Genetically engineered NK cell therapy receives FDA Fast Track designation, combined with monoclonal antibody for the treatment of advanced gastric cancer

Written | Edited by Wang Cong | Typesetting by Wang Duoyu | Shui Chengwen According to the latest global cancer burden data released by the World Health Organization's International Agency for Research on Cancer (IARC) in 2020, gastric cancer is the fifth in annual new cases and the fourth in annual deaths.
cancer
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Although treatment outcomes and options for gastric cancer have improved, advanced gastric cancer remains one of the cancers with the highest mortality rates, with a median survival of only 10-12 months and a 5-year survival rate of 5%-20%
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In May 2021, the FDA granted accelerated approval to pembrolizumab in combination with trastuzumab and standard chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric and gastroesophageal junction (G/GEJ) cancers
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However, the complete remission rate was only 11.
3%
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Natural killer cells (NK cells) are important immune cells in the body.
They are different from T cells and B cells and can non-specifically kill tumor cells and virus-infected cells without prior sensitization
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Now NK cells are becoming a hot spot in tumor immunotherapy, and have achieved certain results in cancer treatment, which is expected to make up for some of the shortcomings of CAR-T cell therapy
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On January 18, 2022, Cellularity's NK cell therapy CYNK-101 received Fast Track designation from the US FDA
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CYNK-101 is a placental hematopoietic stem cell-derived NK cell therapy developed by Celularity, which has been genetically engineered
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The therapy is currently in a Phase 1/2a clinical trial evaluating it in combination with standard chemotherapy and trastuzumab and pembrolizumab in first-line treatment of advanced HER2/neu-positive gastric and gastroesophageal junction cancer (G/GEJ ) safety and preliminary efficacy
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Dr.
Robert Hariri, founder, chairman and CEO of Celularity, said that he is very pleased to receive FDA support for genetically modified NK cell therapy
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CYNK-101 therapy is built on the company's unique placenta-derived material, which has a naturally enhanced proliferative potential compared to other sources of NK cells, which has been shown to be persistent and efficacy potential when treated determinant
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Moreover, through genetic engineering, the expression of CD16 on its surface was enhanced, thereby enhancing the ability of CYNK-101 to synergize with other monoclonal antibodies
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It is reported that this is Celularity's third NK cell therapy to receive FDA Fast Track qualification in the past year.
The first two are unmodified NK cells, which are used for the treatment of acute myeloid leukemia and relapsed multiple leukemia respectively.
Glioblastoma form
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Celularity Inc.
(NASDAQ: CELU), dedicated to the development of allogeneic cryopreserved off-the-shelf placenta-derived cell therapies, including unmodified NK cells, genetically modified NK cells, CAR-T cells, and Plasma-like adherent stromal cells (ASCs)
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Diseases treated by these therapies include hematological cancers, solid tumors, infectious diseases, degenerative diseases, and more
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Celularity's R&D Pipeline About Fast Track: Fast Track is a special FDA approval pathway designed to facilitate and expedite the review of new medicines that treat serious diseases and may address current unmet medical needs, thereby accelerating the delivery of important new medicines to patients.
process
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For new drugs that have obtained fast-track qualifications, the FDA will actively intervene at an early stage to speed up the research and development process.
If the new drugs meet certain standards, they may be eligible for priority review
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Reference: https://celularity.
com/celularity-receives-fast-track-designation-from-us-fda-for-its-nk-cell-therapy-cynk-101/https://celularity.
com/celularity -receives-fast-track-designation-from-us-fda-for-its-nk-cell-therapy-cynk-001-in-development-for-the-treatment-of-aml/Bioworld plans to launch " "NK cell therapy" column, which interprets and introduces the latest research progress and reviews of NK cell therapy every week, as well as reports and interviews of related startups
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We have also established a professional exchange group for NK cell therapy, long press the QR code below, add the editor-in-chief WeChat, and note the unit-research direction/position-name
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Open reprint welcome to forward to Moments and WeChat groups