NEW YORK, Sept. 3, 2020 /PRNewswire/ — Phosplatin Therapeutics, a clinical stage pharmaceutical company focused on oncology therapeutics, today announced that new clinical data from a dose escalation study (NCT 03409458) of lead candidate PT-112, an immunogenic cell death inducer, used in combination with PD-L1 checkpoint inhibitor avelumab, will be presented at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020 taking place September 19-21. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. This abstract is one of only seven abstracts that have been selected for the Mini Oral presentation format in the Investigational Immunotherapy category.
Title: «Phase 1b dose escalation study of novel immunogenic cell death (ICD) inducer PT-112 plus PD-L1 inhibitor avelumab in solid tumors»
Presenter: Daniel D. Karp, MD, Professor, Division of Cancer Medicine, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center
Session Date / Time: Released 9am CET September 18, 2020
Availability: On demand streaming for the duration of the conference
Abstract Number: 1026MO
Abstracts selected for the on-demand Mini Oral format will be made publicly available at 12:05am CET on Friday September 18, 2020. The Mini Oral presentation will be available on the ESMO website (registration required) from 9am CET on September 18, 2020.
«The data to be presented at the ESMO Virtual Congress 2020 further validate our development hypothesis with PT-112, and the demonstration of its feasibility in combination with immune checkpoint inhibition,» said Robert Fallon, co-founder and chief executive officer, Phosplatin Therapeutics. «There is a large, unmet need for patients with advanced cancer not responding to immunotherapy, who essentially have no standard of care. The combination of PT-112 with avelumab has a strong underlying combination rationale based upon PT-112’s immunogenic cell death properties, and offers potential for advancing the treatment landscape.»
The study was conducted as part of a collaboration agreement between Phosplatin Therapeutics, Pfizer, Inc. and Merck KGaA, Darmstadt, Germany (EMD Serono in the US and Canada). Under the terms of the collaboration, Phosplatin Therapeutics is the Sponsor of Phase 1b/2a clinical trials in several indications. Pfizer and Merck KGaA supply avelumab for the trials.
PT-112 is the ﬁrst small molecule conjugate of pyrophosphate developed in oncology therapeutics. PT-112 promotes immunogenic cell death (ICD), or the release of damage associated molecular patterns (DAMPs), that lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a potential best-in-class small molecule inducer of this immunological form of cancer cell death and is under Phase II development. 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» at the ESMO 2018 Annual Congress within the Developmental Therapeutics category. The novelty of its pyrophosphate moiety also results in osteotropism, or the propensity of the drug to reach the mineralized bone. This property is of interest in cancer types that originate in bone or frequently lead to metastatic bone involvement, such as metastatic castrate-resistant prostate cancer (mCRPC). The ﬁrst human clinical results in mCRPC were presented at the 2020 Genitourinary Cancers Symposium.
Avelumab Approved Indications
Avelumab (BAVENCIO®) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Avelumab Important Safety Information from the US FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib [which can be severe and have included fatal cases], and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO® monotherapy include lymphopenia; in patients receiving BAVENCIO® in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.
About Phosplatin Therapeutics
Phosplatin Therapeutics 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 I studies have demonstrated single-agent anti-cancer activity and an attractive tolerability proﬁle, and two Phase II studies of PT-112 are underway. The company’s research and development work to date has spanned ﬁfteen 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 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).
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