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OncoNano Medicine

HQ: Dallas, TX source · onconano.com ↗ · Southwest

Clinical Phase 2

OncoNano Medicine is a clinical-stage oncology company that uses its ON-BOARD™ nanotechnology platform: ultra pH-sensitive polymeric micelles that respond to tumor acidity to deliver anti-cancer payloads to the tumor microenvironment. ONM-501, a nanoparticle-based dual-activating STING agonist, is being tested in a Phase 1 trial as an intratumoral treatment, alone and with the PD-1 checkpoint inhibitor cemiplimab, in patients with advanced solid tumors and lymphomas. Pegsitacianine (ONM-100) is a pH-sensitive fluorescent nanoprobe for real-time surgical imaging of tumors; after a Phase 2 study in patients with peritoneal metastases undergoing cytoreductive surgery, the FDA granted it Breakthrough Therapy Designation. The company is also developing polymer drug conjugates (PDCs) and early assets, such as encapsulated IL-12, and has a research collaboration with Gilead. Source · checked Oct 19, 2026

Sources for this description (14)

Keywords: nanotechnology nanoparticle pH-sensitive ultra pH-sensitive polymeric micelle ON-BOARD platform tumor microenvironment tumor acidity tumor-targeted delivery drug delivery polymer drug conjugate nucleic acids small molecules biologics STING agonist immuno-oncology immunotherapy checkpoint inhibitor PD-1 cemiplimab intratumoral IL-12 bispecific T cell engager image-guided surgery fluorescence-guided surgery intraoperative imaging fluorescence imaging agent surgical imaging tumor imaging nanoprobe indocyanine green pegsitacianine ONM-100 ONM-501 ONM-412 ONM-421 MMAE breakthrough therapy designation peritoneal metastases cytoreductive surgery solid tumors lymphomas oncology cancer triple negative breast cancer Diffuse Large B Cell Lymphoma follicular lymphoma non-hodgkin lymphoma mantle cell lymphoma bladder cancer uveal melanoma cervical cancer carcinoma in situ head and neck squamous cell carcinoma skin cancer metastatic cancer tumor recurrence lung cancer tumor resection surgery peritoneal carcinomatosis breast cancer colorectal cancer prostate cancer ovarian cancer urothelial carcinoma non-small cell lung cancer fluorescent diagnostic agent

Location: Dallas, TX · source · Oct 15, 2026

Profile checked Oct 10, 2026

4Trials (company is sponsor)6NIH grants

Funding and NIH signals

Job counts as of Oct 18, 2026. All funding and NIH signals

Raises and deals from press releases

From the company’s own releases; this list is partial. All raises and deals

Timeline

  1. Partnership Partnership / licensing announced Jan 6, 2026. Source: company's own press page. source ↗
  2. Trial start Phase 1: A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas. source ↗
  3. Trial start Phase 2: A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies source ↗
  4. Trial start Phase 2: A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets source ↗
  5. Trial start Phase 2: A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer source ↗

Funding

Last 2 years.

Clinical trials (lead sponsor) 4

RecordTitlePhaseStatusStartPrimary completion
NCT06022029A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.Phase 1RecruitingOct 13, 2023Apr 30, 2026 (estimated)
NCT05048082A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung MalignanciesPhase 2CompletedApr 13, 2022Aug 31, 2022 (actual)
NCT04950166A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri MetsPhase 2CompletedNov 30, 2021Dec 29, 2022 (actual)
NCT03735680A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of CancerPhase 2CompletedAug 9, 2019Oct 14, 2021 (actual)

NIH awards 6

Annual award amounts. Total $1.8M.

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