OPKO Health’s ModeX Therapeutics Begins Clinical Trial of MDX2004 for the Treatment of Advanced Cancers
ModeX Therapeutics (NASDAQ: OPK) announced dosing of the first patient in a Phase 1/2a clinical trial (NCT07110584) of MDX2004, a first-in-class trispecific antibody-fusion protein designed as a T cell "rejuvenator."
MDX2004 engages CD3, CD28 and binds 4-1BB as a ligand to stimulate stem and memory T cells; the trial will evaluate safety, tolerability and biologic activity in advanced cancers. Two MDX2004 posters are scheduled at the SITC Annual Meeting, Nov 5-9, 2025.
ModeX Therapeutics (NASDAQ: OPK) ha annunciato la somministrazione del primo paziente in una sperimentazione di Fase 1/2a (NCT07110584) di MDX2004, una proteina fusione di anticorpo trispecifico di prima classe progettata come un ringiovanitore delle cellule T.
MDX2004 coinvolge CD3, CD28 e si lega a 4-1BB come ligando per stimolare le cellule T staminali e di memoria; lo studio valuterà sicurezza, tollerabilità e attività biologica in tumori avanzati. Due poster MDX2004 sono programmati per il SITC Annual Meeting, dal 5 al 9 novembre 2025.
ModeX Therapeutics (NASDAQ: OPK) anunció la dosificación del primer paciente en un ensayo clínico de Fase 1/2a (NCT07110584) de MDX2004, una proteína de fusión de anticuerpo trispecífica de primera clase diseñada como un rejuvenecedor de células T.
MDX2004 involucra CD3, CD28 y se une a 4-1BB como ligando para estimular células T madre y de memoria; el ensayo evaluará seguridad, tolerabilidad y actividad biológica en cánceres avanzados. Dos carteles de MDX2004 están programados para el SITC Annual Meeting, del 5 al 9 de noviembre de 2025.
ModeX Therapeutics (NASDAQ: OPK)는 MDX2004의 1/2a상(NCT07110584) 임상 시험에서 첫 환자 투여를 발표했습니다. 이는 T 세포를 “재생시켜주는” 기능으로 설계된 1등급의 trispecific 항체 융합 단백질입니다.
MDX2004는 CD3, CD28에 작용하며 리간드로서 4-1BB를 결합하여 줄기 및 기억 T 세포를 자극합니다. 이 시험은 진행된 암에서 안전성, 내약성 및 생물학적 활성을 평가할 예정입니다. MDX2004의 포스터 두 편이 SITC 연례 회의(2025년 11월 5-9일)에서 발표될 예정입니다.
ModeX Therapeutics (NASDAQ: OPK) a annoncé l'administration du premier patient dans un essai clinique de Phase 1/2a (NCT07110584) de MDX2004, une protéine de fusion d'anticorps trispecifice de première classe conçue comme un régénérateur des cellules T.
MDX2004 active CD3, CD28 et se lie à 4-1BB en tant que ligand pour stimuler les cellules T souches et mémoire; l'essai évaluera la sécurité, la tolérance et l'activité biologique chez des cancers avancés. Deux affiches MDX2004 sont prévues lors de la SITC Annual Meeting, du 5 au 9 novembre 2025.
ModeX Therapeutics (NASDAQ: OPK) gab die Verabreichung des ersten Patienten in einer Phase-1/2a-Studie (NCT07110584) von MDX2004 bekannt, einem First-in-Class Tri-spezifischen Antikörper-Fusionsprotein, das als T-Zell-Renovator konzipiert ist.
MDX2004 rekrutiert CD3, CD28 und bindet 4-1BB als Ligand, um Stamm- und Gedächtnis-T-Zellen zu stimulieren; die Studie wird Sicherheit, Verträglichkeit und biologische Aktivität bei fortgeschrittenen Krebsarten bewerten. Zwei MDX2004-Poster sind auf der SITC-Jahrestagung geplant, vom 5. bis 9. November 2025.
