NEW YORK – Vincerx Pharma on Wednesday said it will begin a Phase Ib trial of its CDK9 inhibitor, VIP152, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) with Richter syndrome and diffuse large B cell lymphoma (DLBCL) in the second half of 2021.
The Palo Alto, California-based firm also said its investigational new drug (IND) application to begin the trial was cleared by the US Food and Drug Administration on Wednesday.
The dose-escalation trial will enroll CLL patients who have been previously treated with a Bruton tyrosine kinase inhibitor and venetoclax. The first stage of the study will focus on these previously treated patients with a planned expansion for patients with CLL and Richter syndrome that caused their disease to become DLBCL, who have relapsed after treatment and who have MYC overexpression, amplification, or translocation.
This trial builds on another study of VIP152 that is evaluating the drug in MYC-driven hematologic malignancies and solid tumors. That trial is expected to begin dosing patients in Q2 of 2021, said Vincerx CEO Ahmed Hamdy.
"The IND clearance for VIP152 in CLL is an important milestone for Vincerx, marking our first IND clearance and now second clinical program for what we believe is the most selective CDK9 inhibitor in clinical development," Hamdy said in a statement. "Preclinical data for VIP152 show highly selective, ATP-independent, inhibition of CDK9 which translates to robust on-target activity across key gene targets. Most importantly, we believe this differentiated profile leads to encouraging early clinical activity, with demonstrated durable single-agent activity in hematologic malignancies and heavily pretreated solid tumors."
Vincerx launched last fall under the name Vincera Pharma and in-licensed VIP152 and six preclinical assets focused on cancer from Bayer. The company also merged with LifeSci Acquisition Corp. and went public through the special purpose acquisition company in December.