CoRegen

What CoRegen does

CoRegen is a clinical-stage biotechnology company developing a single adoptive cell therapy platform for solid tumor cancers, founded from research conducted at the O'Malley Lab at Baylor College of Medicine since the 1970s. The company's core technology involves knocking out a single gene among 22,000+ in regulatory T cells (Tregs), which the company describes as triggering the immune system to identify and permanently eradicate solid tumor cancer cells without toxicity, inflammation, or off-target effects. Preclinical studies in 400+ tumor-bearing mice demonstrated complete cancer eradication and prevention with no toxicity. The platform targets solid tumors including triple negative breast cancer and glioblastoma.

CoRegen's business model is currently pre-revenue and pre-commercial. The company plans to commercialize its therapy as a one-time gene therapy treatment administered via single outpatient Treg infusion at well-equipped infusion centers, contingent on FDA approval. Manufacturing is supported by a strategic partnership with Lonza Group for clinical and commercial-grade cell therapy production. The company is preparing an FDA Investigational New Drug (IND) application in spring 2026, with first-in-human clinical trials planned for fall 2026.

CoRegen is incorporated in Delaware as a privately held corporation headquartered in Houston, Texas, with 51-100 employees. As of early 2026, the company had raised approximately $121.4 million across three funding rounds, capitalizing operations through 2028. The intellectual property portfolio comprises three granted patents with additional filings in progress, and the company's research was recognized with the 2023 Cozzarelli Prize from PNAS. Leadership includes CEO Shawn Tomasello (former Kite Pharma/Pharmacyclics executive), Executive Chairman Steve Gorlin, Chairman Suneet Varma (former Pfizer Oncology President), and CSO Jonathan W. Simons. Founder Bert W. O'Malley Sr., MD, the 'Father of Molecular Endocrinology,' died in 2025; his son Bert W. O'Malley Jr., MD, joined the Board in December 2025 to provide scientific continuity.

Name

CoRegen

Legal name

CoRegen, Inc.

Website

https://coregeninc.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

51–100 employees

Short description

CoRegen is a clinical-stage biotech developing a Treg cell adoptive therapy that eradicates solid tumors via single-gene knockout, targeting cancers such as triple negative breast cancer and glioblastoma with planned outpatient infusion delivery.

Ownership category

akta.pro rank

Product category

Oncology Cell Therapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Cell Therapy Developers (Autologous) (HLAAABAA)

akta.pro secondary industries

Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL), Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies) (HLAAANAK), Genome Editing Gene Therapies (CRISPR/TALEN/ZFN; in vivo/ex vivo) (HLAAACAD)

Keywords

• Adoptive cell therapy
• Gene therapy oncology
• Tumor immunotherapy
• Regulatory T cells
• Solid tumor treatment

Headquarters

HQ city

Aspen

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Gene Therapy Treatments: Pre-revenue clinical-stage company developing adoptive cell therapy for solid tumor cancers. The company plans to commercialize its therapy following FDA approval and successful clinical trials, targeting outpatient administration through infusion centers.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

CoRegen is a clinical-stage biopharmaceutical company developing an adoptive cell therapy that engineers regulatory T cells (Tregs) by knocking out a single gene, enabling the immune system to identify and permanently eradicate solid tumor cancer cells. The therapy is administered as a single outpatient infusion with no toxicity, inflammation, or off-target effects, targeting cancers such as triple negative breast cancer and glioblastoma. The company is preparing for FDA IND filing in 2026 and first-in-human clinical trials in fall 2026.

Product overview

CoRegen is a clinical-stage biopharmaceutical company developing a single adoptive cell therapy platform based on gene regulatory technology from Baylor College of Medicine. The core product involves engineering regulatory T cells (Tregs) by knocking out one gene to trigger permanent destruction of solid tumor cancer cells. Preclinical studies on 400+ tumor-bearing mice demonstrated eradication and prevention of cancer with no toxicity or inflammation. The company is preparing for first-in-human clinical trials with an FDA IND filing planned for 2026, targeting solid tumor cancers including triple negative breast cancer and glioblastoma. Patient treatments will be administered as a single outpatient infusion at equipped infusion centers.

