Bone marrow

City of Hope Research Featuring the Successful Treatment of the Oldest Patient to Achieve Remission for Leukemia and HIV Published in The New England Journal of Medicine (NEJM)

Retrieved on: 
Wednesday, February 14, 2024

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240214747351/en/
    "City of Hope Patient" Paul Edmonds with City of Hope doctors, Jana K. Dickter, M.D., and Monzr Al Malki, M.D.
  • Edmonds is also the person who had HIV the longest — for over 31 years — among these five patients.
  • Known as the “City of Hope patient” among these five patients, Edmonds received a transplant at City of Hope on Feb. 6, 2019, and is now considered to be cured of leukemia.
  • City of Hope has exceptional transplant outcomes year after year, according to the Center for International Blood & Marrow Transplant Research.

TCBP Provides Shareholder Update and Highlights Upcoming Milestones

Retrieved on: 
Wednesday, February 14, 2024

"The previous year was a time of significant operational achievement for TC BioPharm," said Bryan Kobel, Chief Executive Officer.

Key Points: 
  • "The previous year was a time of significant operational achievement for TC BioPharm," said Bryan Kobel, Chief Executive Officer.
  • We look forward/expect to continue this pattern of execution in 2024 and hitting our key milestones as laid out."
  • Entered into a collaboration agreement with Queen Mary University of London (QMUL) to expand the platform into non-oncology indications.
  • Management is focused on leveraging existing strategic relationships in order to execute partnerships and or collaborations in combination with TCB-008.

Global Registrational Phase III Study of Olverembatinib (HQP1351) Cleared by FDA

Retrieved on: 
Wednesday, February 14, 2024

Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation.

Key Points: 
  • Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation.
  • The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.
  • Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma.
  • *Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.

ELREXFIO™ is authorized by Health Canada for adults with relapsed or refractory multiple myeloma in Canada

Retrieved on: 
Tuesday, February 13, 2024

KIRKLAND, QC, Feb. 13, 2024 /CNW/ - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c) to ELREXFIO (elranatamab solution for injection).

Key Points: 
  • KIRKLAND, QC, Feb. 13, 2024 /CNW/ - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions (NOC/c) to ELREXFIO (elranatamab solution for injection).
  • "The approval of ELREXFIO is good news for patients and their healthcare teams as it offers a new treatment possibility for those living with the disease."
  • Multiple myeloma is the second-most common type of blood cancer, with an estimated 11 Canadians being diagnosed with myeloma every day.iii It is estimated that in 2023, 3,900 Canadians were diagnosed with multiple myeloma and 1,700 Canadians died from the disease.iv
    "Multiple myeloma can be an incredibly challenging cancer to live with and manage," said Martine Elias, Executive Director at Myeloma Canada.
  • This is why it's so important that people living with the disease have access to many and new options even more so when they have relapsed."

Launch of the National Cord Blood Network to Optimize Life-Saving Treatment with Cord Blood Transplantation in Hematologic Malignancies

Retrieved on: 
Tuesday, February 13, 2024

CLEVELAND, Feb. 13, 2024 /PRNewswire/ -- The National Cord Blood Network (NCBN) proudly announces its official launch, signaling a new era of advances and collaboration in cord blood transplantation.

Key Points: 
  • CLEVELAND, Feb. 13, 2024 /PRNewswire/ -- The National Cord Blood Network (NCBN) proudly announces its official launch, signaling a new era of advances and collaboration in cord blood transplantation.
  • The NCBN aims to increase accessibility to life-saving cord blood transplantation for patients with hematologic malignancies in US Transplant Centers as well as optimize cord blood transplant practices.
  • Marcie Finney, MBA, Cleveland Cord Blood Center, an experienced leader in healthcare administration, will serve as the Administrative Director of the National Cord Blood Network.
  • Dr. Andromachi Scaradavou, Co-Chair of the NCBN, added, "The launch of the National Cord Blood Network marks a significant milestone in our collective effort to advance our understanding and application of cord blood transplantation.

The International Myeloma Foundation Launches the Iceland Cycling Expedition: A Fundraiser to Advance the Goals of the iStopMM Project and the IMF’s Robust Array of Research Initiatives

Retrieved on: 
Tuesday, February 13, 2024

The ICE biking tour is an inaugural signature IMF Myeloma Cures fundraiser, with the goal of highlighting IMF’S diverse and robust research portfolio.

