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Neurocrine Biosciences Announces Retirement of Christopher O’Brien, M.D., and Appointment of Eiry W. Roberts, M.D., as Chief Medical Officer

On January 7, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, reported that Christopher O’Brien, M.D., Chief Medical Officer, has notified the Company he plans to retire in February 2018, after a transition period with his successor (Press release, Neurocrine Biosciences, JAN 7, 2018, View Source;p=RssLanding&cat=news&id=2325239 [SID1234522940]). Dr. O’Brien joined Neurocrine in 2005, and has led the clinical development and medical affairs activities for more than 12 years. Dr. O’Brien will remain as an exclusive consultant for Neurocrine.

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"On behalf of the board, shareholders and our employees, I want to thank Chris for his tremendous contributions as Chief Medical Officer of Neurocrine," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With his considerable expertise and leadership, we successfully developed and obtained FDA approval of INGREZZA capsules for the treatment of adults with tardive dyskinesia and advanced our clinical development programs for Tourette syndrome, Parkinson’s disease, endometriosis and congenital adrenal hyperplasia. I am very pleased that Chris will continue to be a part of the Neurocrine team for the foreseeable future."

Eiry W. Roberts, M.D., will join the company as Chief Medical Officer, effective January 8, 2018.

"We are very pleased to welcome Eiry to Neurocrine as she brings extensive senior leadership and pharmaceutical management experience to the team," Dr. Gorman said. "Eiry’s strong background in implementing strategic clinical development programs and navigating the regulatory approvals process across phases of drug development from research to commercialization in multiple therapeutic areas, including neuroscience, will be valuable as we execute on our commercialization and clinical plans and advance our pipeline in support of our commitment to relieve patient suffering and enhance lives."

Dr. Roberts has over 25 years of research and development experience in the pharmaceutical industry across all phases of drug development from research through commercialization in multiple therapeutic areas, including neuroscience, inflammation, oncology and metabolic diseases. She joins Neurocrine from Eli Lilly and Company where she held various positions during her tenure, including Vice President, Clinical Pharmacology and Vice President of R&D, BioMedicines Business Unit.

Dr. Roberts was the Chair of the Medical Review Committee, where she was responsible for review and approval of all the integrated clinical plans for molecules in the Lilly portfolio. She was also a member of Lilly’s Corporate Portfolio Management Committee and Lilly Ventures Steering Committee. Dr. Roberts was accountable for early clinical development programs across all therapeutic areas within Lilly, as well as registration for new chemical entities and biproducts in Phase III development. During her time at Lilly, Dr. Roberts established a new therapeutic area, which resulted in the development of five potential novel medicines from Phase I through to approval, with two of them successfully receiving regulatory approval. Dr. Roberts also has extensive leadership and business development experience, including the management of strategic alliances, business partnerships and venture capital collaborations.

Dr. Roberts is a physician who trained in pharmacology and medicine in the UK, qualifying from the University of London in 1987. Her post-graduate clinical training was in clinical pharmacology and cardiology at St. Bartholomew’s Hospital and the Royal London Hospital.

Neurocrine also announced the grant of an inducement award to Dr. Roberts pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. In connection with her employment by Neurocrine, Dr. Roberts will be granted an inducement award consisting of a stock option to purchase 70,000 shares of Neurocrine common stock. The stock option will vest over a period of four years, with 25% vesting on the first anniversary of its grant date and the balance vesting each month over the remaining three years. Dr. Roberts also received 20,000 restricted stock units which vest in equal increments over four years, with 25% vesting each year. These awards are subject to the terms and conditions of Neurocrine’s Inducement Plan, and will be effective on January 8, 2018. The stock option grant will have an exercise price equal to the closing price of Neurocrine’s common stock on the NASDAQ Global Select Market on that date. These awards were granted as an inducement material to Dr. Roberts’ employment pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

Attending the Biotechandmoney conference

On January 5, 2018 MonTa Biosciences reported that attend the Biotechandmoney conference in London on February 5-6 (Press release, MonTa Biosciences, JAN 5, 2018, View Source [SID1234618634]).

Potenza Therapeutics Unveils Pipeline of Immuno-Oncology Programs

On January 5, 2018 Potenza Therapeutics reported insights into its portfolio of immuno-oncology therapies that turn on or off the signaling mechanisms that control a patients‘ own immune system to recognize and destroy cancer (Press release, Potenza Therapeutics, JAN 5, 2018, View Source [SID1234523024]). The lead program in Potenza’s portfolio is its next-generation checkpoint inhibitor, a novel TIGIT antagonist PTZ-201 (ASP8374) which is being developed in partnership with Astellas Pharma Inc. and its affiliates ("Astellas"). In addition, Potenza and Astellas are jointly working on two additional preclinical molecules expected to complete IND-enabling studies in 2018: PTZ-329, which targets a novel immune regulatory pathway; and PTZ-522, a novel approach to a well-validated but as-yet ineffectively addressed immune activating pathway.

