ITI-3000 / HLB Bio Group - LARVOL DELTA

Immunomic Therapeutics Reports Positive Results from Its Phase 1 Clinical Trial of ITI-3000 in Patients Diagnosed with Merkel Cell Carcinoma (Businesswire) - "Immunomic Therapeutics, Inc...announced safety and tolerability results from its phase 1 clinical trial evaluating ITI-3000, a plasmid DNA (pDNA) vaccine, targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV)....'As we expected, ITI-3000 proved to be safe and well tolerated in the study, with no dose-limiting toxicities, no reported treatment-related adverse events or serious adverse reactions. As we are encouraged by the immunological responses in patients, we look forward to continuing the development of ITI-3000'."

P1 data • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

LAMP1 targeting of the large T antigen of Merkel cell polyomavirus results in potent CD4 T cell responses and tumor inhibition. (PubMed, Front Immunol) - P1 | "These findings strongly suggest that in pre-clinical studies, DNA vaccination with ITI-3000, using the UNITE™ platform, enhances CD4 T cell responses to MCPyV-LT that result in significant anti-tumor immune responses. These data support the initiation of a first-in-human (FIH) Phase 1 open-label study to evaluate the safety, tolerability, and immunogenicity of ITI-3000 in patients with polyomavirus-positive MCC (NCT05422781)."

IO biomarker • Journal • Genetic Disorders • Infectious Disease • Melanoma • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • CD4 • CD8 • IFNG • LAMP1

Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC) (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Immunomic Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

PharmaJet Partner Immunomic Therapeutics Receives FDA Fast Track Designation for pDNA Vaccine for Skin Cancer (Businesswire) - "PharmaJet®...today announced that their partner Immunomic Therapeutics received FDA fast track designation (FTD) for the clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer. Enrollment is in progress for the phase 1 study that exclusively uses the PharmaJet Stratis Needle-free Injection System (NFIS)....We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year and look forward to working closely with the FDA on a potential next phase clinical study design, while simultaneously continuing dialogue with possible partners."

Fast track designation • P1 data • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor

Immunomic Therapeutics Receives FDA Fast Track Designation for ITI-3000, a pDNA Vaccine, in Development for the Treatment of Merkel Cell Carcinoma (Businesswire) - "Immunomic Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the ITI-3000 program for the treatment of patients with Merkel cell carcinoma. The company is currently enrolling a phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV)...'We expect to report top-line data from our ongoing phase 1 trial of ITI-3000 in MCC patients next year'..."

Enrollment status • Fast track designation • P1 data • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor

HLB’s U.S subsidiary scores FDA fast track designation for Merkel cell cancer vaccine (Korea Biomedical Review) - "HLB said on Friday that the anticancer vaccine candidate ITI-3000 aiming to treat Merkel cell cancer (MCC) via its U.S. subsidiary Immunomic Therapeutics has received fast track designation by the FDA. ITI-3000 is an anticancer vaccine made by combining lysosomal-associated membrane protein 1 (LAMP1) with the large T antigen of the polyomavirus based on the vaccine platform, UNITE."

Fast track designation • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma (Businesswire) - P1 | N=8 | NCT05422781 | Sponsor: Immunomic Therapeutics | "The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and is being led by Drs. Paul Nghiem...."

P1 data

Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma (Businesswire) - "Immunomic Therapeutics...announced dosing of the first patient in the company’s Phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington....The eight-patient, open label, first-in-humans (FIH) study is designed to evaluate the safety, tolerability, and immunogenicity of 4 mg of ITI-3000 in patients with MCC who have undergone surgery."

Trial status • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC) (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Immunomic Therapeutics, Inc.

New P1 trial • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Solid Tumor

LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses, tumor inhibition, and provides rationale for first-in-human trial (AACR 2022) - "In pre-clinical studies, vaccination with LTS220A-UNITETM (ITI-3000) induced antigen-specific CD4+ T cells that were sufficient to delay tumor growth, and this effect was dependent on their ability to produce IFNγ...The primary objectives will be safety and tolerability, observing dose-limiting toxicities, serious adverse events, standard clinical assessments, and safety laboratory parameters. Immunogenicity of the vaccine will be measured by peripheral blood assessments of T cell activation using ELISpot and flow cytometry assays."

P1 data • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • CD4 • CD8 • IFNG • LAMP1

Immunomic Therapeutics Reports Preclinical Data on Its MCPγV-LT and Her2/Neu DNA Vaccines at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Businesswire) - "Immunomic Therapeutics...announced today that the data from two posters are being presented at the American Association for Cancer Research (AACR) Annual Meeting 2022 held in New Orleans, Louisiana, from April 8-13....Vaccination with LTS220A-UNITE (ITI-3000) induced antigen-specific CD4 Th1 cells that was associated with delayed tumor growth and enhanced survival in treated mice in both the prophylactic and therapeutic settings. This effect was dependent on the CD4 T cells ability to produce IFNγ (interferon gamma), suggesting the potential mechanism of action of ITI-3000."

