PolyPid Announces Release – GuruFocus.com

  • Docetaxel Delivered Topically Through Sustained-Release Delivery via the Company’s PLEX Technology Offers a Potentially Improved Adjuvant Chemotherapy Option

PETACH TIKVA, Israel, June 01, 2022 (GLOBE NEWSWIRE) — PolyPid Ltd. ( PYPD) (“PolyPid” or the “Company”), a late-stage biopharmaceutical company focused on improving surgical outcomes, today announced that animal studies related to OncoPLEX, the Company’s lead intra-tumor product candidate in oncology applied as a paste to the resection bed during surgery, have been published in an abstract in the American Society for Clinical Oncology (ASCO) 2022 Annual Meeting Abstracts Book. The abstract, reduction of local tumor recurrence in a mouse R2 resection model comparing the locally administered docetaxel-releasing product, OncoPLEX, to systemic docetaxeldemonstrated that locally administered OncoPLEX potentially decreases the likelihood of tumor recurrence, with reduced side effects, compared to systemically administered chemotherapy agents.

“We are delighted with the compelling results from these preclinical studies on OncoPLEX,” said Dr. Noam Emanuel, Scientific Director of PolyPid and first author of the studies. “Despite advances in surgical oncology techniques and neoadjuvant and adjuvant treatments, the local recurrence of many solid malignancies still poses a challenge for the long-term survival of oncology patients. Adding controlled local treatment to the current standard of care of systemic chemotherapy could potentially improve patient outcomes for some devastating cancers, such as glioblastoma multiforme (GBM). We look forward to advancing OncoPLEX into the clinic, with the goal of initiating a Phase 1/2 study. »

OncoPLEX utilizes PolyPid’s novel PLEX technology to provide sustained release and controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, to potentially reduce local tumor recurrence and prolong patient survival .

The studies consisted of two tests, one on CT26 (murine colorectal carcinoma, which was found to be resistant to docetaxel) and the other on U-87 (primary human glioblastoma). In both animal model studies, OncoPLEX was applied once to the tumor bed after tumor resection. Control groups received placebo or docetaxel IV in study CT26 and placebo or gemcitabine IP in study U87 every four days, for a total of five injections. Animals were monitored for tumor regrowth. At the end of the 37-day CT26 study, there were more tumor-free animals in the OncoPLEX group (75%) than in the docetaxel IV control group (25%). Study U-87 showed similar results, with a larger group of tumor-free animals treated with OncoPLEX (80%) than the control group treated with gemcitabine IP (30%).

The ASCO Annual Meeting is taking place in Chicago, IL, June 3-7, 2022.

About OncoPLEX

OncoPLEX is PolyPid’s lead intra-tumor product candidate in oncology. OncoPLEX uses the company’s novel PLEX technology to deliver prolonged, controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, directly at the site of the tumor for a few weeks to potentially reduce the local recurrence of the tumor, the potential spread of cancer cells and ultimately improve the overall survival rate of cancer patients. Local delivery of drugs directly into the tumor site, especially in hard-to-reach tumors such as in the brain, can significantly improve clinical outcomes. The OncoPLEX intra-tumor cancer therapy program has been successfully evaluated in various animal tumor models, including colon carcinoma and glioblastoma.

About PolyPid

PolyPid Ltd. ( PYPD) is a late-stage biopharmaceutical company focused on improving surgical outcomes. Through locally-delivered, controlled, time-released treatments, PolyPid’s proprietary PolyPid Polymer-Lipid Encapsulation matriX (PLEX) technology combines with active pharmaceutical ingredients, enabling precise drug delivery at optimal release rates over longer periods of time. ranging from several days to several months. D-PLEX, PolyPid’s lead product candidate100 is in Phase 3 clinical trials for the prevention of surgical site soft tissue infections of the abdominal and sternal bone. Additionally, the company is currently in the preclinical phase to test the efficacy of OncoPLEX for the treatment of solid tumors, starting with glioblastoma. For more information about the company, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

Forward-looking statements
This 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”, “anticipates”, “believes”, “seeks”, “estimates” and similar expressions or variations of these words are intended identify forward-looking statements. For example, the Company uses forward-looking statements when discussing its ongoing clinical trials and ongoing evaluation of preclinical trials of OncoPLEX, that OncoPLEX administered topically potentially decreases the likelihood of tumor recurrence with reduced side effects, that locally administered docetaxel by one-release delivery via PLEX technology offers a potentially improved adjuvant chemotherapy option, this addition of controlled local treatment to the current systemic chemotherapy standard of care could potentially lead to better outcomes for patients for certain devastating cancers, such as glioblastoma multiforme (GBM), which OncoPLEX potentially reduces local tumor recurrence and prolongs patient survival and its goal to initiate a Phase 1/2 study. Forward-looking statements are not historical facts and are based on management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. These expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be realized, and actual results may differ materially from what is expressed 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 February 28, 2022. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting the forward-looking information, except to the extent required by applicable securities laws. If the Company updates 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.

References and links to websites have been provided as a convenience, and information contained on such websites is not incorporated by reference in this press release. PolyPid is not responsible for the content of third party websites.

Corporate contact details

PolyPid Ltd.
Dikla Czaczkes Akselbrad
Executive Vice President and Chief Financial Officer
Tel: +972-747195700

Contact Investor

Bob Yedid
LifeSci Advisors
646-597-6989
[email protected]

Media Contact

Nechama Feuerstein
FINN Partners
551-444-0784
[email protected]

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Jacob L. Thornton