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Tiziana Life Sciences #TILS presents StemPrintER, a superior prognostic test compared to Oncotype DX to predict breast cancer
Tiziana Life Sciences announces presentation of StemPrintER, a superior prognostic test as compared to Oncotype DX to predict breast cancer
· StemPrintER Outperforms Oncotype DX in analysis with 800+ samples from ER+/HER2- postmenopausal breast cancer patients
· SPARE Model is up to 40-50% more accurate than standard clinical markers in analysis with 1800+ samples for prediction of distant metastasis
New York/London – May 29, 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces today results, from a poster selected for discussion session at the American Society of Clinical Oncology (ASCO) Virtual Conference, demonstrating the superiority of StemPrintER stem cell based genomic prognostic tool versus the market leader, Oncotype DX, in predicting recurrence in ER+/HER2- postmenopausal breast cancer patients. A second poster describing results on prediction of distant recurrence using a next generation StemPrintER model, named SPARE, presented in a separate ASCO session, showed even more refined accuracy than standard clinicopathological markers in predicting risk of distant recurrence. Both posters were authored by a team of scientists from the European Institute of Oncology in Milan, and the head-to-head comparison of StemPrintER with Oncotype DX was conducted in collaboration with the Royal Marsden Hospital and Queen Mary University in London.
As announced previously, the Company intends to demerge its StemPrintER and SPARE (together “StemPrintER”) genomics-based personalized medicine businesses into a separate company and effect a capital reduction to facilitate the spin-out and listing of StemPrintER as an independent entity.
Major Highlights of Results
1. The first poster, which was also part of a discussion session, “Comparison of StemPrintER, a Novel Biology-based Genomic Predictor of Distant Recurrence in Breast Cancer, with Oncotype DX in the TransATAC cohort,” shows that StemPrintER
· Outperforms Oncotype DX in 10-year risk prediction in more than 800 ER+/HER2- postmenopausal breast cancer patients in the analysis, including in lymph node-negative (N0) and 1 to 3 lymph node-positive (N1-3) patients1
· Significantly (p<0.0001) stratifies high vs. low risk groups when adjusted for clinical parameters as expressed by clinical treatment scores (CTS)
2. The second poster, “Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer patients,” demonstrates that the next-generation StemPrintER Risk Score (SPARE) model
· Shows approximately 20% superiority to the traditional clinicopathological parameters, as expressed by the CTS, in providing prognostic information for the more than 1,800 patients analyzed and in certain populations was demonstrated to be up to 40-50% more accurate.
· Investigators found that SPARE added substantial prognostic information to CTS, but the inverse was not proven to be the case.
__________________________
1 N0 means nearby lymph nodes do not contain cancer. Numbers after the N (such as N1, N2, and N3) might describe the size, location, and/or the number of nearby lymph nodes affected by cancer. The higher the N number, the greater the cancer spread to nearby lymph nodes.
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person who arranged for the release of this information is Dr Kunwar Shailubhai, the Company’s Chief Executive Officer and Chief Scientific Officer.
About ER+/Her2- breast cancer
Endocrine receptor-positive (ER+) breast cancers constitute the majority of breast cancer cases (~75-80%) and display remarkable variability in clinical behaviour. This heterogeneity makes prognosis and therapy response often challenging to predict using the standard clinicopathological features of the tumor. Although the overall prognosis for this group of patients is good, a significant proportion (>20%) of these women will experience distant recurrence in the first 10 years post-surgery. For ER+ patients who also have a negative HER2 status (HER2-), the standard of care is endocrine therapy with the addition of adjuvant chemotherapy in those patients considered to be at risk of recurrence according to clinicopathological parameters. However, it has become apparent that these parameters are often insufficient to predict risk of recurrence in ER+/HER2- BC patients, and, as a consequence, a significant proportion of these patients are either over- or under-treated. Multigene prognostic tests can assist decision making on treatments, differentiating low risk patients who could be safely SPARE chemotherapy from higher risk patients who might benefit from chemotherapy.
About StemPrintER/SPARE
StemPrintER, and its next generation derivative SPARE that combines StemPrintER with two clinical markers, namely lymph nodal status and tumor size, in a more refined risk model, is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, ER+/HER2- breast cancer patients, based on the detection of 20 cancer stem cell markers normalized to 4 housekeeping genes. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a dual listed (NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn’s Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn’s Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.
Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
Contacts:
Tiziana Life Sciences plc
United Kingdom:
Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray / Jo Turner +44 (0)20 7213 0883
Shore Capital (Broker)
Antonio Bossi / Fiona Conroy +44 (0)20 7601 6125
United States:
Investors
CORE IR
ir@coreir.com
Media
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com
Tiziana Life Sciences #TILS – Demerger of StemPrintER Genomics-Based Personalized Medicine business as a separate listed company
New York and London, May 22, 2020 – Tiziana Life Sciences plc (NASDAQ: TLSA, AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer, inflammatory diseases and COVID-19, today announces that it intends to demerge its StemPrintER and SPARE (together “StemPrintER”) genomics-based personalized medicine businesses into a separate company and effect a capital reductionto facilitate the spin-out and listing of StemPrintER as an independent entity.
