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BlueSphere Bio Names Dr. James Onuffer VP of Product Development in Preparation for Clinical Program

August 26, 2020

Immuno-oncology startup BlueSphere Bio, a company that creates personalized T cell therapies for cancer and blood and marrow transplantation, has appointed James Onuffer, Ph.D., as its vice president of product development.

In this newly established role, Onuffer will build and manage the product development infrastructure and lead efforts in cellular engineering. He will oversee preclinical studies, process development and manufacturing to effectively align BlueSphere Bio’s research and development efforts with clinical product offerings that meet regulatory guidelines and business goals.

“As James joins our experienced leadership team, BlueSphere Bio is focused on rapidly transitioning from our strong scientific foundation to the clinic,” said David Apelian, M.D., Ph.D., M.B.A., BlueSphere Bio’s chief executive officer. “With James’ deep experience in cellular engineering, research and product development — across large pharma, startup biotech and academia — he brings the skills we need to transform our T cell receptor discovery platform into our first clinical T cell product to improve outcomes in high-risk bone marrow transplant.”

With its rapidly growing team, BlueSphere Bio relocated this month to new office space in Pittsburgh’s South Oakland neighborhood. The company will be the first to occupy this newly constructed facility, which will house BlueSphere Bio’s efforts to further develop its TCXpress platform. TCXpress quickly and cost-effectively captures and characterizes T cell receptors (TCR), the key component for any T cell immunotherapy.

TCX-101 is the first clinical program to be advanced by BlueSphere Bio. It will utilize the TCR discovery of TCXPress to generate a T cell therapeutic that will potentially improve the anti-leukemia effect of bone marrow transplant, while improving engraftment and reducing graft versus host disease.

Prior to joining BlueSphere Bio, Onuffer served as vice president of synthetic biology and immunology at F1 Oncology Inc., where he led discovery and development efforts in autologous adoptive immunotherapy products and cell manufacturing systems for targeting solid tumors with CAR-T therapies. His work resulted in two developed products advancing to first-in-human clinical trials.

Onuffer received his bachelor’s degree in microbiology from The Pennsylvania State University and his Ph.D. in biochemistry from the University of California, Berkeley. He has authored multiple scientific articles and is an inventor on several patents in the small molecule, biologics and cell therapy industries.

UPMC Enterprises, the commercialization arm of UPMC, has formed five translational sciences companies in the last two years, including BlueSphere Bio, which are complemented by a growing portfolio of investments sourced from outside the region. With a focus on radically improving patient care, these efforts are part of UPMC’s commitment to invest $1 billion in drugs, diagnostics and devices by 2024, which includes its original $200 million commitment to the Immune Transplant and Therapy Center, a focused effort between the health system and the University of Pittsburgh to use the power of the human immune system to treat and cure a wide range of diseases.