Uncategorized – Page 16870 – 1stOncology™: Cancer Intelligence Service

Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2015 Financial Results and Recent Highlights

On March 10, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the fourth quarter and year ended December 31, 2015 (Press release, Sunesis, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147475 [SID:1234509464]). Loss from operations for the three months and year ended December 31, 2015 was $11.3 million and $39.3 million, respectively. As of December 31, 2015, cash, cash equivalents and marketable securities totaled $46.4 million.

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"In the fourth quarter, we achieved a top 2015 corporate milestone with the submission and validation of our Marketing Authorization Application in Europe for vosaroxin to treat relapsed/refractory AML," said Daniel Swisher, Chief Executive Officer of Sunesis. "We are committed to bringing this important new therapy to a patient population with so few options. We will be providing updates later this year on the progress in Europe and in other major regions, including North America."

Mr. Swisher added: "Another key milestone for Sunesis is the progress of our pipeline of kinase inhibitors representing targeted new approaches to the treatment of cancer. Soon, we expect to initiate clinical development of SNS-062, our differentiated non-covalent BTK inhibitor with a European Phase 1A clinical trial in healthy volunteers, followed by a Phase 1B/2 in B-cell malignancy patients later this year. We also look forward to seeing data from the ongoing multi-arm combination study for the Takeda-partnered pan-RAF inhibitor, TAK-580, and to advancing our PDK-1 inhibitor, SNS-229, through IND-enabling toxicology studies to an IND."

Fourth Quarter 2015 and Recent Highlights

Submission of Marketing Authorization Application for Vosaroxin for the Treatment of Acute Myeloid Leukemia (AML) in Europe. In December 2015, Sunesis submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Vosaroxin for the treatment of relapsed/refractory AML in patients aged 60 years and older. The application was validated by the EMA on December 31, 2015, confirming that the submission was complete and initiating the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The MAA, if authorized, provides a marketing license valid in all 28 EU member states.

Presentation of Results from MD Anderson Sponsored Trial in AML and Washington University Sponsored Phase 1/2 Trial of Vosaroxin in MDS at ASH (Free ASH Whitepaper) Annual Meeting. In December 2015, Sunesis presented results from an ongoing Phase 1B/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodyplastic syndrome (MDS), as well as results from a Washington University-sponsored Phase 1 trial of vosaroxin plus azacitidine in patients with myelodysplastic syndrome, at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida. The oral presentation, titled "Phase I/II Study of Vosaroxin and Decitabine in Newly Diagnosed Older Patients (pts) with Acute Myeloid Leukemia (AML) and High Risk Myelodyplastic Syndrome (MDS)" and the poster "A Phase I Study of Vosaroxin plus Azacitidine for Patients with Myelodysplastic Syndrome," are available on the Sunesis website at www.sunesis.com.

Partnership with Clinigen Group to Initiate Compassionate Use Program for Patients with AML. In December 2015, Sunesis initiated a global Compassionate Use Program for vosaroxin. The program is available to eligible patients diagnosed with relapsed or refractory acute myeloid leukemia (AML) and is being managed by Clinigen Group’s Idis Managed Access division.

First Patient Treated in Indiana University Study of Vosaroxin and Cytarabine in Adults Age 60 Years and Older With Previously Untreated AML. In December 2015, the first patient was treated in an investigator-sponsored study of vosaroxin and cytarabine in adult patients age 60 years and older with previously untreated acute myeloid leukemia (AML). The trial is being conducted at the Melvin and Bren Simon Cancer Center at Indiana University under the direction of Seyed Hamid Sayar, M.D., Assistant Professor of Clinical Medicine.

