Non-Hodgkin lymphoma

ALX Oncology Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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목요일, 3월 7, 2024

SOUTH SAN FRANCISCO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
  • 2023 Full Year and Fourth Quarter Financial Results:
    Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of December 31, 2023, were $218.1 million.
  • Non-GAAP net loss was $38.7 million for the fourth quarter ended December 31, 2023, as compared to a non-GAAP net loss of $24.4 million for the fourth quarter ended December 31, 2022.
  • A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

Werewolf Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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목요일, 3월 7, 2024

WATERTOWN, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • “Werewolf made considerable progress in 2023, setting up 2024 as a year of execution across our pipeline,” said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf.
  • Financial Results for the Fourth Quarter and Full Year 2023:
    Cash position: As of December 31, 2023, cash and cash equivalents were $134.3 million, compared to $129.3 million as of December 31, 2022.
  • Net loss: Net loss was $12.0 million for the fourth quarter of 2023, compared to $11.9 million for the same period in 2022.
  • Net loss was $37.4 million for the full year 2023, compared to $53.8 million for the full year 2022.

Knight Therapeutics Announces Launch of Minjuvi® in Brazil

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목요일, 2월 29, 2024

MONTREAL, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of Minjuvi® (tafasitamab) by its Brazilian affiliate, United Medical Ltda.

Key Points: 
  • MONTREAL, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of Minjuvi® (tafasitamab) by its Brazilian affiliate, United Medical Ltda.
  • Additionally, in October 2023, Knight received pricing approval for Minjuvi® from the Drugs Market Regulation Chamber (“CMED”).
  • “In line with Knight’s commitment to advancing healthcare in Latin America, we are excited to launch Minjuvi in Brazil, an innovative treatment option for addressing a current unmet medical need,” said Samira Sakhia, Knight Therapeutics President and CEO.
  • “Knight’s team in Brazil is thrilled to make Minjuvi® available to health care professionals and centers, improving DLBCL patient care in the country,” said Cristiane Coelho, Knight Therapeutics Brazil General Manager.

Gamida Cell Data Presented at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

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금요일, 2월 23, 2024

BOSTON, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today presented data highlighting its expanded access program (EAP) for FDA-approved allogeneic stem cell therapy Omisirge® (omidubicel-onlv) and Phase 1 data for its allogeneic cryopreserved natural killer (NK) cell therapy candidate GDA-201 at the 2024 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR). The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas.

Key Points: 
  • The hybrid meetings take place February 21-24 virtually and in person in San Antonio, Texas.
  • “The data presented at Tandem provide further evidence of the potential of Gamida Cell’s nicotinamide (NAM) technology to develop potentially curative therapies by expanding and enhancing cells,” said Ronit Simantov, MD, Chief Medical and Scientific Officer of Gamida Cell.
  • It allowed for institutional variability in conditioning regimens and supportive care, more closely reflecting the real-world environment.
  • Patients were heavily pretreated with a median of six prior lines of therapy including CAR-T cell therapy and hematopoietic stem cell transplant.

Artiva Biotherapeutics Receives FDA Fast Track Designation for AlloNK® in Lupus Nephritis

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목요일, 2월 22, 2024

Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AlloNK® (also known as AB-101) for the treatment of lupus nephritis (LN) in combination with rituximab or obinutuzumab.

Key Points: 
  • Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AlloNK® (also known as AB-101) for the treatment of lupus nephritis (LN) in combination with rituximab or obinutuzumab.
  • Artiva previously received FDA clearance of an Investigational New Drug (IND) application for AlloNK in combination with rituximab in LN, marking the first IND clearance of an allogeneic, off-the-shelf NK cell therapy in autoimmune disease.
  • AlloNK is a non-genetically modified, allogeneic, cryopreserved NK cell therapy candidate that enhances the activity of B-cell-targeting monoclonal antibodies to drive B-cell depletion.
  • “The FDA Fast Track designation gives us an opportunity to accelerate our efforts to bring our AlloNK cell therapy to autoimmunity patients,” said Fred Aslan, M.D., Chief Executive Officer of Artiva.

Tampa General Hospital Brings New Hope for Patients with Advanced Blood Cancers

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월요일, 3월 4, 2024

TAMPA, Fla., March 4, 2024 /PRNewswire/ -- As part of its commitment to harness innovative advances in cancer care, the Tampa General Hospital (TGH) Cancer Institute has added a novel approach to its therapeutic armamentarium for the treatment of patients with aggressive forms of B-cell non-Hodgkin lymphomas and other types of blood cancers.

Key Points: 
  • The field of immunotherapy has evolved from an academic research program to an essential pillar in the treatment of many cancers.
  • All are intended for the treatment of blood cancers, including lymphomas, some forms of leukemia and, most recently, multiple myeloma.
  • Following comprehensive planning and discussion, Tampa General's Hospital at Home program has started to be applied to CAR T patients meeting certain criteria.
  • Due the benefit of remote monitoring, the TGH Cancer Institute and Hospital at Home teams have been working on adapting Hospital at Home for oncology patients.

