BlueSphere Bio

We’re thrilled to be featured in UPMC Enterprises’ 2024 Year in Review, highlighting the strides BlueSphere made this year in advancing cell therapies and bringing life-changing treatments closer to patients.   2024 was a landmark year for BlueSphere as we achieved critical milestones, including: ·      The receipt of a letter to proceed from FDA for our first Investigational New Drug (IND) to treat high-risk AML, ALL, and MDS patients in conjunction with CD34+ stem cell transplant. We plan to enroll our first patient for this Phase 1/2a trial in 1Q2025. We also strengthened our commitment to addressing unmet medical needs by: ·      Nominating a second clinical candidate – a TCR T-cell therapy for AML patients with mutant NPM1 ·      Entering into a strategic collaboration with the NIH’s National Cancer Institute to identify TCRs specific for the rare disease recurrent respiratory papillomatosis (RRP) ·      Being accepted as a virtual member of Johnson & Johnson Innovation – JLABS, a premier global network of health incubators. These achievements showcase the UPMC Enterprises model of fostering biotech startups, supporting novel therapies, and driving rapid innovation in health care technology. We’re grateful for the continued support of UPMC Enterprises and our partners as we move into 2025, where we will be committed to transforming research into real-world impact. Check out the report here: https://lnkd.in/e8awJ4nQ

#ICYMI: Check out our Chief Medical Officer, Erkut Bahceci, featured in this CMO360 article, where he discusses how CMOs can leverage adaptive approaches, real-world data, and ex-US trials to accelerate drug development.   Learn more here: https://lnkd.in/eR_Gkvvw

Our Chief Scientific Officer, Zhimei Du, MD, PhD, will be chairing a session at the 16th Annual Bioprocessing Summit in Boston! This is a unique opportunity to gain insights from thought leaders and pioneers driving innovation in bioprocess R&D, scale-up, quality, and analytics. Looking forward to seeing you next week in Boston!   You can find more details about the session and the summit here: https://lnkd.in/eqYsS33

Today, BlueSphere Bio announced that we have been accepted as a virtual member of Johnson & Johnson Innovation - JLABS. We are proud to join the JLABS network, as this opportunity will help us advance our strategy to bring the next generation of TCR-based therapies to the clinic as quickly and efficiently as possible.   JLABS is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-enhancing healthcare solutions to patients around the world. Learn more here: https://bit.ly/4dszpFy

#ICYMI our Chief Scientific Officer, Zhimei Du was featured in a panel hosted by Drug Target Review titled: “Immunotherapy advancements: transforming cancer treatment.” Dr. Du and other leaders in the oncology space discussed the latest advancements in immunotherapy research, highlighted breakthroughs and challenges, and the future direction of the field.   Looking to dive in and learn more about the current landscape of immunotherapy research? Check out the webinar here: https://bit.ly/3SC8tKS

Hear from our CEO, Keir J. LoIacono, Esq., in the Outsourced Pharma article below:

Today we are excited to announce our collaboration with NMDP BioTherapies to advance our TCR T-cell therapy into human trials. NMDP BioTherapies will provide healthy donor materials for our upcoming Phase 1/2a trial (TCX-101) of our first-in-human product (BSB-1001). The Phase 1/2a trial will evaluate BSB-1001 in combination with allogeneic stem cell transplant in patients with high-risk leukemias, including relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS). Learn more here: https://lnkd.in/g4C5kxdy

#ICYMI, last week we celebrated multiple milestones! The FDA cleared our IND application for our first-in-human Phase 1/2a trial evaluating BSB-1001 in patients with high-risk leukemias. We also announced a strategic collaboration with the National Cancer Institute (NCI) to advance treatments for a rare respiratory disease.   Learn more about these exciting developments in Ron Leuty's recent Biotech roundup here: https://lnkd.in/euzC7ZsK

#ICYMI our Chief Executive Officer, Keir J. LoIacono, Esq., participated in a panel discussion at this year’s BIO International Convention (Biotechnology Innovation Organization). The panel, moderated by @Angus Liu, was titled, “What’s Nex-T: Innovator Roundtable on T Cell Therapies in Oncology.” Keir and other industry leaders, including Dan Passeri, CEO of Cue Biopharma, Lola Fahoyin-Aje, MD, MPH, Director of the Office of Clinical Evaluation at the FDA, and David Fontana, Ph.D., Chief Operating and Chief Business Officer of Umoja Therapeutics, discussed the future of T cell-directed cancer therapies. 

We are excited to announce a strategic collaboration between BlueSphere Bio and the National Cancer Institute (NCI) aimed at revolutionizing treatment options for recurrent respiratory papillomatosis (RRP), a rare and challenging orphan disease. Our partnership with the NCI underscores our commitment to innovation and dedication to transforming patients' lives facing unmet medical needs.    The expansion into the rare, non-oncology disease space further highlights the potential of our TCR discovery platform, TCXpress™.   Learn more about our collaboration here: https://lnkd.in/euDS22ST