-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
February 17, 2022/eMedClub News/--On February 15, 2022, Celularity, which focuses on the development of placenta-derived allogeneic cell therapy, announced that the U.
S.
Food and Drug Administration (FDA) has granted its placental hematopoietic stem cell-derived natural killer (NK) Orphan drug designation for cell therapy CYNK-101 for the treatment of gastric or gastroesophageal junction (G/GEJ) cancers
.
Gastric cancer is the fifth most common cancer worldwide
.
Despite recent improvements in treatment quality and options, advanced gastric cancer remains one of the most difficult to treat cancers, with a median overall survival (OS) of 10-12 months and a five-year OS of approximately 5%-20 %
.
In May 2021, the U.
S.
FDA granted accelerated approval to pembrolizumab in combination with trastuzumab, fluoropyrimidine-containing and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-positive G/GEJ cancer first-line treatment of patients
.
CYNK-101 is an experimental genetically engineered NK cell therapy designed to enhance antibody-dependent cell-mediated cytotoxicity (ADCC) through an approved novel antibody therapy
.
In November 2021, the drug's clinical trial (IND) application was approved by the US FDA
.
Ongoing Phase 1/2a clinical trial will evaluate CYNK-101 in combination with standard chemotherapy, trastuzumab and pembrolizumab in first-line treatment of locally advanced unresectable or metastatic HER2/neu-positive G/GEJ adenocarcinoma Patient safety and preliminary efficacy
.
On January 18, 2022, the US FDA granted CYNK-101 Fast Track designation
.
▲ CYNK-101 in combination with antibodies enhances ADCC against tumor targets (Image source: Celularity official website) Celularity founder, chairman and CEO Dr.
Robert Hariri said: "This designation highlights the huge unmet need for these patients.
demand, and the potential of CYNK-101 in new first-line therapeutic strategies
.
We are grateful to the FDA for granting Orphan Drug Designation and Fast Track designation, recognizing this potential treatment model
.
At Celularity, we are committed to creating new therapeutic strategies , harnessing the unique properties of placenta-derived cell therapy to improve the lives of patients with this difficult-to-treat cancer
.
" Andrew Pecora, Ph.
D.
, President of Celularity
, added: "Adding CD16 has significantly enhanced the ADCC of our NK cell therapy
.
We have seen promising clinical data in unmodified NK cell therapy and believe this genetically modified construct has great potential in a range of indications
.
In a Phase 1/2a clinical trial of CYNK-101, We are excited to explore a multi-pronged strategy to inhibit NK cells and activated T cells via checkpoints to potentially enhance the overall efficacy of conventional chemotherapy and trastuzumab in HER2/neu-positive G/GEJ adenocarcinoma Efficacy
.
” Five FDA Designations in One Year Over the years, Celularity has derived and generated a broad range of powerful stem and progenitor cells from the human placenta that can differentiate into virtually every cell type in the body
.
In addition, they can be used as biogenic materials for immunotherapy
.
Some unique immunobiological properties of placental organs make them nature's specialized allografts, which means that it is possible to put placental cells from any donor into any recipient without the need for matching
.
In addition, the immune properties of the placenta are highly protective against cancer and infectious diseases
.
Celularity's innovative cell therapy harnesses the unique therapeutic potential of postpartum placental cells and is primarily focused on developing established placenta-derived allogeneic cell therapies, including unmodified NK cells, genetically modified NK cells, engineered T cells (including CARs) -T cells) and mesenchymal-like adherent stromal cells (ASCs), which already have multiple cell therapy candidates in preclinical and clinical development
.
▲ Celularity's R&D pipeline (Image source: Celularity's official website) Previously, the company's unmodified NK cell therapy CYNK-001 has been granted orphan drug designation by the FDA for the treatment of malignant gliomas (malignant gliomas), and the treatment of polymorphism Fast Track Eligibility for Glioblastoma (GBM) and Acute Myeloid Leukemia (AML)
.
The orphan drug designation granted by the FDA for CYNK-101 is Celularity's fifth designation from the FDA in the past 12 months
.
Recommended reading: Placenta-derived, allogeneic, natural killer NK cell therapy received FDA orphan drug designation for the treatment of glioblastomaYimai Meng broke the news that "spot-type" placenta-derived NK cell therapy received FDA Fast Track qualification, Combining Antibodies to Enhance EfficacyYimai Meng broke through the limitations of efficacy, and the placenta-derived "spot" NK cell therapy was designated by the FDA's fast trackYimai revealed that NK cell therapy received FDA fast track certification again for the treatment of adults with recurrent polymorphism GlioblastomaYimai Meng revealed that NK cells are an important immune cell in the human body and participate in physiological processes such as anti-tumor, anti-viral infection and immune regulation
.
Different from T cells and B cells, NK cells are part of the natural immune system and can kill tumor cells quickly and directly without recognizing tumor-specific antigens, and have stronger cytotoxicity
.
The placenta is one of the important sources of NK cells, and the NK cells derived from the placenta are more primitive, more pure, more capable of expressing interferon, have stronger bone marrow homing function, and have lower immunogenicity
.
Therefore, placenta-derived NK cells are more active and have more advantages in clinical application
.
With the further development of research, placenta-derived NK cell immunotherapy is expected to become a novel and effective treatment for cancer patients who currently have no more treatment options
.
Reference: 1.
https:// -development-for-the-first-line-treatment-of-advanced-her2-neu-positive-gastric-and-gastroesophageal-junction-cancers/2.
https://celularity.
com/3.
WuXi AppTec Express | FDA grants fast track designation for "ready-to-use" placenta-derived NK cell therapy for the treatment of leukemia"
S.
