Drugs / FT500
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | — | “Within the last thirty days, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration ( FDA ) for FT500” fatetherapeutics.com ↗ “In July, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration ( FDA ) for FT500” fatetherapeutics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03841110 | Feb 2019 → Nov 2022 | HER2 positive breast carcinoma, cervical cancer, colorectal cancer, cutaneous neuroendocrine carcinoma +11 | Fate Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2019-12-07 | Fate Therapeutics | Results Fate Therapeutics Announces Clinical Data from Landmark Phase 1 Studies of First-ever Universal, Off-the-shelf, iPSC-derived NK Cell Cancer Immunotherapy Programs fatetherapeutics.com ↗ |
| 2019-08-06 | Fate Therapeutics | Results Fate Therapeutics Reports Second Quarter 2019 Financial Results and Highlights Operational Progress fatetherapeutics.com ↗
The early safety and tolerability signals observed in patients receiving multiple doses of FT500, the first iPSC-derived cell therapy to undergo clinical investigation in the United States , are very encouraging. |
| 2019-05-07 | Fate Therapeutics | Results Fate Therapeutics Reports First Quarter 2019 Financial Results and Highlights Operational Progress fatetherapeutics.com ↗
No Dose-Limiting Toxicities or Serious Adverse Events Reported in Initial Cohort of FT500 iPSC-derived NK Cell Cancer Immunotherapy Patients |
| 2019-04-02 | Fate Therapeutics | Results Fate Therapeutics Announces First Patient Treated with iPSC-derived NK Cell Cancer Immunotherapy FT500 Successfully Completes Initial Safety Assessment fatetherapeutics.com ↗
The patient received three once weekly doses of FT500, and the treatment cycle was well-tolerated with no dose-limiting toxicities or serious adverse events reported during the initial 28-day observation period. |
| 2018-12-04 | Fate Therapeutics | Results Fate Therapeutics Presents Off-the-Shelf CAR T and NK Cell Cancer Immunotherapy Pipeline at ASH Annual Meeting fatetherapeutics.com ↗
An oral presentation at ASH by Dr. Miller showed that FT500 synergizes with T cells and anti-PD1 antibody to produce pro-inflammatory cytokines and completely clear target cancer cells in an in vitro three-dimensional tumor spheroid model. |
| 2018-11-30 | Fate Therapeutics | Regulatory Fate Therapeutics Announces FDA Clearance of Landmark IND for FT500 iPSC-derived, Off-the-Shelf NK Cell Cancer Immunotherapy fatetherapeutics.com ↗ |
| 2018-11-11 | Fate Therapeutics | Regulatory Fate Therapeutics Announces Encouraging Dose-Escalation Clinical Data of FATE-NK100 and Provides Regulatory Update on Landmark IND Application for FT500 fatetherapeutics.com ↗
Submitted Data to FDA Demonstrating FT500 Master iPSC Bank is Free of Adventitious Agents |
| 2018-11-01 | Fate Therapeutics | Results Fate Therapeutics Announces Seven Presentations at the 2018 ASH Annual Meeting fatetherapeutics.com ↗
Using an in vitro three-dimensional tumor spheroid model, the Company demonstrated that FT500, in combination with activated T cells and an anti-PD1 antibody, led to near complete elimination of target cells (>99% reduction) as compared to FT500 or activated T cells alone. |
| 2018-08-06 | Fate Therapeutics | Regulatory Fate Therapeutics Reports Second Quarter 2018 Financial Results and Highlights Operational Progress fatetherapeutics.com ↗ |
All press releases naming this drug 10 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FT500 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03841110 ↗ |
| Modality | Cell therapy | “FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy” NCT03841110 ↗ |