for Older AML Patients
Dismal Prognosis for Older AML Patients 2018 Est. New Average Age of % of Older Patients % of Older Patients Relapse Median Cases (US) AML Patient2 Treated with Achieving Durable Rate3 Survival3 Intensive Therapy4 Complete Remission2 5-10 ~19,000 68 <30% <10% >90% months 5-year OS shows need for bet
Slide 17: Introduction to Venetoclax, BCL-2 Inhibitor
Introduction to Venetoclax, BCL-2 Inhibitor ♦ B-Cell Lymphoma 2 (BCL-2) is one of several proteins encoded by the BCL2 gene family that regulates apoptosis or programed cell death ♦ BCL-2 is overexpressed in certain cancers and enables cancer cells to evade apoptosis ♦ Venetoclax binds to BCL-2 fami
Slide 18: Venetoclax Development in AML
Venetoclax Development in AML ♦ Approved in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) 17p deletion ♦ Being evaluated in patients with NHL, MM, AML and other diseases ♦ Modest single agent activity in AML – synergistic with HMA’s and LDAC ♦ sNDA filed for patient with AML
Slide 19: Unmet Needs Remain in AML with Venetoclax
Unmet Needs Remain in AML with Venetoclax Need a Viable Solution for Patients that Relapse, Stop Responding or Discontinue use of Venetoclax ♦ 6-month Leukemia Free Survival of 52% in relapsed or refractory AML patients (n=33)1 ♦ 54% of patients had Serious Adverse Events (SAE’s) ♦ 13 of 21 responde
Slide 20: Actimab-A's Potential Synergy Via MCL-1 Downregulation
Actimab-A’s Potential Synergy Via MCL-1 Downregulation ♦ MCL1 is up-regulated in refractory AML cells1 ♦ MCL1 and BCL2 prevent apoptotic proteins Promote AML from signaling cells to die Cancer Cell Survival ♦ MCL1 is an anti-apoptotic protein that is a mediator for resistance to Venetoclax2 ♦ Veneto
Slide 21: Radiation is Effective at Depleting MCL-1
Radiation is Effective at Depleting MCL-1 ♦ MCL-1 was highly suppressed by external radiation in human hematopoietic progenitor cells1 ♦ External radiation is not feasible in a diffuse disease such as AML ♦ Actimab-A has the potential to reduce MCL-1 through targeted internalized radiation ♦ MCL-1 d
Slide 22: Demonstrated Synergy with Actimab-A and Venetoclax
Demonstrated Synergy with Actimab-A and Venetoclax ♦ Single-agent cell killing ability comparable between Actimab-A and Venetoclax ♦ Actimab-A and Venetoclax resulted in greater cell killing than Venetoclax or Actimab-A alone ♦ Data implies potential for Actimab-A to be used in synergistic combinati
Slide 23: Strong Rationale for Actimab-A + Venetoclax Trial
Strong Rationale for Actimab-A + Venetoclax Trial Continued unmet medical need and preclinical data supporting synergy provide strong rational for a Actimab-A plus Venetoclax clinical trial ♦ Preclinical data shows clear synergy that may result in higher response rates and improved clinical outcomes
Slide 24: IV. Actimab-A in Combination with Venetoclax
IV. Actimab-A in Combination with Venetoclax Actinium 24 Pharmaceuticals
Slide 25: Dr. Hagop Kantarjian
Dr. Hagop Kantarjian ♦ Professor and Chair of the Department of Leukemia at The University of Texas MD Anderson Cancer Center ♦ Samsung Distinguished Leukemia Chair in Cancer Medicine ♦ Research and collaborations have led to over 20 drugs approved in leukemia ♦ Author of over 1,800 peer-reviewed pu
Slide 26: Dr. Tapan Kadia
Dr. Tapan Kadia ♦ Associate Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center ♦ Focused on developmental therapeutics in acute leukemia for individualized frontline therapies, biologically rational targeted therapy and maintenance strategies ♦ Author of ove
Slide 27: Clinical History of Venetoclax in R/R AML
Clinical History of Venetoclax in R/R AML Promising regimen but not a silver bullet due to limited duration of responses and lack of curative outcomes ♦ It is hypothesized that Venetoclax makes AML blast cells more sensitive to HMAs by reducing apoptosis escape mechanism ♦ Patient relapses and limit
Slide 28: Limitations of Venetoclax & HMA's in R/R AML
Limitations of Venetoclax & HMA’s in R/R AML Actimab-A has the potential to improve outcomes for patient populations where Venetoclax + HMA’s and other therapies are suboptimal ♦ Limited responses seen in certain patients based on1: ♦ Type of AML ♦ Risk factors ♦ Cytogenetics Response Rate by AML Ty
Slide 29: Actimab-A's Potential in R/R AML
Actimab-A’s Potential in R/R AML ♦ Actimab-A has produced responses in patients with high-risk disease ♦ Ac-225 not reliant on cytogenetics – applicable to patients with FLT3 mutations who have poorer responses ♦ Actimab-A produced responses in secondary AML patients who have been heavily pre-treate
Slide 30: Actimab-A's Potential Synergy Via MCL-1 Downregulation
Actimab-A’s Potential Synergy Via MCL-1 Downregulation (6) AML Cell Death (1) DNA damage from Actimab-A (5) HMAs cell killing amplified (2) MCL1 downregulation (4) Pro-apoptotic proteins unhindered (3) Venetoclax binds to BCL2 (1) DNA damage from Actimab-A (3) Venetoclax binds to BCL2 (5) HMAs cell
Slide 31: Actimab-A + Venetoclax + HMA Trial Highlights
Actimab-A + Venetoclax + HMA Trial Highlights Multiple synergistic mechanisms have the potential to improve outcomes for patients with limited viable treatment options ♦ Strong mechanistic rationale for adding targeted radiation via Actimab-A to Venetoclax + HMAs ♦ Minimal toxicity profile of Actima
Slide 32: V. CD33 Program Outlook and Summary
V. CD33 Program Outlook and Summary Actinium 32 Pharmaceuticals
Slide 33: Actimab CD33 Program Development Strategy
Actimab CD33 Program Development Strategy Effectively exploit broad potential of the ARC as a superior targeted conditioning agent and in therapeutic combinations in populations with unmet medical needs to create the industry leading CD33 program in terms of market potential ♦ ARC approach introduce
Slide 34: Actimab CD33 Program Combination Approach
Actimab CD33 Program Combination Approach Leverage novel radiation mechanism to create synergies with other therapeutic modalities for patients with significant unmet needs Actimab-A Combo Trials Multi-faceted Chemotherapy CLAG-M tumor cell killing Mechanistic anti- tumor synergy Targeted Venetoclax
Slide 35: Building the Industry Leading CD33 Program
Building the Industry Leading CD33 Program ♦ CD33 development still focused on AML ♦ ARC approach enable development beyond AML ♦ Only CD33 ARC in clinical development Largest Addressable Patient Population in Aggregate Among CD33 Programs Three Diseases. Therapeutic Combinations. Targeted Condition
Slide 36: CD33 Developments Strengthen Company Outlook
CD33 Developments Strengthen Company Outlook Increasingly attractive and viable opportunity to develop a multi-product commercial opportunity in targeted conditioning in the 2020-2022 period Iomab-B SIERRA Phase 3 trial* Launch Topline data BLA Actimab-MDS* Launch Initiate PoC Data Initiate BLA Phas
Slide 37: Thank-You
Thank-You Actinium Pharmaceuticals, Inc. 37
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