- Urvashi Patel, Ph.D., as Vice President, Regulatory Affairs
- Stacey Bilinski, as Vice President, Clinical Operations
NEW YORK, April 13, 2022 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, today announced the additions to its clinical and regulatory team as the Company seeks to expand its clinical pipeline with at least one new company sponsored investigational new drug application (IND) this year. IN8bio has appointed Urvashi Patel, Ph.D., as Vice President, Regulatory Affairs and Stacey Bilinski, as Vice President, Clinical Operations. They bring deep clinical and regulatory experience to the IN8bio team, from early to late-stage development across the biotechnology and pharmaceutical industries with over 45 years of combined experience.
“To advance the development of our novel programs and pipeline, we have brought two, highly talented and deeply experienced individuals onto our team to help lead our regulatory affairs and clinical operations functions,” said Dr. Trishna Goswami, Chief Medical Officer of IN8bio. “Dr. Patel’s understanding of the intricacies of cell therapy regulatory interactions and Ms. Bilinski’s range of experience conducting multiple trials as a member of contract research organizations, biotechnology and pharmaceutical companies will be especially beneficial to our exceptional team as we continue to advance our preclinical and clinical stage gamma-delta T cell programs.”
Dr. Patel joins IN8bio as Vice President, Regulatory Affairs and her regulatory expertise includes strategic planning for IND submissions, submitting biologics license applications (BLAs), and managing interactions with the U.S. Food and Drug Administration (FDA). Dr. Patel has provided guidance to organizations to ensure standard operating procedures support internal processes and meet regulatory requirements. In addition to her more than 17 years of experience in professional drug development, Dr. Patel has more than 10 years’ experience in cell therapy and oncology, most recently serving as the VP of Regulatory and Quality Systems at WindMIL Therapeutics. Previously, she held positions at Precision for Medicine, Janssen, Elan Pharmaceuticals and Genentech. Throughout her career, she has provided global regulatory oversight and support across multiple therapeutic areas and regulatory filings including new drug applications (NDAs) and biologics license applications (BLAs). Dr. Patel earned her Ph.D. in biological sciences from Stanford University.
Ms. Bilinski joins IN8bio as Vice President, Clinical Operations and brings more than 30 years of diverse clinical and operations experience. Prior to joining, Ms. Bilinski was the Global Senior Director, Operations at Taiho Oncology Inc., where she ran life-cycle management of the LONSURF® program and initiated numerous first in-human and early-phase clinical development programs. Ms. Bilinski was previously the Executive Director of Clinical Operations at Onconova, where she directed clinical operations for programs in myelodysplastic syndrome (MDS), pancreatic, and head and neck cancers. Earlier in her career she held positions at Insmed, Amicus Therapeutics, and Covance. Ms. Bilinski earned her bachelor’s degree from Rutgers University.
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio’s DeltEx platform employs allogeneic, autologous and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.
IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types. For more information about IN8bio and its programs, please visit www.IN8bio.com.
Forward Looking Statements
Certain statements herein concerning the Company’s future expectations, plans and prospects, including without limitation, the Company’s current expectations regarding the advancement of its product candidates through preclinical studies and clinical trials and the prospects for such candidates and underlying technology, including the ability of INB-200 to treat GBM, constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” the negative of these and other similar expressions are intended to identify such forward looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond the Company’s control. Consequently, actual future results may differ materially from the anticipated results expressed in such statements. Specific risks which could cause actual results to differ materially from the Company’s current expectations include: scientific, regulatory, technical and clinical developments; failure to demonstrate safety, tolerability and efficacy; final and quality controlled verification of data and the related analyses; expense and uncertainty of obtaining regulatory approval, including from the U.S. Food and Drug Administration; the impact of the ongoing COVID-19 pandemic on the Company’s clinical trials; and the Company’s reliance on third parties, including licensors and clinical research organizations. Do not place undue reliance on any forward-looking statements included herein, which speak only as of the date hereof and which the Company is under no obligation to update or revise as a result of any event, circumstances or otherwise, unless required by applicable law.
Kate Rochlin, Ph.D.
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