On May 19, 2016 Syros Pharmaceuticals reported that preclinical data on its lead program, SY-1425, in genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) will be highlighted in an oral presentation at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 9-12 in Copenhagen, Denmark (Press release, Syros Pharmaceuticals, MAY 19, 2016, View Source [SID:1234512614]). The Company will also present new preclinical data on its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, SY-1365, in acute leukemia.

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SY-1425 in Novel Genomically Defined Subset of AML and MDS Patients Using its gene control platform, Syros identified a subset of AML and MDS patients whose tumors have a highly specialized regulatory region of non-coding DNA, known as a superenhancer, associated with the RARA gene. The super-enhancer associated with RARA is believed to lead to over-production of the RARα transcription factor, locking cells in an immature, undifferentiated and proliferative state. Treatment with SY-1425, an oral, potent and selective agonist of RARα, appears to promote differentiation of cancer cells with the RARA-associated super-enhancer, inhibiting the cancer’s growth. The oral presentation at EHA (Free EHA Whitepaper) will detail SY-1425’s mechanism of action as well as in vitro and in vivo data showing that a biomarker for the RARA super-enhancer discovered by Syros is predictive of response to treatment with SY-1425 in models of AML, including a survival benefit observed in the mice with the RARA biomarker when treated with SY-1425. Syros is on track to advance SY-1425 into a Phase 2 trial in mid-2016 in subsets of AML and MDS patients whose tumors are positive for the RARA biomarker.

Date & Time: Sunday, June 12, from 9-9:15 a.m. CEST Presentation Title: Super-Enhancer Analysis Defines Novel AML and MDS Sub-Types Sensitive to SY-1425, a Potent and Selective RARα Agonist Session Title: AML Biology – Novel Targeted Therapies Presenter: Michael R. McKeown, Ph.D., Senior Scientist, Syros Pharmaceuticals Abstract Number: S807 Location: Bella Center, Auditorium 2

CDK7 Inhibition as a Novel Treatment Strategy for Acute Leukemia
Certain cancers, including AML and acute lymphoblastic leukemia (ALL), are dependent on high and constant expression of transcription factors for their growth and survival and have been shown to be particularly responsive to selective inhibition of the transcriptional kinase CDK7. The poster presentation at EHA (Free EHA Whitepaper) details preclinical data demonstrating that SY-1365, the Company’s first-in-class selective and potent CDK7 inhibitor, preferentially kills cancer cells by inducing robust and dose-dependent apoptosis in acute leukemia cell lines while not inducing apoptosis in non-cancerous cells. The data also show that SY-1365 produces a significant survival benefit in patient-derived xenograft models of AML. Syros expects to advance SY-1365 into a Phase 1/2 trial in the first half of 2017 in patients with acute leukemia, including AML and ALL.

Date & Time: Saturday, June 11, from 5:30-7 p.m. CEST Presentation Title: First-in-Class CDK7 Inhibitor Induces Robust Apoptosis in Acute Myeloid Leukemia and Demonstrates Durable In Vivo Efficacy Session Title: Acute Myeloid Leukemia – Biology 3 Presenter: Yoon J. Choi, Ph.D., Senior Scientist, Syros Pharmaceuticals Abstract Number: P558 Location: Bella Center, Hall H, Poster Area

On May 19, 2016 OncoCyte Corporation (NYSE MKT: OCX), a developer of novel, non-invasive tests for the early detection of cancer, reported the abstract of data from a bladder cancer study that will be presented as a poster and also highlighted during a live panel discussion on June 6, 2016, during the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held in Chicago, Illinois (Press release, BioTime, MAY 19, 2016, View Source [SID:1234512597]).

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"Our bladder test results are highly encouraging and reflect the depth of quality diagnostics products in our robust pipeline," commented OncoCyte Chief Executive Officer William Annett. "There is a high unmet need for non-invasive tests for bladder cancer and our gene expression classifiers have been shown to provide superior sensitivity in a procedure that is less invasive to patients than the current standard of care. Our results indicate the feasibility of using a urine-based diagnostic test to detect urothelial carcinoma both in screening (hematuria) and recurrence settings."

