On March 20, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, Chief Executive Officer, and Dr. Brian Schwartz, Chief Medical Officer and Head of Research and Development, will present at the 17th Annual Needham Healthcare Conference on March 27th, 2018, at 3:30 p.m. ET at the Westin Grand Central Hotel in New York, New York (Press release, ArQule, MAR 20, 2018, View Source [SID1234524900]).

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You can access the live webcast of the presentation via the "Investors & Media" section of our website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

On March 20, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMpower131 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) reduced the risk of disease worsening or death (progression-free survival; PFS) compared with chemotherapy alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAR 20, 2018, View Source [SID1234525401]). Safety for the TECENTRIQ and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. At this interim analysis a statistically significant overall survival (OS) benefit was not observed and the study will continue as planned. These data will be presented at an upcoming oncology congress.

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"Squamous non-small cell lung cancer is difficult to treat and there have been limited new treatment options over the last few decades," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We will share the IMpower131 results with global health authorities and we look forward to seeing more mature overall survival data."

As per the statistical analysis plan in IMpower131, Arm B (TECENTRIQ plus carboplatin and nab-paclitaxel) must demonstrate a statistically significant OS result vs. Arm C (carboplatin and nab-paclitaxel), before an analysis between Arm A (TECENTRIQ plus carboplatin and paclitaxel) and Arm C can be made for PFS and OS.
Currently, Roche has eight Phase III lung cancer studies underway evaluating TECENTRIQ alone or in combination with other medicines and five are expected to report this year.

About the IMpower131 study
IMpower131 is a Phase III, open-label, multicentre, randomised study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and nab-paclitaxel or TECENTRIQ in combination with carboplatin and paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone in people with stage IV squamous NSCLC who have not been previously treated with chemotherapy. The study enrolled 1,021 people who were randomised equally (1:1:1) to receive:
TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
TECENTRIQ plus carboplatin and nab-paclitaxel (Arm B), or
Carboplatin and nab-paclitaxel (Arm C, control arm)
During the treatment-induction phase, people in Arm A received four or six cycles of TECENTRIQ plus carboplatin and paclitaxel , given on day one of each 21-day cycle. This was followed by maintenance therapy with TECENTRIQ every three weeks until progression of the cancer, or for as long as clinical benefit was observed.
During the treatment-induction phase, people in Arm B received four or six cycles of TECENTRIQ, carboplatin and nab-paclitaxel. TECENTRIQ and carboplatin were administered on day one of each 21-day cycle. Nab-paclitaxel was administered on days one, eight and 15 of each 21-day cycle. This was followed by maintenance therapy with TECENTRIQ every three weeks until progression of the cancer, or for as long as clinical benefit was observed.
During the treatment-induction phase, people in Arm C received four or six cycles of carboplatin and nab-paclitaxel. Carboplatin was administered on day one of each 21-day cycle, and nab-paclitaxel was administered on days one, eight and 15 of each 21-day cycle. In the maintenance phase, participants received best supportive care.
The co-primary endpoints were:
PFS as determined by the investigator using RECIST v1.1 in the intention-to-treat (ITT) population (Arm B vs. Arm C)
Overall survival (OS) in the ITT population (Arm B vs. Arm C)
IMpower131 met its PFS co-primary endpoint per study protocol. This analysis of IMpower131 evaluated Arm B vs. Arm C.
About NSCLC
Lung cancer is the leading cause of cancer death globally.1 Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.2 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.3

About TECENTRIQ (atezolizumab)
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.
TECENTRIQ is already approved in the European Union, United States and more than 60 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.

Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.
To learn more about the Roche approach to cancer immunotherapy please follow this link:
View Source

On March 20, 2018 – Crescendo Biologics Limited (Crescendo), the drug developer of novel,
targeted T-cell engaging therapeutics, announces that Dr Brian McGuinness, Head of New Product and
Business Development, Phil Bland-Ward (CSO) and James Legg (VP R&D) will be presenting a poster at
AACR (American Association for Cancer Research) Annual Meeting in Chicago, USA on 18 April 2018 (Press release, Crescendo Biologics, MAR 20, 2018, View Source [SID1234525091]). The Crescendo team will be available to discuss the poster entitled "Multifunctional biologics for
targeted T-cell therapy based on in vivo matured fully human VH domains" within the "Antibodies,
Fusion Proteins and Related Biologics session". This will cover the beneficial characteristics of
Humabodies and their enhanced therapeutic potential over traditional monoclonal antibodies.

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Poster details

Title: Multifunctional biologics for targeted T-cell therapy based on in vivo matured fully human VH
domains
Authors: J. Legg, B. McGuinness, P. Bland-Ward, P. Pack
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibodies, Fusion Proteins, and Related Biologics
Session Date and Time: Wednesday Apr 18, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 35
Poster Board Number: 11
Permanent Abstract Number: 5766

There will also be a poster by Eleven Biotherapeutics in the same session which includes data from
Crescendo. This poster, entitled ‘Engineering and characterization of anti-PSMA humabody-deBouganin
fusion proteins’, will be at Board Number 15.

