Tyme Inc. (TYME) Highlights New Preclinical Data Showing Anti-Cancer Effect of Cancer Metabolism-Based Pipeline Candidate, TYME-18

Tyme Technologies, Inc. (NASDAQ: TYME) announced new preclinical findings that describe the unique anti-cancer effects of its cancer metabolism-based pipeline candidate, TYME-18, that are being presented at the American Association for Cancer Research 2020 Virtual Meeting from June 22 to June 24, 2020.

TYME’s CMBTs are proprietary investigational compounds that leverage cancer’s altered metabolism and associated vulnerabilities to specifically disrupt fundamental cellular processes. TYME-18 is focused on leveraging decreasing pH levels and toxic tumor environment, while compromising lipid barriers and membrane proteins.

"We believe the opportunity for a safe and effective intra-tumoral agent like TYME-18 could be substantial for both cancer patients with tumors that are difficult or impossible to surgically resect, as well as situations where radiotherapy is considered high-risk," said Dr. Giuseppe Del Priore, MD, Chief Medical Officer at TYME. “TYME-18’s preclinical development is ongoing with the goal of identifying an IND pathway during 2020.”

TYME-18 has been evaluated in three preclinical mouse xenograph studies, each with encouraging efficacy. To investigate the effects of the individual components of TYME-18 on tumor growth, an in vivo xenograft experiment was conducted using the mouse colon cell line CT26 (Figure 1). A minor reduction in tumor cell mass was observed in response to TYME-18’s surfactant component alone, with a statistically significant response observed in the group treated with TYME-18 (surfactant component + sulfonic acid component)1,2 (p=0.001) (Figure 1). The preclinical data showed that 91.6% (11/12) of mice treated with TYME-18 were tumor-free by study end compared with tumor growth of approximately 16 times mean growth in the control group. None of the mice in the control or surfactant alone group achieved tumor-free status, although 25% (3/12) of the surfactant alone group had tumor shrinkage from baseline. Results from this study replicate and confirm observations in preliminary TYME-18 studies.

While not a primary focus of the preclinical studies, TYME-18 did not show local or systemic toxicities in treated mice.

Results of this preclinical study were presented at the American Association for Cancer Research Virtual Meeting from June 22 to June 24, 2020. The poster is available on our website (www.tymeinc.com/data-publications).

Details for the TYME-18 poster presentation are as follows:

Title: In Vivo Mouse Model Data Demonstrating Reduction in Tumor Cell Proliferation Following Intra-tumoral Administration of TYME-18

Authors: John Rothman1, Steve Hoffman2, Jonathan Eckard2, Giuseppe Del Priore2, Allyson Ocean3, Martin Fernandez-Zapico4

Institutions: (1) Varent Life Sciences, New York, NY, (2) TYME Inc., New York, NY, (3) Weill Cornell Medical Center, New York, NY, (4) Mayo Clinic, Rochester, MN

Virtual Session Date: June 22-24, 2020
Virtual Session Location: AACR e-poster website
Abstract Number: 20-A-6858

About TYME-18

TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component2. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. 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.

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.

You May Also Be Interested In

• Visa (V) stock rises as Q2 earnings, revenue come ahead of estimates
• Vertex (VERX) Announces Pricing of Upsized $300 Mln Convertible Senior Notes Offering
• Apple (AAPL) announces 'Let Loose,' a special online event to be held in May