European Patent Covering Vosaroxin Combination Use in AML and Other Hematological Malignancies. In November 2015, the European Patent Office (EPO) granted European Patent No. 2 049 109 B1, claiming certain combined uses of vosaroxin and cytarabine, at doses of 10-120 mg/m2 and 5-1500 mg/m2, respectively, for the treatment of acute myelogenous leukemia and acute myeloblastic leukemia. The patent further provides for combinations of vosaroxin and cytarabine with other therapies, such as radiation, or other chemotherapeutics, including anti-cancer agents, in hematologic disorders, whether administered simultaneously or sequentially. Sunesis is proceeding to validate this patent in multiple EPO member states. The resulting national patents would expire in the third quarter of 2027, but could be eligible for supplementary patent term in EPO member states beyond this date. Related patent applications are pending in several countries, including the United States and Japan.

Poster Presentation of VALOR Responder Survival Analysis at the Chemotherapy Foundation Symposium. In November, Sunesis presented results from a responder survival analysis of the VALOR trial at the 2015 Chemotherapy Foundation Symposium (CFS) in New York City. The analysis examined the impact of complete remission status on overall survival. Results showed that CR status was the strongest independent predictor of overall survival in patients enrolled in the study, regardless of study arm, with median survival for patients in CR lasting more than 12 months longer than patients without a CR. Furthermore, the addition of vosaroxin to cytarabine demonstrated a two-fold increase in CR rate by day 60. The poster presentation, titled "Impact of Complete Remission on Overall Survival in Patients with Refractory/Relapsed Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine or Placebo Plus Cytarabine: Responder Analysis for the Phase 3 VALOR Trial," is available at www.sunesis.com.

Presentations at the 2015 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). In November 2015, two poster presentations from the company’s proprietary kinase inhibitor programs were presented at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The presentations included preclinical data from the company’s selective PDK1 inhibitors SNS-229 and SNS-510, as well as the company’s potent noncovalent second-generation BTK inhibitor, SNS-062.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $46.4 million as of December 31, 2015, as compared to $43.0 million as of December 31, 2014. The increase of $3.4 million was primarily due to net proceeds of $43.8 million from the sale of common and preferred shares and from the exercise of warrants, stock options and stock purchase rights, partially offset by $38.7 million of net cash used in operating activities and $1.7 million of principal payments against notes payable. This capital is expected to be sufficient to fund operations through the first quarter of 2017.

Revenues for the three months and year ended December 31, 2015 were $0.7 million and $3.1 million, as compared to $0.9 million and $5.7 million for the same periods in 2014. Revenue in each period was primarily due to deferred revenue recognized related to the royalty agreement with Royalty Pharma.

Research and development expenses were $7.6 million and $23.7 million for the three months and year ended December 31, 2015, from $6.0 million and $27.7 million for the same periods in 2014, primarily relating to the vosaroxin development program in each year. The decrease of $4.0 million in 2015 was primarily due to a decrease of $5.4 million in clinical trial expenses, partially offset by increases of $0.9 million in personnel costs (including an increase of $0.5 million in stock-based compensation expense), and $0.5 million in other outside services and consulting costs.

General and administrative expenses for the three months and year ended December 31, 2015 were $4.4 million and $18.7 million, as compared to $6.1 million and $23.1 million in 2014. The decrease of $4.5 million in 2015 was due to a decrease of $4.5 million in professional services and personnel costs.

Interest expense was $0.2 million and $0.9 million for the three months and year ended December 31, 2015 as compared to $0.3 million and $1.7 million for the same periods in 2014. The decreases in 2015 were due to the reduced principal balance outstanding on notes payable to the Lenders under the Loan Agreement.

Net other income was nil and $3.6 million for the three months and year ended December 31, 2015, as compared to $10.1 million and $3.8 million for the same periods in 2014. The 2014 and 2015 amounts were primarily comprised of non-cash credits for the revaluation of warrants issued in an underwritten offering in 2010.

Cash used in operations was $38.7 million for the year ended December 31, 2015, as compared to $43.2 million for the same period in 2014.

Sunesis reported loss from operations of $11.3 million and $39.3 million for the three months and year ended December 31, 2015, as compared to $11.2 million and $45.0 million for the same periods in 2014. Net loss was $11.6 million and $36.7 million for the three months and year ended December 31, 2015, as compared to $1.3 million and $43.0 million for the same periods in 2014.

