On December 7, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported positive data from its most recent breast cancer diagnostic test study at the 2017 San Antonio Breast Cancer Symposium (SABCS) (Press release, BioTime, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321631 [SID1234522422]). The data were presented by Philip McQuary, Ph.D., Director of Product Development at OncoCyte.

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This study revealed that a novel blood based diagnostic test may allow for the non-invasive and sensitive detection of breast cancer in BI-RADS category 4 patients, thereby differentiating women who have breast cancer from those who do not. A 19-marker model resulted in an AUC of 0.935 with a sensitivity of 90% and specificity of 82%. The data from this study are consistent with data reported at the San Antonio Breast Cancer Symposium in December 2016.

The poster, titled "Assessment of an Immune Response Panel of Serum Protein Biomarkers for the Non-Invasive Detection of Breast Cancer," discusses details of OncoCyte’s study in which serum samples were collected at four U.S. sites from 136 women with suspicious diagnostic mammography findings undergoing biopsy to determine if they have breast cancer. All 136 subjects had mammograms and were classified as BI-RADS category 4 and had pathology confirmation of their diagnosis (malignant or benign). Statistical screening methodologies were used to identify markers with the potential to distinguish benign from malignant pathology. The candidate markers were further studied and combined to develop a potential diagnostic test.

BI-RADS (Breast Imaging and Reporting Data System) is a scoring system developed by the American College of Radiologists to help clinicians assess the risk of cancer in women with a lump or mass. A BI-RADS category 4 classification indicates a suspicious result, and women in this category are generally referred for a breast biopsy. The AUC of a test is a measure that combines sensitivity and specificity to express its total accuracy, with 1.0 being perfect accuracy and 0.50 being a random result. Sensitivity and specificity are statistical measures of test performance, with sensitivity measuring the percentage of malignant lumps or lesions that are identified correctly by the test and specificity measuring the percentage of benign lumps or masses correctly identified.

The current standard of care for breast cancer diagnosis – annual or biannual mammogram screenings – does not meet the needs of large populations of women for whom mammography alone is not sufficient. These populations include women with dense breast tissue, genetic mutations (BRCA), a family history of breast cancer, or those who have suspicious mammogram screening results (BIRADs 3 or 4). The Company’s non-invasive liquid biopsy breast cancer diagnostic is intended to be a confirmatory, post-mammogram test that potentially would reduce the number of patients subjected to invasive breast biopsy procedures. Further R&D and clinical utility studies are required to determine whether the confirmatory test would be accurate and commercially viable.

According to published reports, there are about 38 million mammograms performed annually in the U.S., resulting in 1.6 million breast biopsies per year. Of these, only 260,000 (16%) result in a cancer diagnosis. The large number of suspicious findings in diagnostic mammograms leads to a significant amount of unnecessary invasive follow-up procedures. The financial burden to the healthcare system imposed by the follow-up testing of false-positive mammograms and breast cancer over-diagnosis is estimated to be $4 billion a year.

About Breast Cancer

Breast cancer is the second most common cancer among US women. Current screening guidelines set forth by the American Cancer Society recommend screening mammography for the early detection of breast cancer in women at average risk. Specifically, guidelines call for annual mammography for asymptomatic women age 45 to 54 and once every two years for women age 55 and older. Suspicious screening mammograms are generally followed up with a diagnostic mammogram and sometimes by an MRI (Magnetic Resonance Image) or an ultrasound. Ultimately, suspicious findings unresolved by imaging typically result in the recommendation of a breast biopsy.

On December 7, 2017 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) reported a collaboration and license agreement that enables Alexion to use Halozyme’s ENHANZE drug-delivery technology in the development of subcutaneous formulations for their portfolio of products (Press release, Alexion, DEC 7, 2017, View Source [SID1234522420]). The agreement provides Alexion with the opportunity for exclusive development of up to four targets, including a next generation subcutaneous formulation of ALXN1210 (ALXN1210 SC), the company’s investigational long-acting C5 complement inhibitor, to potentially further extend the dosing interval of ALXN1210 SC to once every two weeks or once per month.

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"Alexion’s goal is to provide continued innovation and more treatment options that can significantly improve the lives of patients with rare diseases," said John Orloff, M.D., Executive Vice President and Head of Research & Development at Alexion. "We are excited to partner with Halozyme and look forward to utilizing its ENHANZE technology, which enables rapid injection of subcutaneous treatments and potentially increases bioavailablity, in our development programs."

"We are delighted to support Alexion’s innovative development initiatives focused on improving the lives of patients with rare diseases," said Dr. Helen Torley, president and CEO of Halozyme. "ENHANZE has become the industry standard for converting intravenous therapies to a subcutaneous delivery, helping partners and health care providers reduce the treatment burden and administration time for patients."

