Company is Scheduled to Conduct Pre-IND Meeting with the U.S. FDA Later This Month and Potentially Initiate Phase 1/2 Clinical Trial of OncoPLEX for Brain Tumors in 2022
PETAH TIKVA, Israel, Nov. 16, 2021 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a phase 3 biopharmaceutical company focused on developing targeted, locally administered, and prolonged-release therapeutics using its proprietary PLEX technology, today announced the appointment of Frederick Lang, M.D., to its Oncology Advisory Board.
Dr. Lang is chairman of Neurosurgery at The University of Texas MD Anderson Cancer Center (“MD Anderson”), a position he has held since 2018, and is co-leading MD Anderson’s Glioblastoma Moon Shot® initiative, which is dedicated to saving the lives of patients through the development of new therapies and better treatment approaches. Dr. Lang leads the Lang Laboratory at MD Anderson, a clinical and translational research laboratory focused on developing novel gene-, viral- and stem cell-based therapies. He is considered one of the world’s foremost experts in the treatment of brain tumors.
In September 2021, PolyPid announced positive preclinical data for its intra-tumoral OncoPLEX in animal models of Glioblastoma Multiform (GBM). GBM is a fast-growing and aggressive brain tumor that can result in death in six months or less, if untreated. A significant treatment challenge is the blood-brain barrier, which often blocks systemically administered therapeutic agents from reaching the tumor site. The Company is scheduled to conduct a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration later this month to potentially initiate a Phase 1/2 clinical trial in 2022.
“I am elated that Dr. Lang has agreed to join PolyPid’s Oncology Advisory Board,” said Amir Weisberg, Chief Executive Officer of PolyPid. “His vast experience and commitment to innovation in brain cancer will benefit the many patients in need of new treatment options. We are honored to have Dr. Lang on our team.”
Dr. Lang receives compensation as a member of the Oncology Advisory Board, and this financial relationship has been disclosed to MD Anderson’s Conflict of Interest Committee in accordance with institutional policy.
OncoPLEX 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.
PolyPid 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 (SSIs).
For additional company information, please visit polypid.com and follow us on Twitter and LinkedIn.
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,” “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 Company’s scheduled pre-Investigational New Drug meeting with the U.S. Food and Drug Administration later this month to potentially initiate a Phase 1/2 clinical trial in 2022, and the benefits of Dr. Lang joining the Company’s Oncology Advisory Board. 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.
References and links to websites 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.
Dikla Czaczkes Akselbrad
EVP & CFO
Source: PolyPid Ltd.