Bicycle Therapeutics has started dosing of patients in a Phase I/IIa trial designed to examine BT1718 to treat patients with advanced solid tumours.
The trial expects to enrol 120 patients and will study the safety and preliminary efficacy of BT1718 in patients with high expression of membrane type 1 (MT1) tumour, as measured by a proprietary MT1 immunochemistry assay.
After completing a rapid dose escalation phase, the trial is expected to evaluate two schedules of BT1718.
Bicycle Therapeutics chief medical officer Maria Koehler said: “BT1718 is the first clinical candidate from our pipeline of Bicycles, a brand-new class of chemically synthesised medicines.
“We believe that Bicycles, because of their small size and exquisite selectivity, could provide meaningful efficacy to patients suffering from cancer and avoid the toxicities associated with other classes of highly potent anti-cancer drugs.”
Bicycle Therapeutics and Cancer Research UK are co-managing the Phase I/IIa trial.
As part of the agreement, Bicycle retains the right to further advance the BT1718 programme, which undisclosed payment split between cash and equity, success-based milestones and royalty payments would be made to Cancer Research UK.
Cancer Research UK drug development director Dr Nigel Blackburn said: “We urgently need new, safe and effective therapies for patients with hard to treat cancers such as non-small cell lung cancer and triple negative breast cancer that this drug will tested on. Supporting this type of innovative clinical research is a key priority for Cancer Research UK.”
Cancer Research UK’s Centre for Drug Development (CDD) is sponsoring the trial.
BT1718 is a Bicycle Toxin Conjugate that targets membrane type 1 matrix metalloproteinase (MT1-MMP/MMP-14), which has been reported to be highly found in solid tumours.