Full Press Release Details
Announces Positive Preclinical Data of its Intra-tumoral OncoPLEX in Brain Cancer
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
TIKVA, Israel, September 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.
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.
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:
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."
is PolyPid's lead intra-tumoral product candidate in Oncology. OncoPLEX utilizes the Company's novel PLEX technology to provide
controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, directly at the tumor site for few weeks to
potentially reduce local tumor reoccurrence, the potential spreading of cancer cells, and ultimately improve the overall survival rate
of cancer patients. Local delivery of drugs directly into the tumor site, especially in difficult to access tumors such as in the brain,
may significantly improve the clinical outcome. The OncoPLEX intra-tumoral cancer therapy program has been evaluated successfully in
various animal tumor models, including colon carcinoma and glioblastoma.
Ltd. (Nasdaq: PYPD) is a phase 3 biopharma company aiming to improve surgical outcomes through locally administered, controlled, extended-release
therapeutics. PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with medications, enables precise
delivery of drugs at effective release rates, over pre-determined durations ranging from several days to months. PolyPid's lead
product candidate D-PLEX100 is in Phase 3 clinical trials for the prevention of abdominal and sternal surgical site infections
press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act and
other securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes,"
"seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking
statements. For example, the Company is using forward-looking statements when it discusses statements relating to the timing of a pre-IND
Meeting with the U.S. FDA, the timing of trials, and the potential benefits of OncoPLEX, and all statements (other than statements of
historical facts) that address activities, events, or developments that the Company intends, expects, projects, believes, or anticipates
will or may occur in the future. Forward-looking statements are not historical facts, and are based upon management's current expectations,
beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed
in good faith. However, there can be no assurance that management's expectations, beliefs and projections will be achieved, and
actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements
are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the
forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to
the Company's reports filed from time to time with the Securities and Exchange Commission ("SEC"), including, but not
limited to, the risks detailed in the Company's Annual Report on Form 20-F filed on March 5, 2021. Forward-looking statements speak
only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual
results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information
except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference
should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements.
and links to websites and social media platforms have been provided as a convenience, and the information contained on such websites
is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.