HOUSTON, July 7, 2026
CoRegen, Inc. has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance to initiate a Phase 1/2a clinical trial evaluating CRG-150, the company’s novel adoptive cell therapy designed to treat multiple solid tumor cancers. The FDA authorization marks a significant milestone for the clinical-stage biopharmaceutical company, enabling the first-in-human study of CRG-150 in patients with metastatic triple-negative breast cancer (TNBC), HR-positive/HER2-negative breast cancer, and metastatic prostate cancer. The investigational therapy introduces an innovative immunotherapy approach by targeting the SRC-3 gene, a master regulator involved in cancer immune evasion, with the goal of restoring the immune system’s ability to identify and destroy aggressive tumors. The milestone positions CoRegen at the forefront of next-generation cell therapy development for difficult-to-treat cancers while advancing a promising new strategy in precision oncology.
FDA Clears First-in-Human Phase 1/2a Clinical Study
The FDA IND clearance authorizes CoRegen to begin a Phase 1/2a clinical trial focused on evaluating the safety, tolerability, cellular kinetics, and preliminary antitumor activity of CRG-150 across three advanced solid tumor indications. The study will enroll patients with metastatic triple-negative breast cancer, HR-positive/HER2-negative breast cancer, and metastatic prostate cancer, providing critical clinical data to determine the optimal therapeutic dose while assessing the investigational therapy’s potential to stimulate durable immune responses against cancer. The trial represents CoRegen’s transition into a clinical-stage biotechnology company and establishes an important foundation for future expansion into additional oncology indications, including glioblastoma and pancreatic cancer. Company leadership emphasized that the clinical program builds upon years of translational research and reflects the growing momentum behind innovative immune-based cancer therapies.
CRG-150 Targets SRC-3 to Overcome Cancer Immune Evasion
Unlike conventional cancer immunotherapies, CRG-150 is designed to inhibit the SRC-3 (Steroid Receptor Coactivator-3) gene within Regulatory T (Treg) cells, which tumors often exploit to suppress immune responses. By genetically modifying these immune cells, CRG-150 aims to disrupt the protective tumor microenvironment, allowing the body’s natural immune system to recognize, attack, and eliminate cancer cells more effectively. Preclinical studies demonstrated complete tumor eradication in several difficult-to-treat solid tumor models while providing durable protection against tumor recurrence without evidence of systemic autoimmunity. The innovative mechanism has generated considerable scientific interest because it addresses one of the major biological barriers limiting successful cancer immunotherapy and could potentially benefit multiple solid tumor types characterized by immune suppression. The technology originated from pioneering research conducted at Baylor College of Medicine, providing a strong scientific foundation for the clinical development program.
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Strategic Manufacturing Partnership Supports Clinical Development
To support the upcoming clinical program, CoRegen has partnered with Lonza, one of the world’s leading contract development and manufacturing organizations (CDMOs) specializing in advanced cell therapies. The collaboration provides access to world-class manufacturing expertise, established quality systems, and regulatory capabilities necessary to ensure efficient production of CRG-150 for the first-in-human study. As demand for personalized cancer immunotherapies continues to grow, robust manufacturing infrastructure remains essential for successful clinical translation and future commercialization. With FDA clearance now secured and manufacturing preparations in place, CoRegen is positioned to initiate patient enrollment later this year while advancing its broader vision of developing transformative adoptive cell therapies capable of addressing multiple aggressive solid tumors with high unmet medical need.
Source: CoRegen press release
