Cstone partner Agios Announces the Phase 3 ClarIDHy Trial of TIBSOVO (ivosidenib) Achieved its Primary Endpoint

On May 23, 2019 The partner of CStone Pharmaceuticals ("Cstone"; HKEX:2616), Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) ("Agios") reported that the global Phase 3 ClarIDHy trial of TIBSOVO (ivosidenib) in previously treated cholangiocarcinoma patients with an isocitrate dehydrogenase 1 (IDH1) mutation met its primary endpoint (Press release, CStone Pharmaceauticals, MAY 23, 2019, View Source [SID1234536563]). Treatment with TIBSOVO demonstrated a statistically significant improvement in progression-free survival (PFS) by independent radiology review compared with patients who received placebo. The safety profile observed in the study was consistent with previously published data.

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A full analysis of the ClarIDHy trial will be submitted for presentation at the European Society for Medical Oncology Congress in 2019. Agios plans to submit a supplemental new drug application for TIBSOVO in previously treated IDH1 mutant cholangiocarcinoma by the end of 2019.

Cholangiocarcinoma is a very aggressive tumor for which surgical resection is the primary treatment option. Many patients are undiagnosed until the mid-to-late stages when they have missed the time window for surgery. At present, there is no standard second- and third-line treatment for patients with advanced cholangiocarcinoma. Patients typically suffer a poor prognosis and short-term survival.

China is among the countries with the highest incidence of Cholangiocarcinoma which is associated with a variety of high-risk factors including hepatitis B and Clonorchis sinensis infection, diseases that are endemic in the country.

In June 2018, CStone entered into an exclusive collaboration and license agreement with Agios to develop and commercialize TIBSOVO in Greater China region.

ClarIDHy Phase 3 Trial
The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1 mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting. As of the January 31, 2019 data cutoff, 185 patients were randomized.

Patients were randomized 2:1 to receive either single-agent TIBSOVO 500 mg once daily or placebo with crossover to TIBSOVO permitted at the time of documented radiographic progression per RECIST 1.1.
The primary endpoint of the trial is PFS as evaluated by independent radiology review with secondary endpoints including investigator evaluated PFS, safety and tolerability, overall response rate, overall survival, duration of response, PK/PD and quality of life assessments.
The study was designed with 96% power to detect a hazard ratio of 0.5 for PFS (TIBSOVO vs. placebo), with a one-sided alpha of 0.025.
Thermo Fisher Scientific is providing next-generation sequencing to detect IDH1 mutations for all tumor samples as inclusion criteria for enrollment in the study and will develop and commercialize the validated companion diagnostic.
TIBSOVO is not approved in any country for the treatment of patients with advanced cholangiocarcinoma.

About TIBSOVO (ivosidenib)

TIBSOVO is indicated in the United States for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in:

Adult patients with newly-diagnosed AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Adult patients with relapsed or refractory AML.

DXC Technology Delivers Strong Fourth Quarter Results with Sequential Growth in Revenue, Bookings, and Cash Flow

On May 23, 2019 DXC Technology (NYSE: DXC) reported results for the three and twelve months ended March 31, 2019 (Press release, DynPort Vaccine Company, MAY 23, 2019, View Source [SID1234536546]).

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"DXC Technology closed out our fourth quarter, and our fiscal year, by delivering strong digital performance and sequential growth in revenue, bookings, and cash flow," said Mike Lawrie, chairman, president and CEO. "We continued to enhance our portfolio of digital offerings, and we are re-skilling current employees to equip them with new digital capabilities and certifications. We have also hired thousands of new employees with advanced digital skills, and added more through acquisitions, to further scale our digital workforce. Our acquisition of Luxoft is expected to be completed as planned by the end of June, and this will further strengthen DXC’s ability to design and deploy transformative digital solutions for clients at scale."

Financial Highlights – Fourth Quarter Fiscal 2019

Diluted earnings per share from continuing operations was $1.01 in the fourth quarter, including $(0.13) per share of restructuring costs, $(0.24) per share of transaction, separation and integration-related costs, $(0.37) per share of amortization of acquired intangible assets, and $(0.43) per share of pension and OPEB actuarial and settlement losses. This compares with $1.80 in the year ago period.
Non-GAAP diluted earnings per share from continuing operations was $2.19.
Revenue in the fourth quarter was $5,280 million compared with $5,584 million in the year ago period.
Income from continuing operations before income taxes was $354 million for the fourth quarter, including $(47) million of restructuring costs, $(96) million of transaction, separation and integration-related costs, $(138) million of amortization of acquired intangibles, and $(143) million of pension and OPEB actuarial and settlement losses. This compares with $588 million in the year ago period.
Non-GAAP income from continuing operations before income taxes was $778 million compared with $812 million in the year ago period.
Net income was $271 million for the fourth quarter, including $(35) million of restructuring costs, $(66) million of transaction, separation and integration-related costs, $(101) million of amortization of acquired intangibles, and $(116) million of pension and OPEB actuarial and settlement losses. This compares with $565 million in the prior year period.
Non-GAAP net income was $589 million.
Adjusted EBIT was $827 million in the fourth quarter compared with $882 million in the prior year. Adjusted EBIT margin was 15.7% compared with 15.8% in the year ago quarter.
Net cash provided by operating activities was $748 million in the fourth quarter, compared with $557 million in the year ago period.
Adjusted free cash flow was $917 million in the fourth quarter.
Financial Highlights – Fiscal 2019

