On December 17, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that the first patient has been dosed in the Company’s Phase 1 dose-escalation study of VIP152 in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or Richter Syndrome (RS) (Press release, Vincerx Pharma, DEC 17, 2021, View Source [SID1234597377]).
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"The dosing of the first patient in Vincerx’s Phase 1 dose-escalation study of VIP152 in R/R CLL or RS marks the initiation of the second Vincerx-sponsored clinical trial this year, less than one year after becoming a publicly-listed company," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "Our data recently disclosed through an oral presentation at ASH (Free ASH Whitepaper) demonstrated increased selectivity and potency of VIP152 when compared with other CDK9 inhibitors currently in development, leading to cytotoxic activity in primary CLL samples as well as improved survival in a mouse model of CLL. With this compelling preclinical proof-of-concept data in hand, we are focused on advancing VIP152 across challenging indications like R/R CLL and RS, where targeted CDK9 inhibition has the potential to bring meaningful patient benefit. We are continuing our momentum in the clinic and remain on-track to initiate Phase 2 studies of VIP152 in the second half of 2022."
The Phase 1 study will evaluate VIP152 in patients with relapsed/refractory CLL who have failed a Bruton tyrosine kinase inhibitor (BTKi) and venetoclax and in patients with RS who have relapsed after, or been refractory to, at least one prior line of therapy for DLBCL and have MYC overexpression/amplification/translocation. A dose-escalation arm will be performed in R/R CLL before enrolling 20 additional patients in each of the CLL and RS cohorts.
The Phase 1 dose-escalation in CLL and RS builds upon Vincerx’s ongoing first-in-human (FIH) study (NCT04978779) in patients with advanced cancer, which consists of two expansion arms. Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, patients with mantle cell lymphoma who have failed a BTKi, as well as patients with any other type of lymphoma characterized by a MYC aberration. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.