On September 27, 2021 TYME Technologies, Inc. ("TYME" or the "Company") (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported that the first patient has been dosed in the Phase II OASIS trial in patients with metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative ("HR+/HER2-") breast cancer who previously received a CDK4/6 inhibitor regimen being conducted by Georgetown University (NCT04720664) at several MedStar Health hospitals. (MedStar Health is Georgetown’s academic clinical partner (Press release, TYME, SEP 27, 2021, View Source;Breast-Cancer-After-Treatment-with-a-CDK46-Inhibitor [SID1234590323]).)

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"Metastatic breast cancer is still an incurable disease and represents the second-leading cause of cancer death in women.2 The sobering statistics speak to the urgent need to find novel effective therapies that address this difficult-to-treat cancer. As this important trial begins, we are encouraged by the results in breast cancer patients from our prior first-in-human study and compassionate use program, which showed broad anti-tumor activity, including complete responses. We believe the compelling data support our strategic decision to further evaluate oral SM-88 in this setting, and we are hopeful that we will repeat the promising early activity. If so, we believe an effective drug with SM-88’s demonstrated tolerability profile would offer patients an attractive treatment option, while maintaining quality of life," said Richie Cunningham, Chief Executive Officer of TYME.

"We are pleased to be collaborating with Georgetown University to work toward transforming the treatment landscape for these metastatic HR+/HER2- patients. Dosing the first patient is a critical milestone in advancing oral SM-88 as a potential treatment option prior to chemotherapy for this patient population. This is a significant opportunity for TYME, and we look forward to providing updates as the OASIS trial progresses," concluded Cunningham.

The Phase II OASIS Trial

The OASIS clinical trial is an investigator-initiated multicenter Phase II single-arm, prospective open-label study of oral SM-88 used with methoxsalen, phenytoin, and sirolimus ("MPS") in metastatic HR+/HER2- breast cancer who have received a prior CDK4/6 inhibtor regimen. The study is designed to determine efficacy, defined as the overall response rate ("ORR") of this investigational treatment. It is designed as a two-stage trial, initially enrolling 30 patients, with potential expansion up to a total of 50 patients without concurrent cancer therapies. The primary endpoint is RECIST v1.1 tumor response; collection of cell-free DNA from patients will also occur at several time points in their treatment. If anti-tumor activity or a signal is observed among the first 30 patients, the trial may be expanded to confirm the findings.

With this trial, the Company is also incorporating mechanism-of-action and biomarker research, both preclinically and clinically. Preclinically, the Company is working with a Georgetown laboratory on SM-88’s effect in breast cancer models, including models of CDK4/6 inhibitor resistance. Clinically, the Company is collecting cell-free DNA samples from patients at multiple timepoints in their treatment and through progression to possibly identify biomarkers that could further inform future development work.

CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells’ protein synthesis, leading to a breakdown of the cancer’s key defenses and cell death. In clinical trials, SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma, 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 Breast Cancer

According to the American Cancer Society, in 2021 in the United States, approximately 1 in 8 women will be diagnosed with invasive breast cancer in their lifetime, and 1 in 39 women will die from the disease. Breast cancer is the most commonly diagnosed cancer in women, with approximately 280,000 women diagnosed in the U.S. annually and more than 3.8 million breast cancer survivors in the United States today. In the United States, HR+/HER2- represents 73% of diagnoses and is the largest subtype of breast cancer.