Key Points: 
  • The ICE biking tour is an inaugural signature IMF Myeloma Cures fundraiser, with the goal of highlighting IMF’S diverse and robust research portfolio.
  • Durie is elated that the Iceland Cycling Expedition will be inaugurated in Iceland—the home of the iStopMM Research Project.
  • To apply for this exciting expedition or to make donations, visit the IMF Iceland Cycling Expedition fundraiser.
  • The International Myeloma Foundation is grateful to Sanofi, a long-time and unwavering supporter of the IMF, for sponsoring the inaugural Iceland Cycling Expedition.

G1 Therapeutics to Continue Pivotal Phase 3 Trial of Trilaciclib in Metastatic Triple Negative Breast Cancer Following Interim Analysis by Independent Data Monitoring Committee

Retrieved on: 
Monday, February 12, 2024

The DMC did not express any concerns regarding safety or recommend any other changes to the study.

Key Points: 
  • The DMC did not express any concerns regarding safety or recommend any other changes to the study.
  • G1 remains blinded to all data as the early stopping criteria were not met during the interim analysis.
  • PRESERVE 2 is a global, multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in patients with locally advanced unresectable or metastatic TNBC.
  • Patients meeting eligibility requirements were randomized 1:1 to receive either trilaciclib or placebo administered prior to first-line gemcitabine and carboplatin (GCb).

Lauren Barnes Joins Ossium Health’s Board of Directors

Retrieved on: 
Monday, February 12, 2024

Ossium Health, an innovative bioengineering company that established a first-of-its-kind bone marrow banking platform, today announced the appointment of Lauren Barnes to its Board of Directors.

Key Points: 
  • Ossium Health, an innovative bioengineering company that established a first-of-its-kind bone marrow banking platform, today announced the appointment of Lauren Barnes to its Board of Directors.
  • “Lauren’s expertise and proven track record in biopharmaceutical commercialization are invaluable assets,” said Kevin Caldwell, Ossium’s CEO, Co-Founder & President.
  • In addition, Barnes serves as a board member for Ascelia Pharma AB, a Swedish oncology drug development company with two late-stage drug candidates, and she recently completed her time as Chair of the Board of Directors for the non-profit Cancer Support Community.
  • “I am incredibly excited to join Ossium’s Board of Directors at this pivotal moment in the company’s journey,” said Barnes.

Progress update on pilot for academic and non-profit developers of advanced therapy medicines

Retrieved on: 
Friday, February 9, 2024

In December 2021, it was granted eligibility to PRIME, EMA’s scheme to support the development of medicines that target an unmet medical need.

Key Points: 
  • In December 2021, it was granted eligibility to PRIME, EMA’s scheme to support the development of medicines that target an unmet medical need.
  • In a second round which finished in December 2023 a total of 11 candidates had expressed their interest to join the pilot.
  • Non-profit academic developers are a major contributor to the development of ATMPs, but experience has shown that navigating regulatory requirements can be challenging.
  • Upon completion, a report will be published on the lessons learnt from this initiative and the areas for improvement in support to academic developers.

Immix Biopharma Awarded European Union Orphan Drug Designation for NXC-201 in AL Amyloidosis

Retrieved on: 
Wednesday, February 7, 2024

Los Angeles, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis.

Key Points: 
  • European Orphan Drug Designation (“ODD”) qualifies NXC-201 for:
    Reduced fees for EU protocol assistance, marketing authorization applications, inspections before authorization, applications for changes to marketing authorizations made after approval, and reduced annual fees
    U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal, estimated to reach 29,712 patients in 2023
    Los Angeles, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of AL Amyloidosis.
  • “European Union orphan drug designation for NXC-201 represents an important milestone in our global strategy,” said Ilya Rachman, MD PhD, Chief Executive Officer, Immix Biopharma.
  • To qualify for orphan drug designation, a candidate therapy must be intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease that occurs in not more than five in 10,000 people in the EU.
  • The designation provides regulatory, financial and commercial incentives to develop therapies for rare diseases where there are either no satisfactory treatment options or significant benefit to those affected by the disease.