Waldenström's macroglobulinemia

Nurix Therapeutics Presents Positive Clinical Results from its Novel BTK Degrader (NX-2127) at the 64th American Society of Hematology (ASH) Annual Meeting

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Monday, December 12, 2022

SAN FRANCISCO, Dec. 12, 2022 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today presented additional positive clinical data from its Phase 1 clinical trial of NX-2127 in two oral sessions by Anthony Mato, M.D., MSCE, former director of the Chronic Lymphocytic (CLL) Program at Memorial Sloan Kettering Cancer Center, and Omar Abdel-Wahab, M.D., Chair of Sloan Kettering Institute (SKI) Molecular Pharmacology Program at Memorial Sloan Kettering Cancer Center. NX-2127 is a once daily, oral, investigational new drug that combines BTK degradation with immunomodulatory activity. The podium presentations took place at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition which is being held in New Orleans, Louisiana.

Key Points: 
  • The podium presentations took place at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition which is being held in New Orleans, Louisiana.
  • Approximately 78% of this group had previously received both BTK and BCL2 inhibitors and 35% had been treated with the non-covalent BTK inhibitor pirtobrutinib.
  • Of the CLL patients, 48% had one or more identified BTK resistance mutations prior to treatment with NX-2127.
  • These findings translated into clinically meaningful BTK degradation in the Phase clinical 1 trial and clinical activity independent of baseline BTK mutations.

HealthWell Foundation Launches Waldenstrom Macroglobulinemia Fund

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Wednesday, December 14, 2022

GERMANTOWN, Md., Dec. 14, 2022 /PRNewswire/ -- The HealthWell Foundation®, an independent non-profit that provides a financial lifeline for inadequately insured Americans, is proud to announce that it has launched a new fund to provide financial assistance to patients living with Waldenstrom Macroglobulinemia. Through the new fund, HealthWell will provide up to $8,000 in copayment or insurance premium assistance to eligible patients with annual household incomes up to 500 percent of the federal poverty level to obtain prescription medications for the treatment and management of their condition.

Key Points: 
  • GERMANTOWN, Md., Dec. 14, 2022 /PRNewswire/ -- The HealthWell Foundation, an independent non-profit that provides a financial lifeline for inadequately insured Americans, is proud to announce that it has launched a new fund to provide financial assistance to patients living with Waldenstrom Macroglobulinemia.
  • Waldenstrom macroglobulinemia (WM) is a rare type of blood cancer that begins in the white blood cells and is a slow-growing cancer of the lymphatic system.
  • "We applaud the HealthWell Foundation and its donors for recognizing the undue financial burden patients face in accessing and affording their care.
  • To determine eligibility and apply for financial assistance, visit HealthWell's Waldenstrom Macroglobulinemia Fund page.

Mustang Bio Reports Third Quarter 2022 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, November 14, 2022

WORCESTER, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (Mustang) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2022.

Key Points: 
  • WORCESTER, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (Mustang) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating todays medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2022.
  • We anticipate announcing early results from the Mustang-sponsored Phase 1 trial in December 2022.
  • Research and development expenses were $15.5 million for the third quarter of 2022, compared to $14.7 million for the third quarter of 2021.
  • General and administrative expenses were $3.4 million for the third quarter of 2022, compared to $2.4 million for the third quarter of 2021.

Kyowa Kirin and MEI Pharma Announce Topline Data from the Phase 2 MIRAGE Study Evaluating Zandelisib in Patients with Indolent B-cell non-Hodgkin’s Lymphoma in Japan

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Friday, November 18, 2022

We are very pleased to announce the data from Phase 2 MIRAGE study, said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin.

Key Points: 
  • We are very pleased to announce the data from Phase 2 MIRAGE study, said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin.
  • We remain committed to maximizing the value of zandelisib in B-cell malignancies with our partner MEI Pharma and bringing hope to lymphoma patients around the world.
  • In November 2021, MEI Pharma and Kyowa Kirin announced topline data from ongoing Phase 2 TIDAL study ( NCT03768505 ) evaluating zandelisib as a single agent for follicular lymphoma (FL) patients who received at least two prior systemic therapies.
  • MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales.

CytoImmune Therapeutics Appoints Remus Vezan, M.D., Ph.D., as Chief Medical Officer

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Wednesday, September 7, 2022

CytoImmune Therapeutics, a clinical-stage immuno-oncology company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies, today announced the appointment of Remus Vezan, M.D., Ph.D., as Chief Medical Officer.

