Non-Hodgkin lymphoma

Appia Bio to Present Data on API-192 at the 65th American Society for Hematology Annual Meeting and Exposition

Retrieved on: 
Tuesday, December 5, 2023
Malignancy, Research, Non-Hodgkin lymphoma, Canadian Aviation Regulations, ASH, Health, HSC, IND, Gold, Patient, LOS, ACUA, Cancer, Society, Stem cell, Lymphoma, Pharmaceutical industry, Kite

LOS ANGELES, Dec. 5, 2023 /PRNewswire/ -- Appia Bio, Inc., a biotechnology company developing allogeneic chimeric antigen receptor (CAR)-engineered invariant natural killer T (CAR-NKT) cell therapies from hematopoietic stem cells (HSCs) for patients with cancer, today announced that it will present preclinical data on API-192, a first-in-class CAR-NKT allogeneic cell therapy for the treatment of a broad array of B-cell mediated malignancies including non-Hodgkin lymphoma, one of the most common cancers in the U.S.

Key Points: 
  • These data will be delivered in a poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023 in San Diego, CA.
  • API-192 is the first development candidate out of a 2021 collaboration and license agreement between Appia Bio and Kite, a Gilead Company.
  • Under the terms of the agreement, Appia Bio is responsible for preclinical and early clinical research of HSC-derived CAR-NKT product candidates engineered with CARs provided by Kite.
  • "It has been a fantastic team effort to bring API-192 forward as our first development candidate out of our ACUA technology platform.

CD19-Targeting Therapies Show Remarkable Growth, Revolutionizing Cancer Treatment with High Response Rates - ResearchAndMarkets.com

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Wednesday, November 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, FDA, Antibody, Tisagenlecleucel, IND, Acute leukemia, Fast Track, CD19, B-cell lymphoma, Hematological Cancer Research Investment and Education Act, Research, Neurotoxicity, Quality of life, Novartis, Indication, Immune system, Cytokine release syndrome, USD, NHL, CRS, Lymphoid leukemia, Therapy, Patient, Non-Hodgkin lymphoma, ALL, Monoclonal antibody, Vaccine, Pharmaceutical industry, Amgen

Market Opportunity: The global CD19 antibody market is projected to exceed USD 10 billion by 2028, showcasing its remarkable growth potential.

Key Points: 
  • Market Opportunity: The global CD19 antibody market is projected to exceed USD 10 billion by 2028, showcasing its remarkable growth potential.
  • Commercially Approved CD19 Antibodies: Currently, there are 10 approved CD19 antibodies available in the market, indicating a diverse range of treatment options for patients.
  • These therapies, including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, and chimeric antigen receptor T-cell (CAR-T) therapies, have made a significant impact on cancer treatment.
  • To date, nine CD19-targeting therapies have received approval from regulatory bodies, including bispecific antibodies, monoclonal antibodies, antibody-drug conjugates, and CAR-T therapies.

Gamida Cell Presents New Data on Allogeneic Stem Cell Therapy Omidubicel and Natural Killer (NK) Cell Therapy Candidate GDA-201 at Society for Immunotherapy of Cancer (SITC) Annual Meeting

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Saturday, November 4, 2023
Survival, UCB, NAM, Immune reconstitution inflammatory syndrome, Therapy, CD57, MD, Infection, Cell, SITC, Immunotherapy, B cell, Science, NF, Immunophenotyping, Annual general meeting, Kinetics, Culture, Society, Cancer, Patient, CF, Non-Hodgkin lymphoma, Fibroblast, Myelocyte, Pharmaceutical industry, Vaccine, NK

(Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today shared new data on the impact of the company’s proprietary nicotinamide (NAM) technology on its allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201 at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting in San Diego, CA.

Key Points: 
  • (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today shared new data on the impact of the company’s proprietary nicotinamide (NAM) technology on its allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201 at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting in San Diego, CA.
  • Both omidubicel and GDA-201 are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to create potentially curative cell therapies for patients with cancer.
  • Omidubicel was approved under the brand name Omisirge™ (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant; GDA-201 is in Phase 1 study for the treatment of non-Hodgkin lymphoma (NCT05296525).
  • Data on the first three cohorts of the Phase 1 study of GDA-201 were recently reported.

Galapagos reports third quarter 2023 results and releases new encouraging data from CAR-T studies for presentation at ASH 2023

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Thursday, November 2, 2023
B-cell lymphoma, Rheumatoid arthritis, Mantle cell lymphoma, Symantec Endpoint Protection, Ulcerative colitis, Pulmonary embolism, Lupus, CET, Infection, SLE, RT, Bleeding, ORR, Safety, Patient, TYK2, Baltic, DLBCL, CR, Euronext, Galapagos NV, Failure mode and effects analysis, ASH, UK, Follicular lymphoma, Letter, CRS, Non-Hodgkin lymphoma, Survival, ET, Technology transfer, CRR, UC, CD19, Indolent lymphoma, CFO, Burn, Lymphoid leukemia, Pharmaceutical industry, Cryptocurrency, Vaccine, Uranium mining, Pamlab, Galápagos Islands, Dermatomyositis, Central Europe

Overall, 11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12 patients achieved a CRR (75%).

