docetaxel intratumoral (OncoPLEX) / PolyPid - LARVOL DELTA

PolyPid Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results (GlobeNewswire) - "OncoPLEX single intratumoral injection significantly reduced tumor growth and increased survival in two well established and commonly used tumor animal models: murine melanoma and murine colon carcinoma. The intratumoral injection of the PLEX platform could be used as an interventional oncology treatment with additional chemotherapies or other types of molecules, such as monoclonal antibodies, bispecific antibodies and nucleic acids."

Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor

Reduction in local tumor recurrence in a murine R2 resection model comparing locally administered docetaxel-releasing product, OncoPLEX, versus systemic docetaxel. (ASCO 2022) - "Locally administered OncoPLEX in this R2 resection model reduced local tumor recurrence and systemic adverse outcomes. OncoPLEX offers a potentially enhanced local adjuvant chemotherapy option with reduced side effects for solid tumors, independent of the tumor sensitivity or resistance to docetaxel."

Preclinical • Brain Cancer • Colorectal Cancer • Gastrointestinal Cancer • Glioblastoma • Oncology • Solid Tumor

PolyPid Announces Publication of Animal Model Studies in 2022 ASCO Annual Meeting Abstract Demonstrating that Locally Administered OncoPLEX Potentially Decreases the Likelihood of Tumor Recurrence with Reduced Side Effects (GlobeNewswire) - "The studies consisted of two tests—one on CT26 (murine colorectal carcinoma—found to be resistant to docetaxel) and one on U-87 (human primary glioblastoma). In both animal model studies, OncoPLEX was applied once on the tumor bed post-tumor-resection. The control groups were treated with placebo or IV docetaxel in CT26 study and placebo or IP gemcitabine in U87 study every four days, for a total of five injections. Animals were monitored for tumor regrowth. At the completion of the 37-day CT26 study, there were more tumor-free animals in the OncoPLEX group (75%) compared to the control group that was treated with IV docetaxel (25%). The U-87 study showed similar results, with a larger group of tumor-free animals treated with OncoPLEX (80%) than the IP gemcitabine treated control group (30%)."

Preclinical • Oncology

PolyPid Announces Positive Preclinical Data of its Intra-tumoral OncoPLEX in Brain Cancer (GlobeNewswire) - “PolyPid…announced positive preclinical data in two key Glioblastoma Multiform (GBM) animal models of its OncoPLEX intra-tumoral cancer therapy program…OncoPLEX induced strong inhibition of tumor growth and recurrence in a partially resected human glioblastoma subcutaneous mouse model. A single local OncoPLEX application induced 98% tumor growth inhibition (day 41 post operation) compared to the untreated control (p<0.001), and 66% compared to multiple injections of systemic chemotherapy treatment arm (p=0.0165). The day 41 survival rate for OncoPLEX was much higher than the systemic treated mice, or untreated with 60%, 20%, and 10% survival, respectively…‘we intend to conduct a pre-Investigational New Drug (IND) meeting with the U.S. FDA by year-end with the objective of initiating a Phase 1/2 clinical trial in 2022’.”

IND • New P1/2 trial • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology