Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company, announced the first patient has been treated in a phase 2 clinical trial of the company's lead therapeutic candidate, PT-112, in patients with recurrent thymic epithelial tumours (TETs), specifically thymoma and thymic carcinoma. The trial is being conducted under formal collaboration with the National Cancer Institute (NCI), part of the National Institutes of Health. The phase 2 trial is designed to further assess the safety and efficacy of PT-112 in patients with thymoma and thymic carcinoma, and to use correlative studies to explore molecular profiles, examine parameters of immune activation and analyze immune cell infiltration in response to PT-112 treatment, as the candidate is known to promote immunogenic cell death (ICD). ICD is an immunostimulatory form of cancer cell death in the tumour microenvironment, and PT-112's highly potent induction of ICD has been validated in relevant cancer models. Phosplatin is providing NCI with PT-112 drug supply and support for correlative research, and NCI is overseeing enrollment and dosing of the study's intended 53 patients. To be eligible for the study, patients must have uncommon tumours of the thymus (TETs) returned or progressed after treatment with at least one platinum-containing chemotherapy, or have refused standard treatment. The primary endpoint is overall response rate (ORR) per RECIST 1.1 criteria. The secondary endpoint measures include safety, duration of response, progression free survival, overall survival and ORR based on ITMIG-modified RECIST criteria (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," said Arun Rajan, MD, senior clinician in the Thoracic and GI Malignancies Branch at the 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, Phosplatin president and chief executive officer. "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." Phosplatin holds an FDA Orphan Drug Designation for PT-112 in thymoma and thymic carcinoma. TETs, including thymomas and thymic carcinomas, are uncommon tumors of the thymus for which there is no FDA-approved drug. The five-year survival rate for patients with thymoma or thymic carcinoma is 55%. In cases of relapse following surgical intervention, TETs have the potential to metastasize and there are limited options for treatment. PT-112 is the first small-molecule conjugate of pyrophosphate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumour microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbours a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The ?rst in-human study of PT-112 demonstrated an attractive safety pro?le and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO 2018 Annual Congress. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumours was reported in an oral presentation at the ESMO 2020 Virtual Congress. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH is the third completed phase 1 study of PT-112. Monotherapy phase 2 development is ongoing in mCRPC, and now includes the phase 2 proof of concept study in thymic epithelial tumours under the company's formal collaboration with the NCI. The PD-L1 combination Phase 2a study is ongoing in a dose confirmation cohort of non-small cell lung cancer (NSCLC) patients. Phosplatin Therapeutics Inc. is a privately held, clinical stage pharmaceutical company that holds exclusive global license to phosphaplatins, a family of small molecules rationally designed to circumvent the mechanisms of drug resistance and toxicity commonly associated with chemotherapeutic regimens.
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