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.

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.

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

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.

On November 26, 2018 Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, is reported that its Board of Directors appointed Samson Tom, PhD, MBA to serve as President and Chief Executive Officer, effective November 26, 2018 (Press release, Osiris Therapeutics, NOV 26, 2018, View Source [SID1234531628]). Dr. Tom was at Osiris from 2003 to 2011, where he held several leadership positions spanning multiple functional areas including Quality, Operations, Clinical Development, and Product Development. Subsequently, he served as Group Director, Biosurgery Research & Development at Ethicon, Inc. (a Johnson & Johnson company). Prior to rejoining Osiris, he served as Vice President, Research & Development for Surgical Orthobiologics at Bioventus, LLC. Dr. Tom brings a strong combination of scientific and commercial experience in the regenerative medicine space. He earned a BA in Biology and Chemistry from Cornell University, a MS and PhD in Biochemistry from the University of Rochester School of Medicine and Dentistry, and a MBA in General Management from the Johns Hopkins University Carey Business School.

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"Returning to Osiris definitely feels like coming home," said Dr. Tom. "Developing and launching novel solutions to address unmet needs for patients and the medical community have always been at the core of Osiris. I am truly energized to continue this legacy and look forward to working with the entire team during the next phase in the evolution of this innovative company.""I am pleased to welcome Dr. Tom back to Osiris as President and CEO," said Peter Friedli, Chairman of the Board. "At this important juncture for the company, Dr. Tom is a great fit due to his familiarity with our technologies and our culture of innovation. I look forward to working with him to achieve greater operational efficiency and future growth."Jason Keefer, who previously served as Interim President and Chief Executive Officer, will transition to lead the commercial functions of the organization and serve on the management team as Chief Commercial Officer.