VIP943 / Vincerx, Bayer - LARVOL DELTA

Selectivity and Safety of VIP943: A Novel CD123-Targeting Antibody-Drug Conjugate (ADC) Using a Proprietary Linker and Payload Class (ASH 2023) - "The freshly prepared mixture was then incubated VIP716 and ispinesib, a clinical stage KSPi. Additionally, toxicology in non-human primates and in vivo TK studies confirm safety, favorable drug exposures, and little non-specific release of the payload. Based on these data, evaluation of VIP943 in human clinical trials is warranted."

Clinical • Anemia • CNS Disorders • Hematological Disorders • Hematological Malignancies • Neutropenia • Oncology • Thrombocytopenia • CD123 • IL3RA • KIF11

Vincerx Pharma to Implement Cost-Controls to Support Advancing Phase 1 Study of VIP943 (GlobeNewswire) - "Our immediate focus is to give the program time to generate more data, with results from additional cohorts expected by early Q1 2025... Additionally, we will begin exploring strategic alternatives to complement our ongoing fundraising efforts, with the goal of maximizing the value of the VIP943 program and our VersAptx platform."

Commercial • Trial status • Acute Myelogenous Leukemia • Leukemia • Myelodysplastic Syndrome • Oncology

THIRD QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS AND ANTICIPATED MILESTONES (GlobeNewswire) - "VIP943 has shown promising safety, efficacy, and tolerability in an ongoing Phase 1 dose-escalation study for patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275)....Vincerx expects to share additional Phase 1 study data for VIP943 by early 2025."

P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Leukemia • Myelodysplastic Syndrome • Oncology

Vincerx…Provides Pipeline and Corporate Updates (GlobeNewswire) - "Considering the promising VIP236 clinical data, the Company intends to pursue a strategic partner to champion its future development for the benefit of patients. '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'....By transitioning VIP236 to a partnering asset, the Company plans to streamline its operations and focus its efforts on the continued development of its lead ADC, VIP943."

Pipeline update • Gastric Cancer • Triple Negative Breast Cancer

Vincerx Reports Positive Initial Clinical Data from Ongoing VIP943 Phase 1 Dose-Escalation Study… (GlobeNewswire) - P1 | N=36 | NCT06034275 | Sponsor: Vincerx Pharma, Inc. | "The ongoing Phase 1 dose-escalation study of VIP943 has enrolled 22 patients to date...Nine patients (six AML; three HR-MDS) have received at least three doses of an efficacious dose of VIP943 (i.e., ≥1.0 mg/kg). Of these nine patients, four (44%) remain on study. So far, one patient with relapsed AML has achieved complete remission with incomplete hematologic improvement (CRi) and one patient with HR-MDS has achieved complete remission with limited count recovery (CRL) based on international consensus response criteria....As of August 2024, VIP943 has shown favorable safety and tolerability, with no dose-limiting toxicities reported in 22 patients....Enrollment in the once weekly and twice weekly dosing cohorts is ongoing....The company anticipates providing another data update on the ongoing Phase 1 VIP943 study by the end of the year."

P1 data • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Myelodysplastic Syndrome

Vincerx Pharma Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "VIP943: Vincerx expects to share additional Phase 1 study data for VIP943 for patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) by the end of Q4 2024; VIP236: Vincerx looks forward to sharing additional data from this Phase 1 study by the end of Q3 2024."

P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • Solid Tumor

An open-label, multicenter phase 1 study to characterize safety, tolerability, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics of VIP943 monotherapy in patients with advanced CD123+ hematologic malignancies. (ASCO 2024) - P1 | "In an in vivo MOLM-13 model, VIP943 had statistically significant (p <0.001) improvement in tumor growth inhibition compared with the only ADC approved for the treatment of acute myeloid leukemia (AML), gemtuzumab ozogamicin (GO). 2. Stelte-Ludwig et al ASH 2023."