Differentiator

Problem solved

Functional benefit

Products and services

• CoRegen Adoptive Cell Therapy An adoptive cell therapy that engineers regulatory T cells (Tregs) by knocking out a single gene, enabling the immune system to identify and permanently eradicate solid tumor cancer cells. The therapy is delivered as a single outpatient infusion with no toxicity, inflammation, or off-target effects, targeting solid tumor cancers including triple negative breast cancer and glioblastoma. Currently in clinical-stage development with FDA IND filing planned for spring 2026.

Quantifiable outcome

• 100% cancer eradication in 400+ preclinical mouse models with no toxicity or inflammation

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Lonza GroupcoreStrategic or Co-development Partner · 10 March 2026CoRegen has entered into a manufacturing agreement with Lonza Group, the leading expert in cell manufacturing, for the production of its proprietary adoptive cell therapy. This partnership is critical for the company's preparations for clinical trials and subsequent commercial production of its cancer treatment.
• Baylor College of MedicinecoreStrategic or Co-development PartnerCoRegen was founded from Baylor College of Medicine research, specifically from the O'Malley Lab's pioneering work on steroid receptor coactivators (SRCs). The company continues to leverage cutting-edge technology and leading scientists from Baylor College of Medicine.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Iovance Biotherapeutics: Iovance is a leading cell therapy company focused on solid tumors, with an FDA-approved autologous TIL therapy (lifileucel) for advanced melanoma. Most directly comparable to CoRegen in modality (autologous cell therapy) and indication focus (solid tumors).
• Adaptimmune Therapeutics: Adaptimmune develops engineered TCR-T cell therapies for solid tumors, including synovial sarcoma and other solid tumor indications. Comparable to CoRegen as a clinical-stage solid tumor cell therapy developer targeting tumors historically resistant to standard therapies.
• Sonoma Biotherapeutics: Sonoma is pioneering engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, with extensions into oncology. Most directly comparable to CoRegen in cell type (Tregs) and gene-engineering approach.
• Caribou Biosciences: Caribou is developing allogeneic CAR-T cell therapies using CRISPR genome editing. Comparable to CoRegen as a clinical-stage cell therapy company leveraging gene-editing / gene-knockout approaches to engineer immune cells.
• Editas Medicine: Editas is a clinical-stage genome editing company developing CRISPR-based therapies including edited cell therapies. Comparable to CoRegen in gene-editing platform approach and focus on engineered immune cell therapies.
• Cellectis: Cellectis is a clinical-stage gene editing company developing allogeneic CAR-T cells using TALEN-based gene editing. Comparable to CoRegen in gene-engineering of immune cells for oncology indications.

Broad incumbents

• CRISPR Therapeutics: CRISPR Therapeutics is a clinical-stage biotech developing CRISPR/Cas9-based gene-edited cell therapies, including the first approved CRISPR-based therapy (Casgevy). Comparable to CoRegen in the use of gene knockout/editing as a therapeutic modality.
• Fate Therapeutics: Fate is a clinical-stage cell therapy company developing off-the-shelf NK and T-cell therapies using engineered cell platforms. Comparable to CoRegen as a cell therapy platform company pursuing multiple oncology indications.
• Allogene Therapeutics: Allogene is developing allogeneic CAR-T cell therapies for hematologic and solid tumor indications. Comparable to CoRegen as a clinical-stage engineered cell therapy company with overlapping oncology ambitions.
• Nkarta: Nkarta is a clinical-stage cell therapy company developing engineered NK cell therapies for cancer. Comparable to CoRegen as a cell therapy platform company pursuing solid tumor indications with engineered immune cells.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/coregen-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds3 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CoRegen