Macroglobulinemia

Cellectar Biosciences Reports High Rate of Complete Remission in Investigator Initiated Phase I Study of Iopofosine in Combination with External Beam Radiotherapy in Recurrent Head and Neck Cancer

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星期一, 三月 4, 2024
Head, Neck, Recurrence, Toxicity, Anemia, Completeness, Radiation, SPECT/CT, Chemoradiotherapy, EBRT, Macroglobulinemia, Lymphocytopenia, Thrombocytopenia, Patient, Neutropenia, Survival, Poster, Cytopenia, Cancer, Pharmaceutical industry

The twelve patients treated for locoregionally recurrent head and neck squamous cell carcinoma previously received chemoradiation alone (42%), surgery (58%) or surgery combined with radiation or chemoradiation (92%).

Key Points: 
  • The twelve patients treated for locoregionally recurrent head and neck squamous cell carcinoma previously received chemoradiation alone (42%), surgery (58%) or surgery combined with radiation or chemoradiation (92%).
  • The data were presented in a poster at the 2024 Multidisciplinary Head and Neck Cancers Symposium held February 29-March 2, 2024, in Phoenix, AZ.
  • Complete remission was achieved in 64% of patients, with an ORR of 73% (n=11).
  • Observed adverse events were consistent with the known toxicity profile of iopofosine I 131, with cytopenias being the most common with all patients recovering.

Cellectar Biosciences Announces Tranche A Warrants Fully Exercised, Providing Proceeds of $44.1 Million

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星期四, 一月 25, 2024
Cancer, Tranche, Multiple myeloma, NDA, FDA, Exercise, Macroglobulinemia, CNS, Pharmaceutical industry

All participants in the previous financing, led by Rosalind Advisors, exercised their warrants with gross proceeds totaling approximately $44.1 million.

Key Points: 
  • All participants in the previous financing, led by Rosalind Advisors, exercised their warrants with gross proceeds totaling approximately $44.1 million.
  • In connection with the September 2023 private placement, Cellectar also issued to investors five-year Tranche B warrants for potential aggregate proceeds of approximately $34.3 million.
  • “We believe that the exercise of 100 percent of the available Tranche A warrants is a testament to the confidence our investors have in our company and lead asset, iopofosine I 131,” said James Caruso, president and CEO of Cellectar.
  • In parallel, we continue our clinical development of iopofosine in cancers with significant unmet clinical needs, such as multiple myeloma, pediatric high-grade gliomas, CNS lymphoma and others.”

Cellectar Biosciences Broadens Pipeline with Targeted Alpha Therapy (TAT) for Solid Tumors and Releases Promising Preclinical Data

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星期二, 一月 16, 2024
PLE, Patient, Neoplasm, Mouse, Cancer, Tat, Peptide, CLR, Triple-negative breast cancer, Antibody, TAT, Bone marrow, Macroglobulinemia, Actinium-225, Pancreatic cancer, Medical imaging

FLORHAM PARK, N.J., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced promising preclinical data for its proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225 (225Ac-CLR 121225) an actinium-labeled phospholipid ether (PLE), in pancreatic cancer models. The development of this compound will expand the company’s clinical pipeline of PLE cancer targeting compounds to include targeted alpha therapies (TATs), complementing its beta-emitting phospholipid radiotherapeutic conjugate, iopofosine I 131, which achieved its primary endpoint in the CLOVER WaM pivotal study in highly refractory Waldenstrom’s macroglobulinemia patients.

Key Points: 
  • Cellectar’s PLE platform may provide unique advantages which overcome the issues experienced by existing TAT delivery platforms.
  • “Our promising preclinical data with actinium-225 highlights the potential utility of our PLE platform to provide targeted delivery to nearly any isotope resulting in compounds with excellent activity and tolerability.
  • The mice had no end organ toxicities demonstrating good tolerability.
  • The data are consistent with experiments using other alpha emitters conjugated to the company’s proprietary PLE targeted delivery platform.

