Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health.
| NEW YORK, Nov. 15, 2021 /PRNewswire/ -- Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health. Under the terms of the agreement, Phosplatin and NCI will collaborate on the clinical development of Phosplatin’s lead therapeutic candidate, PT-112, for patients with recurrent thymic epithelial tumors (TETs), specifically thymoma and thymic carcinoma, which are rare cancers with no FDA approved therapy.
Phosplatin and NCI anticipate opening the Phase 2 study soon, under a recently approved investigational new drug (IND) application. The study 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 PT-112 is known to promote immunogenic cell death (ICD) in relevant cancer models. Phosplatin will provide NCI with PT-112 drug supply and support correlative research, and NCI will oversee enrollment and care of the study’s intended 49 patients. “Thymoma and thymic carcinoma are rare forms of cancer for which there is currently no FDA approved treatment. There remains a pressing need for novel therapies for relapsed and refractory TETs – induction of immunogenic cell death is an approach of great interest for this population with no approved immunotherapy treatment,” said Arun Rajan, MD, Senior Clinician in the Thoracic and GI Malignancies Branch at the National Cancer Institute. “This clinical trial will evaluate PT-112 as a potential treatment option for our patients with TETs, and we hope to better understand PT-112’s therapeutic potential through this collaborative research program.” The collaboration is based upon early experience with PT-112 in a number of thymoma patients. “In our first Phase 1 trial of PT-112, we observed a durable clinical response in a thymoma patient with advanced metastatic disease, which deepened over many months with symptomatic improvement for the patient,” said Joseph F. O’Donnell, MD, Chief Medical Officer at Phosplatin. “Along with our Phase I safety data, and our demonstration of PT-112’s ICD effects in validated models, this case helped establish the interest in this collaboration. We’re proud to be working with the exceptional colleagues at the NCI in evaluating PT-112 in a patient population that currently has no approved therapeutic options for metastatic disease.” 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 approved FDA-approved drug. In cases of relapse following surgical intervention, TETs have the potential to metastasize and there are limited options for treatment. Further information on this clinical trial (NCT05104736) can be found at clinicaltrials.gov. About PT-112 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 tumor microenvironment. PT-112 may represent the best-in-class inducer of this immunological form of cancer cell death. Further, PT-112 harbors 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 first in-human study of PT-112 demonstrated an attractive safety profile 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 tumors 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 the PD-L1 combination study is ongoing in a dose confirmation cohort of non-small cell lung cancer (NSCLC) patients, and will soon include the Phase 2 proof of concept study in thymic epithelial tumors under the company’s collaboration with the NCI. About Phosplatin Therapeutics 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. The company’s lead candidate, PT-112, is a novel chemical entity under clinical development that exhibits a unique combination of properties, including immunogenic cell death and osteotropism. Clinical data generated to date across three Phase 1 studies have demonstrated single-agent anti-cancer activity and an attractive tolerability profile, and two Phase 2 studies of PT-112 are underway. The company’s research and development work to date has spanned sixteen countries and been funded by private investors and family investment offices in the United States, Europe and Asia, along with a sub-license agreement for the development, commercialization and use of PT-112 in Greater China. The company also sponsors the ongoing clinical study of PT-112 in combination with the PD-L1 inhibitor avelumab under a collaboration agreement with Pfizer and Merck KGaA, Darmstadt, Germany (operating as EMD Serono in the US and Canada), and has an active collaborative research and development agreement (CRADA) with the NCI to explore the use of PT-112 in thymic epithelial tumors. CONTACTS: Phosplatin Therapeutics ICR Westwicke Media:
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