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Clinical Stage Oncology Biotech Leverages Active Ingredient in Abortion Pill to Induce Immunity to Cancer ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI), announced today that its Subsidiary Company Res Nova Biologics, successfully treated four advanced cancer patients with FloraStilbene™. The patients had no adverse events from drug administration and clinical signals of tumor response were observed. All patients have been followed-up with for more than three months. FloraStilbene™ is a drug comprising of a proprietary formulation of the abortion pill’s active ingredient (RU486) and pterostilbene. The drug is manufactured by Compounding Pharmacy Cure Stat1 and is available by prescription under Right To Try. Previously, the Company has demonstrated efficacy of FloraStilbene in stimulating immune responses in animal models of various cancers, with an emphasis on triple negative breast tumor models2. The use of pterostilbene for cancer immunotherapy was patented by Therapeutic Solutions International in 20173, subsequent to which, numerous independent groups have shown the ability of this compound to block prostate4, breast5, melanoma6, glioma7, and lung cancers8. “This is a major step forward in Res Nova’s development plan for FloraStilbene™. These data, combined with existing preclinical and animal studies will serve as the basis for future clinical trials which will provide the basis for FDA sales approval,” said Dr. James Veltmeyer, Chief Medical Officer and the Physician who administered the drug. “From an ethical perspective, we are proud to have the support of several major leaders of the Pro-Life Movement including Bishop Joseph L Coffey (of the Military Archdiocese)9 and Dr. George Delgado (Inventor of the Abortion Pill Reversal) who sit on the Company’s Advisory Board10.” “The brilliant founders of Res Nova, with a miraculous stroke of genius, are turning a drug that destroys life into a 'weapon' that destroys cancer to saves lives,” said Deacon Keith Esshaki, Member of the Company’s Advisory Board. “The rapid translation of FloraStilbene™ from a laboratory discovery to a compounded drug speaks volumes to the power of the team that Ms Ramos has assembled,” said Timothy Dixon, President and CEO of Therapeutic Solutions International. “Through leveraging relationships and resources provided by TSOI, we anticipate accelerated availability of FloraStilbene™ to the multitude of drug resistant cancer patients.” “Breast cancer is a major epidemic for which novel treatments and research directions are urgently needed. We are thankful to our colleagues but most importantly to the brave patients who participated in this study, which we anticipate will be the foundation for a paradigm shifting approach to this dreadful disease,” said Famela Ramos, President and CEO of Res Nova Bio, Inc. 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 . 1 Therapeutic Solutions International Spin-Off Res Nova Bio Partners with Cure Stat Rx to Manufacture First in Class Breast Cancer Immunotherapy Product FloraStilbene™ (yahoo.com) 2 Therapeutic Solutions International Subsidiary Res Nova Bio Inc Discovers New Mechanism of Action for Breast Cancer Immunotherapy Adjuvant FloraStilbene™ | BioSpace 3 US9682047B2 - Augmentation of oncology immunotherapies by pterostilbene containing compositions - Google Patents 4 Inhibition of miR-20a by pterostilbene facilitates prostate cancer cells killed by NK cells via up-regulation of NKG2D ligands and TGF-β1down-regulation: Heliyon 5 Differential Anticancer Activity of Pterostilbene Against Three Subtypes of Human Breast Cancer Cells | Anticancer Research (iiarjournals.org) 6 Pterostilbene supresses inflammation-induced melanoma metastasis by impeding neutrophil elastase-mediated thrombospondin-1 degradation – ScienceDirect 7 Pterostilbene promotes mitochondrial apoptosis and inhibits proliferation in glioma cells | Scientific Reports (nature.com) 8 Pterostilbene exerts anticancer activity on non-small-cell lung cancer via activating endoplasmic reticulum stress | Scientific Reports (nature.com) 9 Bishop Coffey - Archdiocese for the Military, USAArchdiocese for the Military, USA (milarch.org) 10 Res Nova Biologics Recruits Abortion Pill Reversal Founder to Scientific Advisory Board (yahoo.com)