Nurix Therapeutics Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides a Corporate Update

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목요일, 2월 15, 2024

NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).

Key Points: 
  • NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically relevant degradation of IKZF1 (Ikaros).
  • NX-2127 had a manageable safety profile that was consistent with previous reports for BTK-targeted and immunomodulatory therapies.
  • During the year ended November 30, 2023, Nurix achieved research milestones under its collaborations with Gilead and Sanofi totaling $12.5 million and $7.0 million, respectively.
  • Cash, cash equivalents and marketable securities was $295.3 million as of November 30, 2023, compared to $268.7 million as of August 31, 2023.

New Chair and Executive Committee Members Appointed of Lymphoma Research Foundation Mantle Cell Lymphoma Consortium

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목요일, 2월 15, 2024

NEW YORK, Feb. 15, 2024 /PRNewswire-PRWeb/ -- The Lymphoma Research Foundation (LRF) – the nation's largest non-profit organization devoted exclusively to funding innovative lymphoma research and serving the lymphoma community through a comprehensive series of education programs, outreach initiatives, and patient services – is pleased to announce Tycel Phillips, MD of City of Hope and Kami Maddocks, MD of Ohio State University to the Executive Committee members and Peter Martin, MD of Weill Cornell Medicine as Chair of its Mantle Cell Lymphoma Consortium (MCLC) Executive Committee.

Key Points: 
  • "LRF's Mantle Cell Lymphoma Consortium provides a unique forum for the world's leading MCL researchers to share scientific and clinical findings, exchange ideas, and plan new collaborations," said Meghan Gutierrez, CEO of the Lymphoma Research Foundation
    The Mantle Cell Lymphoma Consortium Executive Committee helps to guide the MCLC by identifying gaps in research and patient care for this historically understudied patient population.
  • Since its inception the Mantle Cell Lymphoma Consortium brings together leading international experts to discuss the latest research findings, foster collaboration within the mantel cell lymphoma (MCL) research community, create new directions for research, and ultimately improve diagnosis and treatment for this disease.
  • "The Lymphoma Research Foundation's Mantle Cell Lymphoma Consortium provides a unique forum for the world's leading MCL researchers to share scientific and clinical findings, exchange ideas, and plan new collaborations," said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation.
  • "I'm honored to lead this vital consortium dedicated to improving outcomes for all those impacted by mantle cell lymphoma," said Dr. Martin.

Werewolf Therapeutics Provides Business Update and Highlights 2024 Strategic Outlook

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월요일, 1월 8, 2024

WATERTOWN, Mass., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, today provided a business update and outlined its strategic outlook and expected milestones for 2024.

Key Points: 
  • -  Prioritizing development of wholly owned clinical assets, WTX-124 and WTX-330; key updates from both INDUKINETM programs anticipated in 2024 -
    WATERTOWN, Mass., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, today provided a business update and outlined its strategic outlook and expected milestones for 2024.
  • In 2024, Werewolf plans to report initial data from the Phase 1 clinical trial in the second quarter of 2024.
  • In 2024, Werewolf plans to:
    Present preclinical data from WTX-712 in the first half of 2024.
  • Present preclinical data demonstrating the potential of INDUKINE molecules for inflammatory diseases by the fourth quarter of 2024.

SIRPant Immunotherapeutics Announces FDA Clearance of IND Application for SIRPant-MTM for the Treatment of Solid Tumors

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화요일, 12월 12, 2023

HUMMELSTOWN, Pa., Dec. 12, 2023 (GLOBE NEWSWIRE) -- SIRPant Immunotherapeutics, Inc., a clinical-stage immuno-oncology company focusing on developing next-generation macrophage-based immunotherapies for the treatment of hematological malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for the Company’s lead product candidate, SIRPant-M™, an autologous SIRPαlow activated macrophage therapy, to treat solid tumors.

Key Points: 
  • HUMMELSTOWN, Pa., Dec. 12, 2023 (GLOBE NEWSWIRE) -- SIRPant Immunotherapeutics, Inc., a clinical-stage immuno-oncology company focusing on developing next-generation macrophage-based immunotherapies for the treatment of hematological malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for the Company’s lead product candidate, SIRPant-M™, an autologous SIRPαlow activated macrophage therapy, to treat solid tumors.
  • Eligible tumor types include, among others, head and neck cancer, non-melanoma skin cancers, bladder and kidney cancers, low-grade prostate cancer, triple-negative breast cancer and certain sarcomas.
  • Earlier this year, the company cleared its first IND in Non-Hodgkin Lymphoma (NHL).
  • Under the newly cleared IND, the Company plans to initiate clinical investigation of SIRPant-MTM as a monotherapy and in combination with other immuno-stimulatory modalities such as radiotherapy and immune checkpoint inhibitors for the treatment of select solid tumor indications.