July/August 2023 • PharmaTimes Magazine • 6
// TREATMENTS //
FluoGuide – a company that concentrates on precision cancer surgery – has announce positive results from its phase 2a clinical trial of its FG001 candidate.
The treatment for use among patients with head and neck cancer demonstrated the ability to illuminate tumours in all of the participating individuals. Data showed that all 12 patients within the first two cohorts – who were undergoing surgery for head and neck squamous cell carcinomas (HNSCC) – had their tumours identified with FG001.
The data was also in line with the efficacy data in brain and lung cancers, thereby highlighting FG001’s potential for wider incorporation.
The treatment itself is a fluorophore targeting uPAR – a cancer-specific target expressed extensively in most solid cancers. The fluorophore has the same spectral specifications as the already-approved indocyanine green, meaning that FluoGuide’s candidate could be used on current imaging equipment.
FG001 is administered intravenously prior to surgery, lighting up the cancer during surgery. This assists the surgeon in removing all cancer while, critically, sparing healthy tissue.
Morten Albrechtsen, CEO at FluoGuide, reflected: “We are building up a broad data set showing FG001 is effective across a range of cancers and this – combined with its compatibility with different types of imaging equipment – means it has the potential to significantly improve the outcome of surgery for these patients, with tumours removed more precisely while leaving healthy tissue undamaged.”
A third cohort of four patients has been initiated on a low dose of FG001 in order to investigate a broader dose range. Further results from the FluoGuide’s ongoing research are also expected later this year.
Enterome – a company focused on immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases – has announced initial data from its pivotal phase 1/2 trial of EO2463.
The candidate is an experimental treatment for indolent non-Hodgkin B cell lymphoma (iNHL). Meanwhile, the results – presented at the International Conference on Malignant Lymphoma (ICML) – demonstrate that EO2463, as a monotherapy and in combination with the standard of care, is well tolerated. It also produces a strong immune response associated with early clinical activity.
The positive responses were observed following a six-week course of treatment with EO2463 as monotherapy. There was a preliminary response rate of 50% among evaluable patients for in combination with lenalidomide and rituximab.
The candidate is an off-the-shelf therapy that combines four synthetic OncoMimic peptides. These microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers, including CD20, CD22, CD37 and CD268.
The vital functionality of EO2463 to target multiple B cell markers allows the consequent destruction of malignant B lymphocytes that are abundant in iNHL.
Dr Jan Fagerberg, chief medical officer of Enterome, was encouraged by the initial data: “EO2463 was designed to expand pre-existing memory cytotoxic T cells recognising specific protein sequences from gut bacteria that cross-react with B cell specific proteins to drive targeted anti-tumour activity against B cell malignancies.”
He added: “We are very encouraged that EO2463 is showing promising efficacy with a good safety profile in indolent non-Hodgkin B cell lymphomas, confirming the validity of our approach and the ability of OncoMimics-based immunotherapies to target liquid tumours. We now look forward to continuing the trial with multiple expansion cohorts.”