Iomab-ACT / Actinium - LARVOL DELTA

Study of IOMAB-ACT Followed by CAR-T Cell Therapy for Patients Relapsed or Refractory (Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: University of Texas Southwestern Medical Center | Initiation date: Apr 2025 ➔ Jul 2025

Trial initiation date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Actinium Announces Enrollment of First Patient in the Iomab-ACT Commercial CAR-T Trial at the University of Texas Southwestern Medical Center (PRNewswire) - "Actinium Pharmaceuticals, Inc....today announced that the first patient was enrolled on the trial studying Iomab-ACT targeted conditioning with a commercial CAR-T therapy at the University of Texas Southwestern Medical Center...Initial clinical data from this trial is expected in the second half of 2025."

P1/2 data • Trial status • Diffuse Large B Cell Lymphoma

Study of IOMAB-ACT Followed by CAR-T Cell Therapy for Patients Relapsed or Refractory (Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: University of Texas Southwestern Medical Center | Not yet recruiting ➔ Recruiting | Trial completion date: May 2029 ➔ May 2030 | Trial primary completion date: May 2028 ➔ May 2029

Enrollment open • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Actinium Pharmaceuticals to Host KOL Investor Call at 8am ET Today to Highlight Revamped Clinical Programs and Expanded Market Opportunities Including Newly Initiated Actimab-A Solid Tumor Program (PRNewswire) - "Dr. Atallah will discuss Actimab-A clinical results to date including recently published long-term survival outcomes and the planned pivotal Phase 2/3 clinical trial in r/r AML and trials to be conducted under Actinium's cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI). In addition, Actinium's management will detail its recently announced Actimab-A solid tumor program, which is comprised of several controlled, head-to-head clinical trials that will evaluate the combination of Actimab-A with KEYTRUDA versus KEYTRUDA alone, and Actimab-A with OPDIVO versus OPDIVO alone initially in patients with head and neck squamous cell carcinoma and non-small cell lung cancer with a separate trial for each indication....Actinium will present 3 separate multi-billion-dollar market opportunities for Actimab-A and Iomab-ACT in myeloid malignancies, solid tumors and cell & gene therapy conditioning."

Clinical • Clinical data • Commercial • Acute Myelogenous Leukemia • Solid Tumor

Actinium Pharmaceuticals to Host Investor KOL Call with Dr. Ehab Atallah of the Medical College of Wisconsin and Provide a Pipeline Update Highlighting Revamped Clinical Programs and Expanded Market Opportunities for Actimab-A and Iomab-ACT with Clinical Data in 2H:2025 (PRNewswire) - "Actimab-A expanded into frontline AML in triplet combination with Venetoclax and ASTX-727, Taiho Oncology's hypomethylating agent, under NCI CRADA with initial clinical data expected by year-end 2025...Iomab-ACT commercial CAR-T trial to initiate patient enrollment with clinical proof of concept data expected in 2H:2025...Dr. Atallah will discuss Actimab-A clinical results to date including recently published long-term survival outcomes and the planned pivotal Phase 2/3 clinical trial in r/r AML and trials to be conducted under Actinium's cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI). In addition, Actinium will provide a pipeline update to highlight 3 separate potential multi-billion-dollar blockbuster market opportunities for its targeted radiotherapies..."

Commercial • P1 data • Trial status • Acute Myelogenous Leukemia • Diffuse Large B Cell Lymphoma • Oncology • Solid Tumor

Actinium Pharmaceuticals…Provide a Pipeline Update… (PRNewswire) - "Iomab-ACT sickle cell disease trial expected to initiate in 1H:2025..."

New trial • Sickle Cell Disease

Study of IOMAB-ACT Followed by Yescarta for Patients Relapsed or Refractory (Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: University of Texas Southwestern Medical Center

New P1/2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

MED20-165: Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2025 ➔ Jan 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

Actinium Provides Regulatory Update on Planned BLA Filing and Future Plans for Iomab-B in the U.S. (PRNewswire) - "Actinium will seek strategic partner for Iomab-B in the U.S. following completion of FDA interactions and focus development efforts on Actimab-A, Iomab-ACT and preclinical programs....Actinium Pharmaceuticals, Inc...announced a regulatory update on the Company's planned Biologics License Application ('BLA') filing for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia ('r/r AML')....Despite the SIERRA trial meeting the primary endpoint of durable Complete Remission ('dCR') with statistical significance (p-value<0.0001) and other positive secondary endpoints including Event Free Survival ('EFS') and safety, the FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing."

