CoRegen Receives FDA Clearance for First-in-Human Trial of CRG-150, a Novel Adoptive Cell Therapy Targeting SRC-3 in Multiple Solid Tumors
核心洞察
The FDA has cleared CoRegen's IND application for CRG-150 (搜索), a first-in-class adoptive cell therapy targeting the SRC-3 (搜索) master gene regulator in Treg cells.
The Phase 1/2a trial will enroll patients with metastatic triple-negative breast cancer (搜索), HR+ HER2− breast cancer (搜索), and metastatic prostate cancer (搜索) to assess safety and preliminary efficacy.
Preclinical studies demonstrated complete tumor eradication and durable protection against recurrence in mouse models without systemic autoimmunity.
CoRegen, Inc. (搜索) announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CRG-150 (搜索), a novel adoptive cell therapy designed to target the steroid receptor coactivator 3 (SRC-3 (搜索)) gene as a master regulator of immune checkpoint pathways. The clearance marks CoRegen's transition into a clinical-stage company and enables the initiation of a Phase 1/2a first-in-human study across multiple solid tumor types.
The IND acceptance represents a defining milestone for the Houston-based biopharmaceutical company, which has been advancing research originally conducted at Baylor College of Medicine's O'Malley Lab. "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 at 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."
Mechanism of Action: Targeting SRC-3 (搜索) to Disarm Tumor-Protective Treg Cells
CRG-150 (搜索) is built upon the discovery that SRC-3 (搜索) is a key gene enabling cancer cell immune evasion. Overexpressed in most human cancers, SRC-3 plays a critical role in maintaining the tumor-protective function of regulatory T cells (Treg cells). Under normal physiological conditions, Treg cells maintain immune system balance by suppressing excessive immune responses and preventing autoimmune diseases. However, tumors can co-opt these Treg cells to evade immune attack, facilitating tumor progression and metastatic disease.
By inhibiting SRC-3 (搜索), CRG-150 (搜索) disrupts this protective mechanism, restoring the immune system's ability to recognize and eliminate cancer cells. The therapy has been shown to impact multiple immune checkpoint targets, including PD-1 (搜索), PD-L1 (搜索), CTLA-4 (搜索), LAG3 (搜索), and CCR4 (搜索), functioning as a master gene regulator rather than targeting a single checkpoint pathway.
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—a finding that suggests a potentially favorable safety profile.
Phase 1/2a Trial Design and Patient Populations
The first-in-human Phase 1/2a study will enroll patients diagnosed with three distinct cancer populations: metastatic triple-negative breast cancer (搜索), metastatic HR+ HER2− breast cancer (搜索), and metastatic prostate cancer (搜索). The trial will assess safety, tolerability, cellular kinetics, and antitumor activity of CRG-150 (搜索), while also helping to determine optimal dosing.
Sonal Gupta, MD, PhD, Chief Medical Officer at CoRegen, emphasized the significance of the clinical sites involved: "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."
Dr. Gupta further noted the broader potential of the platform: "While CRG-150 (搜索) 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."
Manufacturing Partnership and Future Expansion
To support its first-in-human clinical study, CoRegen has partnered with Lonza, one of the world's largest and most established contract development and manufacturing organizations (CDMOs). Through this partnership, CoRegen gains access to cell therapy development and manufacturing expertise, established quality systems, and proven regulatory capabilities.
CoRegen remains on track to initiate its Phase 1 trial this year and has outlined plans to expand into additional indications in the future, including glioblastoma and pancreatic cancer—two tumor types with significant unmet medical need.
Scientific Foundation and Company Background
The scientific foundation for CRG-150 (搜索) rests on the pioneering research of the late Dr. Bert O'Malley, who served as the Tom Thompson Distinguished Leadership Professor of Molecular and Cellular Biology and Chancellor at Baylor College of Medicine. His work on steroid receptor coactivators provided the mechanistic insights underlying CoRegen's therapeutic approach.
CoRegen engineers Treg cells so that cancer cells can no longer evade the body's immune system, freeing the immune system to attack and eliminate cancer cells. In 2025, the company spun out Oxia Therapeutics (搜索) and sublicensed its technology for a novel small molecule therapeutic that stimulates the SRC complex for non-oncology treatments, underscoring the versatility of the SRC-targeting platform.