Tyme Announces Encouraging Efficacy and Safety Data from First Human Study of SM-88 in Women with Metastatic Breast Cancer

•  Median overall survival of 35 months in 14 progressive metastatic breast cancer patients despite multiple lines of prior therapy (average 2.5 lines of systemic drug therapy prior to SM-88)

•  43 percent of patients demonstrated complete or partial responses while on monotherapy

•  Responses were seen across genetic profiles, including in triple-negative breast cancer patients (ER/PR/HER2-)

•  Three patients remain alive five years after starting SM-88, and one of these patients achieved a second objective tumor response after SM-88 re-treatment

•  Improvements in quality of life measures observed, including improved ECOG PS from average baseline of 1.8 to 0.6 after six weeks of SM-88 therapy

NEW YORK, November 6, 2017 — Tyme Technologies, Inc. (Nasdaq:TYME), today announced data from its First Human Study evaluating SM-88, the Company’s lead investigational compound, as monotherapy from enrolled breast cancer patients. SM-88 demonstrated clinical benefit in metastatic breast cancer patients without the serious toxicity often seen with many traditional chemotherapies. No drug-related serious adverse events were observed during SM-88 therapy, and all patients either improved or maintained quality of life as measured by the Eastern Cooperative Oncology Group Performance Status (“ECOG PS”).

Fourteen patients (47 percent) in the study had progressive metastatic breast cancer with a median ECOG PS of 2.0 (unable to carry out any work-related activities). Patients had an average of 2.5 prior lines of systemic drug therapy and 4.5 prior therapeutic lines, including systemic, surgical or radiation therapy. Patients presented diseases with varying genetic profiles (ER, PR, and HER2), including three patients with triple-negative breast cancer (TNBC).

RECIST Responses with SM-88 in Breast Cancer

The median tumor objective response rate (ORR) based on RECIST 1.1 criteria was 43 percent (6 of 14), including three (21 percent) complete responses. Five of the six ORR patients had failed prior systemic therapy with an overall average of 2.8 prior systemic treatments, or 6.5 total treatments including radiation and surgery, and entered the study with a median ECOG PS of 2.0. An additional five patients (36 percent) achieved stable disease with a median overall survival of 43 months, highlighting that traditional RECIST criteria may not fully capture the benefits of SM-88’s mechanism of action.

Benefits Across Genetic Subtypes of Breast Cancer

All patients in the SM-88 First Human Study had advanced late-stage breast cancer that included a range of different genetic profiles for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) expression. Overall, there were benefits observed across most patient groups, regardless of genetic disposition and despite some of the subgroups being small. All groups except for triple-positive (ER/PR/HER2+) breast cancer demonstrated at least one RECIST response.

“This broad activity is consistent with SM-88’s mechanism of action, which we believe leverages cancer’s fundamental metabolism and should be independent of these genotypic traits,” said Jonathan Eckard, Ph.D., Chief Scientific Affairs Officer of Tyme.

Impact of Subsequent Treatment, Including SM-88 Re-treatment

Of the 14 breast cancer patients in the study, three received further SM-88 treatment after initial therapy. Two of such patients initially experienced complete responses (CR) with SM-88 monotherapy and the third achieved stable disease (SD) based on RECIST 1.1 criteria.

•  Patient 1 achieved a CR after two months of continuous SM-88, followed by approximately one year of sporadic maintenance SM-88 monotherapy. Five months after stopping SM-88 therapy, the patient experienced disease progression and restarted SM-88 monotherapy. In 2015, the patient achieved a confirmed partial response after an additional nine months of SM-88 treatment. The patient is alive more than five years after starting SM-88 therapy.

•  Patient 2 achieved a CR following approximately two and a half months of SM-88 monotherapy. The patient experienced progressive disease approximately eight months after stopping treatment. In 2014, the patient restarted SM-88 monotherapy for approximately eight months and is alive more than five years after starting SM-88 therapy.

•  Patient 3 initially achieved SD during the study with SM-88 monotherapy, following approximately five months of treatment in 2012. Approximately eight months later in 2014, the patient experienced a recurrence and received approximately three weeks of SM-88 treatment. The patient’s disease has not progressed, and she is alive more than five and a half years after starting SM-88 therapy.

“It is encouraging that patients appear to maintain sensitivity to SM-88 even if they experience disease progression after initial treatment,” said Steve Hoffman, Chief Executive Officer of Tyme. “We’ll continue to explore optimal treatment durations in future studies with the objective to reduce disease recurrence. We believe the cancer’s continued sensitivity to SM-88 underscores the drug’s ability to target a fundamental metabolic process of cancer, potentially reducing selection for resistance to SM-88’s mechanism of action.”

Improvements in Eastern Cooperative Oncology Group Performance Status with SM-88

The average baseline ECOG PS for breast cancer patients in the study was 1.8, which improved to 0.6 following a single six-week cycle of SM-88. As previously reported, patients in the First Human Study with ECOG 2 at baseline had similar survival benefits compared to patients with better baseline performance.

 Indicating the importance of ECOG PS on prognosis, a recent study of 1,655 advanced cancer patients by the Princess Margaret Cancer Centre (Jang, R.W., et al. 2014: Simple Prognostic Model for Patients With Advanced Cancer Based on Performance Status. Journal of Oncology Practice) showed survival was approximately halved for each worsening ECOG PS level, with a median survival time of approximately four months for ECOG 2 patients. 

“Due to toxicity, many cancer therapies are only appropriate for higher-functioning cancer patients with an ECOG performance status of zero or one,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer of Tyme. “We look forward to potentially providing a meaningful alternative to the toxic therapies currently available to cancer patients, as improving the time and quality of patients’ lives are of the utmost importance to Tyme.”

For more information on ECOG PS, please visit http://ecog-acrin.org/resources/ecog-performance-status.

About Tyme

Tyme Inc. is a clinical-stage 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. Tyme’s lead clinical program, SM-88, is a first-in-class combination therapy in Phase II development for prostate cancer, and the Company is preparing to initiate an additional Phase II clinical trial in pancreatic cancer. For more information, visit www.tymeinc.com.

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 drug candidates (including SM-88), their clinical potential and non-toxic safety profiles, our drug development plans and strategies, our completed studies, 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 as “anticipates,” “believes,” “designed,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “would” and similar expressions intended to identify forward-looking statements. 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, 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 analysis, final results of additional clinical trials, or both, may be different from the preliminary data analysis and may not support further clinical development; 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; 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 12, 2017 (available at www.sec.gov). The data set forth in these updated analyses are not necessarily predictive of future patient or clinical data outcomes.

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

Tyme
Jonathan Eckard
Chief Scientific Affairs Officer
Email: jon.eckard@tymeinc.com

Investors:
ICR
Stephanie Carrington
Tel: +1 646 277 1282
Email: stephanie.carrington@icrinc.com

Media:
6 Degrees
Sarah Hall
Email: shall@6degreespr.com
Tel: +1 215 313 5638

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