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Roche announces launch of cobas HPV on the cobas 6800/8800 Systems for cervical cancer screening in markets accepting the CE mark

On March 27, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the CE-IVD launch of cobas HPV for use on the cobas 6800/8800 Systems for cervical cancer screening (Press release, Hoffmann-La Roche, MAR 27, 2017, View Source [SID1234518282]). Human Papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. This HPV DNA assay adds to the growing CE-IVD menu on the cobas 6800/8800 Systems, and gives laboratories the ability to run HPV DNA testing simultaneously with other previously released cobas assays including: Chlamydia and Gonorrhea (CT/NG), HIV-1, HCV, HBV, CMV, plus three next-generation assays for donor screening: cobas MPX, cobas WNV and cobas HEV.

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As demonstrated by the prospective clinical study "ATHENA" comparing screening strategies using cobas HPV test on the cobas 4800 System, screening with the HPV test detects more high-grade disease than a Pap test alone. Identifying women at risk, before pre-cancer or cancer develops, is an important prevention strategy as it helps maintain screening efficiency and helps protect women from the potential harms of overtreatment. Countries are increasingly looking to adopt HPV DNA screening ahead of Pap cytology as part of their national cervical cancer programs.

"In addition to the powerful clinical benefits of the cobas HPV test, Roche now caters to the needs of both low-to-mid volume labs and high-throughput labs who want to consolidate a multitude of validated assays onto a single platform," said Roland Diggelmann, CEO Roche Diagnostics. "As laboratories look toward the future, they require systems that provide the highest performance standards that Roche delivers as well as new ways to increase efficiency, which ultimately benefit everyone receiving or providing health care."
The fully automated cobas 6800/8800 Systems provide the fastest turn-around time, highest throughput and the longest walk-away time compared to other automated molecular platforms, giving laboratories the flexibility to adapt to changing testing demands.

About the Roche Cervical Cancer Portfolio
The Roche Cervical Cancer Portfolio enables healthcare professionals to better screen, manage and diagnose women, based on the confidence and clarity of results across a continuum of patient care. The unique combination of molecular, cellular and tissue-based diagnostic tests provides healthcare professionals powerful information to make patient care decisions and minimize unnecessary treatment.

cobas HPV testing is clinically validated for HPV primary screening, ASC-US triage, or co-testing (HPV and Pap cytology) using the cobas 4800 or cobas 6800/8800 Systems *. The cobas HPV assays provides specific genotyping information for HPV 16 and HPV 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one test and from one patient sample. More information about cobas HPV is available at www.hpv16and18.com.

Using advanced, dual-biomarker technology to simultaneously detect p16 & Ki-67, CINtec PLUS Cytology* definitively identifies transforming HPV infections, providing greater certainty to clinicians to stratify patients for follow-up or intervention. CINtec PLUS Cytology* is an objective triage solution for managing HPV-positive or abnormal Pap cytology primary screening results and helps address some of the limitations of traditional Pap cytology.
CINtec Histology is used to confirm the presence or absence of high-grade cervical disease in women who have had a tissue biopsy. CINtec Histology uses the p16 biomarker for a more conclusive diagnosis to provide distinctive visual confirmation of pre-cancerous cervical lesions that may be missed by H&E or morphologic interpretation alone. Both CINtec assays have been fully automated on the VENTANA BenchMark IHC/ISH instruments*.

About Human Papillomavirus and Cervical Cancer
Persistent infection with high-risk Human Papillomavirus (HPV) is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. It can take 10 to 15 years or longer for cervical cancer to develop, so knowing a woman’s individual risk and finding disease early, before cancer develops, is an important prevention strategy. The World Health Organization estimates there are more than 500,000 new cases of cervical cancer annually.

About the cobas 6800/8800 Systems
The cobas 6800 and cobas 8800 systems are fully integrated, automated solutions that introduce a new standard for routine molecular testing in the areas of viral load monitoring, donor screening, women’s health and microbiology. Based on Nobel prize-winning PCR technology, the systems are designed to deliver full automation, increased throughput and faster turnaround time, providing users with greater flexibility to increase overall workflow efficiencies.

The systems provide up to 96 results in less than 3.5 hours and a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in an eight-hour shift. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required. The systems also enable up to eight hours (cobas 6800) and four hours (cobas 8800) of walk-away time with minimal user interaction.

Additional molecular assays for use on the cobas 6800/8800 Systems include: cobas HIV-1, cobas HCV; cobas HBV and cobas CMV plus three next-generation assays for donor screening: cobas MPX, cobas WNV and cobas HEV.
For more information about the Systems, visit www.cobas68008800.com or View Source

Endocyte Announces Presentations at American Association for Cancer Research (AACR) Annual Meeting 2017

On March 27, 2017 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that eight posters will be presented by Endocyte scientists at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 to be held in Washington, DC, April 1 – 5, 2017 (Press release, Endocyte, MAR 27, 2017, View Source [SID1234518281]).

Key presentations during the meeting include a late-breaking poster presentation of new research from investigators and faculty at the Purdue University Center for Drug Discovery on the application of Endocyte’s SMDC technology in a chimeric antigen receptor (CAR) therapy setting. Additionally, the company will present several posters with preclinical data relating to Endocyte’s SMDC technology, including developments in combination therapies and novel proPBD warheads.

The presentation materials will be available on Endocyte’s website following presentation at the conference.

Presentations are as follows:

Abstract #: 2057
Title: Evaluation of anti-tumor efficacy of EC1456 in low-passage and pre-treated patient-derived xenograft models of triple-negative breast cancer
When: Monday, April 3, 1 p.m. – 5 p.m. CDT
Session Title: Drug Resistance: Other Topics
Location: Halls A-C, Poster Section 3

Abstract #: 2133
Title: Pre-clinical studies of EC2629, a highly potent FR targeted DNA crosslinking agent
When: Monday, April 3, 1 p.m. – 5 p.m. CDT
Session Title: New Targets 2
Location: Halls A-C, Poster Section 6

Abstract #: LB-187
Title: New methods for controlling CAR T-cell mediated cytokine storms
When: Tuesday, April 4, 8 a.m. – 12 p.m. CDT
Session Title: Late-Breaking Research: Immunology
Location: Poster Section 35

Abstract #: 3670
Title: Treatment of epithelial ovarian cancer with folate receptor (α/β) targeted chemotherapy is enhanced by CTLA-4 blockage: Learning from animal models
When: Tuesday, April 4, 8 a.m. – 12 p.m. CDT
Session Title: Dendritic Cells as Critical Immune Targets
Location: Halls A-C, Poster Section 27

Abstract #: 3228
Title: Development and characterization of in vitro assays to detect and quantitate tubulysin B hydrazide in biological samples
When: Tuesday, April 4, 8 a.m. – 12 p.m. CDT
Session Title: Novel Molecular Targets 2
Location: Halls A-C, Poster Section 8

Abstract #: 4017
Title: Development and application of an immunohistochemistry-based assay for evaluating functional and accessible folate receptor expression in vivo
When: Tuesday, April 4, 1 p.m. – 5 p.m. CDT
Session Title: Assay Technology
Location: Halls A-C, Poster Section 1

Abstract #: 4574
Title: Combinatorial strategies of folate receptor-targeted chemotherapy guided by improved understanding of tumor microenvironment and immunomodulation
When: Tuesday, April 4, 1 p.m. – 5 p.m. CDT
Session Title: Clinical Immunotherapy, Viruses, and bacteria
Location: Halls A-C, Poster Section 25

Abstract #: 5147
Title: Novel warheads for targeted therapies of cancer: The concept and design of proPBDs
When: Wednesday, April 5, 8 a.m. – 12 p.m. CDT
Session Title: Novel Drug Delivery Technology
Location: Halls A-C, Poster Section 5
About Endocyte’s SMDC Bi-Specific Adaptors

Endocyte’s SMDC bi-specific adaptors represent a novel approach that makes possible the engineering of a single universal CAR T-cell, designed to bind with high affinity to fluorescein isothiocyanate (FITC). This universal CAR T-cell can be specifically directed to cancer cells through the administration of a tumor targeted FITC-containing SMDC, known as a bi-specific adaptor that acts to bridge the universal CAR T-cell with the cancer cells to cause localized T-cell activation. This approach has been shown pre-clinically to address three key CAR T-cell issues by: (i) avoiding hyper-activation of CAR T-cells leading to a cytokine storm, (ii) enabling termination of CAR T-cell activity upon eradication of the tumor, and (iii) potentially enabling elimination of all cancer cells in heterogeneous solid tumors. In March 2017, Endocyte entered into a research collaboration with Seattle Children’s Research Institute and Dr. Michael Jensen for the development of Endocyte’s SMDC platform in the chimeric antigen receptor T-cell (CAR T-cell) immunotherapy setting through the use of Endocyte’s proprietary SMDC bi-specific adaptor molecules.

Delcath Announces Special Protocol Assessment Agreement With FDA for Pivotal Trial With Melphalan/HDS in Intrahepatic Cholangiocarcinoma

On March 27, 2017 Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported it has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of Delcath’s pivotal trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC) (Press release, Delcath Systems, MAR 27, 2017, View Source [SID1234518278]). The SPA agreement indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS.