Key Points: 
  • Overall, 11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12 patients achieved a CRR (75%).
  • Overall, 11 of 13 patients responded to treatment (ORR of 85%) and 9 of 13 patients achieved a CRR (69%).
  • New preliminary data (data cut-off: 26 April 2023), for 12 patients enrolled in EUPLAGIA-1, will be presented at ASH (see ASH abstract and poster presentation details below).
  • New preliminary data (data cut-off: 2 May 2023) for 14 patients enrolled in ATALANTA-1 will be presented at ASH (see ASH abstract and poster presentation details below).

SELLAS Life Sciences Receives Fast Track Designation from FDA for SLS009 for Treatment of Relapsed/Refractory Peripheral T-cell Lymphomas

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Monday, October 30, 2023
SLS, FDA, Food, Non-Hodgkin lymphoma, Fast Track, PTCL, Treatment, MD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CDK9, Marketing, Doctor of Science, Peripheral T-cell lymphoma not otherwise specified, Breakthrough therapy, Bone marrow, Safety, Therapy, Patient, Lymphoma, Pharmaceutical industry

NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SLS009, its novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL). The Fast Track designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.

Key Points: 
  • The Fast Track designation is intended to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need.
  • The Company is also actively pursuing potential Breakthrough Therapy designation from the FDA for SLS009 for the treatment of r/r PTCL and has a scheduled meeting in the fourth quarter of 2023 to discuss with the FDA.
  • Programs with Fast Track designation can benefit from early and more frequent interactions with the FDA to discuss the candidate’s development plan in addition to a rolling submission of the marketing application.
  • Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.

HotSpot Therapeutics to Introduce First-in-Class MALT1 Scaffolding Inhibitor at 65th ASH Annual Meeting

Retrieved on: 
Thursday, November 2, 2023
CBM, NF-κB, Non-Hodgkin lymphoma, IND, Biotechnology, Drug resistance, Multiple myeloma, Hotspot, Cell, Protein, Society, ASH, Lymphoid neoplasms with plasmablastic differentiation, Pharmacology, Bone marrow, Therapy, Manchester Grand Hyatt Hotel, Pharmaceutical industry, MALT1, Lymphoma

BOSTON, Nov. 2, 2023 /PRNewswire/ -- HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," today announced it will present preclinical data from the Company's highly differentiated mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1) program in an oral presentation at the 2023 American Society of Hemotology (ASH) Annual Meeting, taking place December 9-12, 2023, in San Diego, CA.

Key Points: 
  • MALT1 is a component of the CARD11-BCL10-MALT1 (CBM) protein complex, which serves as a key regulator of NFkB signaling in cells, including B and T cells.
  • MALT1 is implicated in a range of hematological malignancies, including Non-Hodgkin's lymphoma, as well as other lymphomas and selected solid tumors.
  • Leveraging our proprietary Smart Allostery™ platform, HotSpot has developed first-in-class small molecules designed to selectively inhibit the scaffolding function of MALT1, a dominant driver of the NFkB pathway.
  • This oral presentation will describe the differentiated preclinical profile for HotSpot's scaffolding inhibitor, including the potential for an improved efficacy and safety profile versus traditional MALT1 inhibitors that target protease function.

Citius Pharmaceuticals Executes Definitive Agreement to Merge Wholly Owned Subsidiary with TenX Keane Acquisition to Form Publicly Listed Citius Oncology, Inc.

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Tuesday, October 24, 2023
TenX, READ, Suite, Food, Medication, Lexington Avenue, Auxiliary routes of Arkansas Highway 18, SPAC, Sale, Form, Acquisition, ONCE, CTCL, Patient, Person, Commerce, PD-1, Newbridge, Non-Hodgkin lymphoma, FDA, Biologics license application, Regulation of tobacco by the U.S. Food and Drug Administration, Prospectus, Peripheral T-cell lymphoma, Annual report, BLA, Security (finance), Pharmaceutical industry, Bank, Cryptocurrency, Citius, Altius, Fortius

CRANFORD, N.J. and NEW YORK, N.Y., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Citius Pharmaceuticals, Inc. (“Citius Pharma” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition (“TenX”) (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma’s wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange. The newly combined public company will be named Citius Oncology, Inc. (“Citius Oncology”). Upon closing, pursuant to the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024.

Key Points: 
  • The newly combined public company will be named Citius Oncology, Inc. (“Citius Oncology”).
  • Our majority ownership position and shared services agreement ensures that the Citius Pharma management team will remain fully engaged with the development and commercialization efforts at Citius Oncology.
  • “We are very pleased to announce the proposed merger with Citius Oncology,” said Mr. Xiaofeng Yuan, Chairman and CEO of TenX.
  • In the transaction, all shares of Citius Pharma’s wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology.

Citius Pharmaceuticals Executes Definitive Agreement to Merge Wholly Owned Subsidiary with TenX Keane Acquisition to Form Publicly Listed Citius Oncology, Inc.