The abstract entitled Derivation of Gene Expression Classifiers for the Non-invasive Detection of Bladder Cancer in the Hematuria and Recurrence Surveillance Populations, describes OncoCyte’s recent results in the development of a urine-based test for bladder cancer. The detection of bladder cancer is typically accomplished with a combination of cystoscopy and urine cytology, each with inherent limitations. Urine cytology lacks the desired level of sensitivity, whereas cystoscopy is relatively invasive for routine screening and recurrence surveillance. OncoCyte’s study describes the development of four gene expression classifiers (GECs) optimized for the non-invasive detection of both high-grade and low-grade urothelial carcinoma in patients presenting with hematuria or for bladder cancer recurrence surveillance. The results for high-grade screening, high-grade recurrence, low-grade screening and low-grade recurrence were all obtained from single urine samples utilizing four different algorithms. A multi-center study involving 241 patient urine samples was used in the development of this assay.

OncoCyte’s approach of sequential GECs optimized for the detection of high-grade and low-grade malignancies provides the necessary data to distinguish between these different types of lesions and benign conditions in a non-invasive manner. Low-grade urothelial carcinoma is usually a non-aggressive cancer, whereas high-grade urothelial carcinoma is more aggressive, invasive and causes significantly more cancer-related mortality than low-grade urothelial carcinoma.

The GEC optimized for the detection of high-grade urothelial carcinoma in patients presenting with hematuria performed, with a cross-validated ROC AUC of 0.93, while the low-grade performed with an AUC of 0.81. In the recurrence surveillance cohort, the detection of high-grade performed with an AUC of 0.81 and low-grade with an AUC of 0.64. The following table summarizes these results.

ROC AUCs

Low Grade High Grade
Screening (Hematuria) 0.81 0.93

Recurrence 0.64 0.81
"These data establishes the feasibility of our approach, and we look forward to continuing our larger, multicenter study to further validate these findings," added Karen B. Chapman, Ph.D., OncoCyte’s Vice President of Research, who led the study.

About Bladder Cancer

Bladder cancer has been projected to have the highest lifetime treatment costs per patient of all cancers. The high recurrence rate and ongoing invasive monitoring requirements drive the financial burden of this disease. The detection of bladder cancer in Hematuria and Recurrence patients is routinely accomplished with a combination of urine cytology and cystoscopy which is invasive, and lacks the desired level of sensitivity.

On May 19, 2016 AstraZeneca and its global biologics research and development arm, MedImmune, reported that they will provide an update on their extensive oncology pipeline at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, USA, on 3-7 June 2016 (Press release, AstraZeneca, MAY 19, 2016, View Source [SID:1234512562]).

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Highlights will include new data demonstrating the strength and versatility of AstraZeneca’s industry-leading line of DNA damage response (DDR) medicines in multiple types of cancer. New data will highlight the continued momentum behind AstraZeneca’s numerous immuno-oncology (IO) programmes, and showcase small-molecule developments including Tagrisso (osimertinib) in leptomeningeal (brain) disease and the highly-selective Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib, in chronic lymphocytic leukaemia (CLL).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "Oncology is a strategic priority for AstraZeneca because of the potential of our broad pipeline to offer transformational therapies in cancer care. At ASCO (Free ASCO Whitepaper), we will update on our next-generation portfolio focusing on DNA damage response as a breakthrough paradigm in cancer treatment, including new long-term overall survival data for Lynparza. Our increased commitment to DDR therapies complements developments in our exciting immuno-oncology pipeline, from which we are expecting clinical results over the coming year."

DDR: A promising scientific platform, a leading position for AstraZeneca

DDR is a term describing the network of cellular pathways that minimise the daily impact of DNA damage. Currently, many cancers are known to have defects in DDR pathways, which makes them dependent on and therefore, highly sensitive to inhibition of the remaining DDR pathways. Targeting DDR deficiencies to preferentially kill cancer cells, while minimising the impact on normal cells, has potential for more selective, better tolerated therapies to improve survival in multiple cancers.

AstraZeneca is developing a comprehensive pipeline of compounds that target molecular pathways across the DDR system. These include the PARP inhibitor Lynparza (olaparib); Wee1 inhibitor AZD1775, ATM inhibitor AZD0156; ATR inhibitor AZD6738, and Aurora B Kinase inhibitor AZD2811. These compounds act on different cell-cycle points to prevent tumour cells from reproducing.

