drugset
Drugs / CYNK-101
last change Feb 2024 re-read 9 days ago

CYNK-101

Cell therapy

Developed for
gastroesophageal junction adenocarcinoma
Investigated by
Celularity Incorporated

Trials 1

today NCT05207722 · Ph 1/2
2023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT05207722 Apr 2022 → Feb 2024 gastroesophageal junction adenocarcinoma Celularity Incorporated Terminated No outcome recorded Stop: Business

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2022-11-10 Celularity Incorporated Results Celularity Presents Preclinical Data on CYNK-101, its Allogeneic Genetically-Modified Natural Killer Cell Therapy Candidate, at the Society for Immunotherapy of Cancer’s 37th Annual Meeting celularity.com ↗
2022-02-15 Celularity Incorporated Regulatory Celularity Receives Orphan Drug Designation from U.S. FDA for its NK Cell Therapy CYNK-101 in Development for the First-Line Treatment of Advanced HER2/neu Positive Gastric and Gastroesophageal Junction Cancers celularity.com ↗
Celularity Inc. (Nasdaq: CELU) (Celularity), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational natural killer (NK) cell therapy, CYNK-101, for treatment of gastric/gastroesophageal junction cancer.
2022-01-18 Celularity Incorporated Regulatory Celularity Receives Fast Track Designation from U.S. FDA for its NK Cell Therapy CYNK-101 in Development for the First-Line Treatment of Advanced HER2/neu Positive Gastric and Gastroesophageal Junction Cancers celularity.com ↗
2021-12-13 Celularity Incorporated Results Celularity Presents Preclinical Data on Allogeneic Genetically Modified Natural Killer (NK) and Allogeneic CAR-NK Cell Therapy Programs at the 63rd American Society of Hematology Meeting and Exposition celularity.com ↗
2021-11-29 Celularity Incorporated Regulatory Celularity Announces FDA Clearance of Investigational New Drug Application (IND) for Natural Killer Cell Therapy CYNK-101 in First-line Advanced Her2/neu Positive Gastric and Gastroesophageal Junction Cancer celularity.com ↗
2021-11-15 Celularity Incorporated Results Celularity Presents Preclinical Data on Allogeneic Genetically-Modified Natural Killer Cells at the Society for Immunotherapy of Cancer 36th Annual Meeting celularity.com ↗
The results demonstrate the synergistic effect of combining CYNK-101 with Cetuximab to drive antibody dependent cellular cytotoxicity activity against EGFR + tumors.

All press releases naming this drug 7 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as CYNK-101 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05207722 ↗
Modality Cell therapy “NK cell product” NCT05207722 ↗