On April 24, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its first quarter 2019 financial results on Tuesday, May 7, 2019, before the open of the U.S. financial markets (Press release, Clovis Oncology, APR 24, 2019, View Source [SID1234535367]). Clovis’ senior management will host a conference call and live audio webcast at 8:30 a.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss first quarter 2019 results on Tuesday, May 7, at 8:30 a.m. ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 877.698.7048, International participants 647.689.5448, conference ID: 8567356.

On April 23, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported that the company will present at European NeoAG Summit 2019 in Amsterdam on April 24th at 2:30 PM CEST (Press release, Personalis, APR 23, 2019, View Source [SID1234535331]).

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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

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The presentation, entitled "ImmunoID NeXT Platform: Improving Neoantigen Prediction, TME Assessment, and ctDNA Detection for Vaccine Development," will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT. In addition to an overview, the presentation will highlight innovative genomics methods for more comprehensive assessment of neoantigens, which include improving neoantigen-to-MHC binding prediction and ranking and assessing TME/TCR and tumor escape mechanisms that may impact vaccine response.

ImmunoID NeXT is the first platform to provide comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Sean M. Boyle, Ph.D., Director, Bioinformatics Applications for Personalis.

On April 23, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the launch of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast and gastric cancer (Press release, Hoffmann-La Roche, APR 23, 2019, View Source [SID1234535348]). HER2 – human epidermal growth factor receptor 2 – is an important biomarker found in breast and gastric cancers.4 Its detection and inhibition can help to more effectively manage these aggressive cancers.

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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

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The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within the same day, providing clinicians the ability to get results back quicker than the most common methods of confirmatory testing for HER2. Results can be read using light microscopy, eliminating the need for a specialized fluorescence microscope.

"The new VENTANA HER2 Dual ISH assay advances Roche’s commitment to personalized healthcare by delivering critical information on treatment options for breast and gastric cancer patients faster," said Michael Heuer, CEO Roche Diagnostics. "Quick results are crucial in the fight against cancer, and every additional day that a clinician and a patient must wait for test results is a day too long."

This assay is currently being launched in Europe, the Middle East and Africa, as well as Latin America and Asia Pacific. It will be submitted to the U.S. Food and Drug Administration for approval.

For more information about the assay, please visit the Roche Tissue Diagnostics breast cancer IHC/ISH portfolio page or the Anatomic Pathology site.

About the VENTANA HER2 Dual ISH DNA Probe Cocktail assay
Roche is the only provider of a fully automated brightfield Dual ISH solution for the detection of HER2 amplification. With the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay, Roche provides an improved brightfield assay that is fully automated on the BenchMark IHC/ISH instruments. The assay provides clear results to pathology labs more quickly, allowing clinicians to make treatment decisions earlier.
As a global leader in breast cancer diagnostics, Roche provides a comprehensive menu of both diagnostic and predictive assays, including the VENTANA HER2/neu (4B5) Rabbit Monoclonal Primary Antibody that is indicated as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered.

About Herceptin (trastuzumab)
Herceptin is a humanised monoclonal antibody designed to target and block the function of the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Herceptin binds to a specific section of the HER2 protein, inhibiting the signals it sends that encourage tumour cell growth, while also calling on the body’s immune system to attack the cancer cells.

Since it was first approved in 1998, Herceptin has been used to treat over two million patients worldwide, diagnosed with HER2-positive breast and gastric cancers. It has also become the backbone of other innovative treatments for HER2-positive breast cancer, which have continued to improve the outcomes of patients with this otherwise aggressive disease. In addition to the standard intravenous formulation, Herceptin is available in a subcutaneous (SC) formulation which was first approved in 2013. Herceptin SC represents a significant step forward in the treatment of HER2-positive breast cancer as it offers patients a faster, more convenient and less painful way to receive treatment with Herceptin.