FDA event • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Actinium Expands Patent Coverage Over Iomab-ACT, its Next-Generation Targeted Radiotherapy Conditioning Agent, for Gene Edited Stem Cell-Based Therapies for Non-Malignant Indications (PRNewswire) - "Actinium Pharmaceuticals...today announced the issuance of U.S. Patent No. 11,912,780...by the United States Patent and Trademark Office (USPTO). This patent extends into 2040 and covers methods using Iomab-ACT for conditioning patients prior to the administration of gene-edited hematopoietic stem cell (HSC) therapy to treat non-malignant disorders, such as sickle cell disease, severe combined immunodeficiency disease (SCID), β-thalassemia and Fanconi's anemia."

Patent • Anemia • Beta-Thalassemia • Hematological Disorders • Sickle Cell Disease

Iomab-ACT: A Potential Game-Changer for CAR-T Therapy Conditioning (Markets Insider) - "Analyst Jason McCarthy of Maxim Group maintained a Buy rating on Actinium Pharmaceuticals (ATNM – Research Report), retaining the price target of $30.00...Jason McCarthy has given his Buy rating due to a combination of factors surrounding the potential of Actinium Pharmaceuticals’ Iomab-ACT as a conditioning regimen for CAR-T therapies...McCarthy’s positive outlook further stems from the promising preliminary data presented from a phase 1 study at Memorial Sloan Kettering, showcasing Iomab-ACT’s safety, tolerability, and efficacy....In another report released today, H.C. Wainwright also reiterated a Buy rating on the stock with a $50.00 price target."

Stock price • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Oncology

Actinium to Host KOL Webinar to Discuss Iomab-ACT Commercial CAR T-Cell Therapy Trial Design, Objectives and Potential Market Opportunity (PRNewswire) - "Actinium Pharmaceuticals, Inc...announced it will host a KOL webinar on Monday, May 20, 2024, at 8:00 AM ET. The call will highlight and discuss Actinium's recently announced Iomab-ACT commercial CAR T-cell trial being conducted at the University of Texas Southwestern (UTSW) including the study design, objectives and potential commercial opportunity for Iomab-ACT....The trial at UTSW will be the first trial to study Iomab-ACT or any targeted radiotherapy conditioning agent with an FDA approved CAR T-cell therapy."

Clinical protocol • Oncology

Actinium Announces KOL Webinar to Highlight Recently Announced Iomab-ACT Trial with Leading FDA Approved Commercial CAR T-Cell Therapy Being Led by the University of Texas Southwestern (PRNewswire) - "Actinium Pharmaceuticals, Inc...announced it will host a KOL call on Monday, May 20, 2024, at 8:00 AM ET to provide updates and highlight its recently announced clinical trial to study Iomab-ACT with a leading FDA approved CAR-T cell therapy at the University of Texas Southwestern (UTSW)....The trial at UTSW will be the first trial to study Iomab-ACT or any targeted radiotherapy conditioning agent with an FDA approved CAR-T therapy."

New trial • Oncology

Actinium Announces Clinical Trial to Study Iomab-ACT Targeted Radiotherapy Conditioning with Leading FDA Approved Commercial CAR T-Cell Therapy (PRNewswire) - "Actinium Pharmaceuticals, Inc...announced that the University of Texas Southwestern Medical Center (UT Southwestern) will lead a clinical trial studying Actinium's Iomab-ACT, a targeted radiotherapy conditioning agent prior to patients receiving an FDA approved commercial CAR T-cell therapy. UT Southwestern will start recruiting patients following FDA's review and clearance of the study."

New trial • Oncology

Actinium Highlights Improved Survival with Iomab-B in TP53 Positive Relapsed Refractory Acute Myeloid Leukemia Patients in the SIERRA Trial and Other Presentations at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (PRNewswire) - P1 | N=6 | NCT04512716 | "In addition, Actinium presented results from its ongoing phase 1 trial using Iomab-ACT as conditioning prior to CD19 CAR-T therapy for patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia or Diffuse Large B-cell Lymphoma. Importantly, no patients (0/4) developed immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, a major safety measure of the study, as ICANS is observed in 25% or more of pts w/ R/R B-ALL and DLBCL treated with various CAR T-cell products. Iomab-ACT demonstrated transient depletion of peripheral blood lymphocytes and monocytes. Persistence of CAR T-cells up to 8 weeks and minimal non-hematologic toxicities have been observed to date."

P1 data • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Low-Dose Targeted Radioimmunotherapy (Iomab-ACT) Achieves Lymphocyte and Monocyte Depletion Prior to CD19-Targeted CAR T-Cell Therapy for Relapsed of Refractory B-Cell ALL or DLBCL with Minimal CRS and Icans (TCT-ASTCT-CIBMTR 2024) - P1 | "Pt #2 has heavily pre-treated Richter syndrome (RS) and experienced DLT (severe trilineage cytopenias requiring RBC/PLT transfusion support, G-CSF, and romiplostim w/o marrow hypoplasia and w/o other apparent neoplastic/drug-induced etiology, w/ eventual recovery by day 60). Low-dose Iomab-ACT prior to 19-28z CAR-T depletes peripheral lymphocytes/monocytes and has minimal non-hematologic toxicity (including CRS/ICANS); cytopenias requiring blood product/growth factor support can occur in the weeks post-CAR-T. This pilot continues to enroll pts."

