New thymoma and thymic carcinoma treatments being tested

Phosplatin Therapeutics Inc. is a clinical-stage pharmaceutical company. It announced the first patient has now been treated in phase 2 clinical trial of its lead therapeutic candidate, PT-112, for use in patients with recurrent thymic epithelial tumors (TETs), particularly thymoma and thymic carcinoma. The trial for the same is being conducted under a formal collaboration with India’s National Cancer Institute (NCI), part of the National Institutes of Health.

The phase 2 trial was designed to assess further the levels of safety and efficacy of PT-112 in patients with thymoma and thymic carcinoma, and for using correlative studies to explore various molecular profiles, for examining parameters of immune activation, and for analyzing immune cell infiltration in response to PT-112 treatment, as it is known to promote immunogenic cell death (ICD). Immunogenic cell death (ICD is an immunostimulatory form of cancer cell death in the tumor microenvironment, and PT-112 has a highly potent induction of immunogenic cell death (ICD) that has been validated in relevant cancer models.

Phosphate is providing National Cancer Institute (NCI) with PT-112 drug supply and support for correlative research. National Cancer Institute (NCI) oversees the enrollment and dosing of the study’s intended 53 patients. To be eligible for the study,  all the patients must have uncommon tumors of the thymus (TETs) that returned or progressed after treatment with at least one platinum-containing chemotherapy or have refused standard treatment. The primary endpoint is the overall response rate (ORR) per RECIST 1.1 criteria. The secondary endpoint measures will include safety, duration of response, p overall survival, progression-free survival,l, and ORR based on ITMIG-modified RECIST criteria, which is as established by the International Thymic Malignancy Interest Group.

“As an immunomodulatory treatment, PT-112 has performed well in early phase trials for TETs and warrants additional phase 2 testing. Given the significant unmet need for patients with recurrent TETs, with no established immunotherapy option and no approved drug, it is important that we continue to study potential therapies,” Arun Rajan stated. He is the MD and a senior clinician in the Thoracic and GI Malignancies Branch at the National Cancer Institute (NCI),

“In our phase 1 trial of PT-112, we reported favorable safety data and observed a durable clinical response in a patient with advanced metastatic thymoma, which had the signature of potential immune involvement to the response,” said Robert Fallon. “We are excited to work with Dr. Rajan and his outstanding team at the NCI to further study the potential of PT-112 to provide significant benefit to patients with these cancers.” He is Phosplatin president and chief executive officer.

Phosplatin holds a Foood and Drug Authority (DA) Orphan Drug Designation for PT-112 in thymoma and thymic carcinoma. Tumors of the thymus (TETs), including thymomas and thymic carcinomas, are very uncommon tumors of the thymus for which there is no known Food and Drug Authority (FDS)  approved drug. The five-year survival rate for various patients with thymoma or thymic carcinoma is 55%. In cases of relapse following surgical intervention,  tumors of the thymus (TETs) have the potential to metastasize, and there are very limited options for treatment.

PT-112 is the first small-molecule conjugate of pyrophosphate used in oncology. It has a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD) by releasing damage-associated molecular patterns (DAMPs which bind to dendritic cells and can lead to downstream immune effector cell recruitment in the tumor microenvironment.

Phosplatin Therapeutics Inc. is a privately held and clinical-stage pharmaceutical company that has an exclusive global license to phosphaplatins. Phosphaplatins are a family of small molecules designed to circumvent the various drug resistance and toxicity mechanisms commonly associated with chemotherapeutic regimens.