Diluted earnings per share from continuing operations was $4.35 in fiscal 2019, including $(1.25) per share of restructuring costs, $(1.06) per share of transaction, separation and integration-related costs, $(1.42) per share of amortization of acquired intangible assets, $(0.41) per share of pension and OPEB actuarial and settlement losses, and $0.16 per share of tax adjustment related to U.S. tax reform. This compares with $5.23 in the year ago period.
Non-GAAP diluted earnings per share from continuing operations was $8.34.
Revenue in fiscal 2019 was $20,753 million compared with $21,733 million in the year ago period.
Income from continuing operations before income taxes was $1,515 million for fiscal 2019, including $(465) million of restructuring costs, $(401) million of transaction, separation and integration-related costs, $(539) million of amortization of acquired intangibles, and $(143) million of pension and OPEB actuarial and settlement losses. This compares with $1,304 million in the year ago period.
Non-GAAP income from continuing operations before income taxes was $3,063 million compared with $2,758 million in the prior year.
Net income was $1,262 million for fiscal 2019, including $(353) million of restructuring costs, $(299) million of transaction, separation and integration-related costs, $(401) million of amortization of acquired intangibles, $(116) million of pension and OPEB actuarial and settlement losses, and $44 million of tax adjustment related to U.S. tax reform. This compares with $1,782 million in the prior year period.
Non-GAAP net income was $2,387 million.
Adjusted EBIT was $3,269 million in fiscal 2019 compared with $2,989 million in the prior year. Adjusted EBIT margin was 15.8% compared with 13.8% in the prior year.
Net cash provided by operating activities was $1,783 million in fiscal 2019, compared with $2,567 million in the prior year.
Adjusted free cash flow was $2,105 million in fiscal 2019.
Global Business Services (GBS)
GBS revenue was $2,191 million in the quarter compared to $2,361 million for the prior year. GBS revenues decreased 7.2% year-over-year, reflecting headwinds in the traditional applications business, including the impact of accelerated cloud adoption. GBS profit margin in the quarter was 20.4%, up from 19.4% in the prior year, reflecting ongoing workforce optimization. New business awards for GBS were $2,857 million in the fourth quarter.

Global Infrastructure Services (GIS)
GIS revenue was $3,089 million in the quarter compared to $3,223 million for the prior year. GIS revenues decreased 4.2% year-over-year. The GIS revenue reflects the ongoing migration out of legacy infrastructure environments, offset by growth in cloud infrastructure and digital workplace. GIS profit margin in the quarter was 14.1%, down from 14.6% in the prior year, reflecting investments in digital capabilities and assets. New business awards for GIS were $2,968 million in the fourth quarter.

Returning Capital to Shareholders
During the fourth quarter, DXC Technology returned $142 million to shareholders, consisting of $51 million of common stock dividends and $91 million in share repurchases.

Earnings Conference Call and Webcast
DXC Technology senior management will host a conference call and webcast today at 5 p.m. EDT. The dial-in number for domestic callers is (888) 394-8218. Callers who reside outside of the United States should dial +1 (323) 794-2588. The passcode for all participants is 9706900. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until May 30, 2019. The replay passcode is also 9706900.

Non-GAAP Measures
In an effort to provide investors with supplemental financial information, in addition to the preliminary and unaudited financial information presented on a GAAP and pro forma basis, we have also disclosed in this press release preliminary non-GAAP information including: constant currency, earnings before interest and taxes ("EBIT"), EBIT margin, adjusted EBIT, adjusted EBIT margin, non-GAAP income before income taxes, non-GAAP net income, non-GAAP EPS and adjusted free cash flow. Reconciliations of the preliminary non-GAAP measures to the respective most directly comparable measures calculated on a GAAP or pro forma basis, as well as the rationale for management’s use of non-GAAP measures, are included below.

