Phosplatin Therapeutics Announces Collaboration with Pfizer and Merck KGaA, Darmstadt, Germany to Evaluate Combination of PT-112 and Avelumab in Phase I / II Studies
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- Published on Saturday, 09 September 2017 16:36
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NEW YORK, NY, USA I September 9, 2017 I Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology drug development, announced today it has entered into a collaboration agreement with Pfizer and Merck KGaA, Darmstadt, Germany, to evaluate PT-112, a novel small molecule inducer of apoptosis with evidence of downstream immunogenic cell death (ICD) properties, currently in Phase I development, in combination with avelumab*, a human anti-PD-L1 IgG1 monoclonal antibody.
Avelumab has received accelerated approval by the US Food and Drug Administration (FDA) for the treatment of metastatic Merkel cell carcinoma, and previously treated patients with locally advanced and metastatic urothelial carcinoma, and is under further clinical investigation across a range of tumor types under a global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer. Under the terms of the collaboration, Phosplatin Therapeutics will be responsible for conducting Phase Ib/IIa clinical trials in several indications.
"We are delighted to be working with Pfizer and Merck KGaA, Darmstadt, Germany, on this combination trial," said Robert Fallon, President & CEO of Phosplatin Therapeutics. "PT-112 has demonstrable potential to change the oncology landscape and benefit patients. Its attractive safety profile and potent immunogenic properties make it an ideal candidate to combine with avelumab."
"As part of our efforts to expand the role of avelumab in immuno-oncology, we are working to deepen our understanding of how novel combinations can be used to potentially improve patient outcomes," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "PT-112 exhibits clinically encouraging activity and we are eager to study how this could potentially benefit a range of patients when combined with avelumab."
"While the use of monotherapy immunotherapy regimens in cancer has grown substantially over the last few years, we believe the next evolution in care will involve innovative immuno-oncology combinations," Alise Reicin, Head of Global Clinical Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "There remains a large unmet need for patients with challenging cancers and we hope that this new collaboration with Phosplatin will be part of the next advance in the treatment landscape."
*Avelumab is under clinical investigation for treatment of solid tumors and hematological malignancies in combination with PT-112 and has not been demonstrated to be safe and effective for these uses. There is no guarantee that avelumab will be approved for solid tumors or hematological malignancies by any health authority worldwide.
PT-112 is a novel anti-cancer agent, the first small molecule conjugate of pyrophosphate and platinum, that promotes damage associated molecular patterns (DAMPs) leading to downstream T cell recruitment in the tumor microenvironment. As such, it represents a potential best-in-class small molecule inducer of an immunological form of apoptosis. It was rationally designed to solve issues of toxicity while providing enhanced therapeutic benefit and minimizing DNA repair-based drug resistance, historically associated with chemotherapy treatment. The first-in-human PT-112-101 Phase I study was the subject of a poster discussion session at the ASCO 2017 Annual Meeting, in which a positive therapeutic index was reported among heavily pre-treated advanced solid tumor patients.
Avelumab is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. Avelumab is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T cells, exposing them to anti-tumor responses. Avelumab has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
Indications in the US
The US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) mMCC in adults and pediatric patients 12 years and older and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications were approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
Important Safety Information
The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.
For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com.
Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US
Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, US, enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer's PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.
About Phosplatin Therapeutics
Phosplatin Therapeutics is a private, clinical stage pharmaceutical company located in New York, US, which holds the exclusive 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 research and development work to date has spanned thirteen 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. See: www.phosplatin.com.
SOURCE: Phosplatin Therapeutics