Cellectar Biosciences Partners with MiBA, a Data Subsidiary of American Oncology Network, to Advance the Treatment of Waldenstrom's Macroglobulinemia in the Community Setting

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星期四, 一月 11, 2024
Waldenström macroglobulinemia, WM, Patient, AON, Partnership, PDC, MRR, Cancer, Food, Safety, FDA, Macroglobulinemia, Physician, Pharmaceutical industry

"AON is currently managing over 650 Waldenstrom’s macroglobulinemia patients,” said Dr. Fred Divers, chief medical officer of AON.

Key Points: 
  • "AON is currently managing over 650 Waldenstrom’s macroglobulinemia patients,” said Dr. Fred Divers, chief medical officer of AON.
  • “We are committed to providing promising new radiotherapies, starting with Cellectar’s iopofosine I 131, a novel phospholipid radiotherapeutic conjugate, throughout our nationwide network of clinics.
  • Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company's previously reported safety data.
  • Currently there are limited treatment options with only one approved class of drugs and no established standard of care beyond second-line therapy.

Cellectar Biosciences Announces Positive Topline Data Achieving Primary Endpoint in Pivotal Clinical Study of Iopofosine I 131 in Waldenstrom’s Macroglobulinemia

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星期一, 一月 8, 2024
Sequela, Quality of life, Febrile neutropenia, WM, Death, Anemia, International, IWMF, Disease, Neutropenia, NDA, WAM, News, Cancer, Thrombocytopenia, SCR, Macroglobulinemia, MCI, MRR, Mayo Clinic, Mitt, Patient, Safety, Medicine, Cytopenia, Immunoglobulin M, Pharmaceutical industry

The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61% (95% confidence interval [44.50%, 75.80%, two-sided p value

Key Points: 
  • The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61% (95% confidence interval [44.50%, 75.80%, two-sided p value
  • Notably, iopofosine monotherapy achieved an 8% stringent complete remission (sCR) in this highly refractory WM population.
  • “The results from this pivotal study utilizing just four doses of iopofosine monotherapy in heavily pretreated patients are very compelling, demonstrating deep and durable remissions.
  • “Iopofosine’s high major response rate and achievement of the study’s primary endpoint in highly refractory, Waldenstrom’s macroglobulinemia patients exhibits its potentially practice-changing clinical profile.

Cellectar Biosciences to Announce Top-line Data from WM Pivotal Trial on January 8, 2024

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星期三, 一月 3, 2024
Cancer, Macroglobulinemia

FLORHAM PARK, N.J., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced it will host a call detailing top-line data from its pivotal trial of iopofosine I 131 in Waldenstrom’s macroglobulinemia on Monday, January 8, 2024 at 8:00 am ET. The company will also be presenting at the Biotech Showcase conference the following day. Details for each event are as follows:

Key Points: 
  • Management to host conference call on Monday, January 8, 2024, at 8:00 am ET
    FLORHAM PARK, N.J., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced it will host a call detailing top-line data from its pivotal trial of iopofosine I 131 in Waldenstrom’s macroglobulinemia on Monday, January 8, 2024 at 8:00 am ET.
  • The company will also be presenting at the Biotech Showcase conference the following day.
  • Details for each event are as follows:

Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

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星期二, 一月 2, 2024
Medical Subject Headings, Marketing, INN, B-cell lymphoma, Infection, ATC, Pharyngitis, Pneumonia, Pain, CD20, Hypertension, Capsule, International, Bleeding, European, Platelet, Disease, Nose, Neutropenia, Language, Mouth, Cancer, Chronic lymphocytic leukemia, Waldenström macroglobulinemia, Thrombocytopenia, Lymphocytosis, Death, Rituximab, CLL, Neutrophil, DSM-IV codes, European Medicines Agency, BTK, Growth, Select, Patient, Bruise, Time, Anatomy, Bone marrow, IIA, Macroglobulinemia, Rash, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Brukinsa, zanubrutinib, Date of authorisation: 22/11/2021, Revision: 8, Status: Authorised

Cellectar Biosciences Strengthens Intellectual Property Protection for its PDC Platform

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星期二, 十二月 12, 2023
PDC, Christian democracy, Cancer, Patent, Macroglobulinemia, Flavagline, IP, Pharmaceutical industry

These patent allowances in key global regions follow prior allowances for the same patent in the US, Europe, Australia and Canada.

Key Points: 
  • These patent allowances in key global regions follow prior allowances for the same patent in the US, Europe, Australia and Canada.
  • The patent provides composition of matter and use protection for the Cellectar’s Phospholipid Drug Conjugate™ (PDC) platform as a targeted delivery vehicle in combination with a class of small molecules known as flavaglines.
  • Flavaglines are a family of natural (plant derived) cytotoxic molecules that, when targeted to cancer, have been shown to kill the tumor cells.
  • Our robust global IP portfolio provides the foundation as we drive forward our mission to transform cancer care for people worldwide.”

10 Studies on InnoCare’s Oncology Pipelines Selected at the Upcoming 65th Annual Meeting of ASH

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星期三, 十一月 15, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, HKEX, Macroglobulinemia, PM, Treatment, Refractory, MCL, ASH, Impact, OLR, SSE, Cancer, EST, Society, Relapse, Chronic lymphocytic leukemia, Pharmaceutical industry, Vaccine, Flour, Cyclophosphamide, Patient, Safety

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that 10 studies from InnoCare’s oncology pipeline were selected for presentation at the 65th American Society of Hematology (ASH) Annual Meeting on December 9-12, 2023 in San Diego, California, United States.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that 10 studies from InnoCare’s oncology pipeline were selected for presentation at the 65th American Society of Hematology (ASH) Annual Meeting on December 9-12, 2023 in San Diego, California, United States.
  • A Prospective Multicenter Phase II Study of Orelabrutinib-Lenalidomide-Rituximab (OLR) in Patients with Untreated Mantle Cell Lymphoma (MCL) in China (POLARIS Study): Preliminary Analysis on Efficacy, Safety, Mutation Spectrum and Impact of Mutation Profiling on Treatment Responses
    Session Name: 623.
  • Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
    Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (cwCLL-001 Study)
    Presentation Time: 6:00 PM - 8:00 PM, Dec. 11, 2023 (Monday, EST)
    Orelabrutinib Monotherapy in Patients with Relapsed or Refractory Waldenström's Macroglobulinemia in a Single-Arm, Multicenter, Open-Label, Phase 2 Study: Long Term Follow-up Results
    Session Name: 623.
  • Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
    Presentation Time: 6:00 PM - 8:00 PM, Dec. 10, 2023 (Sunday, EST)
    Preliminary Safety, Pharmacological, and Efficacy Data from Patients with Relapsed or Refractory B-cell Malignancies Treated with the ICP-248, a Next Generation BCL2 Inhibitor

Cellectar to Release Top-line Data from WM Pivotal Trial During the JP Morgan Healthcare Conference the Week of January 8, 2024

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星期四, 十一月 2, 2023
FDA, Research, Macroglobulinemia, Patent, Food, PRIME, G&A, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Development, JPMorgan Chase, PDC, Second line, State Administrative Expenses, HERE, Hand, NDA, Cancer, PIPE, Patient, ADAR1, Cash, AUGC Deportiva Ceuta, Pharmaceutical industry

FLORHAM PARK, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced that top-line data from the pivotal trial in Waldenstrom’s macroglobulinemia (WM) will be released during the JP Morgan Healthcare conference the week of January 8, 2024.

Key Points: 
  • The PRIME designation was awarded based upon data from a pre-planned interim assessment in the pivotal study and six patients from the Phase 2a.
  • “We continue to collect and evaluate patient data from our pivotal trial and expect to announce top-line data the week of January 8, 2024.
  • We view this data announcement as a potentially transformational event for Cellectar and as such merits optimal market and industry awareness, which the JP Morgan conference provides.
  • Stockholders and other interested parties may participate in the conference call by dialing 1-888-886-7786 (in the U.S.) or 1-416-764-8658 (outside the U.S.).