Retrieved on: 
Tuesday, October 24, 2023
TenX, READ, Suite, Food, Medication, Lexington Avenue, Auxiliary routes of Arkansas Highway 18, SPAC, Sale, Form, Acquisition, ONCE, CTCL, Patient, Person, Commerce, PD-1, Newbridge, Non-Hodgkin lymphoma, FDA, Biologics license application, Regulation of tobacco by the U.S. Food and Drug Administration, Prospectus, Peripheral T-cell lymphoma, Annual report, BLA, Security (finance), Pharmaceutical industry, Bank, Generic drug, Citius, Altius, Fortius

CRANFORD, N.J. and NEW YORK, Oct. 24, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition ("TenX") (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma's wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange. The newly combined public company will be named Citius Oncology, Inc. ("Citius Oncology"). Upon closing, pursuant to the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024. 

Key Points: 
  • The newly combined public company will be named Citius Oncology, Inc. ("Citius Oncology").
  • "We are very pleased to announce the proposed merger with Citius Oncology," said Mr. Xiaofeng Yuan, Chairman and CEO of TenX.
  • Pursuant to the proposed agreement, TenX will acquire Citius Pharma's wholly owned subsidiary via a merger, with the newly combined publicly traded company to be named Citius Oncology, Inc.
  • In the transaction, all shares of Citius Pharma's wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology.

Fortress Biotech Subsidiary Helocyte Announces Option Agreement with City of Hope for Exclusive Worldwide Rights to use a Novel Bispecific CMV/HIV CAR T Cell Therapy (optionally in combination with Triplex) for the Treatment of Adults Living with HIV-1

Retrieved on: 
Monday, October 16, 2023
Patent, Investigational New Drug, Engineering, Food, California Institute for Regenerative Medicine, Viral load, Research, Drug resistance, Trial of the century, Cytomegalovirus, Criticism of the Food and Drug Administration, Risk, Gene, HIV-1, Aaron, Safety, University, HIV, HCT, Survival, ART, City, Vaccination, City of Hope, Non-Hodgkin lymphoma, Regenerative medicine, Bone marrow, Virus, CAR, Leukemia, Fortress Biotech, DSM-IV codes, 2004 California Proposition 71, San Diego, CIRM, Division of Acquired Immunodeficiency Syndrome, Patient, CMV, Vaccine, Triplex, Hope

MIAMI, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Helocyte, Inc. (“Helocyte”), a subsidiary company of Fortress Biotech, Inc. (“Fortress”) (Nasdaq: FBIO), today announced that it executed an exclusive option agreement with City of Hope for patent rights to use Triplex, a cytomegalovirus vaccine, in combination with cytomegalovirus (“CMV”)-specific, Anti-Human Immunodeficiency Virus (“HIV”) Chimeric Antigen Receptor (“CAR”) (collectively, CMV/HIV-CAR) T Cells for the treatment of adults living with HIV. Triplex was initially developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015.

Key Points: 
  • Triplex was initially developed by City of Hope , one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015.
  • Additionally, the California Institute for Regenerative Medicine (“CIRM”) recently awarded a $11.3 million grant to City of Hope to fund a Phase 1 clinical trial.
  • The trial will initially enroll at City of Hope and University of California at San Diego.
  • The study illustrated the potential long-term durability of the combination therapy, which induced therapeutic immune cells to take hold in bone marrow.

Prime Therapeutics and Magellan Rx to present three managed care pharmacy research studies at AMCP Nexus

Retrieved on: 
Monday, October 16, 2023
Nexus, Haemophilia, ABR, Bleeding, Weight loss, Cytokine release syndrome, Radiation, Pharmacotherapy, Non-Hodgkin lymphoma, AMCP, Lymphoma, Cancer, Diabetes, Patient, MRX, Therapy, B-cell lymphoma, DPP4, PMPM, Documentation, Canadian Aviation Regulations, CAR, CRS, Pharmacy, Overalls, Doctor of Pharmacy, Research, NHL, Toxic epidermal necrolysis, Nursing, Pharmaceutical industry, Health insurance, Vaccine, Birth control

EAGAN, Minn., Oct. 16, 2023 /PRNewswire/ -- Prime Therapeutics LLC/Magellan Rx Management (Prime/MRx) will present three research studies at the 2023 Academy of Managed Care Pharmacy (AMCP) Nexus event, October 16-19 in Orlando, Fla.

Key Points: 
  • EAGAN, Minn., Oct. 16, 2023 /PRNewswire/ -- Prime Therapeutics LLC / Magellan Rx Management (Prime/MRx) will present three research studies at the 2023 Academy of Managed Care Pharmacy (AMCP) Nexus event , October 16-19 in Orlando, Fla.
    Health outcomes teams from the organization used integrated medical and pharmacy claims data to evaluate real-world drug utilization, managed care pharmacy programs, and associated costs of care for a range of conditions, including diabetes, lymphoma, and hemophilia.
  • This study illustrates the impact of comprehensive hemophilia care and managed care strategies which led to more than $3.7 million in cost avoidance.
  • More information about these presentations can be found on Prime Therapeutics' events page or the AMCP Nexus website .
  • And for further insights on the studies noted above, visit Prime Therapeutics' newsroom .