ImmuneFx is a therapeutic vaccine candidate which expresses a bacterial antigen on the surface of a patient’s own tumor cells. IFx primes and educates the immune system to destroy tumor cells throughout the body without harming healthy cells and tissues.
ImmuneFx is a multi-indication cancer vaccine that effectively combines cell and gene therapy to mobilize multiple components of the innate and adaptive immune systems that target the entire antigenic repertoire of heterologous tumors by maximizing antigen presentation and inter-antigenic epitope spreading in a clinically relevant manner.
ImmuneFx is delivered by intratumoral injection. Once delivered into the cancer lesion, the bacterial antigen is expressed on the surface of the patient’s tumor cells. Once on the cell, IFx breaks tolerance to multiple tumor antigens through a phenomenon known as antigen presentation and inter-antigenic epitope spreading.
Clinical Trial NCT03655756: pDNA Intralesional Cancer Vaccine for Cutaneous Melanoma
- Six male and/or female adult patients (greater than or equal to 18 years old), of any ethnicity and race, with unresectable stage III or stage IV cutaneous melanoma with accessible lesions, will be eligible for enrollment and treatment with IFx-Hu2.0.
- To be eligible for this study, patients with unresectable metastatic disease must have failed, refused or been deemed not candidates for at least one form of systemic anti-PD-1-based immunotherapy as well as BRAF inhibition, if BRAF V600 mutated.
- Talimogene laherparepvec (IMLYGIC®) is indicated for local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Therefore, patients with unresectable cutaneous, subcutaneous, and nodal melanoma lesions recurrent after initial surgery must have failed, refused or been deemed not candidates for talimogene laherparepvec to be eligible for this study.
- Enrollees will receive IFx-Hu2.0 at a single time point. Depending on the number of accessible lesions, a patient could receive up to three doses across three lesions (one dose per lesion).
- Forty milliliters of peripheral blood will be collected from these patients prior to treatment administration and at the follow-up visit four weeks later.
- The target dose will be 100 μg of plasmid DNA per lesion injected at a final dose volume of 200 μL per lesion. To allow for the observation of any acute toxicity in the first subject enrolled and prevent any occurrence of excessive toxicities in subsequent subjects, the first subject enrolled will receive a single dose of IFx-Hu2.0. Subsequent subjects will be administered the product after at least seven days.
- Beyond the first subject, the maximum number of lesions to be injected at any given time point in the study phase proposed is three lesions.
- These samples will be used to perform complete blood counts (CBC) and clinical chemistry tests.
- A urine sample will be obtained for urinalysis for protein and blood at the same frequency.
- Blood samples will be drawn for immune response evaluation as well.
- At the end of the study period, a biopsy of the lesion injected and a non-injected lesion (if applicable) will be collected. If the patient has a response to therapy, the patient will have the option of continuing the study at three-week intervals so long as they have not progressed.
- Optional tumor biopsies and peripheral blood collections may be obtained on subsequent treatment cycles.