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-Promontory Therapeutics presents at ESMO I-O 2022 safety and efficacy data of PT-112 in combination with PD-L1 inhibition in the treatment of advanced non-small cell lung cancer
The data suggest that the combination of PT-112 and PD-L1 is well tolerated and has significant clinical benefits in treatment-experienced patients with no known predictive markers of response to immunotherapy.
NEW YORK, Dec. 8, 2022 /PRNewswire/ -- Promontory Therapeutics Inc., a clinical-stage pharmaceutical company developing small molecule immunotherapies in oncology, today presented at the European Society of Oncology's Immuno-Oncology Congress 2022 Medical (ESMO I-O) Phase 2a clinical data on the safety and efficacy of the leading therapeutic candidate PT-112 in combination with PD-L1 inhibition, in patients with advanced non-small cell lung cancer (NSCLC).
The poster entitled "A phase 2a study of the novel immunogenic cell death (ICD) inducer PT-112 plus avelumab in advanced non-small cell lung cancer patients" demonstrated that the combination of PT-112 and avelumab is well tolerated with a profile of manageable safety, and showed significant clinical benefits in patients without known predictive markers of response to immunotherapy. Based on the observed clinical activity, the study results support further evaluation of combinations of PT-112 with immuno-oncological agents and evaluation of the immunological effects of PT-112 in patients.
"These data provide us with proof-of-principle for the use of the immunogenic inducer of cell death PT-112 in combination with immune checkpoint inhibition in patients with NSCLC, and support future opportunities to bring our immunotherapy combinations." for cancer patients," said Matthew Price, co-founder and chief operating officer of Promontory Therapeutics. "Together with the correlative immunological findings, the results are encouraging. As the field of small molecule immunogenicity continues to evolve, we are pleased to continue demonstrating the ICD effects of PT-112 in human patients. Our published clinical and nonclinical studies to date have demonstrated the potential of this approach to date."
The 18 patients included in the study were treated with PT-112 360 mg/m2 on days one, eight, and 15, and avelumab 800 mg on days one and 15, of a 28-day cycle. Eligible patients received no more than 4 prior lines of therapy and must have progressive disease and prior anti-PD-1/PD-L1 and platinum therapy. Study results include:
Based on preclinical models, PT-112 is an immunogenic small molecule that induces ICD, recruits immune effector cells into the tumor microenvironment, and synergizes with immune checkpoint inhibitors.
For more information on PT-112 and the Promontory Therapeutics portfolio of clinical products, visit www.PromontoryTx.com.
PT-112 is the first small molecule pyrophosphate conjugate 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 the recruitment of downstream immune effector cells into the tumor microenvironment. PT-112 is a very potent inducer of this immunologic form of cancer cell death. In addition, PT-112 possesses a property known as osteotropism, that is, the propensity of the drug to reach its highest concentrations in certain areas of the bone, which makes it a candidate for the treatment of patients with cancers that originate in bone or metastasize to it. The first human study of PT-112 demonstrated an attractive safety profile and evidence of durable responses in heavily pretreated patients, and won the "Best Poster" award in the Developmental Therapeutics category at the ESMO Annual Congress 2018. Phase 1b dose escalation combination study of PT-112 with the PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at ESMO Virtual Congress 2020 and the Phase 2a dose confirmation cohort in patients with non-small cell lung cancer (NSCLC) was reported at ESMO IO 2022. 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. Phase 2 monotherapy development is ongoing at mCRPC, now including the Phase 2 proof-of-concept study in thymic epithelial tumors as part of the company's formal collaboration with NCI.
Acerca de Promontory Therapeutics
Promontory Therapeutics Inc. is a private, clinical-stage pharmaceutical company focused on small molecule immunotherapy. The company's lead candidate, PT-112, is the first small molecule pyrophosphate conjugate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death, through the release of damage-associated molecular patterns (DAMPs). that bind to pattern recognition receptors on dendritic cells and promote adaptive immune responses in the tumor microenvironment. Clinical data generated in three phase 1 studies have demonstrated single-agent anticancer activity and an attractive tolerability profile, and three phase 2 studies with PT-112 are ongoing. The company's research and development work has been conducted in the United States, Europe, and Asia, along with a sublicensing agreement for the development, commercialization, and use of PT-112 in Greater China. The company is also sponsoring the ongoing clinical study of PT-112 in combination with the PD-L1 inhibitor avelumab under a collaborative agreement with Pfizer and Merck KGaA, Darmstadt, Germany (doing business as EMD Serono in the United States and Canada ), and has an active Phase 2 trial underway with the NCI using PT-112 in thymic epithelial tumors in which PT-112 has received orphan drug designation.
To learn more about Promontory Therapeutics, visit the company's website here.
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