ONM-501 / OncoNano Medicine - LARVOL DELTA

Results from Part 1 of ON-5001: a multi-center, dose escalation and dose finding Phase 1 trial of ONM-501, a dual-acting STING agonist, alone or in combination with cemiplimab in patients with solid tumors and lymphoma (AACR-NCI-EORTC 2025) - "ONM-501 can be safely administered both as monotherapy and in combination with cemiplimab. Early results suggest enhanced efficacy in advanced cutaneous malignancies, particularly in patients with SCC. Part 2 of this study is open to accrual in patients with advanced basal cell carcinoma (BCC), cSCC, and melanoma."

Clinical • Combination therapy • Late-breaking abstract • P1 data • Basal Cell Carcinoma • Eye Cancer • Hematological Malignancies • Lymphoma • Melanoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • Uveal Melanoma • STING

OncoNano Medicine, Inc…announced encouraging first-in-human results from Part 1 of its Phase 1 ON-5001 trial evaluating ONM-501, a dual-acting STING agonist, as monotherapy and in combination with Libtayo (cemiplimab), Regeneron’s PD-1 inhibitor, in patients with advanced solid tumors and lymphomas. (FinancialContent) - "ONM-501 was well tolerated and demonstrated early signs of clinical benefit. Among 39 patients treated (15 with ONM-501 monotherapy and 24 in combination with cemiplimab), no dose-limiting toxicities were observed, and the most common adverse events were mild fatigue and injection-site reactions. Systemic interferon-γ levels remained within normal limits across all cohorts...Part 2 of the ON-5001 study (NCT06022029) is now open and enrolling patients with advanced basal cell carcinoma, cutaneous squamous cell carcinoma and melanoma."

P1 data • Trial status • Basal Cell Carcinoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Melanoma • Squamous Cell Skin Cancer • Triple Negative Breast Cancer

OncoNano Medicine Announces Presentation at AACR-NIC-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Businesswire) - "Presentation Details - Title: Results from part-1 of ON-5001: a multi-center, dose escalation and dose finding Phase 1 trial of ONM-501, a dual-acting STING agonist, alone or in combination with cemiplimab in patients with solid tumors and lymphoma."

P1 data • Lymphoma • Solid Tumor

A phase 1 dose-escalation and expansion study of an intratumorally administered dual STING agonist (ONM-501) alone and in combination with cemiplimab in patients with advanced solid tumors and lymphomas. (ASCO 2024) - P1 | " ONM5001 (NCT06022029) is a first-in-human, open-label, multi-center clinical trial. Secondary endpoints include characterization of pharmacokinetics and pharmacodynamics, as well as initial efficacy based on RECIST evaluation criteria. Enrollment began in November 2023."

Clinical • Combination therapy • Metastases • P1 data • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • STING

OncoNano Medicine To Present a Trials in Progress Poster for ON-5001 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) - "OncoNano Medicine...announced that it will present a Trials in Progress poster at the upcoming 2024 American Society for Clinical Oncology (ASCO) Annual Meeting....The poster will highlight the study objectives and design of the ongoing ON-5001 study, a phase 1/1b, multicenter, open label, non-randomized dose escalation and dose expansion to examine the safety, tolerability and optimal dosing of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist, as a monotherapy and in combination with cemiplimab (Libtayo) in patients with advanced solid tumors and lymphomas (NCT06022029)."

Trial status • Lymphoma • Solid Tumor

OncoNano Medicine Announces First Patient Dosed in Phase 1 Study Evaluating ONM-501 in Patients with Advanced Solid Tumors and Lymphomas (Businesswire) - "OncoNano Medicine...announced that the first patient has been dosed at University of Pittsburgh Medical Center (UPMC) in its Phase 1 clinical trial evaluating ONM-501, a dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications formulated with OMNI, the company’s core immune activating polymer technology. The ONM-501 trial (NCT06022029) is a multicenter Phase 1, dose escalation and dose expansion study in patients with advanced solid tumors and lymphomas."

Trial status • Lymphoma • Solid Tumor

ON-5001: 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. (clinicaltrials.gov) - P1 | N=168 | Recruiting | Sponsor: OncoNano Medicine, Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Bladder Cancer • Breast Cancer • Cervical Cancer • Diffuse Large B Cell Lymphoma • Eye Cancer • Follicular Lymphoma • Genetic Disorders • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma • CD4

OncoNano and Regeneron Enter into Clinical Trial Supply Agreement for Use of Libtayo (cemiplimab) in ONM-501 Study (Businesswire) - "OncoNano Medicine, Inc. today announced a clinical trial supply agreement with Regeneron for the use of Libtayo^® (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate. The ONM-501 first-in-human trial (NCT06022029) is a multicenter Phase 1a/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab."

Licensing / partnership • Bladder Cancer • Breast Cancer • Eye Cancer • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Ocular Melanoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma

ON-5001: 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. (clinicaltrials.gov) - P1 | N=168 | Not yet recruiting | Sponsor: OncoNano Medicine, Inc.

Combination therapy • Metastases • New P1 trial • Bladder Cancer • Breast Cancer • Cervical Cancer • Diffuse Large B Cell Lymphoma • Eye Cancer • Follicular Lymphoma • Genetic Disorders • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Uveal Melanoma • CD4

ONM-501, a dual-activating polyvalent STING agonist, enhances tumor retention and demonstrates favorable preclinical safety profile (AACR 2023) - "Systemic exposure to ONM-501 was lower after IT than SC administration, which is consistent with increased ONM-501 retention in tumors. Combined with preclinical toxicology studies, ONM-501 showed a favorable pharmacokinetic, tolerability and safety profile that support its continued development in cancer patients."

Late-breaking abstract • Preclinical • Oncology • STING

OncoNano Presents Compelling Data for ONM-501 and a Novel Tumor Specific Delivery Technology at AACR Annual Meeting 2023 (Businesswire) - "OncoNano Medicine, Inc. presented three posters at the American Association for Cancer Research (AACR) Annual Meeting 2023. The posters detail positive nonclinical data for ONM-501, the Company’s dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate, formulated with the company’s OMNI™ polymer technology as well as positive data for encapsulated bispecific antibody and cytokine using ON-BOARD™ tumor specific delivery technology....In vivo pharmacodynamic (PD) analysis confirmed STING activation, enhanced tumor lymphocyte infiltration, and tumor PD-L1 upregulation by ONM-501 and demonstrated the target-engagement activity of ONM-501 in multiple species."

Preclinical • Oncology • Solid Tumor

OncoNano Medicine to Present at the American Association for Cancer Research (AACR) Annual Meeting 2023 (Businesswire) - "OncoNano Medicine, Inc. today announced three poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19, 2023 at the Orange County Convention Center, Orlando, Florida."

Preclinical • Oncology • Solid Tumor

ONM-501, a polyvalent STING agonist, exhibits anti-tumor efficacy with increased tumor T-cell infiltration in mice and is well tolerated in rats and non-human primates (SITC 2022) - "Toxicology studies in rats and primates demonstrated a strong safety profile and large therapeutic window. The novel dual STING agonist ONM-501 is a promising therapeutic candidate for clinical evaluation in solid tumors."

IO biomarker • Preclinical • Oncology • Solid Tumor • CXCL10 • IFNB1 • IRF7

OncoNano Medicine Announces Pre-Clinical Data for Dual-Activating STING agonist at the Society for Immunotherapy of Cancer (SITC) Annual Meeting (Businesswire) - "OncoNano Medicine...announced the presentation of data on its pre-clinical candidate ONM-501 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, Massachusetts. ONM-501, OncoNano’s lead therapeutic program in development, is a dual-activating STING (Stimulator of Interferon Genes) agonist advancing towards a first in human trial planned to be initiated in the first half of 2023....In vivo PD analysis confirmed STING activation, enhanced tumor lymphocyte infiltration, and tumor PD-L1 upregulation by ONM-501, and demonstrated the target-engagement activity of ONM-501 in multiple species, and high tolerability in rodents and non-human primates, making it a promising therapeutic candidate for clinical evaluation."

Preclinical • Oncology • Solid Tumor

OncoNano Medicine to Present Data on Novel Development Candidates at the Society for Immunology of Cancer (SITC) Annual Meeting (Businesswire) - "An oral and poster presentation by Dr. Qiang Feng detail new pre-clinical data for ONM-405, an IL-2-Fc construct formulated with OncoNano’s proprietary ON-BOARD™ polymeric-micelle delivery system....OncoNano will also present a poster detailing data from studies involving the use of the ON-BOARD™ platform for encapsulation and delivery of bispecific T cell engagers. In addition, a poster will feature new preclinical data of ONM-501, a novel dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications."

