TEST:

StemPrintER™

These data demonstrate that StemPrintER can be run reliably on FFPE tissue up to 14 years old. In addition, our laboratory has demonstrated that assay results are highly linear and reproducible. Additional studies are planned to build on preliminary surgical prediction data and determine whether the assay can meet the unmet need of identifying the ideal surgical intervention in patients with early-stage ER+/HER2- breast cancer.

"AccuStem Sciences, Inc...and EmeritusDX...announced the execution of an agreement wherein both companies will jointly manage scientific operations and R&D for AccuStem’s product portfolio...Initial plans as part of the collaboration will be to immediately focus on furthering the validation of AccuStem’s core offering, StemPrintER, for patients with breast cancer."

"AccuStem Sciences, Inc...signs further agreement with the IEO, one of the most renowned comprehensive cancer centers in Europe. This important milestone will support the company’s strategic vision following positive results from transATAC study where StemPrintER assay outperformed the current market leader in risk of recurrence testing for women with early stage breast cancer. With the extension of the StemPrintER licensing agreement, originally transferred with all rights and obligations from Tiziana Life Sciences, AccuStem and the IEO have established and refined goals on the timing of commercialization and have broadened the number of regulatory pathways to bring the test to market in the US and abroad."

"AccuStem Sciences, Inc...announced the establishment of a joint clinical collaboration agreement with University Hospitals...Per the terms of this agreement, University Hospitals will provide tissue samples with clinical outcomes to AccuStem for research purposes. The scope of the agreement covers a multitude of different cancers but will initially focus on breast cancer cases to support further validation of the StemPrintER test."

"AccuStem Sciences, Inc...announced a strategic plan to further develop and operationalize the StemPrintER assay...AccuStem has signed an agreement with a leader in the genomic testing space that will support further clinical validation of the StemPrintER with the goal of operationalizing the assay in their laboratory. The partnership will leverage the similarity in platforms, technologies and human capital at both companies."

"AccuStem Sciences, Inc...announced today that it is taking an extension of time to respond to a formality notice for application 17/907,601 with the US Patent and Trademark Office. The patent...covers a methodology combining the results of the 20-gene StemPrintER test with certain clinical factors to better stratify patients with early stage breast cancer according to their recurrence risk."

"AccuStem Sciences...announced today that the US Patent and Trademark Office has issued a new patent, No. 11,441,191, further strengthening the company’s foundation of intellectual property for its novel StemPrintER test. The patent...covers the methodology behind the 20-gene StemPrintER test which stratifies patients with early stage breast cancer according to their recurrence risk. The test is designed to measure the 'stemness' of tumors, or how much they behave like stem cells, which may indicate the likelihood of cancer progression and response to standard treatment modalities. Studies have shown that StemPrintER is highly prognostic, with 'high stemness' patients up to 4 times as likely to experience a distant recurrence as 'low stemness' patients."

"Tiziana Life Sciences Ltd.’s...former subsidiary, AccuStem Sciences, Inc...(formerly AccuStem Sciences Ltd.), today announced publication of new data in the European Journal of Cancer. Results demonstrate that StemPrintER is highly prognostic for risk of distant recurrence in women with breast cancer...The pivotal TransATAC study has been used to evaluate many of the commonly used breast cancer risk scoring assays, including OncotypeDX, Prosigna, EndoPredict and Breast Cancer Index...In this analysis, investigators demonstrated that patients with a StemPrintER Risk Score (SPRS) Low result had significantly better outcomes than patients with a SPRS High result. Patients with a SPRS Low result had a 5.8% risk of distant recurrence at 10 years versus 23.2% risk of distant recurrence in patients with a SPRS High result."

In postmenopausal ER+/HER2- breast cancer patients, SPRS provided more prognostic information than RS for DR when used alone or in combination with the CTS. The SPRS could therefore potentially identify high-risk patients, who might benefit from aggressive treatments, from low-risk patients who might safely avoid adjuvant chemotherapy or prolongation of endocrine therapy.

"SPARE represents a more refined clinical tool, compared to standard clinicopathological parameters, that could be used for personalized therapeutic decision making in ER+/HER2- BC patients. Research Funding: Italian Association for Cancer Research (AIRC)"

" The likelihood χ2 (LRχ2) and Kaplan-Meier survival analyses were used to assess prognostic information provided by SPRS, RS and the clinical treatment score (CTS) in 818 TransATAC patients treated with anastrozole or tamoxifen for 5 years. In ER+/HER2- TransATAC BC patients, SPRS was highly prognostic for DM and was superior to RS in providing additional prognostic information to conventional clinicopathological parameters. Research Funding: Italian Association for Cancer Research (AIRC), Cancer Research UK (CRUK)"