TYME Announces Abstract Selected for Publication at the 2021 American Society of Clinical Oncology Annual Meeting
TYME Technologies, Inc. (Nasdaq: TYME) announced that an abstract on its investigational therapy SM-88 will be published at the virtual ASCO Annual Meeting from June 4-8, 2021. The abstract, titled Phase II Study of SM-88 in Ewing’s and Other Sarcomas, focuses on promising results across 15 cancers with minimal serious adverse events noted. SM-88 is designed to disrupt cancer cell metabolism, potentially leading to cell death. It remains an investigational therapy and is not yet FDA approved.
- Abstract on SM-88 selected for publication at ASCO Annual Meeting.
- Encouraging tumor responses across 15 cancers reported.
- Minimal serious adverse events associated with SM-88.
- SM-88 is not FDA approved.
- Forward-looking statements suggest inherent risks in trial outcomes.
TYME Technologies, Inc. (Nasdaq: TYME) (the “Company” or “Tyme”), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), today announced that its abstract featuring data from the Company’s investigational therapy, SM-88, has been selected for publication at the American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually June 4-8, 2021.
Details about the abstract selected for publication can be found below:
Title: Phase II Study of SM-88 in Ewing’s and Other Sarcomas
Abstract Number: e23505
Authors: Giuseppe Del Priore, MD, MPH, Victoria S. Chua, Kitty Zheng, Ted Kim, Semmie Kim, Sant P. Chawla, MD
Session: Publication Only - Sarcoma
The Publication Only abstracts are under embargo until 5:00 p.m. ET on May 19, 2021. For more information about the Annual Meeting, please visit: asco.org.
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. SM-88 is an investigational therapy that is not approved for any indication in any disease.
About TYME Technologies, Inc.
TYME Technologies, Inc. is an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™) 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. With the development of TYME-18 and TYME-19, the Company believes that it is also emerging as a leader in the development of bile acids as potential therapies for cancer and viruses such as COVID-19. For more information, visit www.tymeinc.com. Follow us on social media: Facebook, LinkedIn, Twitter, YouTube and Instagram.
Forward-Looking Statements
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 drug candidates (including SM-88 and TYME- 18) and their clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned preclinical or clinical trials, including the proposed TYME-19 proof-of-concept study, preliminary data results and the therapeutic design and mechanisms of our drug candidates. The words “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” “anticipates,” and similar expressions (including their use in the negative) are intended to identify forward-looking statements. Forward-looking statements can also be identified by discussions of future matters such as: the effect of the novel coronavirus (COVID-19) pandemic and the associated economic downturn and impacts on the Company's ongoing clinical trials and ability to analyze data from those trials; the cost of development and potential commercialization of our lead drug candidate and of other new products; expected releases of interim or final data from our clinical trials; possible collaborations; and the timing, scope, status, objectives and strategy of our ongoing and planned trials; the success of management transitions; and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations and projections which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of our 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, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include but are not limited to: the severity, duration, and economic and operational impact of the COVID-19 pandemic; that the information is of a preliminary nature and may be subject to change; uncertainties inherent in the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply, and in the ability to achieve adequate start and completion dates, as well as uncertainties in clinical trial design and patient enrollment, dropout or discontinuation rates; 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 data from any clinical trials may differ from prior or preliminary study 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 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; the ability of TYME and its collaborators to develop and realize collaborative synergies; 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 May 22, 2020, 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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FAQ
What is the significance of the SM-88 abstract at ASCO 2021 for TYME Technologies?
When will the ASCO Annual Meeting occur, where TYME's SM-88 data will be presented?
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