QuadraMune® Commercially Available “Checkpoint Inhibitor Nutraceutical” Shown to Target Immune Suppressive Indolamine 2,3 Deoxygenase Pathway

Therapeutic Solutions International announced today receipt of a Notice of Allowance from the United States Patent and Trademark Office regarding its patent application entitled “Nutraceuticals for Suppressing Indolamine 2,3 Deoxygenase.”

To the knowledge of the Company, this is the first issuance of a patent on a nutraceutical supplement for stimulating the immune system by blocking immune suppressive activities used by cancer and viruses in the IDO pathway. The supplement, termed “QuadraMune®” is commercially available on the Company website and through Amazon.

Numerous drugs such as Optivo®, Yervoy®, and Keytruda®, have been approved by the FDA for treatment of cancers by boosting immunity though blocking immune inhibiting mechanisms. This class of drugs, called “checkpoint inhibitors” represent a 15.2 billion dollar a year market¹.

“The indolamine 2,3 deoxygenase (IDO) pathway is believed to be one of the major immunological checkpoints based on the fact that small molecule blockade of this pathway results in immune mediated destruction of tumors in animals,” stated Dr. Thomas Ichim, Board Member and Co-Inventor of the patent. “Unfortunately, prior approaches to suppress this pathway relied on toxic compounds which did not perform well in clinical trials, in part due to inability to administer sufficient doses without evoking toxicity. We are excited by the possibility that QuadraMune®, a nutraceutical composition that is commercially available may act as a potent immune booster targeting the IDO pathway without drawbacks of other approaches.”

In 2013² and subsequently in 2018³, Dr. Ichim and colleagues published regression of breast cancer by inhibiting the IDO pathway using an RNA interference approach. The current data and patent granted are representation of years of basic scientific investigation on the relationship between IDO and the immune system.

“As a physician that sees firsthand the devastation caused by cancer and viruses, I am extremely excited about our ability to modulate critical immunological pathways using naturally occurring ingredients such as pterostilbene, thymoquinone, epigallocatechin gallate and sulforaphane,” said Dr. James Veltmeyer, Chief Medical Officer of the Company and Co-Inventor of the patent. “What is particularly important is that after filing of our patents, numerous independent universities have validated the anti-COVID activity of the individual ingredients. These studies are summarized in our previous press release⁴.”

“The acceptance of our data by the United States Patent Office in granting of the current patent is a major accomplishment for the Company,” said Timothy Dixon, President and CEO, and Co-Inventor of the patent. “The Company has numerous patent applications filed covering multiple nutraceuticals and uses including; a) published patent application #16/866430 entitled ‘Nutraceuticals for the Prevention, Inhibition, and Treatment of SARS-Cov-2 and Associated COVID-19’, b) #16/898472 entitled ‘Nutraceuticals for Reducing Myeloid Suppressor Cells’ and c) #16/907335 entitled ‘Treatment of SARS-CoV-2 with Dendritic Cells for Innate and/or Adaptive Immunity’.”

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/

1 Global Checkpoint Inhibitors Market (2021 to 2030)

2 Silencing IDO in dendritic cells: A novel approach to enhance cancer immunotherapy in a murine breast cancer model - Zheng - 2013

3 A new cancer immunotherapy via simultaneous DC‐mobilization and DC‐targeted IDO gene silencing using an immune‐stimulatory nanosystem - Zhang - 2018

4 Therapeutic Solutions International Discusses Claims of Possible COVID-19 Suppressive Activity of QuadraMune™ Ingredients by Independent Universities Made After Patent Filing

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