1stOncology™: Cancer Intelligence Service – Page 15624 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

AVEO Reports First Quarter 2018 Financial Results and Provides Business Update

On May 8, 2018 AVEO Oncology (NASDAQ:AVEO) reported financial results for the first quarter ended March 31, 2018 and provided a business update (Press release, AVEO, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347579 [SID1234526198]).

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!

"We continue to work toward reporting topline results from our Phase 3 TIVO-3 Study, which we now anticipate will occur in the third quarter of 2018. We are working closely with our contract research organization (CRO) to shorten the time required to do the data cleaning and analysis upon reaching the requisite number of events. Together with the TIVO-1 study, the TIVO-3 study has been designed to serve as the basis for a potential U.S. approval of tivozanib as a first- and third-line treatment for advanced renal cell carcinoma (aRCC)," said Michael Bailey, president and chief executive officer of AVEO. "This important milestone, if achieved, would add to the continued commercial progress of FOTIVDA which is approved in Europe, with launches currently underway in Germany, the U.K. and Austria. We finished the quarter with $27 million in cash, cash equivalents and investments as of March 31, 2018. Under our agreement with our partner EUSA, we have double-digit royalty payments due to us on net sales of FOTIVDA in Europe, potential milestone payments including $8 million related to reimbursement approvals for France, Germany, Italy, and Spain, and $20M in potential R&D reimbursement for access to TIVO-3 data in the event of a positive study."

Mr. Bailey added, "As we work toward our goal of commercialization in the U.S., we also continue to aggressively pursue the third pillar of our tivozanib strategy, combinations with immunotherapy. We were pleased to present results from the ongoing Phase 2 portion of the TiNivo study of tivozanib and nivolumab (OPDIVO) in aRCC at ASCO (Free ASCO Whitepaper) GU. These early results demonstrated a combination of a favorable safety profile and activity that we believe hold significant promise for patients with aRCC and potentially other tumor types such as hepatocellular carcinoma (HCC)."

Tivozanib TIVO-3 Study North America Update

Update on Anticipated Timeline to Topline Data from Phase 3 TIVO-3 Study. AVEO reported that the pre-specified number of progression free survival (PFS) events required to trigger data analysis of the Phase 3 TIVO-3 trial have not been reached at this time and, as such, the Company is amending its guidance for the anticipated topline data readout from the second to the third quarter of 2018. In collaboration with the CRO conducting the TIVO-3 study, AVEO has taken measures to shorten the data cleaning and analysis period following the pre-specified events trigger from 8-10 weeks down to 6-8 weeks. Together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of aRCC, TIVO-3 is designed to support regulatory approval of tivozanib in the U.S. as a first- and third-line treatment for aRCC.

Tivozanib (FOTIVDA) European Union Updates

Tivozanib (FOTIVDA) Launched in Austria for the Treatment of aRCC. In April 2018, FOTIVDA was launched in Austria for the treatment of adult patients with aRCC. This follows the February 2018 publication by the United Kingdom’s National Institute for Health and Care Excellence (NICE) of a Final Appraisal Determination recommending FOTIVDA for the first line treatment of adult patients with aRCC, which triggered the commercial launch in the UK as well as a $2M milestone payment to AVEO from EUSA Pharma, the licensee for tivozanib in Europe. FOTIVDA is now available in the Germany, the U.K., and Austria.

FOTIVDA was granted European Commission (EC) approval in August 2017 for the treatment of adult patients with aRCC in the European Union plus Norway and Iceland.
Additional Tivozanib Updates

