Alder BioPharmaceuticals® Appoints Paul B. Cleveland as Interim President and Chief Executive Officer

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.

Crescendo Biologics to present poster at AACR Annual Meeting 2018, Chicago

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.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

Oncolytics Biotech has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, Oncolytics Biotech, 2018, MAR 19, 2018, View Source [SID1234524879]).

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Abstracts at AACR Describe Unique Way that ONC201 Kills Dopamine-Dysregulated Tumors

On March 19, 2018 Oncoceutics, Inc. reported that multiple abstracts from the company and its commercial and academic collaborators will be presented at the 2018 annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in Chicago, Illinois, on April 14th to April 18th (Press release, Oncoceutics, MAR 19, 2018, View Source [SID1234558371]).

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These abstracts highlight the unique way that ONC201 engages the dopamine receptor, leading to downstream direct anti-tumor and immune oncology effects, which are especially pronounced in tumors with dopamine pathway dysregulation. These tumors include H3 K27M mutant high grade gliomas and other cancers, where ONC201 is now in advanced clinical trials.

Additionally, the abstracts showcase the continued preclinical advancement of other members of the imipridone family. ONC212 will be featured in an oral presentation highlighting its ability to treat aggressive leukemias as a single agent, and effectively synergize with other anti-leukemic agents, specifically BCL-2 inhibitors, due to its unique GPCR target. ONC206 demonstrates parallel characteristics with ONC201, while also being differentiated by a unique binding profile.

The abstracts are listed below and categorized by topic: ONC201 clinical translation; ONC201 preclinical single agent and combinatorial activity; and analogs (ONC206 and ONC212). All poster presentations will be in McCormick Place South, Exhibit Hall A, and the oral presentation of ONC212 will take place in Room S102 – McCormick Place South (Level 1) at the times described below.

ONC201 Clinical Translation:

Selective targeting of dopamine receptor dysregulation in high grade gliomas with imipridone ONC201
April 17, 2018, 8:00 AM

ONC201 induction of apoptosis in hPheo1 cell line supports use of this oral agent in ongoing phase 2 clinical trial against neuroendocrine tumors
April 17, 2018, 1:00 PM

Clinical immunostimulatory activity of imipridone ONC201, a selective DRD2 antagonist, in advanced solid tumor patients
April 18, 2018, 8:00 AM

ONC201 Preclinical Single Agent and Combinatorial Activity

Treatment and signaling contexts for the application of the imipridone ONC201 to prostate cancer cells
April 15, 2018, 1:00 PM

LB-082. ONC201 sensitizes resistant breast cancer cells to TRAIL through death receptor 5 upregulation

April 16, 2018, 8:00 AM – 12:00 PM

Synergistic antitumor effect of ONC201 in combination with radiation therapy
April 16, 2018, 1:00 PM

Combination ONC201 and radiation therapy in the treatment of breast cancer
April 16, 2018, 1:00 PM

Analogs (ONC206 and ONC212):

Receptor pharmacology and anti-cancer activity of selective DRD2/3 antagonist imipridone ONC206
April 17, 2018, 1:00 PM

The novel imipridone ONC212 highly synergizes with the BCL-2 inhibitor ABT-199 in AML and activates orphan receptor GPR132
April 17, 2018, 3:35 PM – Oral Presentation

Arvinas to Present at the 17th Annual Needham Healthcare Conference

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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