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TYME and The Joseph Ahmed Foundation Announce Initiation of the HopES Phase II Trial Evaluating the Potential Benefits of SM-88 for Patients with High-Risk Sarcomas. The HopES trial is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following primary or palliative treatments for Ewing's sarcoma patients with a high risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. The Joseph Ahmed Foundation is providing funding and patient support for this investigator-initiated HopES Phase II trial of SM-88 in patients with previously-treated metastatic sarcomas. The primary objectives are to measure overall response, stable disease and progression free survival. Secondary objectives include duration of response, overall survival, clinical benefit rate using response evaluation criteria in solid tumors (RECIST v1.1), and incidence of treatment-emergent adverse events.

TYME-18 is a cancer metabolism-based investigational cancer therapy designed for the intra-tumoral delivery to increase the permeability of cancer cells while delivering a therapy that will have a selective cytotoxic effect on the tumor. TYME-18 is distinct in composition, but like TYME SM-88, it aims to enhance the susceptibility of a cancer to the highly acidic and toxic tumor microenvironment, while minimizing the impact to normal tissues. TYME Technologies Inc.

Patients and physicians can access TYMETRIALS on TYME Technologies Inc website for more information about ongoing SM-88 clinical trials. SM-88 is not approved for the treatment of patients with any disease condition. TYME remains dedicated to advancing its pipeline of proprietary Cancer Metabolism-Based Therapies (CMBTs™) for difficult-to-treat cancers. Our focus is to advance our research to reach patients in need around the world who experience advanced metastatic cancers and life-threatening rare diseases. Clinical trials are essential to our research and development work, through which we want to ensure that our medicines are better and safer. We strive to give cancer patients with limited treatment options hope for a longer, better life.

Patients and physicians can access TYMETRIALS on TYME Technologies Inc website for more information about ongoing SM-88 clinical trials. SM-88 is not approved for the treatment of patients with any disease condition.

TYME Cancer Metabolism-Based Therapies (CMBTs™), SM-88, is an oral investigational modified proprietary tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, both solid and liquid tumors, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious Grade 3 or higher adverse events. More information may be found on the TYME Technologies Inc. website.

TYME's lead candidate, oral SM-88 (racemetyrosine) is an oral, investigational cancer metabolism-based therapy that has demonstrated responses across 15 different cancers

SM-88 is a novel oral monotherapy that is used in investigational studies with three other drugs: methoxsalen, phenytoin, and sirolimus (hereafter, referred to as SM-88 used with MPS). SM-88 (D,L-alpha-metyrosine; racemetyrosine [USAN]) is a proprietary dysfunctional tyrosine derivative and is the backbone of SM-88 used with MPS. Tyrosine is a non-essential amino acid that is readily consumed by cancer cells but has shown minimal uptake by normal healthy cells. SM-88 is designed to be absorbed by the cancer cell as if it were a functional tyrosine, but after uptake, interrupt the processes of protein synthesis. Disrupting the protein synthesis also impedes key defenses of the cancer cell, making it vulnerable to oxidative stress and apoptosis. The key target we aim to disrupt within the cancer cell is mucin, specifically mucin 1, produced by the MUC1 oncogene. Mucin is highly overexpressed by most cancer cells and acts as a protective layer on the outside of each cancer cell, offering multiple defenses to the harsh tumor microenvironment and shielding it from the immune system. The internal environment of cancer cells is also harsh, with elevated levels of free radicals or reactive oxygen species (ROS) created from the altered metabolism that cancers utilize (aerobic glycolysis). MUC1 has also been shown to be important in balancing the elevated ROS by triggering the upregulation of key antioxidant defenses of the cell and preventing cancer from triggering its own death (apoptosis). Overall, SM-88’s disruption of the cancer cell’s protein synthesis further destabilizes an already vulnerable cell with a goal of triggering cell death and potentially immune recognition of the cancer cell.