Protection of T Cells from Tumor-Induced Suppression Suggests Potential for Enhancing Efficacy of Checkpoint Inhibitor and CAR-T Therapies

Company Plans to Initiate Phase I/II Clinical Trial in Advanced Breast Cancer Patients

Therapeutic Solutions International, Inc. (TSOI), announced today that its breast cancer focused immuno-oncology subsidiary, Res Nova Bio, Inc., has identified and filed a patent on a novel mechanism of action of its immunotherapy-enhancing product FloraStilbene™.

The Company has demonstrated that administration of FloraStilbene™, which is a proprietary combination of pterostilbene and the active ingredient in the abortion pill, mifepristone, suppresses loss of T cell activity caused by growing breast cancer. In a series of experiments, it was demonstrated that FloraStilbene™ stopped degradation of a protein called “T cell receptor zeta chain” which has previously been shown to be inactivated by the enzyme caspase-3¹. Breast cancer patients with higher levels of T cell receptor zeta chain have been reported to possess superior survival as compared to patients with lower levels².

“Breast cancer takes an incredible toll on patients, which I have witnessed firsthand,” said Dr. James Veltmeyer, Chief Medical Officer of the Company, and co-inventor on the patent. “The data presented today, which is the basis for our proposed clinical trial, potentially will help to enhance efficacy of the brand-new type of medicine called 'immunotherapy' which to date has resulted in many cures of cancers which were previously considered incurable.”

“Therapeutic Solutions International has a long history of advancing the field of cancer immunotherapy, dating back to 2015 when we filed our now issued patent # 9682047 entitled 'Augmentation of oncology immunotherapies by pterostilbene containing compositions' which covers the utilization of pterostilbene and various derivatives in increasing the therapeutic index of immunotherapy,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International and co-inventor. “I am honored to see the work led by Ms. Ramos which has advanced our science to the point where it is close to initiating clinical trials.”

“Immunology has revolutionized cancer therapy. Now that the concept has been established that the immune system can be trained to kill cancer, it is time to optimize the existing medications whether they be proteins, cells, or oncolytic viruses,” said Famela Ramos, President and CEO of Res Nova Bio and co-inventor. “Overcoming systemic immune defects induced by the cancer seems to us to be the first step in the optimization of immunotherapy. This is what we are aiming to accomplish in the clinical development of FloraStilbene™.”

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.

1 Gastman et al. Caspase-mediated degradation of T-cell receptor zeta-chain. Cancer Res. 1999 Apr 1;59(7):1422-7.

2 De Boniface et al. Tumor-dependent down-regulation of the ζ-chain in T-cells is detectable in early breast cancer and correlates with immune cell function. Int J Cancer. 2012 Jul 1;131(1):129-39.

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