On May 12, 2026 ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), reported preclinical data demonstrating the in vivo generation of CAR-T cells and deep systemic B-cell depletion achieved with its MDX3001 candidate in animal models. The data, generated using ModeX’s CD3xCD28 antibody-conjugated lipid nanoparticle (LNP)/mRNA platform, will be presented at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting, being held May 11-15 in Boston.
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The abstract, titled "Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T Cell Generation with Deep B-Cell Depletion," highlights preclinical studies showing B-cell depletion in blood and lymphoid tissues, including spleen, bone marrow, and lymph nodes. Activity was confirmed in both humanized mouse and non-human primate models.
By combining CD3 with CD28 costimulatory engagement, the technology enables efficient T-cell transfection, activation, and functional CAR-T cell generation directly in vivo. The antibody-conjugated LNP directs cell-specific gene delivery, and the mRNA nature of the platform, obviates the need for pre-conditioning chemotherapy while allowing for repeat dosing, leading to expansion and persistence of functional memory T-cell populations.
"These data demonstrate the strength of our in vivo targeting technology," said John Mascola, M.D., Chief Scientific Officer of ModeX Therapeutics. "Our antibody-conjugated LNP platform offers a simple and versatile approach to gene delivery for immune cells in vivo, and has the potential to simplify treatment access by eliminating the burden of ex vivo manufacturing."
"Our targeted gene delivery platform uses proprietary ModeX technology to generate CAR-T cells directly in patients," said Gary Nabel, M.D., Ph.D., President and Chief Executive Officer of ModeX Therapeutics. "It offers a promising clinical modality for diverse diseases, including autoimmunity and oncology."
Oral Presentation Details
Title: Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T Cell Generation with Deep B Cell Depletion
Abstract Number: 338
Meeting: ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting
Date/Time: May 14, 2026 at 10:15 a.m. Eastern time
Location: Thomas M. Menino Convention Center, Boston
(Press release, Opko Health, MAY 12, 2026, View Source [SID1234665554])