AACR’s Annual Meeting is being held in Chicago, Illinois from 14 – 18 April. The theme is ‘Driving
Innovative Cancer Science to Patient Care’. Presentations at the Annual Meeting will cover the latest
basic, translational, clinical, and prevention-focused research in the field, including important areas such
as early detection, cancer interception, and survivorship in all populations.

On March 20, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported that Paul B. Cleveland, a member of the Company’s Board of Directors, has been appointed to serve as Interim President and Chief Executive Officer, effective immediately. Mr. Cleveland will continue to serve as a director of the Company (Press release, , 20 20, 2018, View Source [SID1234524905]).

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Mr. Cleveland’s appointment follows the mutual determination by Randall C. Schatzman and the Board that now is the right time for Dr. Schatzman to step down as President, Chief Executive Officer and as a director. Dr. Schatzman has agreed to serve as a consultant to the Company for an interim period in order to help ensure a smooth transition. Alder has retained Russell Reynolds Associates, a leading executive search firm, to assist with identifying a permanent successor.

Mr. Cleveland has more than two decades of leadership experience with significant operational and financial expertise. He currently serves as the Chairman of the Board of Adverum Biotechnologies, Inc., where he previously served as the President and Chief Executive Officer. Prior to that, he was President and Chief Executive Officer of Celladon Corporation, where he previously served as that company’s Chief Financial Officer. Mr. Cleveland served as Executive Vice President, Corporate Strategy and Chief Financial Officer at Aragon Pharmaceuticals before its acquisition by Johnson & Johnson, and prior to Aragon, he was General Partner and Chief Operating Officer at Mohr Davidow Ventures and Executive Vice President, Corporate Development and Chief Financial Officer for Affymax. Mr. Cleveland was previously a Managing Director at J.P. Morgan Chase and Co. and a predecessor firm, Hambrecht & Quist, and a corporate lawyer at Cooley LLP, Sidley Austin LLP, and Davis Polk & Wardwell LLP.

"I joined the Alder Board in 2015 because of my deep appreciation of Alder’s mission to transform the treatment paradigm for migraine prevention," said Mr. Cleveland. "I look forward to leveraging my prior CEO and CFO experience in this interim role as we work to identify a permanent successor and further build out the team for the next stage of Alder’s growth and development. On behalf of the Board and the Alder team, I want to thank Randy for his immense dedication and invaluable contributions since co-founding the Company in 2004. Randy’s leadership has positioned Alder for continued growth as we advance towards the commercial launch of eptinezumab."

Dr. Schatzman said, "It has been an honor to lead Alder since co-founding the Company in 2004 and work with such a bright and passionate group of employees to change the lives of highly impacted episodic and chronic migraine patients. I am proud of all that we have accomplished at Alder during my tenure including the development of two late-stage therapeutic candidates, eptinezumab and clazakizumab, assembling a talented team of over 190 employees, the majority of which are scientists and drug developers, and positioning Alder to positively impact the lives of migraine sufferers. Now is the right time to pass the baton to the next generation of leadership. I am confident that Alder is well-placed to set a new standard for what can be achieved in migraine prevention to benefit patients and their families."

Mr. Cleveland concluded, "Alder has made tremendous progress over the last year. We achieved positive Phase 3 pivotal data for both episodic and chronic migraine patients, demonstrating that eptinezumab’s clinical profile is highly differentiated and consistently delivered predictable results for rapid, effective and sustained migraine prevention across the spectrum of migraine disease. We plan to share additional data from our PROMISE 1 and PROMISE 2 pivotal trials, and the results from our open-label safety study of eptinezumab, in the first half of this year. We also continue to expect our pharmacokinetic comparability study to be completed in the second half of 2018. In addition, through our recent IP settlement and licensing agreement with Teva, we now have a non-exclusive license to Teva’s CGRP patent portfolio, which, importantly, clarified our ability to develop, manufacture and commercialize eptinezumab in the U.S. and globally. The submission of our planned Biologics License Application (BLA) for eptinezumab is the top priority, and we continue to make progress on all key clinical data milestones, BLA and commercial preparedness activities, including our CMC and manufacturing initiatives. I look forward to reviewing these programs thoroughly in my new role and plan to provide a business update in connection with the announcement of our first quarter 2018 financial and operating results."

As of February 28, 2018, Alder had cash, cash equivalents, short-term investments and restricted cash totaling more than $600 million.

On March 20, 2018 Arvinas LLC, a private biotechnology company creating a new class of drugs based on protein degradation, reported that John Houston, Ph.D., President and Chief Executive Officer of Arvinas, will present a company overview at the 17th Annual Needham Healthcare Conference on Tuesday, March 27, 2018 at 8:30 a.m. ET in New York, NY (Press release, Arvinas, MAR 19, 2018, View Source [SID1234524882]).

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