Food and Drug Administration (FDA) has granted its placental hematopoietic stem cell-derived natural killer (NK) Orphan drug designation for cell therapy CYNK-101 for the treatment of gastric or gastroesophageal junction (G/GEJ) cancers
.
Gastric cancer is the fifth most common cancer worldwide
.
Despite recent improvements in treatment quality and options, advanced gastric cancer remains one of the most difficult to treat cancers, with a median overall survival (OS) of 10-12 months and a five-year OS of approximately 5%-20 %
.
In May 2021, the U.
S.
FDA granted accelerated approval to pembrolizumab in combination with trastuzumab, fluoropyrimidine-containing and platinum-containing chemotherapy for locally advanced unresectable or metastatic HER2-positive G/GEJ cancer first-line treatment of patients
.
CYNK-101 is an experimental genetically engineered NK cell therapy designed to enhance antibody-dependent cell-mediated cytotoxicity (ADCC) through an approved novel antibody therapy
.
In November 2021, the drug's clinical trial (IND) application was approved by the US FDA
.
Ongoing Phase 1/2a clinical trial will evaluate CYNK-101 in combination with standard chemotherapy, trastuzumab and pembrolizumab in first-line treatment of locally advanced unresectable or metastatic HER2/neu-positive G/GEJ adenocarcinoma Patient safety and preliminary efficacy
.
On January 18, 2022, the US FDA granted CYNK-101 Fast Track designation
.
▲ CYNK-101 in combination with antibodies enhances ADCC against tumor targets (Image source: Celularity official website) Celularity founder, chairman and CEO Dr.
Robert Hariri said: "This designation highlights the huge unmet need for these patients.
demand, and the potential of CYNK-101 in new first-line therapeutic strategies
.
We are grateful to the FDA for granting Orphan Drug Designation and Fast Track designation, recognizing this potential treatment model
.
At Celularity, we are committed to creating new therapeutic strategies , harnessing the unique properties of placenta-derived cell therapy to improve the lives of patients with this difficult-to-treat cancer
.
" Andrew Pecora, Ph.
D.
, President of Celularity
, added: "Adding CD16 has significantly enhanced the ADCC of our NK cell therapy
.
We have seen promising clinical data in unmodified NK cell therapy and believe this genetically modified construct has great potential in a range of indications
.
In a Phase 1/2a clinical trial of CYNK-101, We are excited to explore a multi-pronged strategy to inhibit NK cells and activated T cells via checkpoints to potentially enhance the overall efficacy of conventional chemotherapy and trastuzumab in HER2/neu-positive G/GEJ adenocarcinoma Efficacy
.
” Five FDA Designations in One Year Over the years, Celularity has derived and generated a broad range of powerful stem and progenitor cells from the human placenta that can differentiate into virtually every cell type in the body
.
In addition, they can be used as biogenic materials for immunotherapy
.
Some unique immunobiological properties of placental organs make them nature's specialized allografts, which means that it is possible to put placental cells from any donor into any recipient without the need for matching
.
In addition, the immune properties of the placenta are highly protective against cancer and infectious diseases
.
Celularity's innovative cell therapy harnesses the unique therapeutic potential of postpartum placental cells and is primarily focused on developing established placenta-derived allogeneic cell therapies, including unmodified NK cells, genetically modified NK cells, engineered T cells (including CARs) -T cells) and mesenchymal-like adherent stromal cells (ASCs), which already have multiple cell therapy candidates in preclinical and clinical development
.
▲ Celularity's R&D pipeline (Image source: Celularity's official website) Previously, the company's unmodified NK cell therapy CYNK-001 has been granted orphan drug designation by the FDA for the treatment of malignant gliomas (malignant gliomas), and the treatment of polymorphism Fast Track Eligibility for Glioblastoma (GBM) and Acute Myeloid Leukemia (AML)
.
The orphan drug designation granted by the FDA for CYNK-101 is Celularity's fifth designation from the FDA in the past 12 months
.
Recommended reading: Placenta-derived, allogeneic, natural killer NK cell therapy received FDA orphan drug designation for the treatment of glioblastomaYimai Meng broke the news that "spot-type" placenta-derived NK cell therapy received FDA Fast Track qualification, Combining Antibodies to Enhance EfficacyYimai Meng broke through the limitations of efficacy, and the placenta-derived "spot" NK cell therapy was designated by the FDA's fast trackYimai revealed that NK cell therapy received FDA fast track certification again for the treatment of adults with recurrent polymorphism GlioblastomaYimai Meng revealed that NK cells are an important immune cell in the human body and participate in physiological processes such as anti-tumor, anti-viral infection and immune regulation
.
Different from T cells and B cells, NK cells are part of the natural immune system and can kill tumor cells quickly and directly without recognizing tumor-specific antigens, and have stronger cytotoxicity
.
The placenta is one of the important sources of NK cells, and the NK cells derived from the placenta are more primitive, more pure, more capable of expressing interferon, have stronger bone marrow homing function, and have lower immunogenicity
.
Therefore, placenta-derived NK cells are more active and have more advantages in clinical application
.
With the further development of research, placenta-derived NK cell immunotherapy is expected to become a novel and effective treatment for cancer patients who currently have no more treatment options
.
Reference: 1.
https:// -development-for-the-first-line-treatment-of-advanced-her2-neu-positive-gastric-and-gastroesophageal-junction-cancers/2.
https://celularity.
com/3.
WuXi AppTec Express | FDA grants fast track designation for "ready-to-use" placenta-derived NK cell therapy for the treatment of leukemia"
