13 slides from Actinium Pharmaceuticals, Inc. (delaware)'s technical presentation, 2022
Slide 1: High Rates of Transplantation in the Phase III SIERRA Trial Utilizing Iomab-B
High Rates of Transplantation in the Phase III SIERRA Trial Utilizing Anti-CD45 Apamistamab with 131-Iodine (Iomab-B) Conditioning with Successful Engraftment and Tolerability in Relapsed/Refractory Acute Myeloid Leukemia Patients after Lack of Response to Conventional Care and Targeted Therapies SI
Slide 2: Relevant Disclosures
Relevant Disclosures ♦ Dr. Sunil Abhyankar: Incyte, Therakos • Dr. Margarida Magalhaes-Silverman: Actinium, Incyte, Marker Therapeutics ♦ Dr. George Chen: Actinium • Dr. Rajesh Nath: Actinium, Incyte ♦ Dr. James Foran: Pfizer, Novartis, Servier, BMS, Revolution Medicine, Taiho, Syros, • Dr. Johnnie
Slide 3: Background & Objectives
Background & Objectives ♦ Patients 55 years and older with relapsed/refractory (R/R) acute myeloid leukemia (AML) with active disease are usually not considered candidates for potentially curative allogeneic hematopoietic cell transplantation (HCT). ♦ Complete remission (CR) rates in R/R AML patient
Slide 4: Iomab-B: Iodine (131I) apamistamab
Iomab-B: Iodine (131I) apamistamab ♦ Radioactive iodine (131I) - labeled anti-CD45 antibody was developed at Fred Hutchinson Cancer Research Center. ♦ CD45 is expressed on hematopoietic cells, including majority of malignant myeloid, lymphoid and immune cells. ♦ Targeted hematopoietic irradiation de
Slide 5: SIERRA Phase III Study Design
SIERRA Phase III Study Design Key Eligibility Criteria • > 55 years of age • KPS > 70 • HLA-matched related vs. unrelated donor (8/8, allele- level) • Primary Induction Failure Primary Endpoint Secondary Endpoint • First Early Relapse • Relapse/Refractory 6-month Overall to Salvage dCR Survival • 2n
Slide 6: SIERRA Iomab-B Treatment Schedule
SIERRA Iomab-B Treatment Schedule Internal Use Only ~7 days ~12 days TBI Dosimetric Therapeutic NMA 200 cGy Dose Dose Iomab-B FLU (< 20 mCi) Iomab-B (24 Gy to liver) 30 mg/m2/d HCT Days -12 -4 -3 -2 -1 0 Imaging Immunosuppression NMA: nonmyeloablative conditioning; FLU: fludarabine; TBI: total body
Slide 7: Patient Characteristics
Patient Characteristics Complete Enrollment, N = 153 Iomab-B Arm Conventional Care Arm (76) (77) Crossed Over to Iomab-B with HCT (40) Age 65.0 (55.1-77.3) 66.1 (55.1-76.8) 64.6 (55.3-76.8) median, (range) Favorable: 5.3% Favorable: 3.9% Favorable: 5% Cytogenetic and Intermediate: 32.9% Intermediate
Slide 8: Targeted Therapy Pre & Post Enrollment
Targeted Therapy Pre & Post Enrollment Targeted Therapy Pre-Enrollment 66% patients received targeted therapies prior to SIERRA enrollment ♦ Of those, 66% received Venetoclax-based therapy ♦ Median of 3 prior regimens (range 1-7) 84% (31/37) Use of Targeted Therapy in CC Group 47% of patients enroll
Slide 9: Transplant Characteristics & Engraftment
Transplant Characteristics & Engraftment Patients who received Iomab-B and are evaluable demonstrated 100% engraftment. Iomab-B Arm (76) Conventional Care (77) Transplant Did not Achieve CR Achieved CR and received Characteristics Received Iomab-B/HCT Crossed over to standard of care HCT (66) Iomab-
Slide 10: Day +100 Non-Relapse Mortality (NRM)
Day +100 Non-Relapse Mortality (NRM) Received Iomab- Crossed over to Standard of Care B/HCT Iomab-B/HCT HCT (66)* (40) (14) Day +100 NRM Out of Evaluable 6/65 2/40 2/14 Patients Actinium Pharmaceuticals * One patient not evaluable due to withdrawal of consent 10
Slide 11: Grade ≥3 Adverse Events (AEs) in ≥10% of All Patients
Grade ≥3 Adverse Events (AEs) in ≥10% of All Patients Conventional Care Arm Iomab-B Arm (N=76) Adverse Event (N= 77) % (N) % (N) Febrile Neutropenia (FN) 27 (35.5) 35 (45.4) Sepsis1 p = 0.002 4 (5.3) 18 (23.4) Mucositis2 10 (13.2) 9 (11.7) Hypertension 9 (11.8) 11 (14.3) Pneumonia 6 (7.9) 10 (13.0)
Slide 12: Conclusions
Conclusions ♦ High rate of allogeneic HCT with Iomab-B-based conditioning in patients with R/R AML − Majority of study patients were able to undergo allogeneic HCT despite not achieving CR after standard chemotherapy and targeted agents. ♦ 100% neutrophil and platelet engraftment − All evaluable stu
Slide 13: Clinical Sites
Clinical Sites Actinium Pharmaceuticals 13