CAR T-Cell Therapy • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Neutropenia • Oncology • Richter's Syndrome • Transplantation • PTPRC

MED20-165: Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

Actinium Announces NIH Grant Extension to Advance Clinical Development of Next-Generation CD45 Targeted Conditioning Agent Iomab-ACT with Memorial Sloan Kettering's CAR-T Cell Therapy (PRNewswire) - "Actinium Pharmaceuticals, Inc...announced the National Institutes of Health (NIH) awarded Actinium a Small Business Technology Transfer grant extension to support its clinical collaboration with Memorial Sloan Kettering Cancer Center (MSK) to study Iomab-ACT, Actinium's CD45-targeting radiotherapeutic, for targeted conditioning to achieve lymphodepletion therapy along with the reduction of cytokine release syndrome and neurotoxicity prior to administration of a CD19-targeted CAR-T cell therapy developed at MSK....This grant will advance the ongoing study of Iomab-ACT for patients with relapsed or refractory B-ALL or DLBCL."

Financing • B Acute Lymphoblastic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Oncology

MED20-165: Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2024 ➔ Jan 2025 | Trial primary completion date: Jan 2024 ➔ Jan 2025

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

"Could $atnm iomab-ACT help here?" (@TedStamos)

Actinium Pharmaceuticals Reports 2022 Financial Results and Highlights Recent and Upcoming Clinical Data and Milestones (PRNewswire) - "Upcoming 2023 Milestones...The Company intends to present clinical proof-of-concept data from its NIH-funded Iomab-ACT collaboration with MSKCC and provide a program update for additional development opportunities for cell and gene therapy; The Company is working with its partner Immedica to support the Marketing Authorization Application (MAA) and commercialization of Iomab-B in the EU."

Commercial • P1 data • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

An Ongoing Pilot Study of Targeted Radioimmunotherapy (131-I Apamistamab) Conditioning Prior to CD19-Targeted CAR T-Cell Therapy for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (ASH 2022) - P1 | "Within the last year alone, the FDA approved brexu-cel for adults w/ R/R B-ALL and expanded indications for liso-cel and axi-cel to include DLBCL w/ primary refractory disease or early first relapse...Anti-cytokine therapies beyond tocilizumab (anti-IL-6R mAb) are being investigated for prevention of CRS/ICANS, including lenzilumab (anti-GM-CSF mAb) and anakinra (IL-1R antagonist)...Accordingly, we designed and initiated a pilot study of Iomab-B w/ adoptive cellular therapy (Iomab-ACT; Fig 1A).Study design and Iomab-ACT is a single-institution pilot study of Iomab-B (w/o chemotherapy) as conditioning prior to 19-28z CAR-T in adults w/ R/R B-ALL or DLBCL (NCT04512716)...Unexpected toxicity (given low dose of ARC) observed in 1 pt included severe trilineage cytopenias lasting >8 wks (requiring RBC/PLT transfusion support, G-CSF, romiplostim) w/o marrow hypoplasia and w/o other apparent neoplastic or drug-induced etiology; this met criteria for dose-limiting..."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD19 • CSF2

Iomab with Adoptive Cellular Therapy (Iomab-ACT): A Pilot Study of 131-I Apamistamab Followed By CD19-Targeted CAR T-Cell Therapy for Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (ASH 2021) - P1 | "However, following fludarabine/cyclophosphamide (Flu/Cy) conditioning and CAR T-cell therapy w/ a CD28 costimulatory domain (e.g. 19-28z CAR T-cells), rates of grade ≥3 ICANS and grade ≥3 cytokine release syndrome (CRS) in pts w/ R/R DLBCL and morphologic R/R B-ALL exceed 30%. If dose-limiting toxicity (severe infusion-related reactions, treatment-resistant severe CRS/ICANS, persistent regimen-related cytopenias, among others defined in protocol) is seen in 0-1 of the first 3 pts treated, then up to 6 total (up to 3 additional) pts will be treated. We have designed this study to provide preliminary data to support further investigation of CD45-targeted ARCs prior to adoptive cellular therapy."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD19 • CD8 • IL10 • IL6

MED20-165: Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2023 ➔ Jan 2024 | Trial primary completion date: Jan 2023 ➔ Jan 2024

CAR T-Cell Therapy • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Chronic Myeloid Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

"Will you be able to discuss any details related to Iomab-ACT?" (@BlackmanRolondo)