Boston — Liberate Bio has appointed Steven H. Bernstein, M.D., as Chief Medical Officer as the biotechnology company prepares to advance its lead in vivo cell-programming programs toward initial human studies.
Bernstein, whose appointment took effect July 13, will lead Liberate’s clinical development strategy and oversee its planned clinical trials. He will also direct the company’s translational medicine efforts, including biomarker selection, clinical endpoint development and the use of patient data to guide pipeline priorities.
Liberate is developing genetic medicines designed to reprogram immune cells directly inside the body. Its lead programs use liver-detargeted lipid nanoparticles to deliver RNA payloads selectively to monocytes and macrophages, with applications in autoimmune diseases and cancer.
“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.”
Bernstein most recently led clinical development, translational medicine, regulatory science and clinical operations for Regeneron’s Cell Medicine Unit.
He previously served as Chief Medical Officer of 2seventy bio, where he helped advance autologous cell therapy programs, including work involving Abecma, the first U.S. Food and Drug Administration-approved BCMA-directed CAR-T therapy for multiple myeloma.
Earlier in his career, Bernstein held clinical and translational leadership roles at Turnstone Biologics and Bristol Myers Squibb. He also worked as an academic physician-scientist focused on lymphoma immunobiology and clinical research.
“Liberate has built a differentiated platform with the potential to bring cell therapy-like activity to far broader patient populations,” Bernstein said. “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 RAPTOR platform directly screens lipid nanoparticles in nonhuman primates and generates delivery data used for biological selection and artificial intelligence-assisted nanoparticle optimization.
The company said its lead lipid nanoparticles are designed to deliver RNA to myeloid-lineage cells while minimizing liver and T-cell delivery. This approach is intended to program monocytes and macrophages inside the body as therapeutic effector cells.
In preclinical studies, Liberate’s lead in vivo CAR-M approach programmed circulating monocytes in nonhuman primates and produced peripheral B-cell depletion of up to 99% at well-tolerated doses.
The company said Bernstein will help select the first clinical indication, oversee its initial human studies and use early clinical findings to guide later-stage and registrational development.
