On December 1, 2017 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported that it will present data from its most recent breast cancer diagnostic study during a poster session at the 2017 San Antonio Breast Cancer Symposium (SABCS) on December 7, 2017 (Press release, BioTime, DEC 1, 2017, View Source;p=RssLanding&cat=news&id=2319585 [SID1234522329]). The SABCS will take place at the Henry B. Gonzalez Convention Center in San Antonio, Texas, from December 5-9, 2017.

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The data to be presented are from the Company’s NICE-BC (Non-Invasive Confirmatory dEtection (of) Breast Cancer follow-on study. The data confirm the findings from OncoCyte’s previous breast cancer study, which were presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2016. In the earlier study, the 15-marker model resulted in an area under the curve (AUC) of 0.92 with a sensitivity of 90% and specificity of 76%. Given this level of accuracy, and subject to successful completion of further R&D and clinical studies, OncoCyte’s novel panel of serum protein biomarkers may become the foundation of a highly accurate, non-invasive breast cancer diagnostic test.

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 masses that are identified correctly by the test and specificity measuring the percentage of benign lumps or masses correctly identified.

"We look forward to reporting data from our breast cancer diagnostic development program at this prestigious conference," said William Annett, President and Chief Executive Officer. "The data from our breast cancer studies are compelling and we look forward to continuing to advance the development program in 2018. We believe our test would address a significant unmet need by reducing the number of unnecessary invasive breast biopsies and lowering the financial burden to the healthcare system."

The data from the NICE-BC study will be presented at SABCS 2017 by Philip McQuary, Ph.D., Director, Product Development, at OncoCyte.

Abstract Title: Assessment of an immune response panel of serum protein biomarkers for the non-invasive detection of breast cancer
Poster Session: 2 (P2-02-03)
Session Title: Detection/Diagnosis: Circulating Markers
Session Date: December 7, 2017
Session Time: 7:00 am CT – 9:00 am CT

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 would address the needs of some of these populations, thereby reducing the number of patients subjected to invasive procedures.

According to published reports, there are about 39 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 1, 2017 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported that it will participate in the Citi 2017 Global Healthcare Conference on Wednesday, December 6, 2017, in New York City (Press release, Medtronic, DEC 1, 2017, View Source;p=RssLanding&cat=news&id=2319639 [SID1234522334]).

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Geoff Martha, executive vice president and president of the Medtronic Restorative Therapies Group (RTG), will answer questions about the company beginning at 8:45 a.m. EST (7:45 a.m. CST).

A live audio webcast of the presentation will be available on December 6, 2017, by clicking on the Investor Events link at View Source, and an archive of the session will be available on the same webpage later in the day.

On December 1, 2017 Carrick Therapeutics, a biopharmaceutical company focusing on the innovative research and development of transformative oncology medicines, reported that the first patient has been dosed in the phase 1 clinical programme of CT7001 – an orally bio-available Cyclin-dependent Kinase 7 (CDK7) selective inhibitor, that has shown striking efficacy in multiple pre-clinical cancer models (Press release, Evotec, DEC 1, 2017, View Source [SID1234522324]).

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Elaine Sullivan, chief executive of Carrick Therapeutics, said:

"We are excited by the potential of CT7001 to make a major difference in cancer treatment, and intend to rapidly progress CT7001 through clinical development and bring this promising new medicine to patients as quickly as possible. This is a significant achievement for Carrick to take a pre-clinical candidate to first patient dosed in less than two years."

CDK7 inhibition has emerged as a promising strategy in a range of cancer indications. CDK7 acts as a master regulator of transcription, as well as a regulator of the cell cycle through phosphorylation of members of the CDK family. Inhibition of CDK7 suppresses the expression of key oncogenes such as c-Myc.

CT7001 was found to be effective in pre-clinical models of breast cancer, both hormone receptor positive and triple-negative, and transcriptionally driven cancers such as acute myeloid leukemia and small-cell lung cancer (SCLC). All these cancers continue to have major unmet medical need, for example, very little progress has been made for decades in the treatment of SCLC and triple-negative breast cancer (TNBC). Due to its differentiated mechanism, CT7001 is also predicted to be efficacious where resistance has developed to current therapies.

CT7001 originated from Cancer Research UK funded scientists at Imperial College London and was licensed to Carrick by the charity’s Commercial Partnerships Team. Rapid subsequent preclinical development by the company’s experienced research and development team has led to approval for the first-in-human Phase I study. Efficacy studies are planned to start in 2018.

Carrick Therapeutics was established with an initial funding round that saw it raise $95 million, and continues to build its portfolio through partnering. Significantly, whilst other companies bank on a single molecule or biological mechanism, Carrick will build a portfolio that targets multiple mechanisms that drive cancer. In close partnership with a network of clinicians and scientists in internationally leading research institutes and hospitals, the business will drive its portfolio of ground-breaking cancer therapies from laboratories to the clinic.

The funding of Carrick Therapeutics was co-led by ARCH Venture Partners and Woodford Investment Management, with participation from Cambridge Enterprise, Cambridge Innovation Capital, Evotec, GV (formerly Google Ventures), and Lightstone Ventures.

On November 30, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that Stephen Hurly, President and Chief Executive Officer, will present a company overview at the LD Micro Main Event 2017 in Los Angeles, CA on Thursday, December 7, 2017 at 8:30 a.m. PST (Press release, Eleven Biotherapeutics, NOV 30, 2017, View Source [SID1234522322]).

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A live webcast can be accessed from the Investors & Media section of Eleven’s website, www.elevenbio.com. An archived replay of the webcast will be available on the Company’s website for 90 days after the conference.

On November 30, 2017 Pfizer Inc. (NYSE:PFE) and Basilea Pharmaceutica Ltd. (SIX:BSLN), an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, reported they have entered into an agreement whereby Pfizer will be granted the exclusive development and commercialization rights in China and several countries in the Asia Pacific region to CRESEMBA (isavuconazole) (Press release, Pfizer, NOV 30, 2017, View Source [SID1234522326]). CRESEMBA is a novel antifungal medicine for the treatment of adult patients with diagnosed invasive aspergillosis and mucormycosis1, two serious infections associated with significant morbidity and mortality among immunocompromised patients, such as those with advanced HIV and those with cancer.

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Under the terms of the agreement, Pfizer will have exclusive rights to develop, distribute and commercialize CRESEMBA in sixteen Asian Pacific countries and China (including Hong Kong and Macao). These rights do not include Japan. In addition, Pfizer will become the marketing authorization holder for the Asia Pacific Region and China. The specific financial terms of the agreement remain confidential. The agreement is subject to customary regulatory approval.

In July 2017, Pfizer completed an agreement with Basilea to obtain the exclusive commercialization rights to CRESEMBA in Europe (with the exception of the Nordic countries). Since that time, Pfizer has assumed responsibility for the commercialization of CRESEMBA in Austria, France, Germany, Italy, and the United Kingdom and successfully launched CRESEMBA in Spain with additional launches expected in 2018 and beyond.

CRESEMBA was developed in response to the urgent medical need for antifungal medicines for the treatment of invasive fungal infections, which are naturally resistant to many antifungal therapies and have become increasingly resistant to other available therapies. Today, invasive aspergillosis is the most frequently reported fungal infection in immunocompromised individuals within the Asian Pacific region.

"We are excited to extend our partnership with Basilea, a company that shares our passion and commitment to confronting the global challenges of infectious disease management," said Suneet Varma, global president of Pfizer APAC, Greater China and Global Brands. "We believe our extensive geographic footprint in APAC and China, together with our expertise in successfully commercializing innovative medicines, will help enable us to continue to address the unmet medical needs of patients, especially in the area of anti-infectives."

"CRESEMBA is a well differentiated drug that addresses a critical medical need in patients with invasive mold infections," said Ronald Scott, chief executive officer of Basilea. "We are very pleased to be expanding our partnership with Pfizer to China and Asia Pacific where it has a strong commercial presence and a proven track record of successfully developing and commercializing hospital antifungals. We have now established partnerships for isavuconazole with leading pharmaceutical companies in all major markets around the world."

About Pfizer Anti-Infectives

Today, Pfizer is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products. Since its pioneering work on penicillin in the 1940s, Pfizer has been actively engaged in the research and development of innovative medicines and creation of policies and educational programs to address the evolving needs of patients and physicians in the area of infectious diseases. In December 2016, Pfizer completed the acquisition of AstraZeneca PLC’s small molecule anti-infective business, which includes both marketed agents and clinical development assets primarily outside the United States.

About invasive aspergillosis and mucormycosis

Invasive fungal diseases (IFDs) are an increasingly common complication associated with high morbidity and mortality among immunocompromised patients such as those with advanced HIV infection and those with cancer. Rates of mortality associated with invasive fungal infections depend upon the pathogen, geographic location and underlying patient characteristics and can be as high as 80-90%. Today, there are limited treatment options available for patients diagnosed with invasive aspergillosis and mucormycosis.

About CRESEMBA (isavuconazole)

CRESEMBA is an intravenous (IV) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. The European centralized marketing authorization was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. The drug is commercialized in the US by Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. Pfizer does not have commercialization rights to CRESEMBA in the United States.