On July 20, 2023 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing immunogenic small molecule approaches in oncology, reported that it has expanded its clinical presence to France (Press release, Promontory Therapeutics, JUL 20, 2023, View Source [SID1234633336]). This week the company treated its first four patients in France – at Gustave Roussy and at the Military Hospital (HIA) Bégin in Paris – on the ongoing Phase 2 clinical trial of lead therapeutic candidate, PT-112, in patients with late-stage metastatic castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02266745).

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The Phase 2, open-label, multi-center proof of concept study has the objective of characterizing the benefit-risk ratio and selecting the optimal dose regimen for pivotal development of PT-112, in line with the FDA’s Project Optimus. In addition to proof of concept via safety and efficacy findings among late-stage metastatic patients, the study aims to generate meaningful supportive data via correlative research, for example on immune activation by PT-112 monotherapy, and by examining circulating tumor cell reductions.

Within France, the study is being led by primary investigator Dr. Karim Fizazi, MD, PhD, medical oncologist at Gustave Roussy, and professor of oncology at the University of Paris-Saclay. Gustave Roussy and HIA Bégin, the latter led by investigator Carole Helissey, MD, are the first two of ten sites across France that will recruit patients for the study. Promontory plans to enroll up to 109 patients in total on the study.

"Dr. Fizazi is a global leader in prostate cancer and under his guidance, we are looking forward to treating mCRPC patients in France and further understanding the potential impact of PT-112 on these late-stage mCRPC patients, who currently have few options for life-prolonging therapy," said Promontory Therapeutics Chief Medical Officer Johan Baeck, MD.

"We are very pleased to begin treating patients in France with advanced, metastatic prostate cancer, as part of the ongoing Phase 2 clinical trial of PT-112" said Dr. Fizazi. "Based upon early data, PT-112 has the potential to offer a promising form of immune activation to such patients, who generally do not have effective immunotherapy options to date."

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 clinical development in oncology. PT-112 has numerous advantages — including its tolerability and inhibition of ribosomal biogenesis (RiBi) which leads to 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 and data were published in eClinicalMedicine, part of The Lancet. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in a mini-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, as detailed in a trial-in-progress poster presentation at ASCO (Free ASCO Whitepaper) GU 2023, and also includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal CRADA with the NCI. Interim data from the NCI study were published at ASCO (Free ASCO Whitepaper) 2023.