Actinium Announces Acceptance of Five Abstracts for Presentation at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMTR®
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Insights
The recent advancements in targeted radiotherapies presented by Actinium Pharmaceuticals signify a promising shift in treatment paradigms for high-risk relapsed/refractory acute myeloid leukemia (R/R AML). The use of Iomab-B (131I-Apamistamab) as a conditioning regimen prior to allogeneic hematopoietic cell transplant (HCT) showcases a novel approach that could potentially overcome the limitations of current therapies, especially in older patients and those with TP53 mutations. The mutation-agnostic nature of this therapy could address the challenge of heterogeneity within AML, offering a more universal solution that does not rely on the presence of specific mutations for efficacy.
From a clinical perspective, the robust engraftment and dose-response relationship leading to durable complete remission are particularly noteworthy. These factors are critical in evaluating the potential for long-term survival benefits and improved quality of life for patients. Moreover, the minimal cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) observed with the low-dose Iomab-ACT in the context of CAR T-cell therapy for B-cell acute lymphoblastic leukemia (ALL) or diffuse large B-cell lymphoma (DLBCL) indicate a safety profile that could enhance the feasibility of these advanced treatments.
The data presented by Actinium Pharmaceuticals at the TCT Meetings could have significant implications for the biotech and pharmaceutical industry, particularly in the niche of targeted radiotherapy. The positive Phase 3 SIERRA trial results for Iomab-B suggest a strong potential for regulatory approval and market entry, which could disrupt current treatment standards for R/R AML. Moreover, the ability to achieve lymphocyte and monocyte depletion with minimal adverse effects could position Iomab-ACT as a viable pre-treatment for CAR T-cell therapies, potentially expanding its applicability beyond AML to other hematologic malignancies.
Investors and stakeholders should note the strategic importance of presenting these findings at a prominent conference, as it not only underscores the scientific credibility of the results but also aids in fostering collaborative relationships with key opinion leaders and institutions. These relationships are crucial for the successful commercialization of new therapies, as they can accelerate adoption in clinical practice and potentially expand indications through further research collaborations.
Actinium's focus on targeted radiotherapy for bone marrow transplant and CAR-T cellular therapy positions the company within two high-growth areas of the oncology market. The aging population and the rising incidence of hematological malignancies increase the demand for innovative treatments like Iomab-B. The market's receptivity to these results, as indicated by the positive reception from the medical and scientific communities, suggests a favorable environment for Actinium's pipeline products.
Considering the competitive landscape, Actinium's advancements could attract partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical companies seeking to enhance their oncology portfolios. The company's stock market performance will likely be influenced by the outcomes of these presentations, regulatory milestones and the execution of their go-to-market strategy. The data's potential to set a new standard of care could lead to significant market share capture, provided that post-approval, the company can ensure adequate production, distribution and reimbursement strategies.
- Two oral presentations and three poster presentations will highlight Iomab-B and Iomab-ACT CD45 targeted conditioning for bone marrow transplant and CAR-T cellular therapy
Sandesh Seth, Actinium's Chairman and CEO, said, "We are excited to continue to build recognition for Iomab-B and the SIERRA data with the transplant community at the upcoming TCT meetings. Over the last year, we have highlighted to the global transplant and hematology communities that an Iomab-B led transplant improves outcomes for patients with high-risk relapsed/refractory acute myeloid leukemia, including those with a TP53 mutation, who have limited treatment options and poor outcomes with current therapies. These results exemplify the unique capabilities of targeted radiotherapy and its potent, mutation-agnostic mechanism of action. We are highly encouraged by the positive receptivity by the medical and scientific communities to date and look forward to building on this momentum in 2024."
Oral Presentations:
Title: 131I-Apamistamab Improves Outcomes in Patients 65 Years and Older with Relapsed or Refractory AML
Date & Time: Saturday, February 24, 2024, at 11:45 AM
Title: Targeted Myeloablative Radiation Using 131I-Apamistamab Prior to Allogeneic Hematopoietic Cell Transplant for Patients with R/R AML Results in Robust Engraftment
Date & Time: Saturday, February 24, 2024, at 10:30 AM
Poster Presentations:
Dose-Response Demonstrated for Durable Complete Remission Following High-Dose Targeted Radiation with 131I-Apamistamab Prior to HCT in Patients with R/R AML
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
131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant for Patients with TP53 Mutated R/R AML Results in Significantly Improved Outcomes
The posters will be presented on Thursday, February 22, 2024, from 6:45 – 7:45 PM
About the TCT Tandem Meetings
The Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR are the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Administrators, clinicians, data manager / clinical research professionals, fellows-in-training, investigators, laboratory technicians, MD/PhDs, nurses, nurse practitioners, pharmacists, physician assistants, and other allied health professional attendees benefit from a full scientific program that addresses the most timely issues in hematopoietic cell transplantation and cellular therapy.
About Actinium Pharmaceuticals, Inc.
Actinium develops targeted radiotherapies to meaningfully improve survival for people who have failed existing oncology therapies. Advanced pipeline candidates Iomab-B (pre-BLA), an induction and conditioning agent prior to bone marrow transplant, and Actimab-A (National Cancer Institute CRADA pivotal development path), a therapeutic, have demonstrated potential to extend survival outcomes for people with relapsed and refractory acute myeloid leukemia. Actinium plans to advance Iomab-B for other blood cancers and next generation conditioning candidate Iomab-ACT to improve cell and gene therapy outcomes. Actinium's technology platform is the basis for collaborations with Astellas Pharma for solid tumors, AVEO Oncology/LG Chem Life Sciences for HER3 solid tumors, and several internal programs in solid tumors. Actinium holds more than 220 patents and patent applications.
For more information, please visit: https://www.actiniumpharma.com/
Forward-Looking Statements
This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 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 current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.
Investors:
investorrelations@actiniumpharma.com
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SOURCE Actinium Pharmaceuticals, Inc.
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