NEW YORK – Phosplatin Therapeutics said on Monday that it has partnered with the National Cancer Institute to study PT-112 as a treatment for thymoma and thymic carcinoma patients, and to explore patients' molecular profiles as they correlate with PT-112 response.
For its part of the cooperative research and development agreement, Phosplatin will provide the NCI with a supply of PT-112 and support correlative research studies. NCI, meanwhile, will conduct a Phase II trial enrolling roughly 49 patients with recurrent thymic epithelial tumors (TETs), including thymoma and thymic carcinomas.
The correlative studies are intended to shed light on patients' molecular profiles as well as parameters of immune activation and patients' immune cell infiltration following PT-112.
News of the collaboration comes shortly after the US Food and Drug Administration cleared an investigational new drug application, allowing PT-112 to enter Phase II studies. Previously, a Phase I study showed PT-112 led to durable clinical response in a patient with advanced metastatic thymoma.
The agent has received orphan drug designation from the FDA as a treatment for TETs, which have no FDA-approved options. The drug is designed to promote immunogenic cell death by releasing damage-associated molecular patterns, which bind to dendritic cells, in turn recruiting immune effector cells to the patient's tumor microenvironment. The agent's properties make it a particularly encouraging option for cancers that either originate in or metastasize to the bone.
New York City-based Phosplatin is also evaluating PT-112 in other solid tumors, including non-small cell lung cancer and metastatic castration-resistance prostate cancer, both alone and in combination with PD-L1 inhibitor avelumab.