NEW YORK, June 2, 2023 /PRNewswire/ -- Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, announces 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. 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) Annual Meeting.
"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.
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 2020 Virtual Congress and the Phase 2a dose confirmation cohort in non-small cell lung cancer (NSCLC) patients was reported at ESMO I-O 2022. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH 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.
About Promontory Therapeutics
Promontory Therapeutics Inc. is a privately held, clinical stage pharmaceutical company focused on small molecule immunotherapy. The company's lead candidate, 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 pattern recognition receptors on dendritic cells and promote an anti-cancer immune response in the tumor microenvironment. Clinical data generated across three Phase 1 studies have demonstrated single-agent and combination 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 has been conducted in the United States, Europe and Asia. The company also sponsored the completed 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 Phase 2 trial underway with the NCI utilizing PT-112 in thymic epithelial tumors where PT-112 has received Orphan Drug designation.
To learn more about Promontory Therapeutics, visit the company's website here.
Brooke Raphael, MS
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SOURCE Promontory Therapeutics Inc.