Bicycle Therapeutics Announces Pipeline Progress Update
Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, today announced progress updates for its wholly owned, next-generation Bicycle Toxin Conjugates (BTCs) targeting oncological indications, as well as its novel, fully synthetic Bicycle tumor-targeted immune cell agonists (TICAs).
“We are excited to start 2021 by announcing clinical progress across our internal oncology pipeline, with both our next-generation Bicycle Toxin Conjugates (BTCs) and our Bicycle tumor-targeted immune cell agonists (TICAs), positioning us for multiple inflection points over the coming year,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “Our lead program, BT1718, remains on track in the Cancer Research UK sponsored Phase IIa trial, and notably, we have observed preliminary signs of anti-tumor activity in the Phase I monotherapy portion of our trial of BT5528, including one partial response and additional evidence of tumor reductions. We continue to make strong progress with BT8009 as we expect to begin recruiting at our first clinical site outside of the US shortly, and we are encouraged by its initial pharmacokinetic (PK) profile. In our immuno-oncology pipeline, we expect BT7480, for which preclinical data has indicated a potential unique anti-tumor killing mechanism, to enter the clinic this year, and we have identified new TICAs targeting natural killer (NK) cells, which we are moving into lead optimization. Overall, we are pleased with our progress as we pursue our goal of realizing the full potential of our disruptive Bicycle technology, and we look forward to providing additional updates on our oncology pipeline, as well as our partnered programs beyond oncology, throughout the year.”
BT1718, a potential first-in-class BTC targeting a key tumor antigen MT1-MMP, is progressing in the Phase IIa portion of the Cancer Research UK sponsored Phase I/IIa clinical trial in patients with advanced solid tumors
- Patient enrollment in the Phase IIa portion of the Phase I/IIa trial sponsored by Cancer Research UK’s Center for Drug Development remains ongoing and is proceeding according to schedule. In this Phase IIa portion of the trial, all patients are MT1-MMP-positive based on a prespecified tumor membrane H-score. To date, the percentage of patients determined to be MT1-MMP-positive at the pre-specified cutoff is consistent with previous translational research findings. Enrollment is ongoing at four clinical sites, with additional sites expected to begin enrolling patients during the first half of 2021. Patients are currently being enrolled into two solid tumor cohorts, one in squamous non-small cell lung cancer (NSCLC) and the other in an all-comers “basket” cohort. Depending on results from these first two cohorts, Cancer Research UK may initiate up to two additional cohorts.
In the Phase I portion of the Phase I/IIa trial, BT1718 was generally well-tolerated. As previously announced, based on the Phase I trial results, 20 mg/m2 of BT1718
administered once weekly was selected as the Phase IIa dose. This dose is within the efficacious dose range predicted by preclinical models, in which an equivalent dose level was associated with
complete responses. With once-weekly dosing, BT1718 appeared tolerable, with manageable adverse events. Though the primary objective of the Phase I portion of the BT1718 trial was evaluating
safety and tolerability in an unselected group of patients with advanced solid tumors, some signs of anti-tumor activity were observed: