On March 28, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it has entered into a global development and commercialization agreement with AstraZeneca for Daiichi Sankyo’s lead antibody drug conjugate (ADC), [fam-] trastuzumab deruxtecan (DS-8201), currently in pivotal development for multiple HER2 expressing cancers including breast and gastric cancer, and additional development in non-small cell lung and colorectal cancer (Press release, Daiichi Sankyo, MAR 28, 2019, https://www.prnewswire.com/news-releases/daiichi-sankyo-and-astrazeneca-announce-global-development-and-commercialization-collaboration-for-daiichi-sankyos-her2-targeting-antibody-drug-conjugate-fam–trastuzumab-deruxtecan-ds-8201-300820766.html [SID1234534724]).

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Daiichi Sankyo and AstraZeneca will jointly develop and commercialize [fam-] trastuzumab deruxtecan as a monotherapy or a combination therapy worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and the supply of [fam-] trastuzumab deruxtecan.

As announced separately by Daiichi Sankyo, a Biologics License Application (BLA) submission to U.S. FDA for [fam-] trastuzumab deruxtecan in HER2 positive metastatic breast cancer previously treated with ado trastuzumab emtansine (T-DM1) will be accelerated to the first half of fiscal year 2019.

Designed using Daiichi Sankyo’s DXd proprietary ADC technology, [fam-] trastuzumab deruxtecan is comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload compared to the way chemotherapy is commonly delivered.

"[Fam-] trastuzumab deruxtecan is the flagship asset in our oncology pipeline created by our relentless pursuit of science and technology, the most important strengths of our company," said George Nakayama, Representative Director, Chairman and CEO of Daiichi Sankyo Company, Limited. "Through the strategic collaboration with AstraZeneca, a company with a wealth of global experience and expertise in oncology, we will combine our respective skill sets to maximize the value of [fam-] trastuzumab deruxtecan, and accelerate the establishment of our global oncology business. By aiming to provide new treatment options across a wide range of cancers as soon as possible, we will maximize our contribution to patients with cancer and their families around the world."

"We believe that [fam-] trastuzumab deruxtecan could become a transformative new medicine for the treatment of HER2 positive breast and gastric cancers," said Pascal Soriot, Chief Executive Officer, AstraZeneca. "In addition, [fam-] trastuzumab deruxtecan has the potential to redefine breast cancer treatment as the first therapy for HER2 low expressing tumors. It also has the potential to treat other HER2 mutated or HER2 overexpressing tumors, including lung and colorectal cancers. We are proud to be working with Daiichi Sankyo, a long-term collaborator of AstraZeneca in other disease areas."

Financial Terms
Under the terms of the agreement, AstraZeneca will pay Daiichi Sankyo an upfront payment of $1.35 billion. Contingent payments of up to $5.55 billion include $3.8 billion for achievement of future regulatory milestones and other contingencies, as well as sales-related milestones of up to $1.75 billion. Total payments under the agreement have the potential to reach up to $6.90 billion.

Daiichi Sankyo and AstraZeneca will share equally development and commercialization costs as well as profits from [fam-] trastuzumab deruxtecan worldwide, except for Japan. Daiichi Sankyo is expected to book sales in U.S., certain countries in Europe, and certain other markets where Daiichi Sankyo has affiliates. AstraZeneca is expected to book sales in all other markets worldwide, including China, Australia, Canada and Russia.

The impact on Daiichi Sankyo’s consolidated results for the fiscal year ending March 31, 2019 is immaterial because the upfront payment will be booked in revenue over the period in which Daiichi Sankyo has contractual performance obligations under this collaboration. The collaboration is expected to contribute to enhancing the corporate and shareholder value of Daiichi Sankyo over the medium to long term.

About [Fam-] Trastuzumab Deruxtecan
[Fam-] trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in U.S. only; trastuzumab deruxtecan in other regions of world) is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.

A broad and comprehensive development program with [fam-] trastuzumab deruxtecan is underway in North America, Europe and Asia including five pivotal studies. [Fam-] trastuzumab deruxtecan is in pivotal phase 3 development in previously treated HER2 low expressing metastatic breast cancer versus investigator’s choice (DESTINY-Breast04); phase 3 development in HER2 positive metastatic breast cancer versus ado-trastuzumab emtansine (T-DM1) (DESTINY-Breast03); and phase 3 development in HER2 positive metastatic breast cancer versus investigator’s choice post T-DM1 (DESTINY-Breast02). [Fam-] trastuzumab deruxtecan also is in pivotal phase 2 clinical development for HER2 positive metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01); pivotal phase 2 development for HER2 positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01); phase 2 development for HER2 expressing advanced colorectal cancer; phase 2 development for metastatic non-squamous HER2 overexpressing or HER2 mutated NSCLC; and, phase 1 development in combination with nivolumab for HER2 expressing metastatic breast and bladder cancer.

[Fam-] trastuzumab deruxtecan has been granted Breakthrough Therapy designation for the treatment of patients with HER2 positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after T-DM1, and Fast Track designation for the treatment of HER2 positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2 targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). [Fam-] trastuzumab deruxtecan has received SAKIGAKE Designation for the treatment of HER2 positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW).

[Fam-] trastuzumab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On March 28, 2019 Cytonus Therapeutics Inc., a biotechnology company developing new platforms for delivering biologics, reported that it will be presenting preclinical data for its Cargocyte technology platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting March 29 – April 3, at the Georgia World Congress Center in Atlanta (Press release, Cytonus Therapeutics, MAR 28, 2019, View Source [SID1234534723]).

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Cargocytes are engineered allogenic cell lines that can carry a variety of payloads like small molecule compounds, gene editing therapies, therapeutic RNAs, and powerful biologics such as immune modulating cytokines, antibodies and oncolytic viruses.

"Cytonus Therapeutics will be presenting preclinical data from our growing oncology pipeline that supports the versatility of our Cargocytes as a groundbreaking allogeneic, off-the-shelf, immune-therapy platform," said Remo Moomiaie-Qajar, M.D., president and CEO of Cytonus. "Our preclinical results in our Triple Negative Breast Cancer model experiments are impressive and exciting. We are able to demonstrate that 40 percent of our animals being treated with our Cargocyte associated IL-12 are showing no sign of disease more than 260 days post treatment where as our control animals are dying typically 25 to 30 days into the experiments. These experiments are still ongoing and our mice are doing well. We have replicated these studies multiple times and have found the pattern to exist."

Details of the presentation:

Abstract Title: Cargocytes: A novel cell therapy platform to drive anti-tumor immunity

Session Category: Immunology
Session Title: Late-Breaking Research: Immunology 1
Session Date and Time: Monday, April 1, 2019 8:00 AM – 12:00 PM
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 41
Poster Board Number: 12
Permanent Abstract Number: LB-067
Cytonus will also be presenting at:
Association Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), April 29-May 2, 2019 in Washington, D.C.
Bio International Convention, June 3-6, 2019 in Philadelphia

On March 28, 2019 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported the launch of new solutions designed to advance cancer research as part of its highlights at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting from March 29 to April 3, 2019, in Atlanta, Georgia (Press release, Qiagen, MAR 28, 2019, View Source [SID1234534722]). More than 30 studies being presented at AACR (Free AACR Whitepaper) 2019 cite molecular testing tools from QIAGEN’s Sample to Insight portfolio.

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These products involve:

New solution bundles for all QIAseq and QIAact DNA panels for next-generation sequencing (NGS), integrating its market-leading CLC Genomics Workbench and QIAGEN Clinical Insight-Interpret software with these assays for seamless secondary analysis and tertiary interpretation of complex genomic data. The proprietary technology driving the superior performance of QIAGEN’s NGS panels was described in a recent Nature article: View Source
QIAGEN is introducing its exoRNeasy Midi and Maxi Kits for isolation of exosomes and other extracellular vesicles from urine and other samples, as well as the miRNeasy 96 Advanced QIAcube HT Kit for automated purification of total RNA, including miRNA, from serum and plasma samples. These are two novel liquid biopsy workflows for cancer research designed to enable non-invasive extraction and purification of ribonucleic acid (RNA).

On March 28, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its fourth quarter ended December 31, 2018 (Press release, NantHealth, MAR 28, 2019, View Source [SID1234534721]).

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"Our financial results over 2018 reflect continued overall progress to our business," said Bob Petrou, Interim Chief Financial Officer of NantHealth. "On a sequential quarterly basis, we grew revenue, significantly lowered total operating expenses and reduced our cash burn. We are particularly pleased with the growth of our entire SaaS business. Looking ahead, our well-developed sales pipeline bodes well for the company’s topline, and our entire team is focused on further growing the business, managing costs and driving meaningful improvement in our financial performance."

Software and Services Highlights:

Clinical Decision Support (Eviti):
In Q4, deployed release 7.5, with new features that include:
A new configuration, known as the Treatment Warning and Deviation Configuration, that enables payers to display custom drug deviation messages, enhancing value-based care and compliance with payer guidelines
A new analyzer deviation that supports the Febrile Neutropenia (FN) risk factor associated with white blood cell (WBC) growth factors, a key driver of regimen costs
Updated the Medical Policy QA report that assists partners/resellers with their internal quality assurance process
Enhanced the Precision Insights Portal, features include:
All treatment plans that are presented to a user are saved and stored, enabling analytics for the understanding of treatment plan trends and improvement in the presentation of the plans to users
Enhanced drug mapping management feature in the portal enables a comparison of the Precision Insights portal recommended drugs to the evidence based Eviti drug recommendation to help align to the standard of care library
Payer Engagement (NaviNet):
Completed 12 client service implementation projects in Q4, for a total of 57 in 2018
In Q4, introduced two key features for NaviNet Open
Routing Attributes for Document Exchange were enhanced to provide health plans more control over document routing to users
NaviNet Open subscribers are now provided a detailed view of user activity for all Authorization Appeals in a monthly report delivered to the health plan
In December 2018, at the Healthcare Payers Transformation Assembly hosted by the Millennium Alliance, the company met with Payer groups and led a roundtable discussion entitled, "Looking at the Challenges Health Plans Face with the Convergence of Precision Medicine and Value Based Care." As a result, the company is engaged in a number of ongoing sales conversations based on discussions initiated at this event
Connected Care (DeviceConX):
In Q4, completed a DeviceConX implementation in Sweden, which included our first deployment with physiological waveform capabilities
In Q4, as previously announced, collaborated with B. Braun Australia, GE Healthcare and iProcedures to demonstrate the exchange of data between patient devices and medical records at the Interoperability Showcase as part of the Healthcare Information and Management Systems Society (HIMSS) Asia Pacific Conference
Significantly increased connectivity license sales in Q1, driving improved recurring maintenance revenue on a go forward basis
In Q1, deployed DeviceConX Version 5.15 upgrade, with the ability to push OS security patches directly to HBox Connected Care hardware devices
Sequencing and Molecular Analysis – Highlights

