Waldenström

Mustang Bio Announces Vision for CAR T-Cell Therapy Platform Expansion into Autoimmune Diseases

Retrieved on: 
Thursday, March 28, 2024
Mustang, Rheumatoid arthritis, Rituximab, Chronic lymphocytic leukemia, Patient, DSM-IV codes, CD20, Cancer, Translation, NHL, B cell, Clinical trial, Society, Waldenström macroglobulinemia, Hematology, Health, Lymphoma, Waldenström, Autoimmune disease, Pharmaceutical industry

WORCESTER, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced its expansion into autoimmune diseases with MB-106, a personalized CD20-targeted, 3rd-generation autologous CAR T-cell therapy. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”). Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.

Key Points: 
  • MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).
  • Mustang and Fred Hutch are in preliminary discussions to explore a potential Phase 1 investigator-sponsored clinical trial to evaluate MB-106 for the treatment of autoimmune diseases.
  • “MB-106’s observed safety profile, encouraging efficacy data, and our robust manufacturing capabilities have the potential to translate to improved outcomes for patients with autoimmune diseases.
  • Several antibody therapies targeting CD20 on B-cells have successfully transitioned from cancer to autoimmune diseases, such as rituximab for both lymphoma and rheumatoid arthritis.

CALQUENCE (Acalabrutinib) Emerging Drug Insights and Market Forecasts, 2019-2022 and 2023-2032: Focus on 7MM - United States, Germany, France, Italy, Spain, United Kingdom, and Japan - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023
Health, Science, Pharmaceutical, Research, Clinical Trials, Carboplatin, Chemotaxis, Waldenström macroglobulinemia, AstraZeneca, BTK, MCL, Rituximab, B-cell lymphoma, Patient, Ifosfamide, ABC, SWOT, EU4, Etoposide, Follicular lymphoma, Acalabrutinib, Waldenström, RICE, CLL, Axicabtagene ciloleucel, Risk management, Pharmaceutical industry, DLBCL, Phase

The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about CALQUENCE for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets.
  • Further, it also consists of future market assessments inclusive of the CALQUENCE market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of CALQUENCE in DLBCL.

Mustang Bio Announces MB-106 CD20-Targeted CAR-T Data Selected for Presentation at 65th American Society of Hematology (ASH) Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
FDA, DSM-IV codes, Translation, Fred Hutchinson Cancer Research Center, Infrared spectroscopy correlation table, Bone marrow, University of Washington, Disclosure, Chronic lymphocytic leukemia, Waldenström, Society, PET-CT, Disease, Cancer, Follicular lymphoma, Mustang, University, DL, NHL, Safety, Patient, Investigational New Drug, Associate, American Society of Hematology, HCL, Lymphoma, Pharmaceutical industry, WM

MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).

Key Points: 
  • MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”).
  • All patients displayed MB-106 expansion, with peak levels between 7-14 days post-infusion, and CAR-T cell persistence is ongoing at 6 months.
  • From a safety perspective, 3 patients experienced Grade 1 cytokine release syndrome and no occurrences of immune effector cell-associated neurotoxicity syndrome were reported.
  • Dose-limiting toxicities (“DLT”) were monitored through day 28, and no DLTs were observed at DL1.

Cellectar Biosciences Partners with Florida Cancer Specialists & Research Institute to Support the Treatment of Waldenstrom's Macroglobulinemia in the Community Setting

Retrieved on: 
Wednesday, October 25, 2023
Oncology, Radiation, FDA, Practitioner, Macroglobulinemia, Food, Waldenström macroglobulinemia, Hematology, Physician, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Waldenström, Health, PDC, Partnership, NDA, Cancer, FCS, Patient, Lymphoma, Pharmaceutical industry, WM

FLORHAM PARK, N.J, Oct. 25, 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, announced today a partnership with Florida Cancer Specialists & Research Institute, LLC (FCS), a world-class cancer care organization serving oncology patients throughout the state of Florida. Through this partnership, Cellectar and FCS will evaluate and further define unmet needs that exist across the Waldenstrom's macroglobulinemia (WM) treatment landscape within the community oncology setting to advance patient care.

