Therapeutic Solutions International's Subsidiary MolecuVax, Inc. Announces Licensing of "Universal Cancer Vaccine" With Demonstrated Efficacy in Breast Cancer

OCEANSIDE, CA--(Marketwired - May 09, 2016) - Therapeutic Solutions International, Inc., (OTC PINK: TSOI) announced today the signing of an exclusive license agreement between its subsidiary, MolecuVax, Inc., (MVAX) and UniVax, LLC covering composition of matter of a new cancer vaccine that targets a molecule found in cancer stem cells of a variety of types of cancers. The vaccine target, termed CTCFL or Brother of the Regulator of Imprinted Sites (BORIS), was discovered by researchers at the National Institutes of Health (NIH)¹, and has been shown in numerous peer-reviewed studies to be essential for cancer survival and progression²,³,⁴.

The patent covers vaccines that stimulate the immune system to selectively kill tumor cells that are expressing this universal "cancer specific" protein. In contrast to other vaccines, our vaccine is targeting BORIS protein that is critical for the growth of histologically different cancers. This possesses important implications in that if a cancer cell mutates to lose expression of the target, then the cancer cell will no longer be cancerous.

"The technology licensed positions MolecuVax in an ideal situation given the rapidly expanding interest in cancer immunotherapy clinical trials. The great successes of CAR-T cells and checkpoint inhibitors have already saved many lives and are testimony to the efficacy of this approach to cancer. We aim to utilize the licensed technology to enter clinical trials, in part through our existing collaboration with the Pan Am Cancer Treatment Center⁵, as well as our planned FDA Investigational New Drug (IND) submission," said Timothy Dixon, President and CEO of Therapeutic Solutions International.

This vaccine was developed at the Institute for Molecular Medicine in Huntington Beach, California by Michael Agadjanyan, Ph.D. D.Sc., Head of the Cancer Vaccines Laboratory and Anahit Ghochikyan, Ph.D., Head of the Alzheimer's Disease Vaccines Laboratory. The vaccine is important because it not only prevents onset of cancer, but can also be used in patients that have cancer, thus it is termed a "therapeutic vaccine". Additionally, the vaccine can be used as part of dendritic cell immunotherapy, which the inventors previously published as being "extremely effective" against breast cancer in animal models⁶.

"After working on the concept of selectively killing cancer by immunologically targeting BORIS / CTCFL for over a decade, it is with great excitement to see this work translated from a scientific hypothesis, to issued US and International patents, and now on the road to commercialization and to patients," said Thomas Ichim, Ph.D, Board Member of TSOI. "In the past I was honored to have co-authored publications on BORIS / CTCFL with Dr. Agadjanyan and researchers at the NIH on this technology⁷,⁸,⁹. Now leveraging the infrastructure and expertise of MolecuVax, the time towards its clinical entry is rapidly approaching".

About MolecuVax, Inc.
MolecuVax -- is a subsidiary of TSOI where the intellectual property surrounding immune-oncology is housed. On May 2, 2016 TSOI retired to the treasury of MVAX 62,500,000 common shares of our holdings in MVAX. After this retirement, we now own 37,500,000 common shares of MVAX. On May 3, 2016 MVAX issued 37,500,000 of its common shares to UNIVAX, LLC in conjunction with the licensing agreement announced today. See www.molecuvax.com for more information.

About Therapeutic Solutions International, Inc.
The Company's corporate website is www.therapeuticsolutionsint.com. Our new products can be viewed on www.projuvenol.com and products can be ordered at www.youcanordernow.com.

These Supplement products have not been evaluated by the United States Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any diseases.

Safe Harbor Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our SEC filings. To the extent that statements in this press release are not strictly historical, including statements as to product launch timing, revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future collaboration agreements, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.

¹ Loukinov et al. Proc Natl Acad Sci U S A. 2002 May 14;99(10):6806-11, http://www.ncbi.nlm.nih.gov/pubmed/12011441
² Asano et al. Oncotarget. 2016 Mar 8;7(10):11223-37. http://www.ncbi.nlm.nih.gov/pubmed/26849232
³ Alberti et al. PLoS One. 2015 Jul 17;10(7):e0132977.
⁴ Dougherty et al. Biochem Biophys Res Commun. 2008 May 23;370(1):109-12. http://www.ncbi.nlm.nih.gov/pubmed/18355444
⁵ http://cancerimmunotherapy.mx/web/
⁶ Mkrtichyan et al. Cell Immunol. 2011;270(2):188-97. http://www.ncbi.nlm.nih.gov/pubmed/21641588
⁷ Loukinov et al. J Cell Biochem. 2006 Aug 1;98(5):1037-43. http://www.ncbi.nlm.nih.gov/pubmed/16741971
⁸ Ghochikyan et al. J Immunol. 2007 Jan 1;178(1):566-73. http://www.ncbi.nlm.nih.gov/pubmed/17182597
⁹ Mkrtichyan et al. Gene Ther. 2008 Jan;15(1):61-4. http://www.ncbi.nlm.nih.gov/pubmed/17972923