Long-term Follow-up Results from TIVO-1 Extension Study (Study 902), Published in the European Journal of Cancer. In March 2018, AVEO announced the publication of long-term follow-up results from Study 902, where patients were treated with tivozanib (FOTIVDA) as second-line treatment for aRCC, in the European Journal of Cancer. Findings from the study underscore the activity of tivozanib in the refractory setting, with evidence of encouraging clinical responses, disease control and overall survival outcomes in patients previously treated with a VEGFR TKI and support the rationale for the ongoing Phase 3 TIVO-3 study. The publication, titled "Efficacy of Tivozanib Treatment after Sorafenib in Patients with Advanced Renal Cell Carcinoma: Crossover of a Phase 3 Study," is available on our website at www.aveooncology.com.
Results from Phase 2 Portion of the TiNivo Study of Tivozanib and Nivolumab (OPDIVO) in mRCC Presented at ASCO (Free ASCO Whitepaper) GU. In February 2018, Bernard Escudier, M.D., from the Institute Gustav Roussy in Paris, France presented results from the ongoing Phase 2 portion of the TiNivo study at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Genitourinary Cancers Symposium (ASCO GU). TiNivo is a Phase 1b/2 multi-center trial of oral tivozanib in combination with intravenous nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, for the treatment of metastatic renal cell carcinoma (mRCC). The presentation noted the favorable safety profile and promising preliminary anti-tumor activity observed to date. These results continue to support the potential advantages of using a high-specificity VEGF inhibitor TKI in building upon the benefit of immune checkpoint therapy in renal cancer. AVEO and EUSA Pharma expect to present further updates to the TiNivo study at upcoming medical meetings in the second half of 2018.
Phase 1b/2 Study Results of Tivozanib in Patients with Advanced Hepatocellular Carcinoma Presented at ASCO (Free ASCO Whitepaper) GI. In January 2018, AVEO announced the presentation of data from a multi-center, Phase 1b/2 study of tivozanib in previously untreated patients with advanced, unresectable HCC at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI). Findings from the study suggest that tivozanib has the potential to yield comparable PFS and a favorable response rate when compared to current first-line standards of care for HCC patients, and demonstrated a favorable safety profile which may enable therapeutic combinations with immunotherapy. The Phase 1b/2 study was led by Renuka Iyar, M.D., from the Roswell Park Cancer Center and was one of several studies funded by a grant provided to the National Comprehensive Cancer Network by AVEO.
Ficlatuzumab Update

Trials in Progress Poster for Phase 1b Study of Ficlatuzumab in Combination with Gemcitabine and Nab-paclitaxel in Pancreatic Cancer to be Presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting. An ongoing, investigator-sponsored Phase 1b study to test the safety and tolerability of ficlatuzumab when combined with Nab-paclitaxel and Gemcitabine in previously untreated metastatic pancreatic ductal cancer (PDAC) will be presented as a trials in progress poster (Poster Board: #330b, Abstract TPS4152) at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL. The study, which is being conducted under the direction of Kimberly Perez, M.D. at the Dana-Farber Cancer Institute, is currently enrolling, with an expected total enrollment of approximately 30 patients.
Corporate Updates

Refinanced Debt Facility, Extending Cash Runway into 2019. In January 2018, AVEO announced that it completed the refinancing of its existing $20.0 million debt facility with Hercules Capital, Inc. and its affiliates, the terms of which enable approximately an additional $12.1 million in cash flow over 2018 and 2019, when compared to the prior loan. The new $20.0 million facility has a 42-month maturity from closing, no financial covenants, a lower interest rate and an interest-only period of no less than 12 months, which could be extended up to a maximum of 24 months, assuming the achievement of specified milestones relating to the development of tivozanib. Extension of the interest-only period is expected to enable the Company to extend its cash runway into the first quarter of 2019. Proceeds of the new facility were used to retire the Company’s previous $20.0 million of secured debt with Hercules.
Strengthened Board of Directors. In February 2018, AVEO announced the appointment of John H. Johnson to the Company’s Board of Directors. Mr. Johnson brings to AVEO over three decades of experience in the biotechnology and pharmaceuticals industries, having held commercial and executive management roles at leading global corporations that have a focus on oncology.
First Quarter 2018 Financial Highlights

AVEO ended Q1 2018 with $27.0 million in cash, cash equivalents and marketable securities as compared with $33.5 million at December 31, 2017.
Total revenue for Q1 2018 was approximately $1.0 million compared with $2.5 million for Q1 2017.
Research and development expense for Q1 2018 was $5.4 million compared with $8.0 million for Q1 2017.
General and administrative expense for Q1 2018 was $2.6 million compared with $2.3 million for Q1 2017.
Net loss for Q1 2018 was $9.0 million, or a loss of $0.08 per basic and diluted share, compared with net loss of $8.8 million for Q1 2017, or a loss of $0.12 per basic and diluted share. Approximately $1.5 million of the Q1 2018 net loss was a non-cash loss attributable to the increase in the fair value of the warrant liability that principally resulted from the increase in the stock price that occurred within the quarter. In Q1 2017, the non-cash loss attributable to the increase in the fair value of the warrant liability was $0.5 million.
Financial Guidance

We believe that our $27.0 million in cash resources would allow us to fund our planned operations into the first quarter of 2019. This estimate assumes no receipt of additional milestones from our partners or related payment of potential licensing milestones to third parties, no additional funding from new partnership agreements, no additional equity or debt financings, and no sales of equity through the exercise of our outstanding warrants issued in connection with our 2016 private placement.

