On November 20, 2018 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that management will participate in three upcoming investor conferences: the Piper Jaffray 30th Annual Healthcare Conference, the Evercore ISI HealthCONx Conference, and the BMO Prescriptions for Success Conference (Press release, CymaBay Therapeutics, NOV 20, 2018, View Source [SID1234531499]).

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Piper Jaffray 30th Annual Healthcare Conference
Date: Tuesday, November 27
Time: 12:00pm Eastern Time
Location: Lotte New York Palace Hotel

Evercore ISI HealthCONx Conference
Date: Wednesday, November 28
Time: 9:05am Eastern Time
Location: Boston Harbor Hotel

BMO Prescriptions for Success Conference
Date: Wednesday, December 12
Time: 11:40am Eastern Time
Location: Mandarin Oriental NYC
To access a live webcast and subsequent archived recording of each presentation, please visit the "Events" section on the CymaBay website at View Source

On November 19, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported that it will present results from two large studies of the Oncotype DX Breast Recurrence Score test at the 2018 San Antonio Breast Cancer Symposium (SABCS), which will be held December 4-8 (Press release, Genomic Health, NOV 19, 2018, View Source [SID1234531438]). The study findings reinforce the value of the Oncotype DX test in optimizing treatment and outcomes in patients with both node-negative and node-positive early-stage breast cancer. Presentations include:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Results from a large population-based clinical outcomes study based on the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute (NCI), the premier source of cancer statistics in the United States. To provide long-term (nine years) real-world evidence for both prognosis and chemotherapy benefit, the study assessed breast cancer-specific survival in patients with node-negative and node-positive disease who were treated based on their Oncotype DX Breast Recurrence Score test results.
Analysis of 500 early-stage breast cancer patients age 40 or younger to further the understanding of the value of the Oncotype DX test in guiding chemotherapy treatment decisions. The analysis is based on a multi-center prospective cohort study led by Dana-Farber Cancer Institute investigators in Boston.
Complete results from both studies will be announced in accordance with the SABCS embargo policy. Following are details for the two poster presentations:

Abstract: P3-11-02Poster: Breast cancer specific mortality in patients with node-negative and node-positive breast cancer guided by the 21-gene assay: A SEER-genomic population-based studyAuthors: Hortobagyi GN, Shak S, Sledge GW Jr., Winer EP, Albain KS, Mamounas EP, Jakubowski DM, Petkov VI, Wolmark NLocation: Hall 1Date and Time: Thursday, December 6, 7-9 a.m. CST
Abstract: P2-08-07Poster: Prognostic impact of the 21-gene Recurrence Score assay among young women with node-negative and node-positive early-stage breast cancerAuthors: Poorvu PD, Gelber SI, Rosenberg SM, Ruddy KJ, Tamimi RM, Collins LC, Peppercorn J, Schapira L, Borges VF, Come SE, Warner E, Jakubowski DM, Russell C, Winer EP, Partridge AHLocation: Hall 1Date and Time: Thursday, December 6, 7-9 a.m. CST
About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. With more than 950,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeDX.com or www.MyBreastCancerTreatment.org.

On November 19, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that management will present at the 30th Annual Piper Jaffray Healthcare conference that is being held at the Lotte New York Palace hotel, November 26-29 (Press release, Actinium Pharmaceuticals, NOV 19, 2018, View Source [SID1234531439]). The live webcast of the presentation will be available on Actinium’s investor relations webpage at: View Source or by clicking on the following link: View Source;tp_key=f710d7f814. Details of Actinium’s presentation are as follows:

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Date: Tuesday, November 27, 2018
Time: 2:10 PM ET
Location: Harlem Track – Kennedy 2, 4th Floor
Venue: Lotte New York Palace

Conference attendees may schedule a meeting with Actinium’s management by contacting Steve O’Loughlin, Actinium’s Principal Financial Officer, [email protected].

On November 19, 2018 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported its data from the Company’s Phase 2 study of TRC102 and Temodar (temozolomide) in patients with recurrent glioblastoma at the Society for Neuro-Oncology (SNO) annual meeting, taking place in New Orleans (Press release, Tracon Pharmaceuticals, NOV 19, 2018, View Source [SID1234531440]). TRC102 is a small molecule inhibitor of the base excision repair (BER) pathway that causes resistance to Temodar chemotherapy in preclinical tumor models.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In an oral presentation by Dr. Lisa Rogers, Director of Medical Neuro-Oncology at Cleveland Medical Center, entitled, "Phase 2 Trial of Temozolomide and TRC102, Base Excision Repair Inhibitor, in Bevacizumab Naive Glioblastoma at First Recurrence", safety and efficacy data were presented from patients who received TRC102 and Temodar at the time of recurrence following first line therapy with Temodar chemotherapy and radiation therapy.

The combination of TRC102 and Temodar was tolerable, but did not meet the primary efficacy endpoint of demonstrating objective responses by Response Assessment in Neuro-Oncology criteria in the initial 19 enrolled patients, most of whom were treated at Cleveland Clinic. Two patients (10.5%) demonstrated evidence of clinical benefit and met the secondary endpoint of progression free survival (PFS) beyond 6 months. Both patients who demonstrated PFS for more than 11 months remain alive over 30 months following treatment initiation with TRC102 and Temodar for recurrent glioblastoma. PFS of greater than 11 months was associated with N-methylpurine DNA glycosylase expression, a biomarker that initiates the BER pathway of resistance that is inhibited by TRC102.

"We recognized that the primary endpoint of objective response in the Phase 2 trial of Temodar and TRC102 represented a high efficacy hurdle, that of resensitizing recurrent glioblastoma patients to Temodar treatment. We were encouraged to see certain patients demonstrate prolonged clinical benefit that was associated with evidence of activation of the BER pathway of resistance that is inhibited by TRC102," said Dr. Charles Theuer, President and CEO of TRACON Pharmaceuticals. "Our efforts will continue to focus on identifying possible biomarkers that are prognostic of response to TRC102 in four ongoing clinical trials supported by the National Cancer Institute."

About TRC102

TRC102 is a novel, clinical stage small molecule inhibitor of the base excision repair pathway that is implicated in resistance to alkylating and antimetabolite chemotherapy. TRC102 has been combined safely with Temodar, Alimta (pemetrexed) and Fludara (fludarabine) in phase 1 trials and is being studied in a broad program of clinical trials supported by the National Cancer Institute, including a Phase 2 trial of TRC102 and Temodar in patients with solid tumors, a Phase 2 trial of TRC102 and Alimta in patients with non-small cell lung cancer, a Phase 1 trial of TRC102 with chemotherapy and radiation therapy in patients with non-small cell lung cancer, and a Phase 1 trial of TRC102 with Alimta and cisplatin in patients with solid tumors. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

On November 19, 2018 Astellas Pharma Inc. (TSE: 4503) (President and CEO: Kenji Yasukawa, Ph.D. "Astellas") reported it will present new data in Acute Myeloid Leukemia (AML) research at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 1-4, 2018 in San Diego, California (Press release, Astellas, NOV 19, 2018, View Source [SID1234531523]). Among the data being presented are updated results from a Phase 1 study of gilteritinib in combination with induction and consolidation chemotherapy in patients with newly diagnosed AML.

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At ASH (Free ASH Whitepaper), collaborating researchers from renowned academic medical centers will present data exploring the use of gilteritinib to treat patients across the FLT3 mutation-positive (FLT3mut+) AML care continuum—from newly diagnosed to relapsed or refractory patients—and on healthcare resource utilization in the current treatment of FLT3mut+ AML. Additionally, Astellas will sponsor two sessions in ASH (Free ASH Whitepaper)’s Friday Satellite Symposia program prior to the meeting.

"Patients with this life-threatening disease have long had limited treatment options. Developing new therapies that help address unmet medical needs and provide physicians with new tools to treat patients in multiple stages of the FLT3mut+ AML journey is our priority," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "We’re pleased to present new data at ASH (Free ASH Whitepaper) examining the potential for gilteritinib to treat diverse groups of FLT3mut+ AML patients, and to share research on healthcare resource utilization among this patient population."

The following abstract will be presented during an oral presentation session:

Title: Updated Results From a Phase 1 Study of Gilteritinib in Combination With Induction and Consolidation Chemotherapy in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) (Abstract 564)

Presenter: Keith W. Pratz, M.D., John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

Session Date/Time: Monday, December 3, 8:15 a.m. PST
Location: Manchester Grand Hyatt, Seaport Ballroom F
In addition to the oral presentation, Astellas will present the following abstracts during poster sessions:

Title: Impact of Minimal Residual Disease and Achievement of Complete Remission/Complete Remission With Partial Hematologic Recovery (CR/CRh) on Overall Survival Following Treatment With Gilteritinib in Patients With Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) With FLT3 Mutations (Abstract 1458)

Lead Author: Mark J. Levis, M.D., Ph.D., John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

Session Date/Time: Saturday, December 1, 6:15 p.m. PST
Location: San Diego Convention Center, Hall GH
Title: Multicenter, Open-Label, 3-Arm Study of Gilteritinib, Gilteritinib Plus Azacitidine, or Azacitidine Alone in Newly Diagnosed FLT3 Mutated (FLT3mut+) Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Induction Chemotherapy: Findings From the Safety Cohort (Abstract 2736)

Lead Author: Jordi Esteve, M.D., Ph.D., Hospital Clínic de Barcelona, Barcelona, Spain

Session Date/Time: Sunday, December 2, 6:00 p.m. PST
Location: San Diego Convention Center, Hall GH
Title: Treatment Patterns and Healthcare Resource Utilization (HRU) in Patients With Relapsed/Refractory (R/R) FLT3-Mutated (FLT3mut) and FLT3-Wild Type (FLT3wt) Acute Myeloid Leukemia (AML): A Multi-Country Medical Chart Study (Abstract 4824)

Presenter: James D. Griffin, M.D., Dana-Farber Cancer Institute, Boston

Session Date/Time: Monday, December 3, 6:00 p.m. PST
Location: San Diego Convention Center, Hall GH
Astellas will sponsor the following symposia during the pre-meeting Friday Satellite Symposia:

Title: Moving Toward Precision Therapy for Patients With AML: Clinical Challenges and Future Directions

Session Date/Time: Friday, November 30, 12:30 p.m. PST
Location: Marriott, San Diego Ballroom
Title: Novel Therapies for AML: Expanding Future Options

Session Date/Time: Friday, November 30, 12:30 p.m. PST
Location: San Diego Convention Center, Room 1AB
About Gilteritinib
Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in approximately one-third of patients with AML. Further, gilteritinib has also demonstrated inhibition of the AXL receptor in AML cell lines. Astellas is currently investigating gilteritinib in various AML patient populations through several Phase 3 trials. Visit AstellasAMLTrials.com to learn more about ongoing gilteritinib clinical trials.

Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and potentially commercialize gilteritinib.

The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development), which is included in this press release are not intended to constitute an advertisement or medical advice.