Preclinical • Oncology

OncoNano Medicine Announces Oral Presentation of Phase 2 Study Data at the World Molecular Imaging Congress 2022 (Businesswire) - "OncoNano Medicine, Inc. today announced a presentation of data from its ongoing Phase 2 study of pegsitacianine at the World Molecular Imaging Congress (WMIC), occurring September 27 – October 1, 2022. The presentation will be given during the Cancer: Innovations in Molecular Imaging session....ONM-501...is advancing towards a first in human trial in the first half of 2023."

New trial • P2 data • Oncology

ONM-501: A polyvalent STING agonist for oncology immunotherapy (AACR 2022) - "ONM-501 demonstrated marked anti-tumor efficacy in a panel of syngeneic tumor models. The anti-tumor effect was mediated by host STING and dependent on CD8+ T cells and DCs. These results support further evaluation of ONM-501 as a clinical candidate for the potential treatment of solid tumors."

IO biomarker • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • CXCL10 • IFNB1 • STING

OncoNano Medicine Announces Positive Preclinical Data for ONM-501 at AACR 2022 Annual Meeting (Businesswire) - "OncoNano Medicine...announced positive results from a preclinical study of ONM-501, a novel dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications. The data, presented at the American Association for Cancer Research (AACR) Annual Meeting 2022, demonstrate the efficacy and tolerability of ONM-501 in animal models for multiple tumor types....'We look forward to continuing our IND-enabling activities as we advance ONM-501 toward our first in human trial in early 2023'."

New trial • Preclinical • Oncology

OncoNano Medicine to Present at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Businesswire) - "OncoNano Medicine...announced two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2022, taking place April 8-13, 2022 in New Orleans, Louisiana."

Oncology

OncoNano Announces $18.4 Million Equity Investment by the Cancer Prevention and Research Institute of Texas (Businesswire) - "OncoNano Medicine, Inc. today announced that the Cancer Prevention and Research Institute of Texas (CPRIT) will convert $18.4 million in grant award funding into an equity investment in OncoNano. Proceeds of the financing will be used to support OncoNano’s Phase 3 clinical trials in the U.S. and Europe for pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first internal therapeutic development program, ONM-501, a novel immune-therapeutic formulated with the company’s core delivery technology. This conversion will close OncoNano’s Series B financing round with $68.4 million in total committed capital."

Commercial • Oncology • Solid Tumor

OncoNano Medicine Announces Positive Preclinical Data for ONM-501 at AACR Virtual Conference on Tumor Immunology and Immunotherapy (Businesswire) - "OncoNano Medicine...announced positive results from its preclinical study of ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications. The data, presented at The American Association for Cancer Research (AACR) Virtual Conference on Tumor Immunology and Immunotherapy, demonstrate strong efficacy in multiple tumor models....'We look forward to continuing our IND-enabling activities as we advance ONM-501 to first in human trials.'"

Preclinical • Oncology

OncoNano Medicine to Present at The American Association for Cancer Research Virtual Conference on Tumor Immunology and Immunotherapy (Businesswire) - “OncoNano Medicine, Inc....announced a poster presentation at The American Association for Cancer Research (AACR) Virtual Conference on Tumor Immunology and Immunotherapy to be held on October 5-6, 2021…. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023.”

Clinical data • New trial • Oncology

OncoNano Medicine Announces Expanded Research Collaboration With UT Southwestern Medical Center to Advance Development of New Cancer Therapies (Businesswire) - “OncoNano Medicine, Inc….announced a multi-year collaboration with The University of Texas Southwestern Medical Center (UTSW) to discover and conduct translational research of novel cancer therapeutics that leverage OncoNano’s core nanotechnology platform....OncoNano will have an exclusive option to license new technology arising from the research conducted under this agreement….ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications, is advancing toward a first in human study planned for early 2023.”

Licensing / partnership • New trial • Oncology

Study Reveals Compelling Data for a New Nanoparticle-based Immuno-Therapeutic to Treat Cancer (Businesswire) - "OncoNano Medicine, Inc. today announced that a research paper titled “Prolonged activation of innate immune pathways by a polyvalent STING agonist” published in Nature Biomedical Engineering shows that a pH-sensitive nanoparticle-based drug developed by Dr. Jinming Gao and team at the University of Texas Southwestern Medical Center (UTSW)...Preclinical studies showed that ONM‑501 used in combination with a checkpoint inhibitor produces an immune response effective in treating multiple cancer types."

Preclinical • Oncology