In Q4, total orders (GPS Cancer and Liquid GPS) increased 10% to 1,021 from 930 in Q3
In Q4, the company expanded the molecular analysis reporting of GPS Cancer to provide information on a patient’s pharmacogenomic profile. These results, now available in the GPS Cancer test report, provide insights into potential drug toxicity and/or interactions
In December 2018, at the San Antonio Breast Cancer Symposium, the company and NantOmics presented the findings of three investigations, which examine the theme of providing oncologists with insights that enable cancer treatment tailored to the individual characteristics of each patient
In Q4, expanded existing employer reimbursement contract with Northwest Firefighters Benefits Trust to include Liquid GPS coverage and signed a net new reimbursement contract for both GPS Cancer and Liquid GPS with an additional city fire/police employee trust
Business and Financial Highlights

The company adopted a new revenue recognition standard on January 1, 2018. Please note that the financial results presented below include only new revenue standard values. For additional information and reconciliations of the company’s financial results between the new and previous revenue recognition standard, see the additional tables included in this press release and in the company’s Form 10-K to be filed with the Securities and Exchange Commission.

For the 2018 full year, total net revenue increased 3.2% to $89.5 million from $86.7 million in 2017. Gross profit was $45.2 million, or 51% of total net revenue, compared with $45.2 million, or 52% of total net revenue, for the prior year. Selling, general and administrative (SG&A) expenses decreased to $70.8 million from $75.0 million in 2017. Research and development (R&D) expenses decreased to $20.9 million from $33.9 million in 2017.

Financial results for 2018 included a non-cash charge for loss from related party equity method investment, including impairment, of $108.4 million, and an unrealized loss from change in fair value of the Bookings Commitment liability of $16.9 million. Net loss from continuing operations, net of tax, was $190.4 million, or $1.74 per share, compared with $131.4 million, or $1.12 per share, for the 2017 full year. Loss from discontinued operations, net of tax, was $1.7 million, or $0.02 per share, compared with $43.8 million, or $0.37 per share. Net loss was $192.2 million, or $1.76 per share, compared with $175.2 million, or $1.49 per share, for 2017.

For the 2018 full year, on a non-GAAP basis, adjusted net loss from continuing operations was $44.5 million, or $0.41 per share, compared with $55.5 million, or $0.47 per share, for 2017.

For the 2018 fourth quarter, total net revenue was $22.9 million, compared with $22.3 million in 2017 fourth quarter. Gross profit was $11.5 million, or 50% of total net revenue, compared with $13.4 million, or 60% of total net revenue, for the prior year. SG&A expenses declined to $14.6 million, from $20.8 million in 2017 fourth quarter. R&D expenses decreased to $5.0 million from $8.8 million.

Financial results for the fourth quarter of 2018 included a non-cash charge for loss from related party equity method investment, including impairment, of $18.9 million, and an unrealized loss from change in fair value of the Bookings Commitment liability of $16.9 million. Net loss from continuing operations, net of tax, was $49.2 million, or $0.45 per share, compared with $22.6 million, or $0.21 per share, for the 2017 fourth quarter. Net loss was $49.1 million, or $0.45 per share, compared with $21.6 million, or $0.20 per share, for 2017 fourth quarter.

For the 2018 fourth quarter, on a non-GAAP basis, adjusted net loss from continuing operations was $9.0 million, or $0.08 per share, compared with $7.8 million, or $0.07 per share, for the 2017 fourth quarter.

In August 2017, NantHealth sold its provider/patient engagement assets to Allscripts to focus on core competencies and accelerate the plan to achieve profitability. As a result, the company has classified the current and prior period operating results of its provider/patient engagement business as discontinued operations. All results presented above represent the company’s continuing operations.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the fourth quarter ended December 31, 2018. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 1059708. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

On March 28, 2019 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported that Bonnie H. Anderson, chairman and chief executive officer, is scheduled to present at the 18th Annual Needham Healthcare Conference in New York City on Wednesday, April 10, 2019 at 8:00 a.m. EDT (Press release, Veracyte, MAR 28, 2019, View Source [SID1234534720]).

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A live audio webcast of the company’s presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.