Ph 1/2 Duravelo-3 trial for zelenectide in NECTIN4-amplified breast cancer and Duravelo-4 trial in NECTIN4-amplified NSCLC to be discontinued; trial design of Duravelo-2 trial to be changed
“We have successfully completed the dose selection portion of the Duravelo-2 trial and received regulatory alignment that the 6mg dose and schedule is optimal for zelenectide in mUC based on strong anti-tumor activity and its differentiated safety profile. We look forward to sharing these data at an upcoming scientific conference. Based on the regulatory feedback we have received, the existing Duravelo-2 trial design is no longer considered acceptable as an approval path for zelenectide in mUC. Preliminary discussions with regulatory agencies have outlined several potential paths for zelenectide’s approval in mUC. While we believe the strength of these data and the clear medical need justify continued development of zelenectide, we have reached the difficult decision to deprioritize this program for internal development at this time. We have initiated a process to convert our ongoing Duravelo-2 trial to a randomized Phase 2 study. Once we have these randomized Phase 2 data in hand, we will determine the most appropriate path for zelenectide,” said Bicycle Therapeutics CEO Kevin Lee, Ph.D. “We believe these data provide further validation of the ability of our Bicycle technology to deliver oncology therapeutics with a potentially improved benefit/risk profile compared to existing modalities. In view of this, we have decided to conduct a strategic reprioritization, which includes a proposed workforce reduction, to best position the company to focus our resources on our promising pipeline of next-generation therapeutics.”
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