{"success":true,"data":{"pressRelease":{"id":"31352","rtpr_id":"nGNX3kxbDS","ticker":"OPK","exchange":"NASDAQ","all_tickers":["OPK"],"title":"OPKO Health’s ModeX Therapeutics Will Present Data Demonstrating In Vivo CAR-T Cell Generation and Deep B-Cell Depletion in Preclinical Studies","author":"Globe Newswire","published_at":"2026-05-12T12:00:02.128Z","article_body":"Multispecific antibody conjugated LNP/mRNA platform enables in vivo T-cell\nengineering and systemic B-cell depletion in animal models \n\nData will be presented at the American Society of Gene & Cell Therapy (ASGCT)\n2026 Annual Meeting\n\nWESTON, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an\nOPKO Health company (NASDAQ: OPK), will announce preclinical data\ndemonstrating the in vivo generation of CAR-T cells and deep systemic B-cell\ndepletion achieved with its MDX3001 candidate in animal models. The data,\ngenerated using ModeX’s CD3xCD28 antibody-conjugated lipid nanoparticle\n(LNP)/mRNA platform, will be presented at the ASGCT 2026 Annual Meeting, being\nheld May 11-15 in Boston.\n\nThe abstract, titled “Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T\nCell Generation with Deep B-Cell Depletion,” highlights preclinical studies\nshowing B-cell depletion in blood and lymphoid tissues, including spleen, bone\nmarrow, and lymph nodes. Activity was confirmed in both humanized mouse and\nnon-human primate models.\n\nBy combining CD3 with CD28 costimulatory engagement, the technology enables\nefficient T-cell transfection, activation, and functional CAR-T cell\ngeneration directly in vivo. The antibody-conjugated LNP directs cell-specific\ngene delivery, and the mRNA nature of the platform, obviates the need for\npre-conditioning chemotherapy while allowing for repeat dosing, leading to\nexpansion and persistence of functional memory T-cell populations.\n\n“These data demonstrate the strength of our in vivo targeting technology,”\nsaid John Mascola, M.D., Chief Scientific Officer of ModeX Therapeutics.\n“Our antibody-conjugated LNP platform offers a simple and versatile approach\nto gene delivery for immune cells in vivo, and has the potential to simplify\ntreatment access by eliminating the burden of ex vivo manufacturing.”\n\n“Our targeted gene delivery platform uses proprietary ModeX technology to\ngenerate CAR-T cells directly in patients,” said Gary Nabel, M.D., Ph.D.,\nPresident and Chief Executive Officer of ModeX Therapeutics. “It offers a\npromising clinical modality for diverse diseases, including autoimmunity and\noncology.”\n\nOral Presentation Details\n* Title: Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T Cell Generation\nwith Deep B Cell Depletion\n* Abstract Number: 338\n* Meeting: ASGCT 2026 Annual Meeting\n* Date/Time: May 14, 2026 at 10:15 a.m. Eastern time\n* Location: Thomas M. Menino Convention Center, Boston\nAbout ModeX Therapeutics\n\nModeX Therapeutics is a clinical-stage biopharmaceutical company developing\ninnovative platforms for biologic delivery of therapies with multispecific\nbiologics for cancer, immunology, and infectious diseases. Its platforms unite\nthe power of multiple biologics in a single molecule to create multispecific\nantibody therapeutics designed to address complex diseases. The ModeX pipeline\nincludes first-in-class candidates for oncology indications against both solid\nand hematologic tumors, autoimmune and immunological diseases, and for\ninfectious disease indications against the most pressing viral threats. Its\nfounding team includes globally recognized medical innovators with proven\ntrack records of delivering breakthrough medicines for patients. ModeX\nTherapeutics Inc., an OPKO Health company (NASDAQ: OPK), is based in Weston,\nMassachusetts. For more information, visit www.modextx.com.\n\nAbout OPKO Health, Inc.\n\nOPKO is a multinational biopharmaceutical and diagnostics company that seeks\nto establish industry-leading positions in large, rapidly growing markets by\nleveraging its discovery, development and commercialization expertise, and\nnovel and proprietary technologies. For more information, visit www.opko.com.