On May 15, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that two posters will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Meeting to be held from June 22 to June 24, 2020 (Press release, TYME, MAY 15, 2020, View Source [SID1234558209]).

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TYME’s presentations include findings from preclinical data on two CMBTs: SM-88 and TYME-18. TYME’s CMBTs are proprietary investigational compounds that leverages cancer’s altered metabolism and associated vulnerabilities to specifically disrupt fundamental cellular processes. This can include altering protein synthesis, increasing oxidative stress, decreasing pH levels, and compromising protein or lipid barriers. In addition, CMBTs may target select survival mechanisms including autophagy, as well as altering the tumor microenvironment to improve immune recognition of the cancer. In clinical trials, SM-88 (racemetyrosine) has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma cancers with minimal serious grade 3 or higher drug-related adverse events.

The first abstract describing SM-88 showed that mice receiving SM-88 monotherapy demonstrated significantly reduced tumor size as compared to control mice. The preclinical data suggest SM-88 monotherapy increases oxidative stress from reactive oxygen species (ROS) and interferes with autophagy, an important survival mechanism utilized by cancer cells. Both of these effects may be associated with SM-88’s intended mechanism of specifically disrupting cancer cell metabolism with a dysfunctional amino acid. Additionally, preclinical data supports that SM-88 modulates tumor immunity, specifically tumor associated macrophages (TAMs) reducing immunosuppressive (M2) macrophages that have demonstrated a critical role in overall tumor immune dynamics.

Separately, new data will be presented for TYME’s CMBT compound, TYME-18. TYME-18 is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions.

Additional information on the meeting can be found on the AACR (Free AACR Whitepaper) website at: View Source

Details for the poster presentations are as follows:

Title: In Vitro and In Vivo Anticancer effects of D/L-alpha-metyrosine (SM-88), a Novel Metabolism-Based Therapy
Virtual Session Date: June 22-24, 2020
Virtual Session Location: AACR (Free AACR Whitepaper) e-poster website
Abstract Number: 20-A-7314

Title: In Vivo Mouse Model Data Demonstrating Reduction in Tumor Cell Proliferation Following Intratumoral Administration of TYME-18
Virtual Session Date: June 22-24, 2020
Virtual Session Location: AACR (Free AACR Whitepaper) e-poster website
Abstract Number: 20-A-6858

About Autophagy

Autophagy plays a housekeeping role in removing misfolded or aggregated proteins, clearing damaged organelles, such as mitochondria, endoplasmic reticulum and peroxisomes, as well as eliminating intracellular pathogens. Thus, autophagy is generally thought of as a survival mechanism, although its deregulation has been linked to non-apoptotic cell death.

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed 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, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

About TYME-18

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 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.