MorphoSys to Present at Upcoming Investor Conferences

On May 23, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that will present at the following conferences (Press release, MorphoSys, MAY 23, 2019, View Source [SID1234536565]):

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Jefferies Healthcare Conference
Date: June 5, 2019, 8:00am EDT (2:00pm CEST, 1:00pm BST)
Venue: New York, NY, U.S.
Presenter: Jens Holstein, Chief Financial Officer of MorphoSys AG
Dr. Julia Neugebauer, Director Corporate Communications & IR

dbAccess Berlin
Date: June 6, 2019
Venue: Berlin, Germany
Presenter: Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG
Dr. Verena Kupas, Manager Corporate Communications & IR

Goldman Sachs 40th Annual Global Healthcare Conference
Date: June 12, 2019
Venue: Los Angeles, CA, U.S.
Presenter: Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG
Dr. Sarah Fakih, Head of Corporate Communications & IR

J.P. Morgan European Healthcare Conference
Date: June 20, 2019
Venue: London, UK
Presenter: Dr. Sarah Fakih, Head of Corporate Communications & IR
Dr. Julia Neugebauer, Director Corporate Communications & IR

Meet the Team – Analyst and Investor Event
Date: June 25, 2019, 10:00am EDT (4:00pm CEST, 3:00pm BST)
Venue: New York, NY, U.S.
Participants: Management Team of MorphoSys AG and MorphoSys US Inc.

PDF versions of the presentations will be provided at www.morphosys.com. Links to available webcasts will be filed under www.morphosys.com/conference-calls.

Incyte to Present at Upcoming Investor Conference

On May 23, 2019 Incyte Corporation (Nasdaq:INCY) reported that it will present at the 40th Annual Goldman Sachs Global Healthcare Conference onTuesday, June 11, 2019 at 2:00 pm (PDT) / 5:00 pm (EDT) in Rancho Palos Verdes (Press release, Incyte, MAY 23, 2019, View Source [SID1234536547]).

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The presentation will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations". Investors interested in listening to the live webcast should log on before the start time in order to download any software required.

Innate Pharma announces publication on next generation immunotherapies targeting the adenosine pathway in “Cell Reports”

On May 23, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported a publication in Cell Reports describing two new monoclonal antibodies, IPH5201 and IPH5301, that target CD39 and CD73, respectively, to inhibit the adenosine pathway and promote activation of the immune system against cancer (Press release, Innate Pharma, MAY 23, 2019, View Source [SID1234536548]). The full manuscript, titled "Blocking antibodies targeting the CD39/CD73 immunosuppressive pathway unleash immune responses in combination cancer therapies" appeared in the online issue of Cell Reports on May 21st, 2019.

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Cancer immune evasion largely involves the generation of high amounts of immunosuppressive adenosine (Ado) within the tumor environment. An increase in CD39 and CD73 at the tumor bed signals an immunosuppressive environment inhibiting anti-tumor immune responses and favoring tumor spreading. The impact of blocking CD39 and CD73 ectoenzymes to overcome Ado-mediated immunosuppression and to reinforce anti-tumor immunity has been investigated by combining genetic and antibody-mediated approaches.

The work published by Innate Pharma and collaborators shows that CD39 deficiency enhances the benefits from combined cancer therapies in preclinical mouse solid tumor models. We report the generation and characterization of two blocking antibodies against human CD39 and CD73, referred to as IPH5201 and IPH5301, respectively. The anti-CD39 antibody IPH5201 blocked ATP hydrolysis by both membrane and soluble CD39, thereby promoting DC maturation and macrophage activation, whereas the anti-CD73 antibody IPH5301 blocked the degradation of AMP into immunosuppressive Ado and displays different functional characteristics over currently used antibodies. Both IPH5201 and IPH5301 prevented the Ado-mediated inhibition of T cells purified from patients with breast cancer or melanoma. We also observed that IPH5201 efficiently increased the anti-tumor activity of the ATP-inducing chemotherapeutic drug oxaliplatin in a mouse tumor model. These data provide the scientific rationale for the clinical development of IPH5201 and IPH5301 and their use in cancer immunotherapy.

"The published data continue to support our rationale to evaluate IPH5201 and IPH5301 in cancer, particularly if these antibodies are used in combination with each other, with immune checkpoint inhibitors or with chemotherapies", commented Pr. Eric Vivier, Innate Pharma CSO. "We are excited to further explore the potential of these antibodies as an innovative and differentiated approach to reverse immunosuppression in the tumor microenvironment and expect INDs to be filed for IPH5201 in the second half of 2019 and for IPH5301 in the first half of 2020."

In October 2018, Innate Pharma and AstraZeneca entered into a development collaboration and option agreement for further co-development and co-commercialization for IPH5201.

Reference

Ivan Perrot, Henri-Alexandre Michaud, Marc Giraudon-Paoli, Séverine Augier, Aurélie Docquier, Laurent Gros, Rachel Courtois, Cécile Déjou, Diana Jecko, Ondine Becquart, Hélène Rispaud-Blanc, Laurent Gauthier, Benjamin Rossi, Stéphanie Chanteux, Nicolas Gourdin, Beatrice Amigues, Alain Roussel, Armand Bensussan, Jean-François Eliaou, Jérémy Bastid, François Romagné, Yannis Morel, Emilie Narni-Mancinelli, Eric Vivier, Carine Paturel, and Nathalie Bonnefoy. Blocking Antibodies Targeting the CD39/CD73 Immunosuppressive Pathway Unleash Immune Responses in Combination Cancer Therapies. Cell Reports, May 21, 2019.