On April 23, 2019 AVEO Oncology (NASDAQ:AVEO) reported the triggering of a $2 million milestone payment to AVEO from EUSA Pharma (Press release, AVEO, APR 23, 2019, View Source [SID1234535332]). The milestone payment relates to the reimbursement approval and commercial launch in Spain of FOTIVDA (tivozanib) as a first line treatment of adult patients with advanced renal cell carcinoma (RCC). Commercial launch in Spain is the third of five EU5 country launches to trigger a $2 million payment under the terms of AVEO’s license agreement with EUSA Pharma. In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for RCC. Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor.

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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

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"We are pleased to see Spain recognize the benefit of patient access to FOTIVDA and continued expansion of the FOTIVDA commercial footprint in Europe," said Michael Bailey, president and chief executive officer of AVEO. "We continue to work toward reporting more mature interim overall survival results from our TIVO-3 study in the fourth quarter of 2019, and remain confident in the significant commercial potential for a VEGF therapy that has demonstrated activity and tolerability in all lines of RCC therapy, including highly refractory patients with prior exposure to PD-1 therapy."

EUSA Pharma is the licensee for tivozanib in Europe, North and South Africa, Latin America and Australasia. Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $382 million in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. Thirty percent of milestone and royalty payments received by AVEO, excluding research and development funding, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee in Europe. In the United States, the royalty obligation to KHK would range from the low- to mid-teens on net sales upon approval and commercialization.

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 (RCC) 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.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal and breast cancers. In addition, a new formulation of tivozanib is in pre-clinical development for the treatment of age-related macular degeneration.

On April 23, 2019 Mereo BioPharma Group plc (AIM: MPH), a clinical stage, UK-based, biopharmaceutical company focused on rare diseases, reported that the merger with OncoMed Pharmaceuticals, Inc. ("OncoMed" NASDAQ:OMED) announced on 5 December 2018 has completed (Press release, Mereo BioPharma, APR 23, 2019, View Source [SID1234553301]).

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This follows the approval from the stockholders of OncoMed on 17 April 2019 of the transactions contemplated by the merger agreement dated 5 December 2018 (the "Merger") between Mereo, OncoMed and certain other parties thereto (the "Merger Agreement"), and OncoMed has today become a wholly-owned indirect subsidiary of Mereo following the effective filing of a certificate of merger with the Secretary of State of the State of Delaware. In connection with completion of the Merger:

Mereo has today issued 24,783,320 new ordinary shares (the "New Shares") to Citibank, N.A., London Branch, as custodian, and will instruct Citibank, N.A., as depositary, to deliver 4,956,664 American Depositary Shares (the "ADSs") to former OncoMed stockholders, each ADS representing five New Shares. The ADSs are expected to be admitted to trading on the Global Market of Nasdaq Stock Exchange Market LLC on 24 April 2019, under the ticker symbol "MREO"; and

Michael Wyzga and Deepa Pakianathan, Ph.D. today become non-executive directors of Mereo.
Mereo also announces today that its preliminary results for the Financial Year ended 31 December 2018 will be published on Monday 29 April 2019.

Commenting on the announcement, Mereo’s Chief Executive Officer, Dr. Denise Scots-Knight, said:

"We are pleased to have completed our merger with OncoMed which has broadened our asset base, strengthened our cash position and will enable us to further progress our two rare disease programmes. We are delighted to welcome both Michael and Deepa to our Board.

The ADR programme we have now initiated on NASDAQ, together with our existing AIM listing, will facilitate a deeper engagement with a broader international pool of capital. As we look forward to the remainder of 2019 we continue to anticipate several important data points from our two rare disease products. These include initial 6 month data from the open label arm our Phase 2b dose ranging study for BPS-804 in the treatment osteogenesis imperfecta in Q2 2019, 12 month data for this programme in Q4 2019 and data from our Phase 2 dose-ranging study with MPH-966 for alpha-1 antitrypsin deficiency (AATD), which we expect around the end of 2019.

Partnering discussions for BCT-197 for severe exacerbations of COPD are progressing following our successful end of Phase 2 Type B meeting with the FDA. We also intend to initiate partnering discussions for navicixizumab, which has generated encouraging clinical data in ovarian cancer and for BGS-649 in hypogonadotrophic hypogonadism in parallel with the regulatory interactions to determine the next development steps. We look forward to updating our shareholders on the progress of our pipeline more comprehensively on the publication of our preliminary financial results for 2018 at the end of April."

