Drugs / IMGN779
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | acute myeloid leukemia and myelodysplastic syndromes related to alkylating agent | 2015-10-27 | “submitted an IND for IMGN779, the first ADC to utilize one of our new DNA-acting cancer-killing agents.” abbvie.com ↗ “submitting the IND for our fourth wholly owned program, IMGN779, to the FDA on schedule.” abbvie.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02674763 | Mar 2016 → Jun 2019 | acute myeloid leukemia | ImmunoGen, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2018-12-01 | AbbVie | Results ImmunoGen Presents New Data Highlighting Potential of Novel ADCs in Oral Presentations at ASH Annual Meeting abbvie.com ↗
Maturing Data for CD33-Targeting IMGN779 Reflect Consistent Activity and Tolerability Profile in AML; Dose Exploration Continues |
| 2017-12-09 | AbbVie | Results ImmunoGen Presents New Clinical and Preclinical Data at ASH Annual Meeting abbvie.com ↗
The Phase 1 data presented at ASH demonstrate that IMGN779 was well-tolerated with no dose-limiting toxicities (DLTs) observed in patients with relapsed or refractory AML across nine dose levels administered once every two weeks (Q2W) and one dose level administered once a week (QW). |
| 2017-06-26 | AbbVie | Results ImmunoGen Presents Data from Phase I Study of IMGN779 in Acute Myeloid Leukemia abbvie.com ↗
The first-in-human data demonstrate the safety and tolerability of IMGN779 across seven dose levels, with no dose limiting toxicities (DLTs), as well as evidence of dose-dependent biological and anti-leukemia activity. |
| 2016-12-05 | AbbVie | Results Preclinical Data on IMGN632, a Novel CD123-Targeting ADC, Presented at ASH Annual Meeting abbvie.com ↗
The data demonstrated enhanced activity in several AML models including patient derived tumor cells and a disseminated AML xenograft model. |
| 2016-11-03 | AbbVie | Results ImmunoGen Announces Preclinical Data Presentations for Two ADCs With Novel IGN Payloads at Upcoming 58th ASH Annual Meeting abbvie.com ↗ |
| 2014-06-16 | AbbVie | Results ImmunoGen, Inc. Announces Preclinical Findings for IMGN779, a Potential Treatment for Acute Myeloid Leukemia abbvie.com ↗
ImmunoGen, Inc. (NASDAQ: IMGN), a biotechnology company that develops novel anticancer therapeutics using its antibody-drug conjugate (ADC) technology, disclosed for the first time preclinical data for IMGN779. |
All press releases naming this drug 7 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 | IMGN779 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02674763 ↗ |
| Route | Intravenous | “IMGN779 Administered Intravenously” NCT02674763 ↗ |