Under the terms of the agreement, Halozyme will receive an initial $40 million with the potential to earn additional payments of up to $160 million for each target developed, subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on sales of commercialized products.

The Halozyme ENHANZE technology is based on a proprietary recombinant human hyaluronidase enzyme (rHuPH20) that temporarily degrades hyaluronan — a glycosaminoglycan or chain of natural sugars in the body — to aid in the dispersion and absorption of other injected therapeutic drugs. For Halozyme partners, this technology may allow for more rapid delivery of injectable medications through subcutaneous injection (just under the skin). This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

Alexion is Halozyme’s eighth global collaboration and license partner for the ENHANZE technology, and the third partnership formed in 2017. These partnerships cover nearly 50 therapeutic targets and include three commercialized products.

On December 7, 2017 AVEO Oncology (NASDAQ:AVEO) reported clinical updates for two of its oncology programs: FOTIVDA (tivozanib), the Company’s potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, and ficlatuzumab, the Company’s humanized IgG1 antibody that binds to the hepatocyte growth factor (HGF) ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway (Press release, AVEO, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321570 [SID1234522414]).

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"We continue to build strong momentum in our oncology programs, including progress with our lead program, tivozanib, and the advancement of our other oncology programs, including ficlatuzumab and AV-203," said Michael Bailey, president and chief executive officer of AVEO. "With approval of tivozanib and commercial sales underway in Europe, we are squarely focused on the next two pillars of our tivozanib strategy: the potential for U.S. registration and additional immunotherapy combination studies. As these strategies unfold, 2018 is expected to be another transformative year, with anticipated top-line results in the TIVO-3 study of tivozanib in third line advanced renal cell carcinoma (RCC), as well as development of our earlier-stage programs, including the TiNivo study of tivozanib in combination with Opdivo, and the initiation of two ficlatuzumab investigator-sponsored studies."

Tivozanib Updates

Enrollment Complete in Phase 2 Portion of Phase 1/2 TiNivo Trial in Advanced RCC. AVEO announced today that enrollment of 21 patients is now complete, with one patient remaining in screening, in the Phase 2 portion of the TiNivo study, a Phase 1/2 multicenter trial of tivozanib in combination with Bristol-Myers Squibb’s OPDIVO (nivolumab), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced RCC. In the Phase 1 dose escalation portion of the trial, tivozanib was administered in two escalating dose cohorts, 1.0 and 1.5 mg daily, in combination with nivolumab at 240 mg every 2 weeks (n=6).

Phase 1 data from the study, which were presented at the 16th International Kidney Cancer Symposium, demonstrated that the combination of Opdivo and tivozanib was well tolerated up to the full dose and schedule of single agent tivozanib (1.5 mg daily), with no dose limiting toxicities. The most common adverse events (any grade) were hypertension, asthenia and decreased appetite. No grade 4 adverse events were reported. Two grade 3 events were reported beyond cycle 1 (stomatitis and increased ALT), which did not lead to study discontinuation and were managed concurrently. Best response at the time of presentation included a 67% (4/6) partial response (PR) rate and a 100% disease control rate (4 confirmed PR + 2 stable disease, 1 of which was unconfirmed). Additional results from the Phase 1 portion of the trial and initial results from the Phase 2 portion are expected to be presented at scientific meetings in the first half of 2018, including at the 2018 Genitourinary Cancers Symposium taking place February 8-10, 2018, and co-sponsored by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).
Ficlatuzumab Updates

Phase 2 Study of Ficlatuzumab in Combination with Cetuximab in HNSCC Initiated. The Company announced today the initiation of an investigator-sponsored randomized, multicenter Phase 2 trial of ficlatuzumab and cetuximab (ERBITUX), an EGFR-targeted antibody, in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC). AVEO is partnered with Biodesix, Inc. on the developments of ficlatuzumab. The study will seek to confirm findings from a Phase 1 study where the addition of ficlatuzumab to cetuximab resulted in a disease control rate of 67%, and prolonged progression free and overall survival compared to historical controls, in addition to being well tolerated. This Phase 2 multi-center study, which is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center, is expected to enroll approximately 60 patients randomized to receive either ficlatuzumab alone or ficlatuzumab and cetuximab.
Phase 1b Study of Ficlatuzumab in Combination with Gemcitabine and Nab-paclitaxel in Pancreatic Cancer Initiated. The Company announced today the initiation of an 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). The goal of the study, which is based on preclinical findings demonstrating a synergistic effect of these drugs in a preclinical model of PDAC, is designed to determine maximum tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel. Secondary outcome measures include response rate and progression free survival. The study, which is being conducted under the direction of Kimberly Perez, M.D. at the Dana-Farber Cancer Institute, is expected to enroll approximately 30 patients.
About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. currently divide all worldwide development costs for ficlatuzumab and are seeking a commercialization partner. Ficlatuzumab is currently being evaluated in investigator-sponsored trials in squamous cell carcinoma