Preclinical • Merkel Cell Carcinoma • Oncology • Solid Tumor

Immunomic Therapeutics Announces Two Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Businesswire) - "Immunomic Therapeutics...announced today that the company will be presenting two posters at the American Association for Cancer Research (AACR) Annual Meeting 2022 being held in New Orleans, Louisiana, from April 8-13. The posters to be presented at AACR are developed from the investigational nucleic acid platform, UNITE™ (UNiversal Intracellular Targeted Expression) for two vaccines, ITI-3000 for Merkel cell carcinoma and Her2/Neu-LAMP DNA vaccine, both which fuse a tumor associated antigen with lysosomal associated membrane protein 1 (LAMP-1)."

Preclinical • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer

PharmaJet Partner Immunomic Therapeutics Initiates Clinical Trial of DNA Vaccine for Skin Cancer (Businesswire) - "PharmaJet...announced that its partner Immunomic Therapeutics will be starting a phase 1 clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer. The study will be conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Research Center in Seattle, Washington and will exclusively use the Stratis Needle-free injection System for delivery of the vaccine....'This therapeutic vaccine trial is the first of its kind in the world and may help address the fact that MCC recurs in 40% of cases after initial treatment, but no adjuvant therapy is approved for these patients,' noted Dr. Paul Nghiem..."

Media quote

PharmaJet Partner Immunomic Therapeutics Initiates Clinical Trial of DNA Vaccine for Skin Cancer (Businesswire) - "PharmaJet...announced that its partner Immunomic Therapeutics will be starting a phase 1 clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer. The study will be conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Research Center in Seattle, Washington and will exclusively use the Stratis® Needle-free injection System for delivery of the vaccine."

New P1 trial • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Immunomic Therapeutics Announces Clinical Trial of ITI-3000 for the Treatment of Merkel Cell Carcinoma (Businesswire) - "Immunomic Therapeutics, Inc...today announced its first Phase 1 clinical study evaluating ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV)....'This therapeutic vaccine trial is the first of its kind in the world and may help address the fact that MCC recurs in 40% of cases after initial treatment, but no adjuvant therapy is approved for these patients,' noted Dr. Paul Nghiem...."

Media quote • Trial status

Immunomic Therapeutics Announces Clinical Trial of ITI-3000 for the Treatment of Merkel Cell Carcinoma (Businesswire) - "Immunomic Therapeutics, Inc...announced its first Phase 1 clinical study evaluating ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). The single-center study will be conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and will be led by Drs. Paul Nghiem, Song Park and David Koelle."

Trial status • Merkel Cell Carcinoma • Oncology • Skin Cancer

Immunomic Therapeutics scores FDA approval to conduct P1 study of Merkel cell carcinoma treatment (Korea Biomedical Review) - "Immunomic Therapeutics, a subsidiary of HLB, said it has received U.S. Food and Drug Administration’s approval to conduct the phase 1 clinical trial of ITI-3000, a Merkel cell carcinoma treatment. ITI-3000 is an anticancer vaccine made by combining LAMP1 (lysosomal-associated membrane protein) with the large T antigen of polyomavirus based on Immunomic's cell therapy vaccine platform UNITE."

IND • New P1 trial • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

[VIRTUAL] LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses and prevents tumor growth (SITC 2020) - "Additionally, ITI-3000 synergized with PD-1 blockade, further reducing tumor burden and enhancing survival in mice receiving combination therapy. Conclusions We find that DNA vaccination with ITI-3000 using the UNITE platform enhances CD4+ T cell responses to MCPyV-LT and results in anti-tumor immune responses in a mouse model of Merkel cell carcinoma."

IO Biomarker • Late-breaking abstract • Merkel Cell Carcinoma • Neuroendocrine Tumor • Oncology • Skin Cancer • Solid Tumor • CD8 • IFNG • IL1B • IL2 • TNFA

[VIRTUAL] LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses and prevents tumor growth (SITC 2020) - "Additionally, ITI-3000 synergized with PD-1 blockade, further reducing tumor burden and enhancing survival in mice receiving combination therapy. Conclusions We find that DNA vaccination with ITI-3000 using the UNITE platform enhances CD4+ T cell responses to MCPyV-LT and results in anti-tumor immune responses in a mouse model of Merkel cell carcinoma."

IO Biomarker • Late-breaking abstract • Merkel Cell Carcinoma • Neuroendocrine Tumor • Oncology • Skin Cancer • Solid Tumor • CD8 • IFNG • IL1B • IL2 • TNFA

Immunomic Therapeutics to Present at The Society for Immunotherapy of Cancer’s (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (Businesswire) - "Immunomic Therapeutics, Inc. will present preclinical data on its investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression), that elicits potent immune responses when used with its investigational UNITE vaccine, ITI-3000, in mice. UNITE fuses a tumor-associated antigen, here a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV), with lysosomal-associated membrane protein 1 (LAMP1). This lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response, as ITI-3000 activated antigen-specific CD4+ T cells in vivo."

Preclinical • Merkel Cell Carcinoma • Oncology