The pivotal trial is titled "A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma." Under the SPA, the study will enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The primary endpoint is overall survival (OS) and secondary and exploratory endpoints include safety, progression-free survival (PFS), overall response rate (ORR) and quality-of-life measures. The Company expects to initiate the study in the Fall of 2017.

Full details of the registration trial will be made public upon the launch of the study and will be available at www.clinicaltrials.gov.

"We look forward to initiating this important study in ICC under a SPA with the FDA," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "The promising outcomes and observations in this tumor type identified by European investigators at our global Key Opinion Leader Forum last year were discussed at length with the agency, and provide us with considerable confidence in the potential of our therapy as a treatment for ICC. A manuscript of the European investigator data will be submitted to a peer-reviewed journal for publication."

"This pivotal study in ICC is designed to be cost effective and pursued in a financially prudent manner. Given the sequential nature of the trial design, Delcath’s investment in this study will be modest in 2017 as the Melphalan/HDS segment of the study will not occur until late in the year," added Dr. Simpson.

Separately, the Company announces that it intends to file financial results for the three and 12 months ending December 31, 2016 on Form 10-K with the U.S. Securities and Exchange Committee on or before March 30, 2017.

About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application. Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety.

About Intrahepatic Cholangiocarcinoma
Intrahepatic cholangiocarcinoma is the second most common primary liver tumor and represents approximately 10-20% of new hepatocellular carcinoma (primary liver cancer or HCC) cases diagnosed annually, or approximately 3,100 new cases every year in the U.S.1 Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.

ZIOPHARM Announces Successful End-of-Phase 2 Meeting with FDA for Ad-RTS-hIL-12 Gene Therapy in Recurrent Glioblastoma

On March 27, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported the receipt of positive guidance from an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for its lead gene therapy product candidate, Ad-RTS-hIL-12 plus orally administered veledimex (V), to harness and control IL-12 production for the investigational treatment of recurrent glioblastoma (GBM), an aggressive form of brain cancer with few treatment options (Press release, Ziopharm, MAR 27, 2017, View Source [SID1234518275]).

"We are pleased with our productive interactions with the FDA and the valuable direction we received at the End-of-Phase 2 meeting. Our controlled approach utilizing the RheoSwitch platform represents the next-generation of gene therapy enabling IL-12 to be regulated through a transcriptional switch. We appreciate the FDA’s feedback surrounding our plans to advance Ad-RTS-hIL-12-based therapy to a pivotal registration study for patients with recurrent GBM in 2017 and look forward to establishing the benefits of this novel therapeutic approach," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM.

"The median overall survival remains very promising and continues to be greater than 12 months for these heavily compromised patients," said Francois Lebel, M.D., Chief Medical Officer of ZIOPHARM. He added, "After positive meetings with both FDA and European regulators, the Company is working towards finalization of the optimal pathway for our pivotal trial for Ad-RTS-hIL-12 + veledimex."

In collaboration with its investigators and regulators, the Company is currently assessing its protocol design options for the pivotal trial, including the potential for a single-arm study comparing Ad-RTS-hIL-12 + V to historical controls in a subpopulation of patients with recurrent GBM. Details of the pivotal Phase 3 trial will be made available following evaluation and completion of discussions with clinical advisors as well as regulators.

About Glioblastoma:
GBM represents approximately 15% of all primary brain tumors and remains a high unmet clinical need that affects roughly 74,000 people worldwide annually. GBM is an aggressive form of brain cancer with recurrence rates near 90%, and prognosis for patients is poor with treatment often combining multiple approaches including surgery, radiation, and chemotherapy. Median overall survival (OS) is only 6 to 7 months in patients who have experienced multiple recurrences, and the prognosis is even poorer for patients who have failed temozolomide and bevacizumab, or equivalent salvage chemotherapy with a median OS of approximately 3 to 5 months.

BioLineRx’s AGI-134 to be Presented at AACR 2017

On March 27, 2017 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that AGI-134, an immunotherapy for the treatment of multiple cancers, obtained through its recently announced acquisition of Agalimmune Ltd., will be featured at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Washington, DC to be held on April 1-5, 2017 (Filing, 6-K, BioLineRx, MAR 27, 2017, View Source [SID1234518274]).

An abstract titled "The novel α-Gal-based immunotherapy AGI-134 invokes CD8+ T cell-mediated immunity by driving tumor cell destruction, phagocytosis and tumor-associated antigen cross-presentation via multiple antibody-mediated effector functions" was accepted for a poster presentation at the T-Cell Immunity to Cancer: New Progress session on April 2nd, 2017.

About AGI-134
AGI-134 is a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response. AGI-134 has completed numerous pre-clinical studies, demonstrating robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional pre-clinical studies when combined with a PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 is in near-clinical development and is expected to commence a first-in-man study in patients with solid tumors in the first half of 2018.