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ROCKVILLE, Md., March 06, 2019 (GLOBE NEWSWIRE) -- Innovative Cellular Therapeutics (ICT), a biotechnology company developing cellular immunotherapies for the treatment of cancer, today announced the opening of a U.S. office in Rockville, Maryland and the appointment of three new U.S.-based members of the executive team, a key corporate milestone for ICT. The new hires are Victor Lu, Ph.D., as Senior Vice President and Head of Regulatory Affairs; Brad Fackler as Senior Vice President, Operations and Business Development; and Timothy Mitchell as Vice President, Quality Assurance and Compliance.
“As we move toward our planned Phase I/II clinical trial initiation in lymphoma in 2019, we are excited to announce a significant U.S. presence out of our new offices in Maryland,” said Lei Xiao, Ph.D., Chief Executive Officer of ICT. “The hiring of team members to oversee our regulatory, clinical, and operational functions here in the United States represents an important milestone for our global company, and we are extremely well-positioned to carry out our clinical development plans.”
The Company’s lead program, ICTCAR014, is a novel “armored CAR” therapeutic candidate that targets CD19 and the PD1/PD-L1 pathway. It is currently in preclinical development for the treatment of Non-Hodgkin Lymphoma in the United States. Research has shown that the inhibition of PD1 may enhance CAR-T cell function.
More detailed biographies of the newly appointed team members are outlined below:
Victor Lu has over 18 years of experience in product development and regulatory affairs specific to cellular and gene therapies. Dr. Lu spent 10 of those years as a Reviewer with the FDA, where his main role was to review IND applications for cellular and gene therapy-based products and biologics license applications (BLAs), including for CAR-T Cells. Dr. Lu also has R&D experience from VIRxSYS Corporation, where he led the vector development effort for the first lentiviral vector-based gene therapy investigational product (VRX496) in human clinical trials. He holds a Ph.D. from the State University of New York at Buffalo in Molecular Virology and completed his postdoctoral training at the University of California San Francisco (UCSF).
Brad Fackler has over 35 years of experience in the pharmaceutical and biotech industries. Prior to joining ICT, he was the Senior Director of BioHealth and Life Sciences for Maryland’s Department of Commerce. Mr. Fackler has also held senior leadership positions with Novartis Pharmaceuticals, Sucampo Pharmaceuticals, and Cellona Therapeutics. He holds a B.A. in Biology from Otterbein University and an MBA from the Leonard Stern School of Business at New York University.
Timothy Mitchell has extensive experience in quality assurance within the human cell therapy, biologics, and pharmaceutical industries. His specific areas of focus include quality assurance and control, global compliance, validation, regulatory affairs, engineering, site management, and manufacturing operations. He was most recently the Head of Corporate Quality for Cell Therapy Technologies and Targeted Nuclear Oncology at Endocyte (a Novartis company). He has also held senior leadership positions with Celgene Corporation, Eli Lilly, and other companies. Mr. Mitchell holds a B.S. in both Genetic Biology and Biochemistry from Purdue University.
About Innovative Cellular Therapeutics
Innovative Cellular Therapeutics (ICT) is a biotechnology company focused on the development of cellular immunotherapies for the treatment of cancer. ICT's novel CAR-T constructs have achieved promising preclinical and clinical results in late-stage leukemia and lymphoma. ICT’s lead CAR-T candidate in the U.S., ICTCAR014, targets CD19 and PD1 for the treatment of Non-Hodgkin Lymphoma. ICT’s lead CAR-T candidate in China, ICTCAR003, targets CD19 for the treatment of B-cell acute lymphoblastic leukemia. The Company also has a broad pipeline of CAR-T candidates targeting other blood and liquid cancers and solid tumors. For more information, please visit www.ictbio.com.
Investor Relations Contacts:
Innovative Cellular Therapeutics
Stern Investor Relations
Media Relations Contact:
Kate L. Barrette