Item 8.01 Other Events.

On June 28, 2022, the United States Patent and Trademark Office (the "USPTO") issued U.S. Patent No. 11371037 (the "037 Patent") and made publicly available provisional patent application (U.S. Application No. 17/374.357) (the "Provisional Patent Applications") to which the 371 Patent claims priority.

The 037 Patent and the Provisional Patent Application described an invention that is directed to a method of preparing zinc-charged pancreatic enzymes, which is further directed to a method of treating cancer and inflammation using the zinc-charged pancreatic enzymes. Charging the pancreatic enzymes with zinc ions activate the pancreatic enzyme's anticancer and anti-inflammation properties and make the enzymes capable of being administered orally. It is observed that the zinc-charged pancreatic enzymes are able to induce apoptosia in various cancer cells without affecting the normal cells. The zinc-charged pancreatic enzymes have also been observed inducing apoptosis in trophoblasts and reducing inflammation in general.

Our study has revealed that amylase-Zn possesses multiple anticancer mechanisms. First, in additional to the induction of apoptosis, amylase-Zn reduced the expression of PD-L1 in cancer cell lines by 90%, suggesting that amylase-Zn may be used as an immunotherapy agent for cancer treatment. Secondly, amylase-Zn reduced the expression of c-Myc by 45%, which may inhibit tumor growth. Third, amylase-Zn inhibited the secretion of IL-6, IL-8 and TNF-alpha, suggesting that amylase-Zn may inhibit cancer metastasis.

In vitro, cell lines study showed that amylase-Zn has strong apoptosis-inducing activity on various pancreatic cancer cell lines such as: BxPC-3, AsPC-1, HPAF-II, and Capan-2. Tissue distribution study further showed that after amylase-Zn was administrated to mice, a high concentration of amylase-Zn was detected in pancreas homogenate. Hence, amylase-Zn may be developed as an anti-pancreatic cancer drug, which will be the focus of the research for this IND application. The efficacy of amylase on pancreatic cancer, toxicology study, and pharmacokinetics study will be all performed as part of this exploration.

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses