CoRegen, Inc. Receives FDA Clearance to Advance CRG-150 into Phase 1/2a Clinical Trials, Pioneering a New Frontier in Cell Therapy for Multiple Solid Tumor Types

Phase 1/2a Clinical Trial to Evaluate Safety and Preliminary Efficacy of CRG-150 in Metastatic Triple-Negative Breast Cancer, HR+ HER2− Breast Cancer, and Prostate Cancer at Leading Academic Medical Centers

HOUSTON, July 07, 2026 (GLOBE NEWSWIRE) -- CoRegen, Inc., a biopharmaceutical company pursuing novel treatments for patients living with some of the most aggressive forms of cancer, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CRG-150, a novel, adoptive cell therapy that has been shown to impact multiple immune checkpoint targets, including PD-1, PD-L1, CTLA-4, LAG3, and CCR4, as a master gene regulator.

The IND clearance enables CoRegen to initiate a Phase 1/2a study that will evaluate CRG-150’s safety and help determine optimal dosing. The Phase 1/2a first-in-human study will enroll patients diagnosed with metastatic triple negative breast cancer, metastatic HR+ HER2− breast cancer and metastatic prostate cancer populations, to assess safety, tolerability, cellular kinetics, and antitumor activity of CRG-150. For patients, this study represents an important first-ever step in evaluating a new immune-based approach designed to harness the body’s own defenses against some of the most difficult-to-treat cancers.

CRG-150 is being developed based on the discovery that steroid receptor coactivator 3 (SRC-3) is a key gene that enables cancer cell immune evasion. By targeting SRC-3, which is overexpressed in most human cancers, CRG-150 disrupts the tumor-protective function of regulatory T cells (Treg cells), restoring the immune system’s ability to recognize and eliminate cancer. In preclinical studies, this approach led to complete tumor eradication in a range of mouse models of hard-to-treat solid cancers and provided durable protection against recurrence, without evidence of systemic autoimmunity.

“Acceptance of our IND application is a defining milestone, transitioning CoRegen into a clinical-stage company, and one made possible by the extraordinary dedication of our team,” said Suneet Varma, Chairman of the Board, CoRegen. “Their sheer rigor and scientific depth have brought us to this moment - the initiation of our first-in-human clinical studies - advancing an approach we believe could fundamentally change the practice of medicine for patients with cancer.”

Sonal Gupta, MD, Ph.D., Chief Medical Officer, added, “Moving into the clinic is a pivotal step, and we are doing so alongside globally renowned major academic cancer centers that will serve as sites for our Phase 1 study. Grounded in the vast volumes of preclinical work our team has conducted at Baylor College of Medicine, we are optimistic about what lies ahead. While CRG-150 will initially be evaluated in patients with three selected tumor types, we believe the potential of this product and our broader pipeline could address critical needs across numerous cancers.”

CoRegen remains on track to initiate its Phase 1 trial this year and plans to expand into additional indications in the future, including glioblastoma and pancreatic cancer.

CoRegen has partnered with Lonza, one of the world’s largest and most established contract development and manufacturing organizations (CDMOs), to support manufacturing for its first-in-human clinical study. Through this partnership, CoRegen gains access to world-class cell therapy development and manufacturing expertise, established quality systems, and proven regulatory capabilities, streamlining clinical execution and strengthening CoRegen's path into the clinic.

About CoRegen
CoRegen is pioneering a novel approach to cancer treatment by inhibiting the SRC-3 gene in Regulatory T (Treg) cells, a type of adoptive cell therapy (ACT), enabling the immune system to recognize and eliminate solid tumors. Research from the O’Malley Lab at Baylor College of Medicine has shown that genetically modified Treg cells alter their behavior, allowing them to penetrate tumors, release cytokines, and recruit immune cells to eradicate tumors in preclinical models. In 2025, CoRegen, as a leader in SRC targeting, spun out Oxia Therapeutics and sublicensed the technology for a novel small molecule therapeutic which stimulates the SRC complex for non-oncology treatments.

About Baylor College of Medicine
Baylor College of Medicine is a health sciences university that creates knowledge and applies science and discoveries to further education, healthcare, and community service locally and globally. The late Dr. Bert O’Malley served as the Tom Thompson Distinguished Leadership Professor of Molecular and Cellular Biology and Chancellor at Baylor College of Medicine. His pioneering research in steroid receptor coactivators laid the scientific foundation for CRG-150.

About Adoptive Cell Therapy (ACT)
Adoptive Cell Therapy (ACT) is a form of immunotherapy in which a patient's own immune cells (or those from a donor) are collected, modified or expanded outside the body, and then infused back into the patient to help the immune system fight diseases, such as cancer.

About Regulatory T (Treg) Cells
Regulatory T (Treg) cells are a specialized subset of T cells, which are part of the immune system. Their primary role is to maintain immune system balance by suppressing excessive immune responses and preventing autoimmune diseases, where the immune system attacks the body’s own tissues. However, these Treg cells can also be co-opted by cancers to evade attack by the immune system, leading to tumor progression and metastatic disease. CoRegen engineers Treg cells so the cancer cells can no longer evade the body’s immune system, freeing the immune system to attack and eliminate the cancer cells.

Media Contact:
Andrew Mielach
LifeSci Communications
amielach@lifescicomms.com

CoRegen Investor Relations Contact:
ir@coregen.com

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