CGMP MANUFACTURING OF LMB-2 IMMUNOTOXIN

NIH RePORTER · NIH · N01 · $98,477 · view on reporter.nih.gov ↗

Abstract

The Human Cancer Models Initiative is an international consortium generating novel, next-generation, tumor-derived models annotated with genomic and clinical data. The models and related data are available as a community resource. The NCI contributes to the initiative by supporting Cancer Model Development Centers (CMDCs), characterizing the models, the parent tumor and normal, collecting clinical data at time of enrollment and some outcome data. Recently we were contacted by a few laboratories which developed NGCMs from rare or underrepresented tumor subtypes. These laboratories could be the same as the currently established CMDCs under Task Order 08 or could be new sites based on direct collaborations with NCI. The models are confirmed to come from cancer based on limited targeted sequencing and/or pathology, e.g. IHC and the developers proposed that they would contribute them for distribution (regulatory materials are in place to the community). These models require the same molecular characterization as was established for those developed by the Cancer Model Development Centers. It is expected that the Genomic Characterization Centers (GCCs) will receive required regulatory documents from the Clinical Data Center (CDC) prior to shipment of samples.

Key facts

NIH application ID
10291506
Project number
75N91019D00024-0-759102000028-1
Recipient
LEIDOS BIOMEDICAL RESEARCH, INC.
Principal Investigator
ETHAN DMITROVSKY
Activity code
N01
Funding institute
NIH
Fiscal year
2020
Award amount
$98,477
Award type
Project period
2020-09-25 → 2025-09-24