14-day Process. No preconditioning therapy necessary.
Day 1
A whole blood sample is drawn. Treg cells are separated and the red cells are returned to the patient's blood stream preventing anemia.
Day 2 -13
Treg cells are sent for processing where gene editing technology is used to delete the SRC-3 gene.
Day 14
The patient's engineered
Treg cells are transfused back through their vein. Since the patient's own cells are used, there is no immune system rejection.
Day 14+
Engineered Treg cells hone into the cancer and allow the immune system to recognize, attack, and kill cancer cells.
Mechanism of SRC-3KO Treg cell mediated tumor eradication
Award-winning science behind our latest discoveries.
CoRegen’s science won the prestigious 2023 Cozzarelli Prize awarded by the Proceedings of the National Academy of Sciences (PNAS) for “Outstanding Scientific Quality and Originality. ” Recognized as the top paper among 2,500 reviewed by the world's leading scientists is a powerful validation of our work.
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Groundbreaking. Disruptive. Scalable. Accessible.
In the future, it will be hard to imagine that we once fought cancer with scalpels, radiation, and toxic drugs. This will be recorded in the history of medicine as the moment CoRegen changed the course of healthcare forever.
The problem
The immune system cannot attack cancer if it is unable to see and engage with it.
Cancer cells multiply when immune effector cells (B, T, NK cells) become incapacitated within the tumor tissue.
Evade
Treg cells block other immune cells from attacking cancer cells.
The Solution
Our novel therapy harnesses the power of SRC-3 engineered Treg cells to enable the patient’s own immune system to recognize, attack, and kill cancer.
We have identified the one cell (Treg) out of 200 and the gene in Treg cells out of over 22,000 that when disabled, results in fundamental changes in the immune system's ability to fight a broad range of cancers. This unique approach not only kills solid tumors, but evidence suggests these SRC-3 engineered Treg cells may provide ongoing protection.
Attack
SRC-3KO Treg cells attack cancer cells and permit other immune cells to also attack.
Currently approved immune checkpoint modulator biologics only inhibit a single target at a time.
Our approach impacts multiple immune checkpoint target genes, leading to a superior anti-tumor effect when compared to existing single-target immune checkpoint biologic drugs. This shows that we are a master regulator of genes.
WE ARE A MASTER REGULATOR OF OVER 1,000 GENES.
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Impressive Efficacy
Compelling preclinical results in mouse models.
Currently approved immune checkpoint modulator biologics only inhibit a single target at a time.
Our approach impacts multiple immune checkpoint target genes expressed by Treg cells, leading to a superior anti-tumor effect when compared to existing single-target immune checkpoint biologic drugs. We show that by targeting the function of the SRC-3 master regulator in Treg cells that these cells will no longer protect tumors from other types of immune cells including CD4+, CD8+ and NK cells.
WE ARE A MASTER REGULATOR OF OVER 1,000 GENES.
Product
Company
2023A Sales
($B)
2030E Sales
($B)
PD-1
PD-LI
IL-23
CTLA-4
LAG
CCR4
TIGIT
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$25.0
$30.3
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$5.3
$14.5
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$4.3
$7.0
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$4.2
$7.0
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$7.8
$16.9
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$3.1
$6.2
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$1.4
$2.5
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$0.6
$2.2
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$0.2
$0.3
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Impressive Efficacy
Compelling preclinical results in mouse models.
Engineered Tregs eradicate triple-negative breast cancer in mice
Engineered Tregs stop prostate cancer in mice
Glioblastoma does not develop with engineered Tregs in mice
Pancreatic cancer does not develop with engineered Tregs in mice
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The Patient Experience
Patient treatments will be done in an outpatient setting.
Phlebotomy (blood draw) and leukapheresis (separating and collecting white blood cells) can be accomplished in many blood banks. Treg cell infusion can be administered in any well-equipped infusion center with only a single therapy treatment.
Hospitalization is not anticipated. Since there is no cytokine release and no toxicity like with CAR-T and chemotherapy; based on preclinical observations, we anticipate a very well-tolerated patient response to our therapy.
The engineered Treg cells are administered without depletion of existing immune cells (preconditioning). This maintains the
normal integrity of the immune system.
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The Benefits
T memory cell population is increased in animals treated with engineered SRC-3 KO Treg cells
Smaller number of engineered SRC-3 KO Treg cellsdominate over existing normal Treg cells within tumor tissue
SRC-3 KO Treg cells attract CD8+, CD4+ and NK tumor killing effector cells into tumors
We are also pursuing next generation gene engineering technologies to replace adoptive cell transfer based therapies.
This adaptable platform opens unprecedented possibilities for precision medicine and genetic therapies.
The Current Solution - Complexity and Cost of Adoptive Cell Transfer
Genetically altering cells to treat disease often requires adoptive cell transfer, a process that is proven to be effective but can be complex and resource-intensive.
Our Approach - A ‘Therapy in a Bottle’
We are developing an injectable biologic capable of genetic engineering directly in the body, eliminating the need for external cell manipulation. This innovation enables treatment anywhere IV access is available, making advanced therapies more accessible.
Disruptive Technology with Far-Reaching Potential
This approach has the potential to replace most adoptive cell therapies, offering a simpler, more scalable alternative for genetic treatments.
Expanding the Possibilities of Gene Engineering
Our technology leverages an in vivo, cell- and tissue-directed Cas9 fusion protein, which can be paired with:
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Any cell-targeting antibody to reach specific cell types
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Any sgRNA to edit any of the ~20,000 human genes