TYME Presents Positive Circulating Tumor Cell Data

Tyme Technologies, Inc. recently reported encouraging data on circulating tumor cells (CTCs) and a correlation with decrease in risk of death using TYME’s lead candidate, oral SM-88 (racemetyrosine), in patients with metastatic pancreatic cancer. The data were presented at the AACR Special Conference on Pancreatic Cancer: Advances in Science and Clinical Care September 6-9, 2019, at the Westin Copley Place in Boston, MA.

CTCs have long been known to exist in cancer patients’ blood, with a clear correlation established between the number of CTCs and disease progression as previously reported by other authors in a number of cancer types including pancreas, prostate, and breast cancer.  CTC data from the TYME-88-PANC Phase II study using oral SM-88 in poor prognosis pancreatic cancer (PDAC) patients illustrate that there are efficacy correlates with overall survival (OS) beyond traditional RECIST responses. The clinical significance of CTCs has shown that the concentration of CTCs in patient’s blood correlates with poor prognosis, at baseline and throughout treatment, and may be a clinically relevant biomarker for patients with metastatic pancreatic cancer.

“These data reporting the use of SM-88 in PDAC illustrate that there are clear efficacy correlates with overall survival beyond traditional RECIST responses, including CTC measures. This is the second TYME study that has shown a CTC effect,” said Giuseppe Del Priore, MD, MPH, Chief Medical Officer at TYME. “The association between decreases in CTCs and overall survival had not been previously as well-documented prospectively in PDAC as compared to other tumor types. CTC reduction may be considered a potential tumor marker for patients treated for pancreatic cancer.  While still preliminary, we believe these data represent another important step forward in advancing cancer metabolism-based therapies for patients with metastatic pancreatic cancer.”

The ongoing multicenter open-label Phase 2 TYME-88-Panc study involved 49 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had significant disease-related morbidity before receiving TYME’s investigational agent SM-88. More than 80% of patients had received at least two prior lines of therapy. Of the 49 patients, 38 patients were evaluable for efficacy, as defined in the protocol. In this study, based on information available as of April 25, 2019, the median overall survival of evaluable patients (N=38) was 6.4 months. Certain efficacy indicators correlated with greater OS, including decreases in CTCs.

The measurement of CTCs continues to emerge as an important prognostic indicator in patients with pancreatic cancer. This is now the second TYME study in cancer patients showing that SM-88 reduces CTCs. In a previous study of patients with prostate cancer, SM-88 treatment was also associated with a reduction in CTC count¹. In the TYME-88-Panc study, the results of the evaluation of CTCs were very encouraging. TYME plans to study CTCs as a potential prognostic indicator in the TYME pivotal pancreatic study.

In the TYME-88-Panc study, the baseline of median CTCs in all evaluable patients was 144.6 CTCs/4mL. Patients with both absolute and relative decrease from baseline CTCs demonstrated greater OS. A median reduction of 63% in CTC burden was observed in evaluable patients. Those patients (10 of 24) with available results reaching an 80% reduction or greater in CTCs demonstrated a 60% decrease in risk of death (hazard ratio=0.40).

A RECIST clinical benefit rate (CBR) of stable disease or better was achieved by 44% of patients (11 of 25) with available imaging. Patients achieving stable disease or better demonstrated a statistically significant (p=0.02) improvement in survival with a 92% reduction in risk of death (hazard ratio=0.08). The CBR was durable, with the majority of these patients remaining in stable disease or better at more than 7 months after receiving treatment with SM-88.

The TYME-88-Panc research results are from an investigational study. SM-88 is not approved for the treatment of patients with any disease condition.

Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 8% and is less than 3% for those with advanced disease.² The median survival for patients in end-stage of the disease is approximately 3 months. There are two main types of pancreatic cancer – adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors.  Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% of all newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death for men and women in the United States.

SM-88 is an oral investigational modified proprietary 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 responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.

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.