Atara Biotherapeutics Announces First Quarter 2018 Financial Results and Recent Operational Progress

On May 8, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, today reported financial results for the first quarter of 2018 and recent operational highlights (Press release, Atara Biotherapeutics, MAY 8, 2018, View Source [SID1234526197]).

"During the first quarter of 2018, we continued to advance our T-cell immunotherapy pipeline and platform," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Our two Phase 3 pivotal studies of tab-cel are progressing, and we remain focused on building Atara’s global commercial and operational capabilities in anticipation of the first tab-cel Phase 3 results and submission of an EU conditional marketing authorization application in the first half of 2019. We are also excited to have recently expanded our collaboration with Memorial Sloan Kettering Cancer Center to develop next generation chimeric antigen receptor T cell (CAR T) technologies, marking our entry into genetically engineered T-cells and furthering our leadership position in off-the-shelf, allogeneic T-cell immunotherapy. I am pleased with our strong operational and strategic execution in the first quarter and look forward to both continuing this momentum and updating you on our progress throughout the rest of the year."

Recent Highlights and Anticipated Upcoming Milestones

Two Phase 3 clinical studies are underway (MATCH and ALLELE) to evaluate tab-cel (tabelecleucel) in patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
9 clinical sites for the MATCH and 12 for the ALLELE studies are now open for enrollment in the U.S. with additional sites expected to open in the U.S. and other geographies.
Continued to expand research and development, operational and commercial leadership as we advance our pipeline, leverage the potential of our technology platform and prepare for the expected tab-cel CMA submission in the EU and potential launch.
Biotech industry veteran Dietmar Berger, M.D., Ph.D., most recently a senior R&D leader at Roche/Genentech, joined Atara as Global Head of Research and Development.
Appointed Mina Kim as Senior Vice President and General Counsel, who has nearly 20 years of corporate legal experience.
Expanded commercial leadership team with the appointment of Manuela Maronati as General Manager, Europe, who brings extensive European commercial launch and operations experience in the oncology and rare disease areas.
Expanded T-cell immunotherapy collaboration with Memorial Sloan Kettering Cancer Center (MSK) to advance next-generation CAR T technologies in oncology, autoimmune and other diseases.
Gained access to several of MSK’s innovative enabling technologies, including a novel CAR T construct that Atara believes has physiologic T cell activation properties, as well as methods for designing CAR T immunotherapies.
Entered into an exclusive research collaboration for multiple targets with Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering at MSK, to employ next-generation technologies in developing novel CAR T immunotherapies.
Plan to rapidly advance novel gene-edited CAR T development programs leveraging our existing off-the-shelf T-cell immunotherapy technology platform, manufacturing expertise and research and development capabilities.
Strengthened cash position with the completion of two underwritten public offerings in the first quarter of 2018 with net proceeds of approximately $293.3 million. Cash, cash equivalents and short-term investments as of March 31, 2018 totaled $407.3 million, which we believe enable us to expand our near-term pipeline and accelerate pre-commercial activities as well as fund our previously planned operations to mid-2020.

Partnered with TrakCel, an industry-leading software provider for cell and gene therapy supply chain tracking and orchestration, to develop Atara MatchMe, the first commercial product delivery solution designed to achieve streamlined supply and delivery of an off-the-shelf, allogeneic T-cell immunotherapy.
Atara MatchMe is being designed to provide a compelling customer experience across a diverse range of treatment centers, partners, systems and geographies to ensure tab-cel is safely and effectively ordered and delivered, globally to patients in the minimum possible time.

At the 44th Annual Meeting of the European and Marrow transplantation (EBMT) in March 2018, Atara and its collaborating investigator at the University of North Carolina at Chapel Hill presented findings from a comprehensive literature review of the mortality burden of PTLD following HCT.
Based on a review of studies published since 2005, the research showed that 42.5% of PTLD patients diagnosed following HCT died as a result of the disease, and in the patients who died, the median time from initial diagnosis of PTLD to death for children and adults was under 8 weeks.
A multinational Phase 1 clinical study to evaluate ATA188 in patients with progressive or relapsing-remitting multiple sclerosis is also underway across clinical sites in the U.S. and Australia.
The primary objective of the Phase 1 study is to assess the safety of ATA188 in patients followed for at least one year after the first dose. Key secondary endpoints in the study include measures of clinical improvement such as expanded disability status scale (EDSS) and annualized relapse rate (ARR), as well as MRI imaging.
The first interim results from the ongoing ATA188 Phase 1 study in patients with progressive MS are expected in the first half of 2019.
Atara plans to initiate a Phase 1/2 clinical study of tab-cel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) in the second half of 2018.

