Phosplatin Therapeutics Announces Collaboration with Pfizer and Merck KGaA, Darmstadt, Germany to Evaluate Combination of PT-112 and Avelumab in Phase I / II Studies - Seite 2

*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.

About PT-112
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.

About Avelumab
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.