About QINPREZO (vosaroxin)

QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

Tokai Pharmaceuticals Reports Full Year 2015 Financial Results

On March 10, 2016 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported company highlights and financial results for the year ended December 31, 2015 (Press release, Tokai Pharmaceuticals, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147507 [SID:1234509466]).

"We have made substantial progress in the last several months, executing on our Phase 3 ARMOR3-SV trial globally and expanding our galeterone development program to include additional underserved patient populations with prostate cancer," said Jodie Morrison, President and Chief Executive Officer of Tokai. "In ARMOR3-SV, we are gaining momentum in patient screening and enrollment throughout the world. In addition, the data unlocking galeterone’s distinct androgen receptor degradation mechanism presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium provide further support for the differentiated profile of galeterone. We look forward to a number of important milestones throughout 2016 and into 2017 that we expect to elucidate the broad potential of galeterone in prostate cancer."

Recent business highlights include:

Progress in ARMOR3-SV, a Phase 3 registration clinical trial of galeterone in AR-V7+ mCRPC. Over 100 clinical sites in the United States, Canada, Australia and Western Europe are open and actively screening patients in ARMOR3-SV, Tokai’s pivotal Phase 3 clinical trial evaluating whether administration of galeterone results in a statistically significant increase in radiographic progression free survival as compared to Xtandi (enzalutamide) in treatment-naïve metastatic castration-resistant prostate cancer (mCRPC) patients whose prostate tumor cells express the AR-V7 splice variant. AR-V7 is a truncated form of the androgen receptor that has been associated with poor responsiveness to commonly used oral therapies for mCRPC. Screening experience in ARMOR3-SV to date indicates that the prevalence of AR-V7 continues to be in line with the company’s expectations and consistent with the published literature. Enrollment in ARMOR3-SV is expected to be completed during the second half of 2016, and top-line results from the trial are anticipated by mid-2017.

Expansion of galeterone clinical development into additional mCRPC populations. Tokai is expanding galeterone clinical development into additional mCRPC populations through the planned initiation of two additional studies in the first half of 2016 in patients who have shown resistance following treatment with either abiraterone or enzalutamide, including:
An open-label Phase 2 clinical trial that will evaluate galeterone in men whose mCRPC rapidly progressed following treatment with either abiraterone or enzalutamide.

An expansion of the ongoing Phase 2 clinical trial of galeterone (ARMOR2) in mCRPC patients who have developed acquired resistance to enzalutamide. This expansion follows results observed in a patient who, following an initial response to enzalutamide, experienced a PSA drop of over 90 percent when treated with galeterone. This patient’s PSA response has remained at less than 0.1µg/L for over a year.

Presentation of galeterone’s novel mechanism of action. At the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium held in January 2016, Tokai presented new data describing the novel mechanism by which galeterone degrades the androgen receptor (AR). These data demonstrate that galeterone selectively inhibits two deubiquitinating enzymes (DUBs) that are not inhibited by either Xtandi or Zytiga (abiraterone acetate), resulting in degradation of the AR via the proteasome, regardless of the presence or absence of a ligand binding domain.
Financial Results

Cash and investments at December 31, 2015 were $64.0 million, as compared to $105.3 million at December 31, 2014.
Research and development expense for the year ended December 31, 2015 was $32.6 million as compared to $14.6 million for the year ended December 31, 2014. The increase in research and development expense was primarily attributable to the initiation of the ARMOR3-SV clinical trial and the development of the AR-V7 clinical trial assay during 2015, and costs associated with other clinical trials to support the submission of a new drug application for galeterone.

General and administrative expense for the year ended December 31, 2015 was $12.6 million, as compared to $8.9 million for the year ended December 31, 2014. The increase in general and administrative expense was primarily attributable to increased headcount, other expenses necessary to operate as a public company, increased patent costs and costs associated with pre-commercialization activities.

Net loss was $45.1 million for the year ended December 31, 2015, or $2.01 per share, as compared to $23.3 million for the year ended December 31, 2014, or $3.60 per share.