Expect to present updated tab-cel results in patients with EBV+ cancers in the second half of 2018.

Expect operations to commence at Atara T Cell Operations & Manufacturing (ATOM) facility in the second quarter of 2018, with completion to support clinical production in 2019.
First Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2018 totaled $407.3 million, which includes $293.3 million in net proceeds from the two underwritten public offerings completed in the first quarter of 2018.
The Company reported net losses of $41.4 million, or $1.05 per share, for the first quarter of 2018, as compared to $25.7 million, or $0.88 per share, for the same period in 2017.
Research and development expenses were $28.5 million for the first quarter of 2018, as compared to $17.5 million for the same period in 2017. The increase in the first quarter of 2018 was due to costs associated with the Company’s continuing expansion of research and development activities, including:
clinical trial, manufacturing and outside service costs related to the initiation of the two tab-cel Phase 3 clinical studies in patients with EBV+ PTLD who have failed rituximab;
clinical manufacturing and the initiation of the Phase 1 clinical study of allogeneic ATA188, which was initiated in October 2017;
higher payroll and related costs from increased headcount, and
an increase in allocated facilities and information technology expenses.
Research and development expenses include $2.9 million and $2.1 million of non-cash stock-based compensation expenses in the first quarters of 2018 and 2017, respectively.
General and administrative expenses were $14.0 million for the first quarter of 2018, as compared to $8.6 million for the same period in 2017. The increase in the first quarter of 2018 was primarily due to increases in payroll and related costs driven by increased headcount to support the Company’s expanding operations and higher professional services costs. General and administrative expenses include $4.1 million and $3.2 million of non-cash stock-based compensation expenses in the first quarters of 2018 and 2017, respectively.

Atara Biotherapeutics Expands T-Cell Immunotherapy Collaboration to Advance Next-Generation CAR T Technologies in Oncology, Autoimmune and Other Diseases

On May 8, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported the Company has expanded its collaboration with Memorial Sloan Kettering Cancer Center (MSK) to develop the next generation of genetically engineered chimeric antigen receptor T-cell (CAR T) immunotherapies (Press release, Atara Biotherapeutics, MAY 8, 2018, View Source [SID1234526196]). This agreement is the next step in Atara’s strategy to leverage the potential of the Company’s technology platform to develop genetically modified off-the-shelf, allogeneic T-cell immunotherapies to transform the lives of patients with serious medical conditions.

Under the agreement, Atara will gain access to several of MSK’s innovative enabling technologies, including a novel CAR T construct that Atara believes has physiologic T-cell activation properties, as well as methods for designing CAR T immunotherapies. Atara is also entering into an exclusive research collaboration for multiple targets with Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering at MSK, to employ next-generation technologies in developing novel CAR T immunotherapies with applications in oncology, autoimmune and infectious diseases.

Dr. Sadelain stated, "We are eager to work with Atara to continue advancing promising allogeneic T-cell immunotherapy technologies that originated at MSK. The new CAR T technologies seek to overcome persistent therapeutic challenges, such as safety and tolerability, durability of treatment response, and activity in areas of significant unmet medical need that are underserved by the current generation of CAR T immunotherapies."

"Our earlier MSK collaboration has been highly productive, highlighted by tab-cel, Atara’s off-the-shelf, allogeneic T-cell immunotherapy currently in Phase 3 development," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "The deepening of our collaboration with MSK allows us to rapidly advance novel gene-edited CAR T development programs leveraging our existing off-the-shelf T-cell immunotherapy technology platform, manufacturing expertise and research and development capabilities. Going forward, we plan to continue to assemble complementary genetic engineering technologies to grow our pipeline and realize the full potential of our platform."

Altimmune to Announce First Quarter 2018 Financial Results on May 16

On May 8, 2018 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported that it will announce financial results for the first quarter ended March 31, 2018 before the market open and host a conference call on Wednesday, May 16 (Press release, Altimmune, MAY 8, 2018, View Source [SID1234526195]).

Conference Call Details
Date: Wednesday, May 16
Time: 8:30am Eastern Time
Domestic: 888-394-8218
International: 323-701-0225
Conference ID: 1336227
Webcast: View Source

Replays, Available through May 30th:
Domestic: 844-512-2921
International: 412-317-6671
Replay PIN: 1336227

AbbVie to Present at the UBS Global Healthcare Conference

On May 8, 2018 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the UBS Global Healthcare Conference on Tuesday, May 22, 2018. Bill Chase, executive vice president and chief financial officer, will present at 7:30 a.m. Central time (Press release, AbbVie, MAY 8, 2018, View Source [SID1234526194]).

A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available