Grant Award Details

AB-205-001 Phase 1b Trial and Related Activities to Support Clinical Development of AB-205
Grant Number: 
CLIN2-11371
Investigator: 
Type: 
PI
Disease Focus: 
Blood Cancer
Cancer
Human Stem Cell Use: 
Adult Stem Cell
Award Value: 
$6,192,579
Status: 
Active

Grant Application Details

Application Title: 
  • AB-205-001 Phase 1b Trial and Related Activities to Support Clinical Development of AB-205
Public Abstract: 

Therapeutic Candidate or Device

AB-205 consists of genetically engineered CD31+ cells derived from Human Umbilical Vein tissue.

Indication

To ameliorate or accelerate recovery from toxicities related to high-dose chemo followed by HDT-ASCT for the treatment of lymphoma and other cancers.

Therapeutic Mechanism

E-CEL UVEC cells (the active ingredient in AB-205) work both via the secretion of angiocrine factors and via direct cell contact signaling with in vivo resident stem and progenitor cells, as well as capillary endothelial cells that comprise the vascular niche which are distributed throughout the body. Infused E-CEL UVEC cells interact with injured or damaged vascular niche cells, aiding in their recovery, which subsequently leads to improved tissue regeneration following chemo/radiation regimes.

Unmet Medical Need

There are currently only a few moderately effective treatments available to reduce the toxic side effects associated with aggressive cancer treatments – hence a high unmet medical need. New approaches are urgently needed to both improve quality of life and reduce the risks of high dose therapy.

Project Objective

Phase 1 trial completed

Major Proposed Activities

  • Production of AB-205 cell product.
  • Initiation of patient recruitment
  • Completion of Phase 1 trial and submission of Final Study Report to FDA
Statement of Benefit to California: 

Lymphoma is the most common blood cancer accounting for about 4% of all cancers and the 6th most commonly diagnosed cancer among men and women in CA. In 2018, it is estimated that there will be over 9,000 new cases with over 2100 deaths. Despite advances, relapsed and refractory disease represents a major treatment challenge. Approaches to reduce the complications associated with the treatment can be beneficial to not only improving quality of life but also improving long term health outcomes.