News | March 7, 2019

TYME Continues To Expand Pipeline Of Cancer Metabolism-Based Therapies To Potentially Benefit Patients With Difficult-To-Treat Cancers

Targeting IND-enabling program for TYME-18 in 2H2019

New York City, NY (GLOBE NEWSWIRE) - Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), announced the addition of a new pre-clinical development candidate, TYME-18, to the Company’s pipeline of medical innovation.

TYME-18 is an investigational cancer metabolism-based therapy (CMBT) designed for intra-tumoral injection to increase the permeability of cancer cells. The direct delivery of TYME-18 to the tumor target, in contrast to conventional systemic therapies, aims to localize the effect of the agent to the tumor, while limiting systemic effects and minimizing damage to healthy tissues. TYME-18, like SM-88, was designed to target a physiological result of the Warburg Effect – the acidic tumor microenvironment – and has demonstrated potent responses with a well-tolerated safety profile within a pre-clinical cancer model.

TYME believes its growing pipeline of investigational CMBTs represents a promising new class of disease-altering therapies that provide an innovative approach to treating a variety of cancers. The precise mechanism of action of CMBTs in the treatment of cancers is still being defined and may differ among types of cancers depending on their underlying pathobiologies. CMBTs have similar intra-tumoral effects involving an increase in oxidative stress and the disruption of protein synthesis, which disarms cancer cells by compromising their protective mucin layer. However, individual CMBTs may demonstrate a unique potency profile that potentially indicates selective applicability for distinct diseases and conditions.

In initial preclinical xenograft mouse studies, TYME-18 was able to completely resolve over 90 percent (11/12 mice) of established colorectal tumors within 12 days versus an average of over 600 percent growth in the control animals. Additionally, there was no detected necrosis of the normal tissue surrounding the tumor site or other identified toxicities in the animals treated with TYME-18. TYME plans to continue with the development of TYME-18 in solid tumors and to provide details of an IND-enabling program in the second half of 2019.

“Our goal is to provide a new approach that can be used to reduce or eliminate difficult-to-reach tumors that may not be accessible surgically in a way that spares healthy tissue,” said TYME CEO Steve Hoffman. “TYME may offer oncologists, as well as surgeons, new treatment tools for patients with remote or inoperable tumors based on a better understanding of ways to induce cancer death through the use of cancer metabolism-based therapies.”

SM-88 and TYME-18 are investigational therapies that are not approved for any disease indication.

About TYME-18
TYME-18 is a cancer metabolism-based investigational cancer therapy designed for the intra-tumoral delivery of medicine 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.

About SM-88
SM-88 is an investigational oral therapy that uses a proprietary dysfunctional 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 response across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

About Tyme Technologies
Tyme Technologies, Inc., is an emerging biotechnology company developing cancer therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.

Forward-Looking Statements/Disclosure Notice
In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our pipeline candidates SM-88, TYME-18 and their clinical potential and non-toxic safety profiles, our pipeline development plans and strategies, ongoing and planned clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words (including their use in the negative) or by discussions of future matters such as the development and potential commercialization of our lead pipeline candidates and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, that the information is of a preliminary nature and may be subject to change; uncertainties inherent in research and development, including the ability to achieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final Phase II data may differ from prior study data or preliminary Phase II data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 and TYME-18 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88 and TYME-18; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on June 13, 2018, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission (available at www.sec.gov).

The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments.

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SOURCE: Tyme Technologies, Inc.