SHANGHAI, Oct. 24, 2023 /PRNewswire/ -- BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "BioRay") announced on October 7th that its clinical trial application for BR105 Injection has received approval from the United States Food and Drug Administration (FDA). This marks BioRay's first project to receive FDA IND approval. BR105 Injection is a humanized monoclonal antibody developed in-house, specifically targeting SIRPα. It can recognize common genotypes of SIRPα (V1, V2, V8) and disrupt the interaction between SIRPα and its ligand CD47, thereby abolishing the "don't eat me" signal between macrophage and tumor cell. This activation enables macrophages to perform their tumor-phagocytosing function, achieving anti-tumor immunotherapy. The efficacy of targeting CD47/SIRPα has been validated in various tumor models, and previous clinical studies suggest that targeting the CD47/SIRPα signaling pathway may have a broad spectrum of anti-tumor activity. CD47/SIRPα-targeted therapy has shown positive results in acute myeloid leukemia, lymphoma, head and neck squamous cell carcinoma, gastric cancer, and other malignancies. Compared to CD47, the expression of SIRPα is more specific. By targeting SIRPα instead of CD47, BR105 exhibits enhanced safety profile intrinsically. Additionally, CD47 interacts with other proteins, such as TSP-1, SIRPγ, leading to a more complex signaling network and increased risks in corresponding targeted therapies. Therefore, developing SIRPα antibodies to block the CD47/SIRPα signaling pathway is a more promising strategy in oncology drug development. Currently, no medicine targeting SIRPα has been approved in the global market. Phase I clinical trial of BR105 Injection is currently on-going in China, and preliminary result has confirmed its good clinical safety. "Based on our global strategic layout of innovative drugs, the FDA IND approval of BR105 Injection as our first FDA approved clinical trial project is a significant milestone for BioRay. Currently, fierce competition exists in the global innovative drug discovery and development arena, where innovation is indispensable. BioRay continues to invest heavily in innovation and build a rich pipeline of innovative biopharmaceuticals," said by Dr. Wei Zhu, Chief Medical Officer of BioRay. "We look forward to transforming these pipelines and BR105 into best-in-class therapies in autoimmunology and immuno-oncology, benefiting an increasing number of patients both in China and overseas." SOURCE BioRay Pharmaceutical Co., Ltd

CAMBRIDGE, Mass., July 13, 2023 /PRNewswire/ -- Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, is pleased to announce that a complete response patient (CR) in Glioblastoma (GBM) cohort from first in human study VT1021-01 (NCT03364400) has now completed 3 full years of dosing with VT1021. When joining the study in July of 2020 the patient had a recurrent case of GBM. After multiple cycles of dosing with VT1021, the tumor was no longer detectable. Now, after 3 years of dosing the tumor continues to be undetectable on regular MRI scans. "The Vigeo Team continues to be encouraged at how well this patient has responded to VT1021 therapy" said Jing Watnick, COO of Vigeo Therapeutics, "Vigeo is currently testing the potential of VT1021 therapy in both newly diagnosed and recurrent GBM patients as part of an ongoing phase II/III clinical study (NCT03970447)." VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME). Tsp-1 blocks the CD47 immune checkpoint and engages CD36 to induce tumor cell apoptosis, inhibit angiogenesis, activate cytotoxic T cells (CTL), and reprogram macrophages from the M2 to M1 phenotype. Vigeo recently reported the outcome of a GBM cohort of recurrent subjects treated with VT1021 as a single agent in which a group of 22 evaluable subjects with rGBM, 3 had a complete response (CR), 1 had a partial response (PR), and 6 had stable disease (SD) with an average study duration of over 120 days. Historically, rGBM patients have a response rate of less than 5% and a median progression free survival of 48 days. About VT1021 Vigeo's lead asset, VT1021, is a first-in-class dual-modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis in tumors and endothelial cells, and increases the M1:M2 macrophage ratio. VT1021 achieves these biological effects via stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that that are associated with poor response to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are more susceptible to attack from the body's immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. About Vigeo Therapeutics Based in Cambridge, MA, Vigeo Therapeutics is a clinical-stage immuno-oncology company pioneering novel cancer therapies. The company is building a first-in-class drug development pipeline being led by VT1021, its dual-modulating compound that blocks the CD47 immune checkpoint and reprograms CD36 mediated activities. VT1021 has been investigated as a single agent in a Phase I/II clinical trial in patients with glioblastoma, pancreatic cancer and other solid tumors, and is currently undertaking late-stage clinical studies. For more information visit vigeotx.com