Vincerx announces results from Phase 1 NIH-sponsored combo study of enitociclib

Vincerx Pharma announced clinical results from a Phase 1 NIH-sponsored study of enitociclib in combination with venetoclax and prednisone for the treatment of relapsed/refractory lymphoma. “Enitociclib continues to differentiate itself in the CDK9 inhibitor field,” said Ahmed Hamdy, Chief Executive Officer of Vincerx. “Enitociclib is well tolerated, making it ‘the partner of choice’ for novel combinations. We are pleased to see the high response rate and tolerability of enitociclib in combination with venetoclax and prednisone in patients with hard-to-treat types of non-Hodgkin’s lymphoma such as peripheral T-cell lymphoma and double-hit diffuse large B-cell lymphoma. Previous reports of venetoclax monotherapy in PTCL show low response rates; thus, we believe we are seeing compelling evidence for synergism between enitociclib and venetoclax in this patient population.” Hamdy continued, “In addition to the exciting results with enitociclib, VIP236 and VIP943, the lead drugs from our cutting-edge VersAptx platform, are rapidly progressing through dose-escalation studies. To date, 15 patients with relapsed/refractory advanced or metastatic solid tumors have been treated with VIP236, and we are observing a promising safety profile and preliminary evidence of clinical activity with once every 3-week dosing. Enrollment in the second cohort of the VIP943 trial is nearly complete. Preliminary pharmacokinetic results from the first cohort of our VIP943 antibody drug conjugate trial show very little free payload in circulation, consistent with the favorable safety profile observed to date. ADCs and bi-specifics have been limited by numerous safety and efficacy challenges, so the profile we are observing in these initial dose levels is exciting.”