▎ WuXi AppTec content team editor
Bicycle Therapeutics today presented the results of its latest clinical trial of its bicyclic peptide-based therapy BT8009, at its annual AACR meeting. BT8009 is the company's second-generation bicyclic peptide-coupled toxin that targets Nectin-4. The trial results showed that the confirmed overall response rate reached 50% in the cohort of patients with urinary intestinal carcinoma treated with BT8009 at a dose of 5.0 mg/m2 per week.
The bicyclic peptide technique introduces chemical modifications into the polypeptides so that they form a fixed three-dimensional molecular conformation. Bicyclic peptide molecules combine the characteristics of antibodies, small molecule drugs and peptides, with similar affinity and specificity to antibodies; at the same time, they have a small molecular weight and can penetrate tissues quickly and deeply; their peptide properties provide a regulatable pharmacokinetic half-life and renal clearance pathway, avoiding liver and gastrointestinal toxicity common in other drug forms.
▲Comparison of the characteristics of bicyclic peptides with small molecules and antibodies (Image source: Bicycle Therapeutics official website)
In this clinical trial, an average of 3 patients with solid tumors who had undergone pre-treatment received different doses of BT8009, of which 49% were patients with urothelial cancer. The trial results showed that in 8 patients with urothelial carcinoma who received BT8009 at a dose of 5.0 mg/m2 per week, 4 patients achieved confirmed remission, and one of them achieved a complete response. Two other patients had stable diseases and a disease control rate of 75%. As of March 7 this year, the median duration of remission had not been reached, and the remission was still maintained in 3 patients who had been treated for at least 24 weeks.
▲BT8009 trial data for the treatment of patients with urinary urothelial cancer (5.0 mg/m2 per week, image source: Bicycle Therapeutics official website)
In terms of safety, no dose-limiting toxicity was found in the 2.5 mg/m2 or 5.0 mg/m2 dose groups. The risk of skin and eye toxicity, neuropathy and hyperglycemia is low. Neutropenia develops in 30% of patients treated with BT8009.
"We believe that the differentiated pharmacokinetic profile of the bicyclic peptide-coupled toxin has the potential to lead to better outcomes for patients," said Dr. Kevin Lee, CEO of Bicycle, "and we look forward to providing more updates to the BT8009 this year and updates to our extensive bicyclic peptide oncology pipeline." ”
Resources:
[1] Bicycle Therapeutics to Present Interim BT8009 Phase I Clinical Trial Results at the 2022 AACR Annual Meeting. Retrieved April 9, 2022, from https://investors.bicycletherapeutics.com/news-releases/news-release-details/bicycle-therapeutics-present-interim-bt8009-phase-i-clinical
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