Issue of New Shares and Total Voting Rights

The New Shares rank pari passu with the existing ordinary shares of Mereo. Application has been made for the New Shares to be admitted to trading on AIM ("Admission") and it is expected that Admission will take place at 8.00 a.m. (BST) on 24 April 2019.

The New Shares represent approximately 25.8% of the enlarged issued share capital of Mereo which, following the issue, consists of an aggregate total of 96,023,592 ordinary shares of £0.003 each, none of which are held in treasury. Shareholders may use this figure as the denominator for the calculations by which they will determine if they are required to notify their interest in, or to notify a change to their interest in, the issued share capital of Mereo.

Appointment of Michael Wyzga and Deepa Pakianathan, Ph.D. as Non-Executive Directors of Mereo

In accordance with the Merger Agreement, Mereo has appointed Michael Wyzga and Deepa Pakianathan, Ph.D. as non-executive directors of Mereo.

Michael Wyzga served as a director of OncoMed from October 2013 until the closing of the Merger today. Mr. Wyzga is currently the President of MSW Consulting Inc., a strategic consulting group focused in the life sciences area. From December 2011 until November 2013, Mr. Wyzga served as President and Chief Executive Officer and a member of the board of directors of Radius Health, Inc. Prior to that, Mr. Wyzga served in various senior management positions at Genzyme Corporation, including as Chief Financial Officer from July 1999 until November 2011. Mr. Wyzga is a member of the boards of directors of Exact Sciences Corporation and LogicBio and is Chairman of the board of directors of GenSight Biologics S.A. and of X4 Biologics. Mr. Wyzga previously served as a member of the boards of directors of Idenix Pharmaceuticals, Inc. and Altus Pharmaceuticals, Inc., and as a member of the supervisory board of Prosensa Holding B.V. He received an M.B.A. from Providence College and a B.S. from Suffolk University.

Deepa Pakianathan, Ph.D. served as a director of OncoMed from December 2008 until the closing of the Merger today. Since 2001, Dr. Pakianathan has been a Managing Member at Delphi Ventures, a venture capital firm focused on biotechnology and medical device investments. Dr. Pakianathan serves on the boards of directors of Alder Biopharmaceuticals, Inc., Karyopharm Therapeutics, Inc., and Calithera Biosciences, Inc. Dr. Pakianathan previously served on the boards of directors of Alexza Pharmaceuticals, Inc., PTC Therapeutics, Inc. and Relypsa, Inc. Dr. Pakianathan received a B.Sc. from the University of Bombay, India, a M.Sc. from The Cancer Research Institute at the University of Bombay, India, and an M.S. and Ph.D. from Wake Forest University.

The following information is disclosed pursuant to Schedule Two paragraph (g) of the AIM Rules for Companies. Michael Stephen Wyzga, aged 63 years, and Deepa Rachel Pakianathan, Ph.D., aged 54 years, have been a director of the following companies during the five years preceding the date of this announcement:

Michael Stephen Wyzga

Current directorships/partnerships Past directorships/partnerships
Exact Sciences Corporation Idenix Pharmaceuticals, Inc
GenSight Biologics S.A. Prosensa Holding B.V.
LogicBio Akebia Therapeutics, Inc.
MSW Consulting Aura Biosciences, Inc.
X4 Biologics Dohman Co.
OncoMed Pharmaceuticals, Inc.
Deepa Rachel Pakianathan

Current directorships/partnerships Past directorships/partnerships
Delphi Management Partners VI, LLC Alexza Pharmaceuticals, Inc.
Alder Biopharmaceuticals, Inc. ForsightVision5
Calithera Biosciences, Inc. NeurAxon, Inc.
Karyopharm Therapeutics, Inc. OncoMed Pharmaceuticals, Inc.
Serplus Bio
Save as set out above there are no further disclosures pursuant to Rule 17 or Schedule Two paragraph (g) of the AIM Rules for Companies in respect of the appointment of Michael Wyzga and Deepa Pakianathan, Ph.D.

Deepa Pakianathan, Ph.D. holds a beneficial interest in 256,734 ADSs.