ModeX Therapeutics (NASDAQ: OPK) أعلنت عن إعطاء جرعة لأول مريض في تجربة سريرية من المرحلة 1/2a (NCT07110584) لـ MDX2004، وهو بروتين اندماج ثلاثي المنافذ من فئة الأول من نوعه مصمم كـ "منعش" لخلايا T.
MDX2004 يجذب CD3، CD28 ويتصل بـ 4-1BB كليغ لتحفيز خلايا T الجذعية والذاكرة؛ ستقيّم التجربة السلامة وتحمل الدواء والنشاط البيولوجي في الأورام المتقدمة. يوجد في SITC Annual Meeting، من 5 إلى 9 نوفمبر 2025.
ModeX Therapeutics（NASDAQ: OPK）宣布在 MDX2004 的 I/IIa 期临床试验（NCT07110584）中给第一位患者给药，这是一种同属第一类的三特异性抗体融合蛋白，设计为 T 细胞“复兴剂”。
MDX2004 作用于 CD3、CD28，并以 4-1BB 作为配体结合，以刺激干细胞和记忆 T 细胞；该试验将评估在晚期癌症中的安全性、耐受性和生物学活性。MDX2004 的两份海报计划在 SITC 年会（2025 年 11 月 5-9 日）发布。
- First patient dosed in Phase 1/2a trial (NCT07110584)
- MDX2004 is a trispecific molecule engaging CD3, CD28, 4-1BB ligand
- Two poster presentations at SITC Nov 5-9, 2025
- No human safety or efficacy results reported yet
- Clinical program remains early-stage with unknown regulatory timeline
Insights
First patient dosed in a Phase 1/2a trial of a trispecific T‑cell "rejuvenator" marks clinical entry for MDX2004.
ModeX Therapeutics initiated and dosed the first patient in a Phase 1/2a study (NCT07110584) of MDX2004, a trispecific antibody‑fusion that engages CD3, CD28 and 4‑1BB and is designed to stimulate stem and memory T cells to replenish cellular immunity. The program also has two poster presentations scheduled at SITC on
The business mechanism is straightforward: the molecule aims to activate multiple T‑cell signaling pathways concurrently to expand and sustain anti‑tumor immunity. The clinical readouts will primarily focus on safety, tolerability, and biologic activity in advanced cancers; dose escalations and early signals of immune activation will determine near‑term development choices. Key dependencies and risks include first‑in‑human safety profile, tolerability of multispecific T‑cell stimulation, and whether the intended engagement of 4‑1BB as a ligand (not via antibody binding) translates into clinically meaningful activity without excessive immune toxicity.
Concrete items to watch in the next 6–18 months: reported dose‑limiting toxicities and maximum tolerated dose from the Phase 1 portion, early pharmacodynamic evidence of stem/memory T‑cell recruitment or expansion, and the posters at SITC (
First patient dosed in Phase 1/2a study with novel immune rejuvenator, a trispecific antibody-fusion protein
Two MDX2004 abstracts accepted for poster presentation at SITC Annual Meeting 2025
WESTON, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), today announced the initiation and recent dosing of the first patient in a Phase 1/2a clinical trial (NCT07110584) with MDX2004, a first-in-class trispecific antibody-fusion protein for oncology and immune disorders. The study is designed to evaluate the safety, tolerability, and biologic activity of MDX2004 as an immunotherapy for advanced cancers.
MDX2004 is designed to stimulate T cells through three signaling pathways to enhance immune activation. This proprietary multispecific antibody engages CD3, CD28, and 4-1BB and is expected to activate T lymphocytes, including stem and memory T cells. Because stem T cells undergo self-renewal and give rise to mature T cells, the drug aims to recruit and replenish, or “rejuvenate,” cellular immunity. Unlike previous 4-1BB antibody therapies, recognition of 4-1BB by this molecule does not involve antibody binding because it binds as a ligand to the natural receptor.
