Actinium

Actinium Announces Iomab-B Markedly Increases Long Term Survival in Patients 65 Years or Older with Active Relapsed or Refractory AML in the Phase 3 SIERRA Trial at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMT

Retrieved on: 
Monday, February 26, 2024

NEW YORK, Feb. 26, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported new analyses from the positive Phase 3 SIERRA trial of Iomab-B in oral presentations at the at the 2024 Tandem Meetings | Transplantation & Cellular Therapy (TCT) Meetings of ASTCT® (American Society for Transplantation and Cellular Therapy and CIBMTR®  (Center for International Blood and Marrow Transplant Research). The presentations reported unprecedented 100% access to potentially curative bone marrow transplant (BMT) and engraftment in evaluable patients with active relapsed or refractory acute myeloid leukemia (r/r AML) and improved long-term survival outcomes greater than 2 years in patients age 65 or older. Patients with r/r AML age 65 and older who also have multiple comorbidities and high-risk cytogenetics have a poor prognosis are seldom offered BMT in current practice due to poor tolerance to induction and conditioning regimens and dismal outcomes. The SIERRA results presented at TCT demonstrate Iomab-B's ability to overcome multiple high-risk features including a TP53 genetic mutation, advanced age and treatment resistant disease. The two oral presentations at this year's TCT mark a total of ten oral presentations of the SIERRA results at various leading transplant, hematology and nuclear medicine conferences in the USA and Europe.

Key Points: 
  • The SIERRA results presented at TCT demonstrate Iomab-B's ability to overcome multiple high-risk features including a TP53 genetic mutation, advanced age and treatment resistant disease.
  • Patients receiving Iomab-B had significantly higher rates of complete remission as well as durable complete remission compared to the control arm.
  • Most importantly, Iomab-B produced improved long-term survival outcomes as only the patients receiving Iomab-B achieved 1-year and 2-year survival.
  • Iomab-B represents an important advancement in transplant conditioning and has the potential to address a significant unmet patient need."

Fusion Pharmaceuticals Announces Clinical Program and Manufacturing Updates

Retrieved on: 
Thursday, January 4, 2024

In February 2023, Fusion acquired an IND for the ongoing Phase 2 clinical trial (the TATCIST trial) evaluating FPI-2265 (225Ac-PSMA I&T).

Key Points: 
  • In February 2023, Fusion acquired an IND for the ongoing Phase 2 clinical trial (the TATCIST trial) evaluating FPI-2265 (225Ac-PSMA I&T).
  • Fusion announced today encouraging early findings from Cohort 2 in the ongoing FPI-1434 Phase 1 clinical trial.
  • Fusion reported today that it has completed validation of its state-of-the-art good manufacturing practice (GMP) manufacturing facility and produced the first clinical dose of a TAT.
  • We built Fusion on a foundation of end-to-end manufacturing expertise, including experience with global radiopharmaceutical logistics and distribution.

Actinium Announces Acceptance of Five Abstracts for Presentation at the 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT® and CIBMTR®

Retrieved on: 
Tuesday, January 2, 2024

NEW YORK, Jan. 2, 2024 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, today announced that five abstracts have been accepted for presentation at the 2024 Tandem Meetings | Transplantation & Cellular Therapy (TCT) Meetings of ASTCT® (American Society for Transplantation and Cellular Therapy and CIBMTR®  (Center for International Blood and Marrow Transplant Research) being held February 21 – 24, 2024 in San Antonio, Texas. Two oral presentations will highlight results from the positive Phase 3 SIERRA trial of Iomab-B (131I-Apamistamab), representing 10 oral presentations of the SIERRA results since they were first reported at the 2023 Tandem Meetings.

Key Points: 
  • Two oral presentations will highlight results from the positive Phase 3 SIERRA trial of Iomab-B (131I-Apamistamab), representing 10 oral presentations of the SIERRA results since they were first reported at the 2023 Tandem Meetings.
  • 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.
  • 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."
  • The posters will be presented on Thursday, February 22, 2024, from 6:45 – 7:45 PM

Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform with Acquisition of RayzeBio

Retrieved on: 
Tuesday, December 26, 2023

PRINCETON, N.J. and SAN DIEGO, Dec. 26, 2023 (GLOBE NEWSWIRE) -- Bristol Myers Squibb (NYSE: BMY) and RayzeBio, Inc. (NASDAQ: RYZB) today announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired. The transaction was unanimously approved by both the Bristol Myers Squibb and RayzeBio Boards of Directors.

Key Points: 
  • The transaction was unanimously approved by both the Bristol Myers Squibb and RayzeBio Boards of Directors.
  • “Radiopharmaceutical therapeutics are already transforming cancer care, and RayzeBio is at the forefront of pioneering the application of this novel modality.
  • Bristol Myers Squibb expects to finance the acquisition with primarily new debt issuance.
  • BofA Securities, Inc., is serving as financial advisor to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

 Bristol Myers Squibb Adds Premier Radiopharmaceutical Platform with Acquisition of RayzeBio

Retrieved on: 
Tuesday, December 26, 2023

Bristol Myers Squibb (NYSE: BMY) and RayzeBio, Inc. (NASDAQ: RYZB) today announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) and RayzeBio, Inc. (NASDAQ: RYZB) today announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of estimated cash acquired.
  • The transaction was unanimously approved by both the Bristol Myers Squibb and RayzeBio Boards of Directors.
  • Bristol Myers Squibb expects to finance the acquisition with primarily new debt issuance.
  • BofA Securities, Inc., is serving as financial advisor to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

