11 slides from Actinium Pharmaceuticals, Inc. (delaware)'s technical presentation, 2021
Slide 1: Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab in R/R AML
Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Older Patients with Active, Relapsed or Refractory (R/R) Acute Myeloid Leukemia Results in Successful and Timely Engraftment Not Related to the Radiation Dose Delivered SIERRA: Study of Iomab-B in Elderly Relapsed/Refr
Slide 2: Iomab-B: Iodine (131I) apamistamab
Iomab-B: Iodine (131I) apamistamab § Radioactive iodine (131I) - labeled anti-CD45 antibody was developed at the Fred Hutchinson Cancer Research Center § CD45 is expressed on hematopoietic cells, including the majority of malignant myeloid and lymphoid cells § Patient-specific dosimetry was used to
Slide 3: SIERRA Phase 3 Trial Design
SIERRA Phase 3 Trial Design Accrual Target: N=150 Iomab-B HCT Conventional Care** Primary End-point: Durable Complete Remission Rate (dCR): CR/CRp at 6 months post-CR Secondary End-points Include: 1-year Overall Survival 3
Slide 4: SIERRA Key Eligibility Criteria
SIERRA Key Eligibility Criteria § Marrow blast count ≥ 5% or the presence of peripheral blasts § ≥ 55 years of age § Karnofsky score ≥ 70 § Medically cleared related/unrelated donor, matching at HLA-A, HLA-B, HLA-C, and DRB-1 (8/8; allele-level) § Secondary AML or treatment-related AML are eligible
Slide 5: 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 6: Hypotheses and Study Status
Hypotheses and Study Status ♦ Hypotheses: Targeted radiation to the marrow, based on a limit of 24 Gy radiation dose to the liver with Iomab-B enables successful engraftment despite active disease in the marrow ♦ Preliminary data presented for first 113 (75%) patients Actinium 6 Pharmaceuticals
Slide 7: SIERRA Trial: Demographic Highlights of First 113 Patients, 75% Enrollment
SIERRA Trial: Demographic Highlights of First 113 Patients 75% Enrollment Patient Characteristics (N=113) Randomized to Conventional Care and Crossed Over to Iomab with HCT (N=30) Iomab-B Arm Conventional Care Arm (N=56) (N=57) 65 (55-77) Favorable: 7% Age Intermediate: 33% 63 (55-77) 65 (55-77) med
Slide 8: SIERRA: Transplant Characteristics
SIERRA: Transplant Characteristics Iomab-B Arm (N=56) Conventional Care Arm (N=57) Achieved CR and Did not Achieve CR Received Iomab-B/HCT received standard of care Crossed over to Iomab- (N=49) HCT B/HCT (N=10) (N=30/47) FLU/MEL (2) FLU/MEL/TBI (1) Conditioning Iomab-B-based BU4/FLU (1) Iomab-B-bas
Slide 9: SIERRA: Neutrophil and Platelet Engraftment
SIERRA: Neutrophil and Platelet Engraftment Iomab-B Arm (N=56) Conventional Care Arm (N=57) Achieved CR Did not Achieve CR Underwent Iomab-B –based and received (N=47/56) Conditioning and HCT standard of care Crossed over, Iomab- (N=49) HCT B/HCT (N=10) (N=30) Days to HCT (Post 30 (23-60) 67 (52-104
Slide 10: SIERRA: Conclusions After 75% Enrollment
SIERRA: Conclusions After 75% Enrollment ♦ Individualized therapy of Iomab-B provided myeloablative doses of radiation to marrow ♦ High rates of allogeneic HCT with curative potential in patients with relapsed and refractory AML: − 88% of patients on Iomab-B Arm − 18% of patients randomized to Conve
Slide 11: Acknowledgements and Currently Active Sites
Acknowledgements and Currently Active Sites Actinium 11 Pharmaceuticals