At the ASCO (Free ASCO Whitepaper) congress, DDR presentations will highlight:

The potential for maintenance of DDR therapies as shown by Lynparza overall survival data from Study 19 in ovarian cancer (Abstract # 5501). This abstract has been selected as a "Best of ASCO (Free ASCO Whitepaper)" abstract.
Opportunities for combination approaches with DDR and immuno-oncology therapies as shown in a Phase I study of the PD-L1 inhibitor, durvalumab, in combination with Lynparza or a VEGFR inhibitor, cediranib, in women’s cancers (Abstract # 3015)
The importance of selecting patients with a DDR pathway defect using the right diagnostic tool (abstract #4041)
The potential of DDR therapies against multiple biological DDR targets in different tumour types, with studies of the highly-selective WEE1 inhibitor, AZD1775, in advanced high-grade serous ovarian cancer (Abstract # TPS5610), squamous cell carcinoma of the head and neck (SCCHN) (Abstract # TPS6106), advanced solid tumours (Abstract # TPS2608) and glioblastoma (GBM) (Abstract # 2008)
Immuno-Oncology: Robust development momentum on track for read-outs in H1 2017

AstraZeneca is leading in a number of first-line studies with its IO strategy, where combined PD-L1 and CTLA-4 blockade – through the combination of durvalumab and tremelimumab – may address a significant unmet medical need for cancer patients who may not benefit from PD-1 pathway drugs in monotherapy.

Key updates include presentations covering pre-clinical data, late-stage trials and biomarker research:

Early study results of durvalumab monotherapy in urothelial bladder cancer from Phase Ib Study 1108 (Abstract # 4502)
Final results from a Phase III study of tremelimumab in mesothelioma (Abstract # 8502)
New study results on safety and clinical activity of durvalumab as first-line treatment in non-small cell lung cancer (NSCLC) (Abstract # 9029)
Ongoing investigation of the potential synergistic effects of durvalumab and the CTLA-4 inhibitor, tremelimumab, in bladder cancer (DANUBE trial – Abstract # TPS4574) and SCCHN (KESTREL trial – Abstract # TPS6101)
Enhanced understanding of PD-L1 biomarker expression in relation to primary versus metastatic tumours and sample age (Abstract # 3025)
Tagrisso in brain metastasis; acalabrutinib in CLL

AstraZeneca’s strong heritage in developing innovative targeted small molecules was underscored by the recent approval of Tagrisso as the first indicated treatment for EGFR T790M mutation-positive metastatic NSCLC in the US, EU and Japan. At ASCO (Free ASCO Whitepaper), new data will highlight the importance of Tagrisso activity in leptomeningeal disease through its ability to penetrate the blood-brain barrier. Further presentations will show the growing role of circulating tumour DNA (ctDNA) testing for diagnosis and treatment monitoring.

Key updates will also include presentation on the potential of our potent, highly-selective BTK inhibitor, acalabrutinib, in chronic lymphocytic leukaemia (CLL):

Data from the BLOOM study of Tagrisso in patients with leptomeningeal disease as a complication of EGFRm-metastatic NSCLC (Abstract # 9002)
Intensive plasma ctDNA profiling in experimental trials to identify markers of acquired drug resistance (Abstract # 11530)
Acalabrutinib – preliminary results from a first-line study as first-line therapy in CLL (Abstract # 7521) and in a Phase II study in combination with pembrolizumab in metastatic pancreatic cancer (Abstract # 4130)

On May 19, 2016 (GLOBE Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP) (Cyclacel or the Company), reported the publication of an abstract selected for an oral presentation on Phase 1 data of an orally administered, combination regimen of seliciclib and sapacitabine in 67 patients with advanced solid tumors at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Cyclacel, MAY 19, 2016, View Source [SID:1234512573]).

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Abstract: 2503
Title: Phase I study of sapacitabine and seliciclib in patients with advanced solid tumors
Date/Time: Monday, June 6, 2016 9:00 a.m. to 9:12 a.m. CDT
Location: E354b
Session Title: Developmental Therapeutics — Clinical Pharmacology and Experimental Therapeutics
Authors: SM Tolaney1, J Hilton1, JM Cleary1, L Gandhi1, EL Kwak1, JW Clark1, A Wolanski1, T Bell1, SJ Rodig3, JH Chiao2, D Blake2, G Shapiro1
1Dana-Farber Cancer Institute, Boston, MA; Massachusetts General Hospital Cancer Center, Boston, MA; 2 Cyclacel Ltd, Dundee, United Kingdom; 3 Brigham and Women’s Hospital, Boston, MA.

The abstract can be accessed through the ASCO (Free ASCO Whitepaper) website, www.asco.org.

On May 19, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "the Company"), reported the availability online of an abstract titled "Intralesional rose bengal for treatment of melanoma" to be presented as a poster at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") being held in Chicago June 3-7, 2016 (Press release, Provectus Pharmaceuticals, MAY 19, 2016, View Source [SID:1234512598]).

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To see this abstract, visit: View Source

The poster for the abstract, ID: TPS9600, is scheduled for presentation June 4, 2016, running from 1:00-4:30 Central Daylight Time.