Advancing a Pipeline of
Next-Generation Therapies
Our robust pipeline targets aggressive cancers with Treg cell engineering and molecular regulators. Using our master gene regulator platform, we are pioneering regenerative healing and advancing precision medicine worldwide.
Triple Negative Breast Cancer
U.S. 44K new cases per year
HR+/HER2- Breast Cancer
U.S. 225K new cases per year
Prostate Cancer
U.S. 288K new cases per year
Pancreatic Cancer
U.S. 64K new cases per year
Colorectal Cancer
U.S. 153K new cases per year
Glioblastoma
U.S. 14K new cases per year
Non-Small Cell Lung Cancer
U.S. 226K new cases per year
Strong Patent Portfolio
No prior art discovered on central SRC-3KO Treg cancer patent: covers all cancers and any method of editing the SRC-3 gene in Treg cells
Treg Cell Engineering
Patent
The manufacturing of SRC-3 gene disrupted human Treg cells by any gene engineering technology for the treatment of any cancer type. This includes the process in which a patient’s own Treg cells are removed from the blood, modified, and given back to the patient.
SRC Molecule Inhibitor Patent
SRC molecule inhibitor blocks the transcriptional activity of SRCs and promotes SRC degradation in cancer cells. The inhibitor has a dual effect: 1. Blocking cancer cell growth directly. 2. Blocking Treg cell mediated suppression of effector immune cells, promoting an elevated immune response.
FDA Regulatory Pathway for Human Clinical Trials
We anticipate initiating human clinical trials in Q3 2025.
We meet all of the FDA criteria for Fast-Track designation which could expedite the approval process. Three of the indications we are targeting qualify for orphan drug status which would grant 7-year regulatory exclusivity in the U.S. as well as eligibility for a Priority Review Voucher.
FDA Regulatory Pathway for
Human Clinical Trials
We anticipate initiating human clinical trials in 2H 2026.
CoRegen meets the FDA criteria for Fast-Track designation which could expedite the approval process. Lead autologous program (CRG-150) complemented by scalable in vivo and allogeneic Treg pipeline.
Product
Indication
Discovery
Pre-Clinical
Studies
IND-enabling
Studies
Phase 1
Clinical Trial
CRG-150 Adoptive Cell Therapy
Solid Cancers
SRC-3KO Treg in vivo approach
SRC-3KO Treg Allogeneic approach