On December 7, 2017 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will present at the BMO Capital Markets 2017 Prescriptions for Success Healthcare Conference at 11:00 a.m. ET on Thursday, Dec. 14, 2017, in New York City (Press release, Neurocrine Biosciences, DEC 7, 2017, View Source;p=RssLanding&cat=news&id=2321693 [SID1234522445]). Timothy P. Coughlin, Vice President Finance of Neurocrine Biosciences, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website at View Source A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.

On December 7, 2017 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the commercial availability of new Vantage 3D Hematology assays as well as the highlights of more than 45 nCounter-based research abstracts that will be presented at the 59th Annual Meeting of the America Society of Hematology being held December 9-12, in Atlanta (Press release, NanoString Technologies, DEC 7, 2017, View Source [SID1234522444]).

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The company announced the launch of new Vantage 3D hematology assays. Three of the studies presented at ASH (Free ASH Whitepaper) (Abstracts 1758, 2481 and 3945) include data from early access versions of NanoString’s Vantage 3D DNA:RNA:Protein Heme Assays, which are launching commercially at ASH (Free ASH Whitepaper). These assays enable simultaneous, multi-analyte analysis of single nucleotide variants (SNVs), RNA, protein, and phospho-protein. The assay includes curated content that covers clinically actionable SNVs and Indels, and provide comprehensive expression profiling of RNA, protein, and phospho-protein in key pathways including PI3K, JAK-STAT, BCR, and TCR signaling.

One of the presentations will be made by Dr. Sergio Rutella, M.D. Ph.D. FRCPath., Professor of Cancer Immunotherapy at the John van Geest Cancer Research Centre at Nottingham Trent University. Dr. Rutella stated, "AML is a rare disease and we need to maximize the amount of information we collect. We are using NanoString’s Vantage 3D DNA:RNA:Protein Heme Assay to capture information about single nucleotide variants, mutations, and new antigens that could be compiled into a ‘super signature’ to better characterize the disease and stratify the treatment of patients."

"Our customers and collaborators are presenting a record body of nCounter-based research at the 59th annual ASH (Free ASH Whitepaper) conference," said Brad Gray, president and chief executive officer of NanoString Technologies. "This research demonstrates the advances that are being enabled with the nCounter platform in subtyping lymphomas and optimizing regimens to achieve better clinical outcomes."

The ASH (Free ASH Whitepaper) Annual Meeting will include at least four oral presentations and forty-one posters in various leukemia, lymphoma, and myeloma malignancies that demonstrate the utility of the nCounter platform across the heme-oncology spectrum. In particular, NanoString’s collaborators in Diffuse Large B-Cell Lymphoma (DLBCL) are presenting 11 abstracts highlighting the potential clinical relevance of NanoString’s Lymphoma Subtyping Test (LST) and its potential for directing treatment decisions, including:

Results from the frontline prospective Phase III BIO-DLBCL04 study conducted by the Fondazione Italiana Linfomi (FIL). The results show that ABC subtype determined by the NanoString LST assay is associated with a worse outcome in untreated, poor-risk, young DLBCL (Abstract #4010).

Researchers from the European Institute of Oncology found that the NanoString LST robustly identifies DLBCL subgroups according to the Cell-of-Origin (COO). The molecular definition of the COO can be used to identify patients at high risk of poor outcome when treated with R-CHOP and who may benefit by intensified high dose chemotherapy or experimental new treatments (Abstract #3998).

Results from an exploratory biomarker analysis of the Phase 3 GOYA Trial comparing the efficacy and safety of obinutuzumab plus CHOP (G-CHOP) with R-CHOP in patients with previously untreated DLBCL. Using the NanoString LST assay and a new cutoff on the Linear Predictor Score (LPS), a new distinct molecular subgroup of GCB DLBCL, referred to as "strong-GCB", was identified. Results from the exploratory analysis show that treatment with G-CHOP confers substantial clinical benefit over R-CHOP in this new subgroup of DLBCL (Abstract #1543).
The table below includes a selection of 2017 ASH (Free ASH Whitepaper) abstracts that best illustrate the potential clinical utility of nCounter across multiple tumor types. You can learn more about the capabilities of the nCounter platform by visiting NanoString at booth #2465 at ASH (Free ASH Whitepaper).