Following the Company’s recent announcement concerning the trial conducted by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company’s stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients, the Company’s Board, which has been considering options for StemPrintER for some time, is pleased to announce that they consider that the results of the trial and the progress made substantiate the viability of StemPrintER as having the potential to be a standalone business and accordingly intend to proceed with steps for a spin-out, by way of demerger, and listing on a public market of a new independent genomics-based personalized medicine company focused on the StemPrintER business.
The rationale of this decision is that, as a standalone genomics-based personalized medicine company and separate legal entity, StemPrintER could:
- Secure separate financial resources, with the goal of enabling accelerated development of the StemPrintER genomic test;
- Separate StemPrintER from Tiziana’s biotechnology and pharmaceutical businesses so it may focus on the personalized medicine market; and
- Allow Shareholders to benefit from both Tiziana’s rapidly developing drug portfolio and the standalone value of StemPrintER as it progresses through its own development milestones and the path to commercialization and allow shareholders to receive the maximum potential value from StemPrintER as a standalone entity.
The Board is taking the necessary preliminary steps in preparation for a potential spin-out, including the incorporation of a new subsidiary to hold the relevant assets. The Company will also put proposals to shareholders at the Annual General Meeting to obtain the approval necessary for a capital reduction which will be required to implement the demerger.
Notwithstanding that the required approval for the capital reduction will be sought, these considerations remain at an early stage and there can be no guarantee that the demerger will be completed. The approval of the capital reduction will enable the Board, in due course, to declare distribution in specie of shares in the new StemPrintER entity to existing Tiziana shareholders.
No record date has yet been set for the entitlement to shares in the new StemPrintER entity as a number of technical, legal and accounting processes need to be completed before the demerger can be formally put to shareholders of Tiziana for approval. For the avoidance of doubt StemPrintER will remain a group business until such time as shareholders formally approve proposals for a demerger.
For shareholder interest and information, StemPrintER will be the subject of a poster discussion session (https://meetinglibrary.asco.org/record/185144/abstract) on 29 May 2020 titled “Comparison of StemPrintER, a novel stem cell biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort” at the virtual annual meeting of American Society of Clinical Oncology 2020 (ASCO20).
Further announcements will be made at the appropriate time.
About StemPrintER and SPARE
StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.
For more information go to http://www.tizianalifesciences.com
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
THE PERSON WHO ARRANGED FOR THE RELEASE OF THIS INFORMATION IS DR KUNWAR SHAILUBHAI, THE COMPANY’S CHIEF EXECUTIVE AND CHIEF SCIENTIFIC OFFICER.
Contacts:
Tiziana Life Sciences plc
United Kingdom:
|
Tiziana Life Sciences plc Gabriele Cerrone, Chairman and founder |
+44 (0)20 7495 2379 |
|
Cairn Financial Advisers LLP (Nominated adviser) Liam Murray / Jo Turner |
+44 (0)20 7213 0883 |
|
Shore Capital (Broker) Antonio Bossi / Fiona Conroy |
+44 (0)20 7601 6125 |
United States:
Investors –
CORE IR
(516) 222-2560
ir@coreir.com
Media –
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com
Tiziana Life Sciences #TILS – ASCO Conference – StemPrintER Study Presentation
Tiziana Life Sciences Announces Data Demonstrating StemPrintER’s Superiority Compared to OncotypeDX in Providing Prognostic Information to Conventional Clinical Parameters in Breast Cancer Patients in Poster Discussion Session at the American Society of Clinical Oncology (ASCO) Virtual Conference
Additional data to be presented validating the SPARE Model for Distant Metastasis Prediction utilizing the Company’s StemPrintER Platform
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
New York/London – May 14, 2020 – Tiziana Life Sciences plc (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, announces today that a new study will be presented by scientists from the European Institute of Oncology in Milan in collaboration with the Royal Marsden Hospital and Queen Mary University in London on the Company’s stem cell biology-based genomic tool, StemPrintER, for the prediction of disease recurrence in breast cancer patients during a poster discussion session at the American Society of Clinical Oncology (ASCO) Virtual Conference. The study demonstrates greater refinement and superiority of StemPrintER over current market leader Oncotype DX in delivering prognostic information as part of the therapeutic decision-making process in ER+/HER2- breast cancer patients. An additional abstract from the scientists at the European Institute of Oncology will be presented in a separate poster session, which details a further refined risk model, the SPARE model, based on the combination of StemPrintER with clinical parameters for distant metastasis prediction. Both abstracts, became available May 13, 2020, while the posters and discussion session will be held during The American Society of Clinical Oncology (ASCO) Virtual Conference May 29-31, 2020.