Verastem to Present Scientific Data Supporting FAK and PI3K/mTOR Inhibition to Target Cancer Stem Cells at the Keystone Symposium on Stem Cells and Cancer

On March 10, 2016 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer, reported the presentation of preclinical data and participation in an expert panel at the Keystone Symposium on Stem Cells and Cancer being held March 6 – 10, 2016 in Breckenridge, CO (Press release, Verastem, MAR 10, 2016, View Source;p=RssLanding&cat=news&id=2147460 [SID:1234509470]).

"The scientific consensus on the importance of targeting cancer stem cells to enable a durable clinical response continues to build," said Dr. Jonathan Pachter, Verastem Head of Research. "Our presentation at the Keystone Symposium describes our current understanding of the role of PI3K/mTOR and FAK in the survival and tumor-initiating capability of cancer stem cells."

"Of particular interest, we have also found that FAK inhibition increases influx of cytotoxic T cells into tumors while reducing immuno-suppressive and stromal density barriers to anti-tumor immune attack," continued Dr. Pachter. "New data from preclinical models presented today demonstrate that FAK inhibition enhances the anti-tumor effect of adoptive T cell transfer. These data suggest that the benefit of FAK inhibitor combination is likely to extend to various approaches that enhance cytotoxic T cell function, including combination with antibodies against PD-1 and PD-L1. We are now clinically testing this with the combination of VS-6063 and pembrolizumab at Washington University in Saint Louis in patients with advanced pancreatic cancer. We also recently announced a clinical collaboration with Pfizer and Merck KGaA to combine VS-6063 and avelumab for the treatment of patients with ovarian cancer."

Details for the presentation at the Keystone Symposium on Stem Cells and Cancer are as follows:
Oral Presentation and Panel
Title: Targeting Cancer Stem Cells with Selective Inhibitors of FAK and PI3K/mTOR
Session: Targeting Cancer Stem Cells: Trials and Translation
Date and time: Thursday, March 10, 2016, 8:00 – 11:00 am PT
A copy of the oral presentation will be available following the presentation at http://bit.ly/R3M6wc.
About Focal Adhesion Kinase
Focal Adhesion Kinase (FAK) is a non-receptor tyrosine kinase encoded by the PTK-2 gene that is involved in cellular adhesion and, in cancer, metastatic capability. VS-6063 (defactinib) and VS-4718 are orally available compounds that are potent inhibitors of FAK. VS-6063 and VS-4718 utilize a multi-faceted approach to treat cancer by reducing cancer stem cells, enhancing anti-tumor immunity, and modulating the local tumor microenvironment. VS-6063 and VS-4718 are currently being studied in multiple clinical trials for patients with cancer.
About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in chemotherapy-resistant models. Verastem is currently conducting a dose escalation trial of VS-5584 in patients with advanced solid tumors.

GenVec Reports Fourth Quarter and 2015 Year-End Financial Results

On March 9, 2016 GenVec, Inc. (NASDAQ: GNVC) reported financial results for the fourth quarter and year ended December 31, 2015 (Press release, GenVec, MAR 9, 2016, View Source [SID:1234509430]). For the year ended December 31, 2015, the company reported a net loss of $6.5 million, or $0.39 per share, compared with a net loss of $2.5 million, or $0.16 per share, for the year ended December 31, 2014. The company ended the year with $8.7 million in cash, cash equivalents, and investments.

"During 2015, CGF166 moved into the dose escalation portion of the Phase 1/2 trial in patients with severe hearing loss. In early January after a total of nine patients had been treated, we were notified by our partner Novartis that enrollment had been paused based on a review of data by the trial’s Data Safety Monitoring Board in accordance with prespecified criteria in the protocol," said Douglas J. Swirsky, president and CEO of GenVec. "It is important to note that we are not aware of any significant adverse events in the trial, and while there is no certainty, we believe that enrollment in the dose escalation portion will resume in the coming months. As a result, we believe that the trial will be completed sometime in 2017 as previously expected."