\n\nCautionary Statement Regarding Forward-Looking Statements\n\nThis press release contains \"forward-looking statements,\" as that term is\ndefined under the Private Securities Litigation Reform Act of 1995 (PSLRA),\nwhich statements may be identified by words such as \"expects,\" \"plans,\"\n\"projects,\" \"will,\" “could,” \"may,\" \"anticipates,\" \"believes,\" \"should,\"\n\"intends,\" \"estimates,\" and other words of similar meaning, including whether\nand when we will initiate and complete clinical studies contemplated for\nMDX3001 and whether final study data will be positive, whether in vivo\ngeneration of CAR-T cells and deep systemic B-cell depletion is reproducible\nin other models, whether MDX3001 will be safe, or have any impact on the\nseverity of disease, the platform’s applicability for other diseases, as\nwell as other non-historical statements about our expectations, beliefs or\nintentions regarding our business, technologies and products, financial\ncondition, strategies or prospects. Many factors could cause our actual\nactivities or results to differ materially from the activities and results\nanticipated in forward-looking statements. These factors include those\ndescribed in our Annual Reports on Form 10-K filed and to be filed with the\nSecurities and Exchange Commission and in our other filings with the\nSecurities and Exchange Commission that earlier clinical results of\neffectiveness and safety may not be reproducible or indicative of future\nresults, and that currently available over-the-counter and prescription\nproducts, as well as products under development by others, may prove to be as\nor more effective than our products for the indications being studied. In\naddition, forward-looking statements may also be adversely affected by general\nmarket factors, competitive product development, product availability, federal\nand state regulations and legislation, the regulatory process for new products\nand indications, manufacturing issues that may arise, patent positions and\nlitigation, among other factors. The forward-looking statements contained in\nthis press release speak only as of the date the statements were made, and we\ndo not undertake any obligation to update forward-looking statements. We\nintend that all forward-looking statements be subject to the safe-harbor\nprovisions of the PSLRA.\n\nContacts \n\nInvestors: \nAlliance Advisors IR\nYvonne Briggs, 310-691-7100\nybriggs@allianceadvisors.com\nor\nBruce Voss, 310-691-7100\nbvoss@allianceadvisors.com\n\nMedia:\nModeX Media Relations\nmedia@modextx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/ed68aecb-6753-42d8-8b52-a6ec3e054b34)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX3kxbDS","title":"OPKO Health’s ModeX Therapeutics Will Present Data Demonstrating In Vivo CAR-T Cell Generation and Deep B-Cell Depletion in Preclinical Studies","author":"Globe Newswire","ticker":"OPK","created":"2026-05-12T12:00:02.128Z","tickers":["OPK"],"exchange":"NASDAQ","article_body":"Multispecific antibody conjugated LNP/mRNA platform enables in vivo T-cell\nengineering and systemic B-cell depletion in animal models \n\nData will be presented at the American Society of Gene & Cell Therapy (ASGCT)\n2026 Annual Meeting\n\nWESTON, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an\nOPKO Health company (NASDAQ: OPK), will announce preclinical data\ndemonstrating the in vivo generation of CAR-T cells and deep systemic B-cell\ndepletion achieved with its MDX3001 candidate in animal models. The data,\ngenerated using ModeX’s CD3xCD28 antibody-conjugated lipid nanoparticle\n(LNP)/mRNA platform, will be presented at the ASGCT 2026 Annual Meeting, being\nheld May 11-15 in Boston.\n\nThe abstract, titled “Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T\nCell Generation with Deep B-Cell Depletion,” highlights preclinical studies\nshowing B-cell depletion in blood and lymphoid tissues, including spleen, bone\nmarrow, and lymph nodes. Activity was confirmed in both humanized mouse and\nnon-human primate models.\n\nBy combining CD3 with CD28 costimulatory engagement, the technology enables\nefficient T-cell transfection, activation, and functional CAR-T cell\ngeneration directly in vivo. The antibody-conjugated LNP directs cell-specific\ngene delivery, and the mRNA nature of the platform, obviates the need for\npre-conditioning chemotherapy while allowing for repeat dosing, leading to\nexpansion and persistence of functional memory T-cell populations.\n\n“These data demonstrate the strength of our in vivo targeting technology,”\nsaid John Mascola, M.D., Chief Scientific Officer of ModeX Therapeutics.\n“Our antibody-conjugated LNP platform offers a simple and versatile approach\nto gene delivery for immune cells in vivo, and has the potential to simplify\ntreatment access by eliminating the burden of ex vivo manufacturing.”\n\n“Our targeted gene delivery platform uses proprietary ModeX technology to\ngenerate CAR-T cells directly in patients,” said Gary Nabel, M.D., Ph.D.,\nPresident and Chief Executive Officer of ModeX Therapeutics. “It offers a\npromising clinical modality for diverse diseases, including autoimmunity and\noncology.”