Key Points: 
  • Through this partnership, Cellectar and FCS will evaluate and further define unmet needs that exist across the Waldenstrom's macroglobulinemia (WM) treatment landscape within the community oncology setting to advance patient care.
  • "WM is a rare type of lymphoma with limited treatment options and no established standard of care in relapsed refractory disease.
  • As leaders in medical oncology and hematology, FCS currently manages over 1,000 Waldenstrom’s macroglobulinemia patients.
  • 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 Closing of up to Approximately $103 Million Private Placement Financing

Retrieved on: 
Monday, September 11, 2023
Second line, Common stock, ADAR1, DLBCL, New Drug Application, Disclosure, NDA, Cancer, Regulation D, Exchange, Sale, B-cell lymphoma, WM, Waldenström, Securities and Exchange Commission (Philippines), PDC, Patient, Oppenheimer, Security (finance), FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AUGC Deportiva Ceuta, Pharmaceutical industry, Series

The financing was led by Rosalind Advisors with participation from AIGH Capital, ADAR1, Second Line, Nantahala Capital, AuGC, and other new and existing institutional investors.

Key Points: 
  • The financing was led by Rosalind Advisors with participation from AIGH Capital, ADAR1, Second Line, Nantahala Capital, AuGC, and other new and existing institutional investors.
  • Conversion of the Series E Preferred Stock into shares of common stock of the Company is subject to approval by the Company's stockholders.
  • Oppenheimer & Co. Inc. acted as the sole placement agent for the private placement.
  • Cellectar has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock underlying the Series E Preferred Stock.

Cellectar Biosciences Announces up to Approximately $103 Million Private Placement Financing

Retrieved on: 
Tuesday, September 5, 2023
Second line, Common stock, ADAR1, DLBCL, PIPE, New Drug Application, Disclosure, Cancer, Regulation D, Exchange, Sale, B-cell lymphoma, WM, Waldenström, Securities and Exchange Commission (Philippines), PDC, Patient, Oppenheimer, Security (finance), FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AUGC Deportiva Ceuta, Series

FLORHAM PARK, N.J., Sept. 05, 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 it has entered into a securities purchase agreement with certain institutional investors for a private placement financing (the “PIPE”) that is expected to result in gross proceeds of up to $102.9 million, including an initial funding of $24.5 million priced at the company’s common stock closing price on September 1, 2023 of $1.82 per share. The financing is being led by Rosalind Advisors with participation from AIGH Capital, ADAR1, Second Line, Nantahala Capital, AuGC, and other new and existing institutional investors.

Key Points: 
  • The financing is being led by Rosalind Advisors with participation from AIGH Capital, ADAR1, Second Line, Nantahala Capital, AuGC, and other new and existing institutional investors.
  • “This financing with current and new investor funds of up to $102.9 million reflects the significant value of our lead asset iopofosine and R&D pipeline,” said James Caruso, president and CEO of Cellectar.
  • “With the initial $24.5 million, we are able to fully fund all corporate activities through the completion of our pivotal trial and expected reporting of top-line data later this year.
  • Oppenheimer & Co. Inc. acted as the sole placement agent for the private placement.

Mustang Bio Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, August 14, 2023
Waldenström macroglobulinemia, Partnership, Mayo Clinic, Arm, CD19, Chronic lymphocytic leukemia, Follicular lymphoma, CRS, Fred Hutchinson Cancer Research Center, CD20, European Hematology Association, Clinical trial, Lymphoma, Research, History, Translation, WM, CAR, Waldenström, Acquisition, International Conference on Afghanistan, London (2010), Cytokine release syndrome, Patient, Cancer, CR, Clinical professor, Immunoglobulin M, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mustang, Conference, ORR, DSM-IV codes, Food, Safety, Disease, Pharmaceutical industry, Cryptocurrency, Video game

WORCESTER, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2023.

Key Points: 
  • WORCESTER, Mass., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2023.
  • Research and development expenses were $10.8 million for the second quarter of 2023, compared to $15.2 million for the second quarter of 2022.
  • Non-cash, stock-based expenses included in research and development were $(0.1) million for the second quarter of 2023, compared to $0.4 million for the second quarter of 2022.
  • General and administrative expenses were $3.1 million for the second quarter of 2023, compared to $3.1 million for the second quarter of 2022.

Mustang Bio Announces Final Results from Follicular Lymphoma Cohort of Single-Institution Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR T Therapy

Retrieved on: 
Thursday, June 15, 2023
University, CD19, Chronic lymphocytic leukemia, Follicular lymphoma, CRS, Fred Hutchinson Cancer Research Center, CD20, European Hematology Association, University of Washington, Lymphoma, History, Associate, Translation, CAR, Waldenström, Asilomar International Conference on Climate Intervention Technologies, Cytokine release syndrome, Patient, Cancer, CR, Mustang, Conference, ORR, DSM-IV codes, Disease, Pharmaceutical industry, Vaccine

WORCESTER, Mass., June 15, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced that final data from the follicular lymphoma (“FL”) cohort of the single-institution Phase 1/2 clinical trial of MB-106 demonstrate treatment with the CD20-targeted, autologous CAR T-cell therapy resulted in high overall response (“ORR”) and complete response (“CR”) rates and CAR T persistence in FL patients. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”) to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHLs”) and chronic lymphocytic leukemia (“CLL”).

