BlueSphere Bio, the first translational sciences biotech startup formed by UPMC Enterprises, announced two major milestones for its novel T cell receptor therapy platform: its first IND clearance and a new strategic collaboration with the National Institutes of Health (NIH) National Cancer Institute (NCI).
These important achievements by BlueSphere exemplify UPMC Enterprises’ model of fostering biotech startups with novel and promising therapeutic candidates and innovative health care technological solutions to achieve rapid success and expansion.
First IND Clearance from U.S. FDA
BlueSphere received IND (Investigational New Drug) clearance from the U.S. Food and Drug Administration for its first-in-human candidate, a novel T-cell receptor (TCR) therapy targeting high-risk leukemia. This milestone marks a critical step in advancing the company’s cell therapy portfolio designed to treat relapsed or refractory acute myeloid leukemia (AML) and other high-risk hematologic malignancies. The IND clearance allows BlueSphere to commence human clinical trials, with the first study set to evaluate this innovative therapy’s safety, tolerability, and preliminary efficacy. This achievement highlights the rapid progress and clinical potential of BlueSphere’s therapeutic pipeline, moving closer to delivering potentially life-saving treatments to patients with limited options facing recurrent and refractory cancers.
Strategic Collaboration Begins with National Cancer Institute
In another significant development, BlueSphere announced a strategic collaboration with the NCI to advance treatments for recurrent respiratory papillomatosis, a rare disease caused by variants of the human papilloma virus. This collaboration will utilize BlueSphere’s TCR technology, TCXpress™, to search for a novel TCR T-cell therapy to treat the rare disease. The collaboration aims to combine BlueSphere’s innovative approach to immune cell engineering with the NCI’s extensive research capabilities to develop breakthrough therapies. The collaboration with the NCI is a testament to BlueSphere’s commitment to tackling high unmet medical needs and its clinical capabilities and expertise in T-cell receptor discovery.
The UPMC Enterprises Model: Nurturing Biotech Startups for Long-Term Success
UPMC Enterprises’ Translational Sciences team provides life sciences startups such as BlueSphere not only capital but the drug development experience and business advisory services that are key resources for success. The team’s model creates stability for researchers and entrepreneurs — from UPMC and University of Pittsburgh or anywhere in the world — so they can focus on translating discoveries into potential life-changing treatments.
“BlueSphere’s first IND and strategic collaboration with NCI are huge achievements for a biotech startup that only began five years ago. These milestones not only showcase BlueSphere’s potential and its clinical progress but also highlight the strength of Enterprises in fostering innovative solutions for pressing unmet medical needs,” said Matthias Kleinz, DVM, PhD, Executive Vice President of Translational Sciences at UPMC Enterprises.
A Proven Model for Health Care Innovation
The Translational Sciences team at UPMC Enterprises focuses on diseases with high unmet medical needs, spanning oncology, ophthalmology, autoimmune disorders, and the central nervous system.
Along with BlueSphere, UPMC Enterprises has employed its same model of financial, technological, and advisory support to other promising startups, including Novasenta, Avista, and Generian, all of which are progressing along similar lines and timescales with their respective programs.
These companies, like BlueSphere, are built on groundbreaking research from UPMC and the University of Pittsburgh’s diverse and talented scientific community and benefit from UPMC Enterprises’ comprehensive support and visionary approach to transforming health care.
“Our primary goal is to translate pioneering research into clinical applications that can significantly improve patient outcomes for challenging diseases,” Dr. Kleinz said. “But BlueSphere’s progress also is great news for Pittsburgh’s burgeoning biotech ecosystem — as more homegrown companies advance, they attract further talent and other companies.”
Additional Reading
Find out how the Translational Sciences team at UPMC Enterprises is adding value through scientific expertise, clinical insights, and capital.
Read about BlueSphere Bio’s recent accomplishments in the following press releases and news features:
- BlueSphere Bio’s huge week with FDA approval for dosing and National Cancer Institute agreement (Pittsburgh Business Times. June 7, 2024)
- BlueSphere Bio Establishes Strategic Collaboration with the National Cancer Institute to Advance Treatments for Rare Respiratory Disease
- BlueSphere Bio Announces IND Clearance of its First-in-Human Candidate and New Cell Therapy Portfolio for High-Risk Leukemia Patients
