On Monday, Vincerx Pharma Inc ( VINC ) presented preliminary Phase 1 data for VIP236 and updates on pipeline progress at the American Association for Cancer Research Annual Meeting 2024.

VNC-236-101 is a Phase 1 dose-escalation study with monotherapy VIP236 for metastatic tumor patients who have exhausted all standard therapy options. 

Fifteen patients have been dosed to date on the once-every-three-weeks (Q3W) schedule:

The Q3W schedule is well tolerated with no dose-limiting toxicity (DLT) in any patients, and no patients have discontinued VIP236 due to an adverse event. 

No severe or life-threatening diarrhea has been observed, validating the purposeful design of VIP236’s optimized camptothecin payload.

Seven patients have achieved objective stable disease, including tumor reduction. Four patients remain on the study, with the longest-treated patient for 168 days.

VNC-943-101 is a Phase 1 dose-escalation study with monotherapy VIP943 for CD123+ acute myeloid leukemia, B-cell acute lymphocytic leukemia, or myelodysplastic syndromes. 

VIP943 is administered once per week. 

No DLTs occurred in Cohort 1 and 2. Four patients have been enrolled in Cohort 3 (0.7 mg/kg) and are undergoing DLT assessment.

VIP943 PK data shows very little free payload in circulation, consistent with the favorable safety profile observed preclinically and clinically.

Vincerx will present additional Phase 1 data for VIP236 and VIP943 on or around the 2024 European Hematology Association Annual Meeting in June 2024.

Vincerx also reported preclinical experiments applying the next-generation effector chemistry of its VersAptx platform to the antibodies of approved antibody-drug conjugates (ADCs), Trodelvy and Enhertu, demonstrating the potential to improve tumor toxicity of ADCs by orders of magnitude.

In in vitro tumor models, Vincerx’s sacituzumab-legumain-KSPi ADC had a 20-fold improvement in tumor toxicity compared with Trodelvy (sacituzumab-govitecan). 

The company’s trastuzumab-legumain-KSPi ADC demonstrated an 8-fold increase in tumor toxicity compared with Enhertu (fam-trastuzumab-deruxtecan).

Price Action: VINC shares are down 73.30% at $1.27 on the last check Tuesday.