Germany-based Glycotope has started enrolment and treatment of first patients in its double-blind, randomised, placebo-controlled Phase IIb clinical trial of PankoMab-GEX for maintenance therapy of patients with ovarian cancer.
PankoMab-GEX is a human glycosylated and glycooptimised antibody (IgG1) recognising the company's new carbohydrate-induced conformational TA-MUC1 epitope expressed on the majority of tumour cells in several cancers.
The epitope includes a tumour-specific carbohydrate antigen together with the immunodominant peptide region of MUC1, combining high tumour-specificity, high number of binding sites and affinity.
It is abundantly present on a larger set of tumour indications, metastasis and cancer stem cells, and virtually absent on normal cells.
The Phase IIb trial is designed to assess the efficacy and safety of maintenance therapy with PankoMab-GEX.
Around 210 patients suffering from recurrent ovarian carcinoma and at least stable under current chemotherapy will be enrolled in the trial, which will be carried out at 41 sites in seven European countries and Russia.
The trial's primary endpoint is progression-free survival, while secondary endpoints include further efficacy data such as time to progression, objective response rate, clinical benefit rate and overall survival, as well as pharmacokinetic and safety data.
In a single agent Phase I trial in patients with progressive disease and with several indications including ovarian and lung carcinoma, PankoMab-GEX showed excellent tolerability, no significant toxicity and strong anti-tumour activity, the company said.
In the trial, patients with progressive ovarian cancer which were resistant or sensitive to their most recent platinum containing therapy and with no further treatment option showed in 80% of the cases clinical benefit with an average duration of over 210 days.
Glycotope founder, CSO and CEO Steffen Goletz said the start of the Phase IIb trial is an important milestone for the company, not only in the clinical development of PankoMab-GEX but also for our comprehensive pipeline of cancer specific GlycoBodies.
"The results PankoMab-GEX achieved already as single agent in a clinical Phase I trial in patients progressive at treatment start are very encouraging with significant tumour reduction, complete and partial responses with long-lasting disease stabilisation of up to 25 months and the virtual lack of relevant toxicities," Goletz added.
Major target indications of PankoMab-GEX include ovarian, lung, breast and gastrointestinal tumours, and other, mostly with over 90% of the patients and tumour cells.
PankoMab-GEX, the lead molecule of Glycotopes' GlycoBody technology, expresses a series of potent anti-tumour modes of action, including antibody-dependent cellular cytotoxicity (ADCC), tumour cell phagocytosis and apoptosis induction, strongly enhanced by glycooptimisation through the company's GlycoExpress platform.
Image: Intermediate magnification micrograph of a low malignant potential (LMP) mucinous ovarian tumour. Photo: courtesy of Nephron.