Tuesday, October 4, 2022

561.316.3330

Biotechnology News Magazine

Immunomic Therapeutics Announces Clinical Trial of ITI-3000 for the Treatment of Merkel Cell Carcinoma

Latest Posts

City of Hope to Accelerate Immunotherapy Research & Treatment Innovation with $15 Mil Gift from Ted Schwartz Family

Ted Schwartz, who is now cancer free, achieved complete remission at City of Hope in 2020 with the center's leading CAR T cell therapy after a 16-year battle with lymphoma, provided the gift to City of Hope to advance treatment options that offer better outcomes and quality of life for people living with cancer.

Neurocrine Biosciences Appoints Dr Ingrid Delaet as Chief Regulatory Officer

Prior to joining Neurocrine Biosciences, Dr Ingrid Delaet served as Senior Vice President, Regulatory Affairs at Intercept Pharmaceuticals, which she joined in 2016.

Astrea Bioseparations Introduces Nereus LentiHERO, a Fit-for-purpose Solution for Lentiviral Vector Purification

“We believe that AstreAdept will be a game-changer,” explained Astrea Bioseparations’ CEO Terry Pizzie. “Our approach was to rapidly develop and incorporate this material into the Nereus LentiHERO, a simple, fit-for-purpose device that radically transforms how lentivirus can be purified [in terms of speed, recovery, and efficiency].

At Pack Expo, Schreiner MediPharm to Debut Functional Labels Designed from More Sustainable Materials

Schreiner MediPharm advises he new label concepts are based on existing items in Schreiner MediPharm’s roster of functional labeling solutions.

Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein) -mediated nucleic acid-based immunotherapy, 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).

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.

The trial is a Phase 1, open label, First in Humans (FIH) study to evaluate the safety, tolerability and immunogenicity of 4 mg of ITI-3000 in patients with Merkel polyomavirus-positive Merkel cell carcinoma (MCC) patients who have undergone surgery. The study’s primary endpoints include Dose Limiting Toxicities (DLTs), Adverse Events/Serious Adverse Reactions, (AEs/SARs) standard clinical assessments and safety laboratory parameters.

ITI-3000 leverages the company’s investigational UNiversal Intracellular Targeted Expression (UNITE) platform, powered by LAMP, which fuses a mutated form of the large T antigen (LT) of Merkel cell polyomavirus (MCPγV) with LAMP1. This lysosomal targeting technology has been shown to result in enhanced antigen presentation and a balanced immune response, including, of note, ITI-3000 activated antigen-specific CD4+ T cells in vivo. The plasmid DNA vaccine will be administered utilizing PharmaJet’s well established Stratis® Needle-free Injection System that precisely targets delivery to the intramuscular tissue layer.

“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, co-lead of the clinical study, and Head of Dermatology at University of Washington.

“This Phase 1 clinical trial of ITI-3000 in MCC is an important milestone, as it expands the reach of our immuno-oncology program beyond our ongoing phase 2 study of ITI-1000 (Umitrelimorgene autodencel) in glioblastoma multiforme, to a second potential indication,” stated Dr. William Hearl, Chief Executive Officer of Immunomic Therapeutics, Inc. “Based on the strength of our UNITE platform and strong pre-clinical data generated, to date, we believe ITI-3000 has the potential to address the urgent unmet medical need for therapies to treat this aggressive form of skin cancer.”

The majority of MCCs are associated with MCPγV infection, making LT an attractive target for therapeutic cancer vaccines. MCPγV integrates into the host genome, resulting in expression of a truncated form of the viral LT in infected cells. While induction of tumor-reactive CD8+ T cells is a major goal of cancer therapy, CD4+ T cells provide essential support to CD8+ T cells by promoting their expression of cytotoxic effector molecules and increasing their proliferation and durability. Cytokines secreted by CD4+ T cells, such as IFNγ, can also exert desirable effects on the tumor microenvironment. Therefore, a cancer vaccine that promotes potent, antigen-specific CD4+ T cell responses to MCPγV-LT may drive robust anti-tumor immune responses.

Latest Posts

Learn More

spot_img

Subscribe

spot_img

Our Sister Publication

Medical Device News Magazine