Company Shifting Resources from Vecabrutinib to Development of PDK-1 Inhibitor SNS-510
SOUTH SAN FRANCISCO, Calif., June 23, 2020 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today announced that the Company will not advance its non-covalent BTK inhibitor vecabrutinib into the planned Phase 2 portion of the Phase 1b/2 trial in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies. The decision was made after assessing the totality of the data including the 500 mg cohort, the highest dose studied in the trial.
“Although vecabrutinib continues to exhibit an excellent safety profile, there is insufficient evidence of activity in BTK-inhibitor resistant B-cell malignancies to advance the drug into the planned Phase 2 portion of the trial. One partial remission was observed after 11 treatment cycles in a CLL patient treated in Cohort 5 (300 mg BID) and a number of patients treated across the dose range explored (25 mg to 500 mg BID) saw stable disease; however, no other remissions have been observed,” said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. “We will complete the Phase 1b and evaluate the best path forward for vecabrutinib. We are grateful for the patients and their families who participated in this trial, as well as the investigators and research staff at our trial sites.”
Mr. Misfeldt continued: “We are shifting our resources and development focus to our first-in-class PDK1 inhibitor SNS-510. SNS-510 inhibits PI3K-dependent and PIP3-independent pathways important in both solid and hematologic malignancies. We remain on track to file an IND by the end of 2020 and expect to present additional preclinical findings at a medical meeting in the second half of the year. We expect that our current cash resources are sufficient to fund the company into 2021.”