Vincerx Shares Promising Early Results from VIP943 Cancer Treatment Study

Vincerx Pharma, Inc., a biopharmaceutical company developing advanced cancer treatments addressing the unmet needs of the patient’s, today announced early positive results of its ongoing Phase 1 trial of VIP943, a next-generation antibody-drug conjugate (ADC) targeting relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and B-cell acute lymphoblastic leukemia (B-ALL). 

Two patients achieved complete responses — one with AML showing incomplete hematologic improvement and another with HR-MDS showing limited count recovery. The trial has enrolled 22 patients, with no dose-limiting toxicities observed, and serious adverse events have aligned with expectations for this difficult-to-treat population. VIP943 demonstrated promising target engagement and a favorable pharmacokinetic profile, leading to ongoing investigations into different dosing schedules. 

Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx, stated “We are excited by the emerging data from our Phase 1 study of VIP943, showing clinical responses in difficult-to-treat patients. We believe these promising clinical responses highlight the potential of VIP943 as a best-in-class therapy for CD123+ hematologic malignancies and validate our VersAptx platform’s ability to create safer, more effective bioconjugates by overcoming the challenges of historical ADCs.”

Dr. Hamdy further continued, “Our initial clinical results demonstrate that VersAptx is a next-generation platform that overcomes key challenges associated with traditional ADCs. The PK profile shows that our linker is stable, cleaving exclusively inside cells without extracellular degradation. Our PD results and clinical responses confirm that the payload effectively kills cancer cells in peripheral blood and bone marrow without harming nearby healthy tissue. This innovative design with proof-of-concept in Phase 1 reinforces our confidence in VersAptx as a transformative platform for ADC development.”

Dr. M. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology, said "Although this is still early data, VIP943 is differentiated from other ADCs, particularly with its favorable safety profile. We’re not seeing neutropenia as a dose-limiting toxicity, which is encouraging and may allow the drug to move into earlier lines of therapy in combination. I look forward to the continued development of VIP943 and its potential to improve treatment options for patients with CD123+ malignancies.” 

The company has also provided updates for VIP236 and Enitociclib. VIP236, a miniature molecule drug conjugate (SMDC), has shown a 45% disease control rate in patients with advanced solid tumors, with no dose-limiting toxicities typical of similar treatments. One patient has remained in therapy for over 300 days. Vincerx seeks a strategic partner for VIP236's future development while focusing its resources on VIP943

“We've made significant progress in identifying an effective dose and schedule. We believe it is now crucial to study VIP236 in the right patient population, which could include triple-negative breast cancer and gastric cancer, where camptothecins are used, especially in combination with other anticancer agents,” commented Ahmed Hamdy, M.D., CEO of Vincerx.

Furthermore, Vincerx's CDK9 inhibitor, enitociclib, is being evaluated in combination with venetoclax and prednisone for relapsed/refractory lymphomas. Initial results show a 57% response rate in seven patients, with some achieving partial responses despite being refractory to prior therapies. Vincerx Pharma is also seeking a partner to advance Enitociclib's development. A corporate webcast will be held today at 5:00 PM EDT, featuring updates on these clinical trials, including commentary from Dr. M. Yair Levy of Texas Oncology and a live Q&A session with company leadership. You can watch the webcast by visiting the "Corporate Overview & Events" page in the Investors section at investors.vincerx.com. A replay will also be available soon after the live event.