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ARIAD Announces Pricing and Reimbursement for Iclusig in France

On May 19, 2016 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that negotiations with the Economic Committee on Health Care Products in France regarding pricing and reimbursement for Iclusig (ponatinib) have now concluded (Press release, Ariad, MAY 19, 2016, View Source [SID:1234512561]). As a result, ARIAD will record net product revenue related to cumulative shipments in France of approximately $25 million in the second quarter of 2016.

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Iclusig has been available to patients in France since late 2012 through a pre-licensed sales mechanism called an ATU (temporary authorization of use). This mechanism allows patient access to potential life-saving drugs prior to full pricing and reimbursement approval.

About Iclusig (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.
Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Click here to view the EU Dear Healthcare Provider Letter (PDF).

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On May 18, 2016 Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported it will present its TTI-621 (SIRPaFc) immune checkpoint inhibitor program at the Trials in Progress Session of the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held in Chicago from June 3-7 (Filing, 6-K, Trillium Therapeutics, MAY 18, 2016, View Source [SID:1234512630]).

Details of Trillium’s ASCO (Free ASCO Whitepaper) presentation are as follows:

Presentation Type: Poster
Abstract #: TPS7585
Title: A phase 1 study of TTI-621, a novel immune checkpoint inhibitor targeting CD47, in subjects with relapsed or refractory hematologic malignancies
Presenter: Stephen Maxted Ansell, M.D., Ph.D., Division of Hematology, Mayo Clinic
Track: Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia
Time/Location: Monday, June 6, 8-11:30 a.m. in Hall A, Poster Board #134b

ONCOCYTE REPORTS FIRST QUARTER 2016 FINANCIAL RESULTS

On May 18, 2016 OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, reported its financial results for the quarter ended March 31, 2016 along with an update on recent corporate developments (Press release, , MAY 18, 2016, View Source [SID:1234512602]).

"We achieved several important milestones during the first quarter, including initiating our first trade as a public company," commented William Annett, Chief Executive Officer. "Operationally, we strengthened our management team and Board of Directors with seasoned healthcare professionals. Clinically, we made significant progress towards commercializing our first product, a confirmatory lung diagnostic, when we received positive research results from our development partner, The Wistar Institute.
"Currently, we are focused on attempting to lock down both the assay and the classifier or algorithm that interprets test results. If successful we plan to initiate an internal analytical validation study, a process to confirm whether the test results can be reproduced using our equipment and in our own lab. We expect this process to continue into the fourth quarter. If the validation study is successful we intend to implement our commercialization plans, including hiring a sales force, building out our commercial infrastructure, moving towards completion and obtaining CLIA certification of a diagnostic laboratory and ultimately launching our lung cancer diagnostic test in the first half of 2017," concluded Mr. Annett.

Recent Accomplishments
Entered into a definitive global licensing agreement with The Wistar Institute for a simple, non-invasive, blood test to aid physicians in the early detection of lung cancer. The agreement provides OncoCyte the exclusive rights to commercialize this lung cancer diagnostic test.

Received positive research results for the Company’s lung cancer diagnostic test being developed at The Wistar Institute. This study replicated a previous study that was carried out at Wistar and which was presented at the American Thoracic Society conference in May 2015.

Selected to have the Company’s bladder cancer abstract presented in a poster session at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago. The abstract will be released on May 18th at 4pm CT on ASCO (Free ASCO Whitepaper)’s website and a live panel discussion led by Karen Chapman, VP Research will be held on June 6th, 2016 at 4:45pm CT.

First Quarter 2016 Financial Results
The Company is still in the development stage and will not generate revenue until after the commercial launch of its lung test.
The net loss for the quarter ended March 31, 2016 was $2.9 million, or $0.12 per share, compared to $1.4 million, or $0.08 per share, in 2015.

Research and development expenses for the quarter ended March 31, 2016 increased to $1.7 million from $1.1 million for the same period in 2016. These increases were primarily the result of increased spending on outside research services, scientific consulting services, clinical trial related expenses, and laboratory expenses. These increases were in part offset by a $104,000 decrease in stock based compensation expenses to employees and consultants allocated to research and development expense.
General and administrative expenses increased to $1.2 million from $250,000 for the same period in 2015. These increases are primarily as a result of increased salary and payroll related expenses, general consulting expenses, accounting and audit related expenses, transfer agent, stock listing and SEC filing expenses.

At March 31, 2016, OncoCyte had $5.9 million of cash and cash equivalents and available-for-sale securities valued at $1.8 million, which OncoCyte may use for working capital purposes, as necessary.