BWXT Medical Expands Collaboration with Fusion Pharmaceuticals Through Strengthened Actinium Supply and Access to Generator Technology

Retrieved on: 
Thursday, November 16, 2023

Under the agreement, BWXT Medical (a subsidiary of BWX Technologies, Inc. (NYSE: BWXT)), will provide Fusion with a preferential supply of radium-225 and access to high-specific activity generator technology (actinium-227-free), enabling Fusion to produce actinium-225 at its Good Manufacturing Practice (GMP) manufacturing facility for the benefit of its clinical trials.

Key Points: 
  • Under the agreement, BWXT Medical (a subsidiary of BWX Technologies, Inc. (NYSE: BWXT)), will provide Fusion with a preferential supply of radium-225 and access to high-specific activity generator technology (actinium-227-free), enabling Fusion to produce actinium-225 at its Good Manufacturing Practice (GMP) manufacturing facility for the benefit of its clinical trials.
  • BWXT’s proprietary generator technology allows for the on-demand isolation of high purity actinium-225 from the radium supplied by BWXT Medical.
  • BWXT Medical’s innovative actinium-225 generator technology will have significant benefits for both clinical and future commercial supply.
  • Under that agreement, BWXT Medical has been providing predetermined amounts of Fusion's actinium supply needs at volume-based pricing.

Actinium Announces Iomab-B Produces High Response Rates and Significant Improvement in Overall Survival in Relapsed Refractory AML Patients with Active Disease Overcoming TP53 Mutation

Retrieved on: 
Monday, December 11, 2023

The oral presentation highlighted significantly improved survival in patients with a TP53 mutation receiving Iomab-B.

Key Points: 
  • The oral presentation highlighted significantly improved survival in patients with a TP53 mutation receiving Iomab-B.
  • Iomab-B is a targeted radiotherapeutic comprised of an anti-CD45 monoclonal antibody with the Iodine-131 radioisotope payload.
  • In addition, Iomab-B significantly improved event-free survival, a secondary endpoint, with a hazard ratio of 0.22 and median overall survival (mOS) was doubled.
  • Data highlighted in the ASH oral presentation, which can be accessed on the investor relations page of Actinium's website, included:
    Overall Survival in Patients with a TP53 Mutation:

Actinium to Highlight Broad Potential of Targeted Radiotherapies Iomab-B and Actimab-A for Relapsed or Refractory and Elderly Acute Myeloid Leukemia Patients at the 65th ASH Annual Meeting & Exposition

Retrieved on: 
Friday, December 8, 2023

Sandesh Seth, Actinium's Chairman & CEO, said, "We are particularly excited for this year's ASH as our four presentations will highlight the differentiated capabilities of Iomab-B and Actimab-A.

Key Points: 
  • Sandesh Seth, Actinium's Chairman & CEO, said, "We are particularly excited for this year's ASH as our four presentations will highlight the differentiated capabilities of Iomab-B and Actimab-A.
  • Better treatment options and outcomes are needed in AML, particularly for elderly patients and those with relapsed or refractory disease who represent a majority of the population.
  • Our strong presence at ASH is indicative of the potential that our targeted radiotherapies have in the management of patients with difficult to treat AML.
  • Details of Actinium's presentations at ASH are as follows:
    Room: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 18-19
    Session Name: 616.

Adverum Biotechnologies Appoints C. David Nicholson, Ph.D. to its Board of Directors

Retrieved on: 
Monday, November 6, 2023

"We are excited to welcome David to Adverum’s Board of Directors.

Key Points: 
  • "We are excited to welcome David to Adverum’s Board of Directors.
  • He brings an exceptional breadth of experience and a track record of success in pharmaceutical R&D and has launched multiple transformative products throughout his career, notably in ophthalmology," stated Patrick Machado, J.D., board chair of Adverum Biotechnologies.
  • “On behalf of the management team at Adverum, I’d like to extend a warm welcome to David,” added Laurent Fischer, M.D., president and chief executive officer of Adverum.
  • from the University of Manchester and his Ph.D. from the University of Wales.

Actinium Presents Preclinical Data at SITC Demonstrating Actimab-A's Potential to Restore T Cell Immunity in the Solid Tumor Microenvironment Supporting Immunotherapy Combinations

Retrieved on: 
Monday, November 6, 2023

The poster highlighted Actimab-A's ability to target and deplete myeloid-derived suppressor cells (MDSCs), which uniformly express CD33.

Key Points: 
  • The poster highlighted Actimab-A's ability to target and deplete myeloid-derived suppressor cells (MDSCs), which uniformly express CD33.
  • MDSCs are a cell population of interest as they remodel the tumor environment and promote immune evasion.
  • Actinium believes Actimab-A has the potential to be used in combination with immunotherapy, including immune checkpoint inhibitors, to enhance antitumor immunity via targeted MDSC depletion.
  • Supportive data from the SITC presentation includes:
    Sandesh Seth, Actinium's Chairman and CEO, commented, "These data further increase our enthusiasm for Actimab-A's potential in solid tumor indications.