Key Points: 
  • The final FL cohort results from the Phase 1/2 clinical trial being conducted at Fred Hutch were presented by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutch and University of Washington, at the 17th International Conference on Malignant Lymphoma (“17-ICML”).
  • Median age was 63 years (range: 44 – 81), and median prior lines of treatment was 4 (range: 1 – 12).
  • One patient, previously treated with a CD19-targeted CAR T-cell therapy, achieved a CR and remains in remission after 18 months.
  • We look forward to reporting initial data from our multicenter Phase 1/2 clinical trial of MB-106 shortly.”
    For more information on the multicenter clinical trial, please visit www.clinicaltrials.gov using the identifier NCT05360238 for the multicenter trial.

Mustang Bio Announces Updated Results from Waldenstrom Macroglobulinemia Cohort of Ongoing Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR T Therapy

Retrieved on: 
Monday, June 12, 2023
Waldenström macroglobulinemia, University, Chronic lymphocytic leukemia, CRS, Lymphoid leukemia, Fred Hutchinson Cancer Research Center, European Hematology Association, University of Washington, Immunoglobulin M, Bone marrow, BTK, Associate, Translation, WM, CAR, Waldenström, Cytokine release syndrome, Patient, Cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mustang, DSM-IV codes, Food, Safety, Disease, Pharmaceutical industry

WORCESTER, Mass., June 12, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced that updated data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy, show a favorable safety and efficacy profile in patients with Waldenstrom macroglobulinemia (“WM”), a rare form of blood cancer. MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center (“Fred Hutch”) to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas (“B-NHLs”) and chronic lymphocytic leukemia (“CLL”).

Key Points: 
  • The updated results from the single-institution Phase 1/2 clinical trial were presented during a poster session at the European Hematology Association 2023 Hybrid Congress (“EHA2023”) by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutch and University of Washington.
  • From a safety perspective, cytokine release syndrome (CRS) occurred in five patients: two patients with grade 1 and three patients with grade 2.
  • No grade 3 or 4 CRS or grade 2, 3 or 4 ICANS has been observed.
  • The MB-106 data from the Phase 1/2 clinical trial taking place at Fred Hutch continue to be encouraging for WM and other B-NHLs.

Mustang Bio Announces Strategic Manufacturing Partnership and Portfolio Updates

Retrieved on: 
Thursday, May 18, 2023
Waldenström macroglobulinemia, Partnership, City of Hope, Mayo Clinic, Employment, Birmingham School of Law, Malignancy, University, GBM, CD20, Fred Hutchinson Cancer Research Center, Neoplasm, Biotechnology, Lead, University of Massachusetts Chan Medical School, Translation, Sale, WM, Security, CAR, PSCA, CDMO, Hematological Cancer Research Investment and Education Act, City, Waldenström, Acquisition, CGMP, Patient, Cancer, XSCID, Birmingham, Ecosystem, Nationwide, Mustang, IND, DSM-IV codes, Leiden University, Vaccine, Bank, Pharmaceutical industry, Fine chemical, Greater Boston

WORCESTER, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced a strategic update, including anticipated milestones for 2023. Mustang intends to optimize the allocation of its resources and focus on MB-106, MB-109, and in vivo CAR T platform technology. Additionally, Mustang announced a partnership with uBriGene (Boston) Biosciences Inc. (“uBriGene”), the U.S. subsidiary of uBriGene Group, a leading cell and gene therapy contract development and manufacturing organization (“CDMO”), which includes the sale of the Company’s development, manufacturing and analytical testing facility in Worcester, Massachusetts to uBriGene.

Key Points: 
  • Mustang intends to optimize the allocation of its resources and focus on MB-106, MB-109, and in vivo CAR T platform technology.
  • Additionally, Mustang announced a partnership with uBriGene (Boston) Biosciences Inc. (“uBriGene”), the U.S. subsidiary of uBriGene Group, a leading cell and gene therapy contract development and manufacturing organization (“CDMO”), which includes the sale of the Company’s development, manufacturing and analytical testing facility in Worcester, Massachusetts to uBriGene.
  • Subject to closing, the parties will enter into a manufacturing supply agreement, under which uBriGene will manufacture Mustang’s lead product candidates, including continuing to support MB-106 manufacturing for the ongoing multi-center Phase 1/2 trial.
  • I want to thank our manufacturing team for their dedication in building and growing our Worcester facility since it opened in 2018.