"The team has made substantial scientific discovery and pre-clinical development progress since we launched Potenza in 2014 and established our R&D Collaboration with Astellas in April 2015," said Dan Hicklin, PhD, co-founder of Potenza and the company’s Chief Executive Officer. "The current portfolio was carefully chosen and includes potential therapies that will be studied for use alone, in combination with standard of care, and in unique combination regimens with each other. The three programs that Potenza is pursuing may have the potential to provide benefit for patients in indications for whom there are currently no effective treatments."

The Phase 1 clinical trial for PTZ-201 (ASP8374) is a dose escalation and expansion safety study in patients with advanced solid tumors with plans to expand into efficacy expansion cohorts in responding tumor types, and is sponsored by Astellas Pharma Global Development, Inc. The primary purpose of the study is to evaluate the tolerability and safety profile of ASP8374 in patients with locally advanced (unresectable) or metastatic solid tumors and to characterize the pharmacokinetic profile of ASP8374 and to determine the recommended Phase 2 dose (RP2D) of ASP8374. The secondary purpose of this study is to evaluate whether ASP8374 has an anti-tumor effect as monotherapy and ultimately in combination with a PD1 inhibitor. Details can be found at www.clinicaltrials.gov.

Peregrine Pharmaceuticals Announces Name Change to Avid Bioservices as Part of Transition to Dedicated Contract Development and Manufacturing Organization (CDMO)

On January 5, 2018 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a company working to improve patient lives by providing high quality biologics manufacturing services to biotechnology and pharmaceutical companies, reported that it is changing its name to Avid Bioservices, Inc. as part of its transition to a dedicated contract development and manufacturing organization (CDMO) (Press release, Peregrine Pharmaceuticals, MAY 5, 2018, View Source [SID1234522974]). In addition to the name change, the company is also adopting the new NASDAQ ticker symbol "CDMO" (NASDAQ:CDMO). The name and ticker symbol changes will both be effective as of market open on Monday, January 8, 2018.

"As our organization transitions to a pure play CDMO, we believe it is appropriate to take advantage of the brand recognition that has been built within this highly specialized marketplace and to change the company’s name and conduct all future operations as Avid Bioservices," said Roger Lias, Ph.D., president and chief executive officer. "Over the past 15 years, Avid has established a reputation for CDMO excellence built on biologics manufacturing expertise and a track record of consistently meeting and exceeding the needs of its clients. This level of quality is highlighted by Avid’s receipt of multiple 2017 Contract Manufacturing Leadership Awards for Quality, Reliability, Capabilities, Expertise and Compatibility. We look forward to continuing to build the Avid brand as we work to grow and diversify our CDMO business by providing our clients with the most sophisticated and highest-quality development and manufacturing services."

Effective at market open on Monday, January 8, 2018, trading for Avid Bioservices will begin under the symbol "CDMO" (NASDAQ:CDMO). At the same time, the company’s preferred stock will begin trading under the symbol "CDMOP" (NASDAQ:CDMOP). The company’s common stock and preferred stock will continue to trade under the ticker symbols "PPHM" and "PPHMP", respectively, until market close on Friday, January 5, 2018. The corporate name change to Avid Bioservices does not affect the rights of the company’s stockholders and no action is required by stockholders with respect to the name change. The company’s common stock has been assigned a new CUSIP number of 05368M 106 and the company’s preferred stock has been assigned a new CUSIP number of 05368M 205 in connection with the name change. Outstanding stock certificates are not affected by the name change and will not need to be exchanged.

Exicure, Inc. to Present at Biotech Showcase 2018

On January 5, 2018 Exicure, Inc., the pioneer in gene regulatory and immunotherapeutic drugs utilizing three-dimensional, spherical nucleic acid (SNA) constructs, reported that the company is scheduled to present at the 10th Annual Biotech Showcase conference held January 8-10, 2018 in San Francisco (Press release, Exicure, JAN 5, 2018, View Source;p=RssLanding&cat=news&id=2325180 [SID1234523073]).

Dr. David Giljohann, Chief Executive Officer of Exicure, will present a company overview on Tuesday, January 9th at 10:15 a.m. Pacific Time at the Hilton Union Square in San Francisco.

A live webcast of the presentation will be available on the Events & Presentations section of Exicure’s website and will also be archived following the presentation.