Conference Call
OncoCyte will host a conference call and webcast today, Wednesday, May 18, 2016, at 5:00 p.m. ET/2:00 p.m. PT to discuss financial and operating results and recent corporate developments.

For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 877-524-8416. For international participants outside the U.S./Canada, the dial-in number is 412-902-1028. For all callers, refer to Conference ID 8993084. To access the live webcast, go to View Source

A replay of the conference call will be available for seven business days beginning about two hours after the conclusion of the live call, by calling toll-free (from U.S./Canada) 888-203-1112; international callers dial 719-457-0820. Use the Conference ID 13634479. Additionally, the archived webcast will be available at View Source

TG Therapeutics, Inc. Announces Clinical Data Presentation at the Upcoming 52nd Annual Meeting of the American Society of Clinical Oncology

On May 18, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX), reported that updated data has been selected for presentation at the upcoming 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 3 – 7, 2016, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, MAY 18, 2016, View Source [SID:1234512600]).

Poster Presentation & Discussion Session:

Title: Long-term follow-up of the PI3Kδ inhibitor TGR-1202 to demonstrate a differentiated safety profile and high response rates in CLL and NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab
Abstract Number: 7512 (Poster Board # 68)
Presentation Date & Time: Monday, June 6, 2016 8:00 AM – 11:30 AM CT
Track: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Howard A. Burris MD, Sarah Cannon Research Institute/Tennessee Oncology
Discussion Session:
1:15 PM – 2:45 PM CT, at Room E354b
A copy of the ASCO (Free ASCO Whitepaper) abstracts were made available today, May 18, 2016 at 5:00pm ET through the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

TESARO Announces Five Abstracts to be Presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 18, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of five abstracts at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, June 3 to June 7, 2016, in Chicago (Press release, TESARO, MAY 18, 2016, View Source [SID:1234512599]). In addition, TESARO will host an investor and analyst briefing in Chicago on Saturday, June 4 at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) annual meeting.

"Delayed chemotherapy-induced nausea and vomiting can be a debilitating side effect of chemotherapy. Because symptoms occur outside the clinic, patients don’t always report their experiences with delayed CINV. The two post-hoc analyses to be presented highlight increased control of CINV for patients who received VARUBI while being treated with chemotherapy for gynecologic and breast cancers," said Mary Lynne Hedley, Ph.D., President and COO, TESARO. "In addition, posters describing currently ongoing studies, including a Phase 1 trial of niraparib plus bevacizumab in patients with ovarian cancer (AVANOVA), a Phase 1 trial of niraparib plus pembrolizumab in patients with triple-negative or recurrent ovarian cancer (KEYNOTE-162) and a Phase 3 trial of niraparib as a maintenance therapy in patients who have responded to first-line, platinum-based chemotherapy (PRIMA) will be presented."

Please visit TESARO at Booth #14159 for information about VARUBI and our pipeline. TESARO will also be providing information on homologous recombination deficiency (HRD) and ovarian cancer at Booth #21047.

Presentation Details:

(VARUBI) Rolapitant

Monday, June 6, 2016, 1:00 PM to 4:30 PM
Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer.
Abstract: 10121, Poster Board: 109, Location: S Hall A

Monday, June 6, 2016, 1:00 PM to 4:30 PM
Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer.
Abstract: 10122, Poster Board: 110, Location: S Hall A

Niraparib

Monday, June 6, 2016, 1:00 PM to 4:30 PM
A phase 1 study of bevacizumab in combination with niraparib in patients with platinum-sensitive epithelial ovarian cancer: The ENGOT-OV24/AVANOVA1 trial.
Abstract #5555, Poster Board #378, Location: S Hall A

Monday, June 6, 2016, 1:00 PM to 4:30 PM
Phase 1/2 study of niraparib plus pembrolizumab in patients with triple-negative breast cancer or recurrent ovarian cancer (KEYNOTE-162).
Abstract #TPS5599, Poster Board #421a, Location: S Hall A

Monday, June 6, 2016, 1:00 PM to 4:30 PM
A randomized, double-blind phase 3 trial of niraparib maintenance treatment in patients with HRD+ advanced ovarian cancer after response to front-line platinum-based chemotherapy.
Abstract #TPS5606, Poster Board #424b, Location: S Hall A

Niraparib is an investigational product candidate that has not been approved by any regulatory agencies.

Investor Briefing and Webcast
TESARO will host an investor and analyst briefing in Chicago on Saturday, June 4 at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) annual meeting. At this briefing, TESARO management will provide a business overview and pipeline update and will answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.

About VARUBI (Rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.