Cell therapy and translational medicine leader joins as the company’s lead in vivo CAR-M programs approach first-in-human studies.

BOSTON: Liberate Bio, Inc., a biotechnology company developing genetic medicines that program immune cells directly inside the body, today announced the appointment of Steven H. Bernstein, M.D., as Chief Medical Officer, effective July 13, 2026.

Dr. Bernstein joins Liberate as the company advances its myeloid-selective, liver-detargeted lipid nanoparticle platform and lead in vivo CAR-M programs toward first clinical evaluation. In this role, he will lead clinical development strategy, oversee execution of upcoming clinical studies, and translate early human data into registrational development plans. He will also guide the company’s translational medicine strategy, including biomarker selection, clinical endpoint development, and integration of patient data to prioritize the pipeline.

“Steven is exactly the clinical leader Liberate needs at this moment,” said Shawn P. Davis, Ph.D., Chief Executive Officer of Liberate Bio. “We have shown that monocytes and macrophages can be reprogrammed into therapeutic effector cells directly in vivo, bringing the potency of engineered cell therapy to patients without the manufacturing and access constraints that have limited it. Steven’s experience advancing cell therapies across the arc from early development through approval gives us the judgment to translate that biology into disciplined human studies and, ultimately, into medicines that reach far more patients.”

Dr. Bernstein is a physician-scientist and biopharmaceutical executive with deep experience in clinical development, translational medicine, regulatory strategy, clinical operations, hematologic oncology, and engineered cell therapies. Most recently, he led Clinical Development, Translational Medicine, Regulatory Science, and Clinical Operations for the Cell Medicine Unit at Regeneron. Previously, he served as Chief Medical Officer at 2seventy bio, where he helped advance autologous cell therapy programs, including work related to Abecma, the first FDA-approved BCMA-directed CAR-T therapy for multiple myeloma. Earlier in his career, Dr. Bernstein held clinical and translational leadership roles at Turnstone Biologics and Bristol Myers Squibb and was an academic physician-scientist focused on lymphoma immunobiology and clinical investigation.

“Liberate has built a differentiated platform with the potential to bring cell therapy-like activity to far broader patient populations,” said Steven H. Bernstein, M.D., Chief Medical Officer of Liberate Bio. “By programming monocytes and macrophages in vivo, the company combines the potency of engineered immune cells with the repeatability and scalability of an RNA medicine. I’m looking forward to translating this platform’s results into clinical studies and development paths designed to demonstrate meaningful patient benefit.”

Liberate’s proprietary RAPTOR™ platform enables direct screening of lipid nanoparticles in non-human primates, generating in vivo delivery datasets that guide both biological selection and AI-enabled LNP optimization. The company’s lead LNPs are designed to selectively deliver RNA payloads to myeloid lineage cells while detargeting the liver and avoiding meaningful T-cell delivery. This delivery profile enables monocytes and macrophages to be programmed directly in vivo as therapeutic effector cells, supporting Liberate’s lead in vivo CAR-M programs in autoimmune disease and oncology.

As previously reported, Liberate’s lead in vivo CAR-M approach has programmed monocytes directly in the circulation of non-human primates, producing up to 99% peripheral B-cell depletion at well-tolerated doses - providing preclinical evidence that immune effector cells can be engineered inside the body rather than manufactured outside it. With Dr. Bernstein’s appointment, Liberate is adding the clinical leadership required to select the optimal first indication, execute its initial human studies, and use early clinical data to shape the next stage of pipeline and registrational development.

About Liberate Bio

Liberate Bio is building the next generation of genetic medicines by solving the most fundamental challenge in the field: delivery beyond the liver. The company’s proprietary RAPTOR™ platform combines high-throughput in vivo screening in non-human primates with AI-driven design and optimization, creating the first biological dataset powerful enough to train artificial intelligence on real delivery outcomes.

Using this feedback loop, Liberate Bio has engineered lipid nanoparticles that target specific immune and bone marrow–resident cell types, including monocytes, macrophages, and hematopoietic stem cells (HSCs). This approach enables the programmable delivery of mRNA, gene editing, and other payloads directly to the cells that drive disease - unlocking the potential to treat oncology, autoimmune, and rare genetic disorders from within the body.

Liberate Bio’s first programs focus on in vivo CAR-M therapies to reprogram immune cells safely and at scale. Longer term, the company’s platform provides a foundation for a new class of AI-informed, systemically delivered genetic medicines that extend to multiple organs and therapeutic areas.

For more information about the company’s technologies, team, and mission, visit www.liberatebio.com.

Fonte: Business Wire