Altimmune Appoints Vipin K. Garg, Ph.D. as its New President and Chief Executive Officer

On November 27, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported the appointment of Vipin K. Garg, Ph.D. as its President and Chief Executive Officer succeeding Bill Enright, current President and Chief Executive Officer, effective November 30 (Press release, Altimmune, NOV 27, 2018, View Source [SID1234531665]).

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"Vipin was chosen in a very competitive selection process and we are very excited to have him join Altimmune as President and CEO," said Mitch Sayare, Chairman of the Board of Altimmune. "His extensive experience and success in building, managing, and financing private and public biotech companies makes him an extraordinary fit for Altimmune. We thank Bill for his contributions over the years and wish him well in his future endeavors."

Dr. Garg added, "The success of the recent financings coupled with a talented scientific and business team position Altimmune for an exciting future. In addition to advancing our current product candidates through the clinic, we plan to explore opportunties to either acquire products or partner in novel immunotherapy indications to expand our pipeline. I am thrilled to be joining the Company and look forward to building and executing a strategy to increase value for our shareholders."

Dr. Garg joins Altimmune with over three decades of experience in the biotechnology and pharmaceutical industries. He has a proven track record of building and managing both private and publicly traded companies. Before joining Altimmune, he served as President and CEO of Neos Therapeutics (Nasdaq: NEOS), where he built a commercial-stage biopharmaceutical company launching three branded therapeutic products including Adzenys XR- ODTTM and Cotempla XR-ODTTM the first ever XR-ODTTM medications for the treatment of ADHD. Prior to Neos, he served as president and CEO of Tranzyme Pharma where he progressed a discovery-stage, emerging biotech company to a Nasdaq-listed clinical-stage, drug development company. Prior to joining Tranzyme, Dr. Garg served as Chief Operating Officer of Apex Bioscence, Inc. (acquired by Curacyte AG of Munich, Germany), and held senior management positions at DNX Bio-Therapeutics, Inc. until its acquisition by Baxter Healthcare Corporation, Sunovion Pharmaceuticals, Inc. (formerly known as Sepracor Inc., now a subsidiary of Sumitomo Dainippon Pharma), and Bio-Response Inc. (acquired by Baxter Healthcare Corporation). Dr. Garg received his Ph.D. in Biochemistry in 1982 from the University of Adelaide, Australia, and his M.S. from IARI Nuclear Research Laboratory, New Delhi, India in 1978.

Halozyme Announces Change In Primary Endpoint For HALO-301 To Overall Survival

On November 26, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that prior to data analysis, the FDA has agreed to Halozyme’s request to change the primary endpoint of the HALO-301 study to the single primary endpoint of overall survival (OS) (Press release, Halozyme, NOV 26, 2018, View Source [SID1234531611]). As a result, the previously planned interim analysis will not be conducted. The company will host a webcast and conference call today at 5 p.m. Eastern / 2 p.m. Pacific to discuss this change in further detail.

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HALO-301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer.

Webcast and Conference Call

Halozyme will webcast a conference call today at 5 p.m. ET / 2 p.m. PT to discuss the HALO-301 statistical plan. Dr. Helen Torley, president and chief executive officer, will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast and additional documents related to the call, please visit www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 387156. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 49634758.

About HALO 301

HALO 301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The trial will now be conducted at approximately 200 sites with a single primary endpoint of overall survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone. Secondary endpoints include progression-free survival and objective response rate. More information may be found at clinicaltrials.gov (search HALO 301 or trial identifier NCT02715804) or www.HALO301.com.

About PEGPH20

PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer.

Magenta Therapeutics to Host Webcast of Investor and Analyst Event During ASH

On November 26, 2018 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of bone marrow transplant to more patients, reported that it will host a live webcast of an investor and analyst event at 8:30 p.m. PST (11:30 p.m. EST) on Sunday, December 2, 2018, during the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Magenta Therapeutics, NOV 26, 2018, View Source [SID1234531627]).

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To access the webcast, please visit the "Events & Presentations" page within the Investors & Media section of the Magenta Therapeutics website at View Source Replays of the webcast will be available on the Magenta Therapeutics website for 90 days following the event.

ABEONA THERAPEUTICS ANNOUNCES CEO TRANSITION

On November 26, 2018 Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported the immediate termination of its Chief Executive Officer, Dr. Carsten Thiel due to personal misconduct that violated the Company’s Code of Business Conduct and Ethics (Press release, Abeona Therapeutics, NOV 26, 2018, View Source [SID1234531740]). The Company has appointed its Head of Research & Development and Chief Medical Officer, Dr. João Siffert, as Interim Chief Executive Officer.

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Dr. Thiel’s termination follows an investigation by independent members of the Company’s Board of Directors and external counsel into allegations of misconduct towards colleagues that the Board concluded violated the Company’s Code of Business Conduct and Ethics and was inconsistent with its expectations for Abeona’s CEO.

Dr. Thiel’s termination is not related to the condition of the Company’s finances, operations or clinical programs, nor due to any disagreement with the Company regarding its management of financial reporting, scientific data or other practices.

"We expect all employees, regardless of title or responsibility, to conduct themselves ethically and in accordance with company policies, and are committed to ensuring an environment of respect, integrity and ethical conduct at Abeona," said Steven H. Rouhandeh, Chairman of the Board and Executive Chairman. "The Board is confident that Abeona is in good hands while we search for a new CEO as João’s deep expertise in drug development and gene therapy will ensure that the company continues operating effectively without interruption."

Dr. Siffert has successfully led multiple drug development programs from pre-clinical to regulatory approvals in the U.S. and Europe, and has held several scientific leadership positions in biotech and pharma, including programs in gene therapy. In 2017, Dr. Siffert was appointed to the Board of Directors of gene therapy developer AveXis, which was subsequently acquired by Novartis. He served as Chief Medical Officer for Ceregene from 2007 to 2011, where he was responsible for clinical development of adeno-associated viral (AAV2)-based gene therapies for Parkinson’s and Alzheimer’s diseases. Dr. Siffert also led the R&D and medical organizations at Avanir Pharmaceuticals and Avera Pharmaceuticals before most recently guiding translational research, clinical development, regulatory, and medical affairs as Chief Scientific and Medical Officer for Nestle Health Science.

The Board has formed a search committee to identify a permanent successor, with the assistance of a leading executive search firm

Seattle Genetics to Webcast Investor and Analyst Event at American Society of Hematology Annual Meeting

On November 26, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that the company will webcast an investor and analyst event on Monday, December 3, 2018 during the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, Calif (Press release, Seattle Genetics, NOV 26, 2018, View Source [SID1234531612]). The program will feature the phase 3 ECHELON-2 trial as well as other key data from the meeting.

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The webcast will begin at approximately 8:15 p.m. Pacific Time. The webcast will be available live and for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.