Each of these studies independently provides significant additional information on the value of StemPrintER — and its derivative SPARE (detailed below) — as clinical tools to aid personalized therapeutic decision-making in women with ER+/HER2- breast cancer. Of particular note is the comparative precision of StemPrintER over Oncotype DX in predicting the potential recurrence of certain types of breast cancer following treatment. The two studies highlight the importance of the stem cell approach to develop a potentially powerful prognostic tool to predict breast cancer prognosis.
Abstract #1020, “Comparison of StemPrintER, a novel biology-based genomic predictor of distant recurrence in breast cancer, with Oncotype DX in the TransATAC cohort,” is an independent validation of the prognostic value of StemPrintER in a cohort of more than 800 luminal ER+/HER2- postmenopausal breast cancer patients from the international TransATAC study and a head-to-head comparison of the prognostic power of StemPrintER with OncotypeDx. Results provide independent validation of StemPrintER as a potentially powerful prognostic tool to stratify patients for the risk of early or late recurrence independently of other clinicopathological parameters. Importantly, the study also shows that StemPrintER is superior to OncotypeDX in the prediction of 10-year recurrence risk in all patients, as well as in N0 and N1-3 patients. The study further demonstrates that StemPrintER is capable of outperforming OncotypeDX in providing additional prognostic information to the standard clinicopathological parameters.
Abstract #1057, “Integration of the stem cell biology-based genomic tool, StemPrintER, with clinicopathological parameters for the prediction of distant recurrence in ER+/HER2- breast cancer (BC) patients,” develops a more refined risk model for distant metastasis prediction, which combines StemPrintER with tumor size (pT) and nodal status (pN). The new model is termed SPARE (StemPrintER for Personalized Adjuvant Therapy in Endocrine Receptor-Expressing Patients) and, in the analysis of a consecutive-retrospective cohort of more that 1,800 ER+/HER2- breast cancer patients with 15-year complete follow-up from the European Institute of Oncology (IEO) in Milan, revealed to be an even more powerful tool, compared to the original StemPrintER for predicting early and late distant metastasis risk independently of standard clinical parameters.
“These data sets demonstrate that StemPrintER has the potential to become an essential prognostic tool that will help clinicians to tailor more or less aggressive therapy based on a more accurate risk assessment of disease recurrence compared to what we have seen to date,” added Dr. Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences. “This product also represents an important addition to our existing therapeutic pipeline as it opens Tiziana into the area of precision medicine, creating an entirely new business line beyond our current patented technology in offering new delivery mechanisms for monoclonal antibodies.”
About StemPrintER
StemPrintER is a multi-gene prognostic assay intended for the prediction of the risk of recurrence in luminal, estrogen receptor-positive HER2-negative breast cancer patients, based on the detection of 20 cancer stem cell markers. The assay has been evaluated in an initial retrospective validation study using a consecutive cohort of approximately 2,400 patients with breast cancer.
The person who arranged for the release of this information is Dr Kunwar Shailubhai, the Company’s Chief Executive Officer and Chief Scientific Officer.
About Tiziana Life Sciences
Tiziana Life Sciences plc is a dual listed (NASDAQ: TLSA & UK AIMS: TILS) biotechnology company that focuses on the discovery and development of novel molecules to treat human diseases in oncology, inflammation and infectious diseases. In addition to milciclib, the Company will be shortly initiating phase 2 studies with orally administered foralumab for Crohn’s Disease and nasally administered foralumab for progressive multiple sclerosis. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world. This phase II compound has potential application in a wide range of autoimmune and inflammatory diseases, such as Crohn’s Disease, multiple sclerosis, type-1 diabetes (T1D), inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. The company is accelerating development of anti-Interleukin 6 receptor (IL6R) mAb, a fully human monoclonal antibody for treatment of IL6-induced inflammation, especially for treatment of COVID-19 patients.
Receive news and updates from Tiziana Life Sciences plc by signing up to get email alerts at https://ir.tizianalifesciences.com.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
Contacts:
Tiziana Life Sciences plc
United Kingdom:
Gabriele Cerrone, Chairman and founder +44 (0)20 7495 2379
Cairn Financial Advisers LLP (Nominated adviser)
Liam Murray / Jo Turner +44 (0)20 7213 0883
Shore Capital (Broker)
Antonio Bossi / Fiona Conroy +44 (0)20 7601 6125
United States:
Investors
CORE IR
ir@coreir.com
Media
Jules Abraham
CORE IR
(917) 885-7378
julesa@coreir.com