Glycotope Reported Promising First-in-Man Data of Novel Glyco-Optimised Monoclonal Anti-TA-MUC1 Antibody PankoMab-GEX

Glycotope GmbH, a global leader in optimising the sugar chains (glycosylation) of biopharmaceuticals, has announced full details of its first-in-man Phase I trial for PankoMab-GEXTM at this year's European Cancer Congress (ECCO 17). PankoMab-GEX is a potent humanised and glycoengineered antibody with respect to its specificity and anti-tumour activity recognising the novel tumour-specific epitope TA-MUC1 expressed in the majority of solid cancer indications and patients and virtually absent on normal cells.

In conclusion, PankoMab-GEX clearly demonstrated clinical activity as single agent in heavily pretreated progressive patients with far advanced cancers and could be safely administered at all tested doses and schedules with a very favorable safety, side-effect and pharmacokinetic profile.

In the open label Phase I dose escalation study (3+3 design), 74 patients with TA-MUC1-positive advanced solid tumours, all progressing after standard treatments, were treated with various doses of PankoMab-GEX from 1 to 2200 mg with three dosing schedules (once every three weeks, once every two weeks and weekly). The primary objective of the study was to evaluate the safety and tolerability profile of this novel compound and to define the recommended Phase II dosing regimen. Secondary endpoints included pharmacokinetics, immunogenicity and object-tumour response.

Activity was seen over all dose levels, with a clinical benefit rate of 50% at dose levels of >= 600 mg (19/34). One complete response in ovarian cancer for 485 days and one partial response for 295 days in non-small cell lung cancer (NSCLC) were observed (RECIST 1.1). The other patients showed continuing sustained clinical benefit in various cancers with an average duration of >240 days and the longest duration of 25 months (patient with pseudomyxoma peritonei with >20% tumour reduction). In the subgroup of ovarian cancer patients the clinical benefit rate at dose levels of >= 600 mg was 60% (9/15) including one complete responder. Progressive ovarian cancer patients previously sensitive or resistant to their last platinum therapy, regardless of additional refractory treatments, showed clinical benefit in all platinum sensitive (5/5) and in most resistant (3/5) patients. One patient refractory to platinum (1/5) showed an extended clinical benefit. NSCLC patients, albeit only treated with lower doses of PankoMab-GEX, showed in four of seven patients a clinical benefit including one partial responder.

PankoMab-GEX showed a very favorable side-effect profile with mild to moderate adverse events, mainly infusion related reactions during the first infusion. No maximum tolerated dose was reached. As expected because its high specificity, pharmacokinetics were linear over all doses with a long half-life allowing administration schedules once every three weeks or shorter.

Steffen Goletz, CEO, CSO and Founder of Glycotope, commented: "We are very pleased with these data. PankoMab-GEX has shown an excellent safety profile at all dose levels and promising efficacy results in heavily pretreated cancer patients already as a single agent. Because of its high specificity and long duration of action, PankoMab-GEX is a highly attractive option for the future treatment of various solid tumors and will be further developed in Phase II trials."