Calidi Biotherapeutics (NYSE: CLDI) is a clinical‐stage biotechnology company focused on developing next‐generation immuno‐oncology therapies. Headquartered in Dallas, Texas, the company is dedicated to harnessing the body’s own immune system—particularly natural killer T (NKT) cells—to target solid tumors. Calidi’s proprietary platforms combine synthetic glycolipid agonists, monoclonal antibodies, and cell‐based therapies to stimulate antitumor immunity and reshape the tumor microenvironment.
The company’s lead programs include novel α-galactosylceramide analogs designed to selectively activate NKT cells and promote durable immune responses against hard‐to-treat cancers such as hepatocellular carcinoma and cholangiocarcinoma. In parallel, Calidi is advancing partner-sponsored antibody–glycolipid conjugates that deliver potent immune stimulants directly to the tumor site. Several candidates are in preclinical development, with initial Phase 1 trials anticipated to commence as early as next year.
Calidi maintains in‐house research and manufacturing facilities equipped for both early‐stage discovery and GMP production of complex biologics. The company collaborates with academic centers and contract research organizations across North America and Europe to accelerate its pipeline and assess combination regimens. These partnerships aim to optimize dose, safety, and efficacy profiles while exploring biomarkers of response and mechanisms of resistance.
Founded in 2012 by a team of immunologists and drug‐development experts, Calidi Biotherapeutics is led by a management team with decades of experience in oncology research, clinical development, and commercial strategy. The organization remains committed to translating innovative science into transformative therapies for patients with unmet medical needs.
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