PankoMab-GEX™ is a potent humanised and glycoengineered antibody that recognises the novel tumor-specific epitope, TA-MUC1, which is virtually absent on normal cells and is expressed in the majority of solid cancer indications and patients.
PankoMab-GEXTM clearly demonstrates clinical activity as single-agent in heavily pre-treated progressive patients, with far advanced cancers, and can be safely administered at all tested doses and schedules, with a very favourable 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 tumors, 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-tumor 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 continual 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% tumor 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-GEXTM, showed in 4 of 7 patients a clinical benefit, including one partial responder.
PankoMab-GEX™ showed a very favourable 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, due to 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 promises efficacy results in heavily pre-treated cancer patients already, as a single-agent. Due to 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."