“Patients with advanced solid tumors may have limited options with existing treatments, facing challenging disease control rates and low long-term survival,” said Giovanni Abbadessa, M.D., Ph.D., Chief Medical Officer of ModeX. “The MDX2004 multispecific antibody aims to rejuvenate T cells and sustain an expanded immune response in a broad range of tumors. We look forward to exploring further via this clinical trial.”
“We are excited to bring MDX2004 to patients as a first-in-class trispecific antibody with a unique design aiming for a specific mechanism of action. By stimulating and sustaining immune function, this T cell rejuvenator has potential to treat diverse cancers and reverse immune impairment caused by chemotherapy, chronic diseases, infection and aging,” said Phillip Frost, M.D., Chairman and CEO of OPKO Health and Gary Nabel, M.D., Ph.D., President and CEO of ModeX and Chief Innovation Officer of OPKO Health.
Preclinical proof-of-concept data as well as clinical dose selection analyses to support the MDX2004 development will be showcased in two poster presentations at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), National Harbor, MD, on November 5-9, 2025.
About MDX2004
MDX2004 is a novel trispecific antibody–fusion protein that targets CD3, CD28, and 4-1BB (CD137) on human T cells. It is designed to promote the expansion of stem and memory T cell populations, thereby rejuvenating immune function and enhancing anti-tumor immunity. This trifunctional approach aims to expand and sustain both stem and mature memory T cell subsets, which have been associated with favorable responses to immunotherapy. It may thus help restore immune function in subjects with underlying immune impairment from aging, chronic diseases such as diabetes, infections or chemotherapies.
Beyond bispecifics: ModeX Synergistic Targeting of Antibody Receptors (MSTAR)
Multispecific antibody therapeutics can help generate medicines of the future by targeting multiple disease pathways simultaneously. Many untreatable or complex conditions arise from multiple root causes; yet most medicines only act on a single target. ModeX overcomes these challenges by combining natural protein structures using a platform known as the ModeX Synergistic Targeting of Antibody Receptors (MSTAR) to create unique multispecific medicines. The platform generates multispecific antibodies from modular building blocks intended to modulate potency and maximize specificity to address multiple disease pathways simultaneously.
About ModeX Therapeutics
ModeX Therapeutics is a clinical-stage biopharmaceutical company developing innovative multispecific biologics for cancer and infectious disease. Its platforms unite the power of multiple biologics in a single molecule to create multispecific antibodies and vaccines with unprecedented versatility and potency in fighting complex disease. The ModeX pipeline includes candidates against both solid and hematologic tumors, as well as several of the world’s most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX, an OPKO Health company, is based in Weston, Mass. For more information, please visit www.modextx.com.
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," “could,” "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including whether and when we will initiate and complete the clinical studies contemplated for MDX2004 and whether final study data will be positive, whether data will support marketing approval, our ability to develop and commercialize MDX2004, whether MDX2004 is capable of effectively treating patients with certain cancers, whether MDX2004 will be safe, or have any impact on the severity of disease, expectations regarding the product, its efficacy, safety and market potential as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, the success of our relationship with our commercial partners, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, and that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Contacts:
Investors:
Alliance Advisors IR
Yvonne Briggs, 310-691-7100
ybriggs@allianceadvisors.com
or
Bruce Voss, 310-691-7100
bvoss@allianceadvisors.com
Media:
ModeX Media Relations
media@modextx.com
FAQ
What is MDX2004 and what targets does it engage in OPK's trial?
When was the first patient dosed in the MDX2004 Phase 1/2a trial (OPK)?
What is the goal of the MDX2004 Phase 1/2a study (NCT07110584)?
Will ModeX/OPK present data from MDX2004 at upcoming conferences?
How might MDX2004’s mechanism differ from prior 4-1BB antibodies?
