On June 2, 2023 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, reported preliminary data from a Phase 2 clinical trial of the company’s lead therapeutic candidate, PT-112, in patients with recurrent thymic epithelial tumors (TETs), specifically thymoma and thymic carcinoma (Press release, Promontory Therapeutics, JUN 2, 2023, View Source [SID1234632393]). The trial is being conducted under formal collaboration with the National Cancer Institute (NCI), part of the National Institutes of Health (see NCT05104736). The data were published online in an abstract for the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
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"Based on preliminary data to date, PT-112 appears to be safe and tolerable, and clinically active in patients with recurrent TETs. The initial translational evidence of PT-112 immune activation is encouraging and supportive of further investigation," said Promontory Therapeutics Chief Medical Officer Johan Baeck, MD. "We are excited to provide a potential treatment option for patients with relapsed TETs, and are thrilled to continue our collaboration with the NCI."
The Phase 2 clinical trial with the NCI is designed to assess the safety, tolerability, and clinical activity of PT-112 in patients with thymoma and thymic carcinoma, and to explore PT-112’s ability to promote immune activation and immune cell infiltration in response to treatment, via the extensive immuno-profiling capabilities of the NCI.
Promontory is providing NCI with PT-112 drug supply and support for correlative research, and NCI is overseeing enrollment and treatment of the clinical trial’s intended 53 patients.
For more information about Promontory’s clinical trials, visit www.PromontoryTx.com.
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 represents a highly potent 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. 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 (Free ESMO Whitepaper) 2020 Virtual Congress and the Phase 2a dose confirmation cohort in non-small cell lung cancer (NSCLC) patients was reported at ESMO (Free ESMO Whitepaper) I-O 2022. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) 2020 is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal CRADA with the NCI.