TRACON Pharmaceuticals Presents Data From Phase 2 Trial Of TRC102 And Temodar® In Patients With Recurrent Glioblastoma At Society For Neuro-Oncology Annual Meeting

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

Astellas to Present New Data on Gilteritinib in Multiple Populations of FLT3 Mutation-Positive Acute Myeloid Leukemia (AML) Patients at the 2018 American Society of Hematology (ASH) Annual Meeting

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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.

vTv Therapeutics to Present at the 30th Annual Piper Jaffray Healthcare Conference

On November 19, 2018 vTv Therapeutics Inc. (Nasdaq: VTVT) reported that company management will present a corporate overview at the Piper Jaffray 30th Annual Healthcare Conference on Tuesday, Nov. 27, 2018 at 2:10 p.m. ET in New York City (Press release, vTv Therapeutics, NOV 19, 2018, View Source;p=irol-newsArticle&ID=2377689 [SID1234531441]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation can be accessed here and will be archived for 30 days following the presentation at www.vtvtherapeutics.com.

vTv Therapeutics is a clinical-stage biopharmaceutical company engaged in the discovery and development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical drug candidates led by programs for the treatment of Alzheimer’s disease and diabetes as well as treatment of inflammatory disorders.

Agilent Technologies Reports Fourth-Quarter Fiscal Year 2018 Financial Results

On November 19, 2018 Agilent Technologies, Inc. (NYSE: A) reported revenue of $1.29 billion for the fourth-quarter ended October 31, 2018, up 9 percent year over year (up 9 percent on a core basis(1)) (Press release, Agilent, NOV 19, 2018, http://www.agilent.com/about/newsroom/presrel/2018/19nov-gp18063.html [SID1234531466]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Fourth-quarter GAAP net income was $195 million, or $0.61 per share. Last year’s fourth-quarter GAAP net income was $177 million, or $0.54 per share.

"The Agilent team delivered an outstanding quarter to wrap up the fiscal year with revenues and earnings per share ahead of expectations," said Mike McMullen, Agilent CEO and President. "Our performance this quarter caps off an excellent 2018 as we achieved our highest annual core growth rate and profitability since becoming a stand-alone life sciences company in 2014."

"During the quarter we continued our investment in growth introducing new and differentiated products and services," continued McMullen. "We leveraged our strong balance sheet completing several acquisitions to further strengthen our portfolio. We also returned over $600 million to shareholders through stock buybacks and dividends this year.

"We enter fiscal 2019 with momentum. Our focus remains on executing our shareholder value creation model to deliver superior earnings growth."

Financial Highlights

Life Sciences and Applied Markets Group

Fourth-quarter revenue of $597 million from Agilent’s Life Sciences and Applied Markets Group (LSAG) grew 8 percent year over year (up 9 percent on a core basis(1)), with broad-based strength across major end markets, platforms and regions. LSAG’s operating margin for the quarter was 25.9 percent. Full-year revenue of $2.3 billion grew 9 percent year over year (up 7 percent on a core basis(1)). LSAG’s operating margin for the year was 24.1 percent.

Agilent CrossLab Group

Fourth-quarter revenue of $441 million from Agilent CrossLab Group (ACG) grew 9 percent year over year (up 9 percent on a core basis(1)). Demand was excellent across both services and consumables. ACG’s operating margin for the quarter was 24.7 percent. Full-year revenue of $1.7 billion grew 11 percent year over year (up 8 percent on a core basis(1)). ACG’s operating margin for the year was 23.3 percent.

Diagnostics and Genomics Group

Fourth-quarter revenue of $256 million from Agilent’s Diagnostics and Genomics Group (DGG) grew 9 percent year over year (up 5 percent on a core basis(1)) led by pharma growth and strong demand for genomics and NASD products. DGG’s operating margin for the quarter was 23.3 percent. Full-year revenue of $943 million grew 10 percent year over year (up 5 percent on a core basis(1)). DGG’s operating margin for the year was 18.9 percent.

2019 First Quarter and Full Year Outlook

For fiscal year 2019, Agilent expects revenue of $5.13 billion to $5.17 billion, representing growth of 4.4 to 5.2 percent and core growth of 5.0 to 5.5 percent(1). Full-year 2019 non-GAAP earnings of $3.00 to $3.05 per share(3). The guidance is based on October 31, 2018 currency exchange rates.

Agilent expects first-quarter 2019 revenue in the range of $1.265 billion to $1.280 billion, representing growth of 4.4 to 5.7 percent and core revenue growth of 4.5 to 5.5 percent(1). First-quarter 2019 non-GAAP earnings are expected to be in the range of $0.71 to $0.73 per share(3).

New Share Repurchase Program

Agilent’s Board of Directors approved a new share repurchase program authorizing the purchase of up to $1.75 billion of common stock. The 2018 share repurchase program commences on November 21, 2018, replacing the previous program.

The number of shares to be repurchased and the timing of any repurchases will depend on factors such as the share price, economic and market conditions, and corporate and regulatory requirements. The share repurchase program may be suspended, amended or discontinued at any time.

Conference Call

Agilent’s management will present more details about its fourth-quarter FY2018 financial results on a conference call with investors today at 1:30 p.m. (Pacific Time). This event will be webcast live in listen-only mode. Listeners may log on at www.investor.agilent.com and select "Q4 2018 Agilent Technologies Inc. Earnings Conference Call" in the "News & Events Calendar of Events" section. The webcast will remain available on the company’s website for 90 days.

Additional information regarding financial results can be found at www.investor.agilent.com by selecting "Financial Results" in the "Financial Information" section.