\n\nOral Presentation Details\n* Title: Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T Cell Generation\nwith Deep B Cell Depletion\n* Abstract Number: 338\n* Meeting: ASGCT 2026 Annual Meeting\n* Date/Time: May 14, 2026 at 10:15 a.m. Eastern time\n* Location: Thomas M. Menino Convention Center, Boston\nAbout ModeX Therapeutics\n\nModeX Therapeutics is a clinical-stage biopharmaceutical company developing\ninnovative platforms for biologic delivery of therapies with multispecific\nbiologics for cancer, immunology, and infectious diseases. Its platforms unite\nthe power of multiple biologics in a single molecule to create multispecific\nantibody therapeutics designed to address complex diseases. The ModeX pipeline\nincludes first-in-class candidates for oncology indications against both solid\nand hematologic tumors, autoimmune and immunological diseases, and for\ninfectious disease indications against the most pressing viral threats. Its\nfounding team includes globally recognized medical innovators with proven\ntrack records of delivering breakthrough medicines for patients. ModeX\nTherapeutics Inc., an OPKO Health company (NASDAQ: OPK), is based in Weston,\nMassachusetts. For more information, visit www.modextx.com.\n\nAbout OPKO Health, Inc.\n\nOPKO is a multinational biopharmaceutical and diagnostics company that seeks\nto establish industry-leading positions in large, rapidly growing markets by\nleveraging its discovery, development and commercialization expertise, and\nnovel and proprietary technologies. For more information, visit www.opko.com.\n\nCautionary Statement Regarding Forward-Looking Statements\n\nThis press release contains \"forward-looking statements,\" as that term is\ndefined under the Private Securities Litigation Reform Act of 1995 (PSLRA),\nwhich statements may be identified by words such as \"expects,\" \"plans,\"\n\"projects,\" \"will,\" “could,” \"may,\" \"anticipates,\" \"believes,\" \"should,\"\n\"intends,\" \"estimates,\" and other words of similar meaning, including whether\nand when we will initiate and complete clinical studies contemplated for\nMDX3001 and whether final study data will be positive, whether in vivo\ngeneration of CAR-T cells and deep systemic B-cell depletion is reproducible\nin other models, whether MDX3001 will be safe, or have any impact on the\nseverity of disease, the platform’s applicability for other diseases, as\nwell as other non-historical statements about our expectations, beliefs or\nintentions regarding our business, technologies and products, financial\ncondition, strategies or prospects. Many factors could cause our actual\nactivities or results to differ materially from the activities and results\nanticipated in forward-looking statements. These factors include those\ndescribed in our Annual Reports on Form 10-K filed and to be filed with the\nSecurities and Exchange Commission and in our other filings with the\nSecurities and Exchange Commission that earlier clinical results of\neffectiveness and safety may not be reproducible or indicative of future\nresults, and that currently available over-the-counter and prescription\nproducts, as well as products under development by others, may prove to be as\nor more effective than our products for the indications being studied. In\naddition, forward-looking statements may also be adversely affected by general\nmarket factors, competitive product development, product availability, federal\nand state regulations and legislation, the regulatory process for new products\nand indications, manufacturing issues that may arise, patent positions and\nlitigation, among other factors. The forward-looking statements contained in\nthis press release speak only as of the date the statements were made, and we\ndo not undertake any obligation to update forward-looking statements. We\nintend that all forward-looking statements be subject to the safe-harbor\nprovisions of the PSLRA.\n\nContacts \n\nInvestors: \nAlliance Advisors IR\nYvonne Briggs, 310-691-7100\nybriggs@allianceadvisors.com\nor\nBruce Voss, 310-691-7100\nbvoss@allianceadvisors.com\n\nMedia:\nModeX Media Relations\nmedia@modextx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/ed68aecb-6753-42d8-8b52-a6ec3e054b34)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-12T12:00:02.471292842Z","server_sent_at_ms":1778587202471},"received_at":"2026-05-12T12:00:02.695Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}