CD138

STEMCELL Technologies Announces FDA De Novo Classification for Its EasySep™ CD138 Positive Selection Kit to Support Cancer Diagnostic Tests

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Tuesday, March 26, 2024

STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit has been granted de novo classification by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.

Key Points: 
  • STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit has been granted de novo classification by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.
  • View the full release here: https://www.businesswire.com/news/home/20240326396951/en/
    STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit is now classified by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.
  • (Photo: Business Wire)
    The kit can be used to enrich plasma cells expressing the CD138 marker (CD138+ cells) from patient bone marrow samples.
  • The EasySep™ Human Bone Marrow CD138 Positive Selection Kit will be available for sale in the United States, the European Union, Canada, and the United Kingdom.

Claudin 6, Cadherin 17, ROR1 and GPRC5D-Targeted Therapies Bundle Research Report 2022 - ResearchAndMarkets.com

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Thursday, August 4, 2022

The "Claudin 6, Cadherin 17, ROR1 and GPRC5D-Targeted Therapies: Target Expression Profile, Safety & Efficacy of Drug Modalities, Pipeline Review, and Competitive Landscape Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Claudin 6, Cadherin 17, ROR1 and GPRC5D-Targeted Therapies: Target Expression Profile, Safety & Efficacy of Drug Modalities, Pipeline Review, and Competitive Landscape Analysis" report has been added to ResearchAndMarkets.com's offering.
  • This report bundle includes four reports about novel cancer targets which have in common a compelling target expression profile with a low risk of on-target/off-tumor toxicity.
  • The tetraspan membrane protein is a member of the claudin family of tight junction proteins.
  • The transmembrane protein CLDN6 is virtually absent from any normal tissue, whereas it is aberrantly and frequently expressed in various cancers of high medical need.

2022 GPRC5D-Targeted Therapy Report - Target Expression Profile, Safety & Efficacy of Drug Modalities, Pipeline Review, and Competitive Landscape Analysis - ResearchAndMarkets.com

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Tuesday, July 19, 2022

The "GPRC5D-Targeted Therapy: Target Expression Profile, Safety & Efficacy of Drug Modalities, Pipeline Review, and Competitive Landscape Analysis" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "GPRC5D-Targeted Therapy: Target Expression Profile, Safety & Efficacy of Drug Modalities, Pipeline Review, and Competitive Landscape Analysis" report has been added to ResearchAndMarkets.com's offering.
  • The report has identified the players in the field and presents a competitive landscape analysis of stakeholders and a pipeline review based on the specific profiles of drug candidates and companies active in the field.
  • The report includes information about business transactions in the field, such as acquisitions, partnerships & collaborations and licensing deals.
  • GPRC5D expression on CD138 cells is independent of B-cell maturation antigen (BCMA) expression and showed a membranous pattern.

Nammi Therapeutics Granted FDA Orphan Drug Designation For QXL138AM for the Treatment of Pancreatic Cancer

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Thursday, June 16, 2022

LOS ANGELES, June 16, 2022 /PRNewswire/ -- Nammi Therapeutics, Inc. (Nammi), a Los Angeles based immunotherapy company, announced today that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of Pancreatic Cancer.

Key Points: 
  • LOS ANGELES, June 16, 2022 /PRNewswire/ -- Nammi Therapeutics, Inc. (Nammi), a Los Angeles based immunotherapy company, announced today that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of Pancreatic Cancer.
  • Nammi has previously received ODD for QXL138AM for treatment of multiple myeloma.
  • Pancreatic Cancer is a relatively rare form of cancer, with the American Cancer Society estimating over 62,210 new cases and 49,830 deaths from Pancreatic Cancer this year.
  • Nammi Therapeutics is expecting to file an Investigational New Drug (IND) application with the FDA to allow initiation of clinical studies this year.

Nammi Therapeutics Granted FDA Orphan Drug Designation For QXL138AM for the Treatment of Multiple Myeloma

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Monday, June 13, 2022

LOS ANGELES, June 13, 2022 /PRNewswire/ -- Nammi Therapeutics, Inc. (Nammi), an LA-based immunotherapy company, announced today that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of multiple myeloma.

Key Points: 
  • LOS ANGELES, June 13, 2022 /PRNewswire/ -- Nammi Therapeutics, Inc. (Nammi), an LA-based immunotherapy company, announced today that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of multiple myeloma.
  • Activation of the IFNAR complex induces direct killing of myeloma cells as well as activating innate and adaptive anti-tumor immunity.
  • Multiple Myeloma is a relatively rare form of cancer, with the American Cancer Society estimating over 34,000 new cases and 12,000 deaths from multiple myeloma this year.
  • Nammi Therapeutics is expecting to file an Investigational New Drug (IND) application with the FDA to allow initiation of clinical studies this year.

Nkarta Presents New Preclinical Data from Engineered NK Cell Platform at AACR Annual Meeting 2022

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Friday, April 8, 2022

SOUTH SAN FRANCISCO, Calif., April 08, 2022 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced the presentation of four preclinical data abstracts focused on its natural killer cell platform and pipeline at the American Association for Cancer Research (AACR) Annual Meeting 2022.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., April 08, 2022 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced the presentation of four preclinical data abstracts focused on its natural killer cell platform and pipeline at the American Association for Cancer Research (AACR) Annual Meeting 2022.
  • Posters are available for download on the Nkarta website ( https://www.nkartatx.com/publications/ ) and on the AACR e-poster website ( https://cattendee.abstractsonline.com/meeting/10517 ).
  • Editing targets included cytokine inducible SH2-containing protein (CISH) and the E3 ubiquitin ligase CBLB, both negative regulators of NK cell function.
  • Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell immunotherapies for cancer patients.