"During 2015 and early 2016, we accomplished a great deal to ramp up GenVec’s business development capabilities and focused our efforts on partnering with the goal of maximizing the value of our AdenoVerse gene delivery and manufacturing platform," Mr. Swirsky continued. "We advanced our work on a second-generation neural stem cell-based cancer treatment with our partner TheraBiologics, and strengthened our intellectual property portfolio, adding patents key to protecting and enabling work with our new gorilla and monkey adenovectors. These vectors are highly suited to the development of molecular vaccines and some of the newer gene-based medicine strategies, such as CAR-T and CRISPR/Cas-9. Last but not least, we’ve kept our operations lean and highly efficient, with a clear understanding that the task at hand is to maintain a low cash burn rate and build value through collaborations."

2016 Guidance

For 2016, GenVec anticipates a cash burn between $6 million and $7 million for 2016 and believes its existing resources are sufficient to fund operations into the second quarter of 2017.

2015 Financial Results

For 2015, revenue decreased 85% to $0.9 million from $6.0 million in 2014, a decrease in revenue for the year of $5.1 million versus the prior year. The decline was primarily the result of milestone payments totaling $5 million from Novartis in 2014; continuation of the CGF166 clinical trial enrollment during 2015 did not trigger additional milestone payments. Additionally, there was a $0.2 million reduction in revenues year-over-year from our work under the contract with the DHS related to our animal health program that was completed in February 2015.

Operating expenses for 2015 decreased 13% to $7.5 million from $8.6 million in 2014. General and administrative expenses decreased 22% to $4.9 million in 2015 from $6.3 million in 2014. In 2015, lower expenses were primarily attributable to the relocation of our corporate offices in 2014 and lower professional costs. These reduced costs were partially offset by increased personnel costs in 2015 as compared to 2014, incurred primarily to enhance GenVec’s business development capabilities.

Research and development expenses increased 13% to $2.6 million in 2015 from $2.3 million in 2014, primarily attributable to increased personnel costs.

Fourth Quarter 2015 Results

For the fourth quarter ended December 31, 2015, GenVec reported a net loss of $1.6 million, or $0.10 per share, compared with net income of $1.7 million, or $0.11 per share, for the comparable prior year period.

The company reported revenues of $0.2 million in the fourth quarter of 2015 compared to $3.5 million for the same period in 2014. The first patient was treated in Novartis’ Phase 1/2 clinical trial of CGF166 in October 2014, triggering a payment of $3 million to GenVec. No milestone payment was realized in the fourth quarter of 2015. Additionally, we experienced a $0.1 million reduction in fourth quarter 2015 revenue for services performed for Novartis in connection with this program as compared to the comparable prior year period. Our work under the contract with the DHS related to our animal health program was completed in February 2015; as a result we experienced reduced revenues of $0.2 million in the fourth quarter of 2015 as compared to the comparable prior year period.

Operating expenses in the fourth quarter of 2015 were $1.8 million, which is comparable to the prior year period. General and administrative expenses in the fourth quarter of 2015 were $1.3 million, which is an increase of 2% and is comparable to the prior year period. Research and development expenses decreased 7% in 2015 from $0.6 million in the fourth quarter of 2014 to $0.5 million in the fourth quarter of 2015 primarily resulting from lower professional costs.

Cash Position

As of March 3, 2016, the company had $7.2 million in cash, cash equivalents, and investments (unaudited).

8-K – Current report

On March 9, 2016 GenVec, Inc. (NASDAQ: GNVC) reported financial results for the fourth quarter and year ended December 31, 2015 (Filing, Q4/Annual, GenVec, 2015 , MAR 9, 2016, View Source [SID:1234509471]). For the year ended December 31, 2015, the company reported a net loss of $6.5 million, or $0.39 per share, compared with a net loss of $2.5 million, or $0.16 per share, for the year ended December 31, 2014. The company ended the year with $8.7 million in cash, cash equivalents, and investments.