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PolyPid announced preclinical data from its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the Company's novel PLEX technology to provide prolonged and controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, in the intra-operative tumor resection setting. OncoPLEX is designed for the delivery of sustained, significant concentrations of docetaxel locally within the tumor site for a few weeks, potentially reducing local tumor recurrence and tumor metastatic spreading. In a syngeneic mouse model for solid tumors of colon carcinoma, a single local application of OncoPLEX at the intra-operative setting post tumor resection compared to the group treated with six cycles of systemic docetaxel treatment with 2-4 days gap between cycles, generated the following key results: OncoPLEX arm showed 25% overall tumor recurrence at the end of the study compared to 75% in the systemic treatment arm, and 100% in the untreated control arm. OncoPLEX arm demonstrated 75% overall tumor free survival at the end of the study, compared to 25% in the systemic treatment arm, and 0% in the untreated control arm. OncoPLEX arm demonstrated 75% overall survival at the end of the study, compared to 50% in the systemic treatment arm, and 0% in the untreated control arm. Dose response was also demonstrated for OncoPLEX in these studies. Systemic toxicity was lower following the local application of OncoPLEX versus systemic docetaxel. Additional data in a pharmacokinetic model showed that the maximal plasma concentration of docetaxel was greater than10 times lower with OncoPLEX than with systemic docetaxel. Based on these compelling preclinical results, PolyPid intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022.

PolyPid announced that the first patient has been enrolled and randomized in the SHIELD II trial, the Company's second of two Phase 3 clinical trials for its lead product candidate, D-PLEX, for the prevention of post-abdominal surgery incisional infection. SHIELD II is a prospective, multinational, multicenter, randomized, double-blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX administered concomitantly with the Standard of Care, compared to a SoC-treated control arm, for the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects with at least one abdominal target incisional infection event within 30 days post-abdominal surgery, determined by a blinded independent adjudication committee. The trial will enroll a minimum of 900 patients, with a maximum of approximately 1,400 subjects, as defined by the adaptive study design, in approximately 60 centers in the United States, Europe and Israel.