Key Points: 
  • CytoImmune Therapeutics, a clinical-stage immuno-oncology company that is developing a novel class of engineered natural killer (NK) cell-based cancer therapies, today announced the appointment of Remus Vezan, M.D., Ph.D., as Chief Medical Officer.
  • Remus brings an ideal combination of expertise to CytoImmune, having led the successful implementation and execution of clinical development strategies for several biopharmaceutical companies focused on both immuno-oncology and cell therapies, said Christina Coughlin, M.D., Ph.D., Chief Executive Officer of CytoImmune.
  • I am pleased to join the team at this exciting time in the evolution of the company.
  • Dr. Vezan joins CytoImmune from CERo Therapeutics where he served as Chief Medical Officer.

MEI Pharma and Kyowa Kirin Announce Publication in The Lancet Oncology of Data from Phase 1b Clinical Study of Zandelisib in Patients with Relapsed or Refractory B-cell Malignancy

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Monday, July 18, 2022

The Phase 1b study ( NCT02914938 ) is an open-label, dose escalation and expansion study evaluating zandelisib in patients with B-cell malignancies.

Key Points: 
  • The Phase 1b study ( NCT02914938 ) is an open-label, dose escalation and expansion study evaluating zandelisib in patients with B-cell malignancies.
  • The study evaluated zandelisib in 56 patients as a monotherapy and 41 patients in combination with rituximab.
  • In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib.
  • MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales.

MEI Pharma and Kyowa Kirin Report New Clinical Data on Zandelisib at American Society of Clinical Oncology Annual Meeting 2022

Retrieved on: 
Saturday, June 4, 2022

As of the data cutoff date, the data are not sufficiently mature to accurately estimate the final DOR in the PEP.

Key Points: 
  • As of the data cutoff date, the data are not sufficiently mature to accurately estimate the final DOR in the PEP.
  • Zandelisib, a selective PI3K inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies.
  • In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib.
  • MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales.

Nurix Therapeutics Announces Positive Dose Finding Data in Chronic Lymphocytic Leukemia and Advances NX-2127 to Next Phase of Clinical Development

Retrieved on: 
Thursday, May 26, 2022

The first expansion cohorts will focus on patients with chronic lymphocytic leukemia (CLL).

Key Points: 
  • The first expansion cohorts will focus on patients with chronic lymphocytic leukemia (CLL).
  • Brown, M.D., executive vice president of clinical development at Nurix.
  • The Phase 1b expansion cohorts will include up to 40 CLL patients enrolled across multiple clinical sites in the United States.
  • The Phase 1a dose escalation portion of the trial will continue to enroll non-CLL patients at doses ranging from 50mg to 300mg orally once daily.

Cellectar Biosciences Announces Positive DMC Review of Pivotal Trial of Iopofosine in Waldenstrom’s Macroglobulinemia

Retrieved on: 
Tuesday, April 26, 2022

The pivotal trial is a global, non-comparator, single-arm, open-label expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131.

Key Points: 
  • The pivotal trial is a global, non-comparator, single-arm, open-label expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131.
  • The DMC is an independent committee of clinical research experts who review data in ongoing clinical trials.
  • The DMC assessment was based on a pre-specified futility analysis within the first 10 patients as defined in the study protocol.
  • Waldenstroms macroglobulinemia (WM) is a rare and incurable disease defined by specific genotypic subtypes that defines patient responses and long-term outcomes.

Global Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma) Clinical Trials Research Review 2022 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, April 13, 2022

The "Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma) - Global Clinical Trials Review, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma) - Global Clinical Trials Review, 2022" clinical trials has been added to ResearchAndMarkets.com's offering.
  • The clinical trial report provides an overview of Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma) Clinical trials scenario.
  • This report provides top line data relating to the clinical trials on Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma).
  • Report provides top level data related to the clinical trials by Region, Country (G7 & E7), Trial Status, Trial Phase, Sponsor Type and End point status
    The report reviews top companies involved and enlists all trials (Trial title, Phase, and Status) pertaining to the company
    The report provides all the unaccomplished trials (Terminated, Suspended and Withdrawn) with reason for unaccomplishment
    Clinical Trials by G7 Countries: Proportion of Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma) to Oncology Clinical Trials
    Clinical Trials by E7 Countries: Proportion of Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma) to Oncology Clinical Trials