Phosplatin Therapeutics Announces Collaboration with Pfizer and Merck KGaA, Darmstadt, Germany to Evaluate Combination of PT-112 and Avelumab in Phase I / II Studies

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.