Benzinga | Sep 13, 2021 07:42AM EDT

PolyPid Announces Preclinical Data In Glioblastoma Multiform Animal Models Of OncoPLEX Program; Says Results Demonstrated 'Single Local Treatment of OncoPLEX Significantly Inhibited Tumor Growth and Prolonged Survival'

* Positive Results in Two Animal Models of Glioblastoma Multiform (GBM) demonstrated that Single Local Treatment of OncoPLEX Significantly Inhibited Tumor Growth and Prolonged Survival

* Company Expects a Pre-IND Meeting with the U.S. FDA by Year End and Potential Initiation of Phase 1/2 Clinical Trial of OncoPLEX in Brain Tumors in 2022

PETAH TIKVA, Israel, Sept. 13, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (NASDAQ:PYPD), a phase 3 biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced positive preclinical data in two key Glioblastoma Multiform (GBM) animal models of its OncoPLEX intra-tumoral cancer therapy program.



OncoPLEX utilizes the Company's novel PLEX technology to provide controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, for a few weeks in the intra-operative tumor resection setting, to potentially reduce local tumor recurrence, tumor spreading and prolong patient survival.

The OncoPLEX intra-tumoral cancer therapy program was evaluated in brain tumors for tumor growth and survival in two Glioblastoma Multiform (GBM) animal models. Key results included:

* 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.

* OncoPLEX was also tested in a GBM brain rat model. OncoPLEX, applied locally next to the non-resected tumor in the brain, showed a 40% survival rate at day 23 following the beginning of treatment, as compared to a 0% survival rate in the standard systemic treatment arm (Temozolomide 33.5 mg/kg, 5 treatment days), the placebo arm (OncoPLEX without Docetaxel) and in the untreated control arm. Only OncoPLEX significantly enhanced the overall survival compared to both the placebo arm and to the untreated arm (p<0.02).

* Dose response was demonstrated for OncoPLEX in the different animal models.

* Local application of OncoPLEX in a rat brain model evidenced good safety profile at the different doses studied.

"The growing set of data from our OncoPLEX preclinical studies continue to look promising," said Dr. Noam Emanuel, PolyPid's co-founder and Chief Scientific Officer. "GBM is one of the most aggressive forms of brain cancer which carries a poor prognosis with current therapy, mainly due to the limited ability of existing approaches to penetrate the blood brain barrier. The novel prolonged intra-tumoral OncoPLEX treatment could provide substantial benefit for patients with these devastating tumors that often cannot be fully resected surgically. Based on the encouraging anti-cancer results of OncoPLEX in various animal models generated to date, including in tumors that are highly resistant to docetaxel, we believe that OncoPLEX warrants further evaluation in the clinical setting. As such, 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."