In addition, a telephone replay of the conference call will be available at approximately November 19, 2018 at 4:30 p.m. (Pacific Time) after the call and through November 26 by dialing +1 855-859-2056 (or +1 404-537-3406 from outside the United States) and entering pass code 6519506.

The adjustment for taxes excludes tax benefits that management believes are not directly related to on-going operations and which are either isolated or cannot be expected to occur again with any regularity or predictability. For the three months and year ended October 31, 2018 and 2017, management uses a non-GAAP effective tax rate of 18.0%.

We provide non-GAAP net income and non-GAAP net income per share amounts in order to provide meaningful supplemental information regarding our operational performance and our prospects for the future. These supplemental measures exclude, among other things, charges related to asset impairments, amortization of intangibles, business exit and divestiture costs, transformational initiatives, acquisition and integration costs, pension settlement gain, gain on step acquisition of Lasergen, NASD site costs, special compliance costs, and adjustment for Tax Reform.

Asset impairments include assets that have been written down to their fair value.

Business exit and divestiture costs include costs associated with business divestitures.

Transformational initiatives include expenses associated with targeted cost reduction activities such as manufacturing transfers including costs to move manufacturing due to new tariffs and tariff remediation actions, small site consolidations, legal entity and other business reorganizations, insourcing or outsourcing of activities. Such costs may include move and relocation costs, one-time termination benefits and other one-time reorganization costs. Included in this category are also expenses associated with company programs to transform our product lifecycle management (PLM) system, human resources and financial systems.

Acquisition and Integration costs include all incremental expenses incurred to effect a business combination. Such acquisition costs may include advisory, legal, accounting, valuation, and other professional or consulting fees. Such integration costs may include expenses directly related to integration of business and facility operations, the transfer of assets and intellectual property, information technology systems and infrastructure and other employee-related costs.

Pension settlement gain resulted from transfer of the substitutional portion of our Japanese pension plan to the government.

Gain on step acquisition of Lasergen resulted from the measurement at fair value of our equity interest held at the date of business combination.

NASD site costs include all the costs related to the expansion of our manufacturing of nucleic acid active pharmaceutical ingredients incurred prior to the commencement of commercial manufacturing.

Special compliance costs include costs associated with transforming our processes to implement new regulations such as the EU’s General Data Protection Regulation (GDPR), revenue recognition and certain tax reporting requirements.

Other includes certain legal costs and settlements in addition to other miscellaneous adjustments.

Adjustment for Tax Reform primarily consists of an estimated provision of $499 million for U.S. transition tax and correlative items on deemed repatriated earnings of non-U.S. subsidiaries and an estimated provision of $53 million associated with the decrease in the U.S. corporate tax rate from 35% to 21% and its impact on our U.S. deferred tax assets and liabilities. The taxes payable associated with the transition tax, net of tax attributes, on deemed repatriation of foreign earnings is approximately $426 million, payable over 8 years.

Our management uses non-GAAP measures to evaluate the performance of our core businesses, to estimate future core performance and to compensate employees. Since management finds this measure to be useful, we believe that our investors benefit from seeing our results "through the eyes" of management in addition to seeing our GAAP results. This information facilitates our management’s internal comparisons to our historical operating results as well as to the operating results of our competitors.

Our management recognizes that items such as amortization of intangibles can have a material impact on our cash flows and/or our net income. Our GAAP financial statements including our statement of cash flows portray those effects. Although we believe it is useful for investors to see core performance free of special items, investors should understand that the excluded items are actual expenses that may impact the cash available to us for other uses. To gain a complete picture of all effects on the company’s profit and loss from any and all events, management does (and investors should) rely upon the GAAP income statement. The non-GAAP numbers focus instead upon the core business of the company, which is only a subset, albeit a critical one, of the company’s performance.

Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies.

The preliminary non-GAAP net income and diluted EPS reconciliation is estimated based on our current information.

Income from operations reflect the results of our reportable segments under Agilent’s management reporting system which are not necessarily in conformity with GAAP financial measures. Income from operations of our reporting segments exclude, among other things, charges related to asset impairments, amortization of intangibles, business exit and divestiture costs, transformational initiatives, acquisition and integration costs, pension settlement gain, gain on step acquisition of Lasergen, NASD site costs, and special compliance costs.

Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies.

We compare the year-over-year change in revenue excluding the effect of recent acquisitions and divestitures and foreign currency rate fluctuations to assess the performance of our underlying business.

(a) The constant currency year-over-year growth percentage is calculated by recalculating all periods in the comparison period at the foreign currency exchange rates used for accounting during the last month of the current quarter, and then using those revised values to calculate the year-over-year percentage change.

(b) The dollar impact from the current quarter currency impact is equal to the total year-over-year dollar change less the constant currency year-over-year change.

The preliminary reconciliation of GAAP revenue adjusted for recent acquisitions and divestitures and impact of currency is estimated based on our current information.

We compare the year-over-year change in revenue excluding the effect of recent acquisitions and divestitures and foreign currency rate fluctuations to assess the performance of our underlying business.

(a) The constant currency year-over-year growth percentage is calculated by recalculating all periods in the comparison period at the foreign currency exchange rates used for accounting during the last month of the current quarter, and then using those revised values to calculate the year-over-year percentage change.

(b) The dollar impact from the current year currency impact is equal to the total year-over-year dollar change less the constant currency year-over-year change.

The preliminary reconciliation of GAAP revenue adjusted for recent acquisitions and divestitures and impact of currency is estimated based on our current information.

Immuno-Oncology Presentation, dated November 2018

On November 19, 2018 Pieris Pharmaceuticals, Inc presented its Immuno-Oncology Presentation 2018 (Presentation, Pieris Pharmaceuticals, NOV 19, 2018, View Source [SID1234531426]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!