Clinical • Metastases • Monotherapy • P1 data • PK/PD data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CD123 • IL3RA • LGMN

A PHASE 1, DOSE-ESCALATION STUDY OF THE CD123 ANTIBODY DRUG CONJUGATE (ADC), VIP943 IN PATIENTS WITH RELAPSED/REFRACTORY AML, HIGHER-RISK MDS, AND B-ALL (EHA 2024) - No abstract available

Clinical • P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome • CD123 • IL3RA

VINCERX PHARMA REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE (Vincerx Pharma) - "VIP236...Vincerx looks forward to sharing additional Phase 1 data by the end of Q3 2024. VIP943...Vincerx expects to present updated Phase 1 dose-escalation data for VIP943 by the end of Q4 2024."

P1 data • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Solid Tumor

Innovations in ADC technology platform with legumain-cleavable KSP-inhibitor payloads adaptable to various aspects of cancer biology (AACR 2024) - P1 | "Our advanced ADC VIP943 is targeting CD123 for the treatment of AML and MDS and is currently in Phase 1 clinical trial (NCT06034275)...Tuning the cleavable linker of cetuximab-ADCs for a higher challenge of legumain-mediated payload release resulted in a 52-fold improved selectivity of cytotoxicity against tumor cells versus HaCaT skin cells...Selected examples of each of these subclasses were coupled to trastuzumab; all conjugates were highly efficacious and resulted in tumor regressions in the SKOV-3 model similar to trastuzumab-deruxtecan. Our technology platform offers options for efficient and safe cancer treatments and allows for versatile adaptations to the various aspects of cancer biology... Our technology platform offers options for efficient and safe cancer treatments and allows for versatile adaptations to the various aspects of cancer biology. 1. Kirchhoff et al, Cancers (2020)."

Oncology • Solid Tumor • CD123 • IL3RA • LGMN

Activity of VIP943 on AML patient-derived leukemic blasts and healthy donor-derived bone marrow hematopoietic stem cells (AACR 2024) - P1 | "Depletion assay: The effect of VIP943 on HVBM was evaluated by measuring the depletion of CD34+ progenitor cell populations in comparison to the anti-CD33-ADC, gemtuzumab ozogamicin (gem-oz). In this in vitro analysis of primary samples from patients with AML, activity of VIP943 is observed in AML patient-derived CD123+ blasts as well as chemoresistant LSCs. At anticipated pharmacologic levels, VIP943 shows no adverse effects on HSCs unlike gem-oz suggesting an improved therapeutic index. In the ongoing first-in-human dose-escalation study in subjects with advanced CD123+ hematologic malignancies, VIP943 demonstrates a promising safety profile (NCT06034275)."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CD123 • CD34 • IL3RA • LGMN

Vincerx Pharma Presents Positive Preliminary Phase 1 Data for VIP236 and Updates on Pipeline Progress at the American Association for Cancer Research (AACR) Annual Meeting 2024 (GlobeNewswire) - P1 | N=36 | NCT06034275 | Sponsor: Vincerx Pharma, Inc. | "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. As the study progresses through the dose escalation, Vincerx will present additional Phase 1 data for VIP943 on or around the 2024 European Hematology Association Annual Meeting in June 2024."

P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update (GlobeNewswire) - "VIP943:...Enrollment in the third cohort is underway, with a total of 9 patients dosed. Preliminary pharmacokinetic results continue to show very little payload circulating in the blood....Vincerx will present more details regarding the preliminary Phase 1 data for VIP943 on or around the 2024 EHA Annual Meeting."

P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Myelodysplastic Syndrome

Mural Oncology Announces Upcoming Presentations at 2024 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Vincerx Pharma, Inc...today announced it will present three posters at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place in San Diego, CA, from April 5 – 10, 2024. Vincerx will also share clinical data for VIP236 at the conference....In addition to the preclinical results of our VersAptx platform, our SMDC poster (#3197) will also present, for the first time, early clinical results for VIP236. To date, 20 patients with relapsed/refractory advanced or metastatic solid tumors have been treated with two different dosing schedules of VIP236."

P1 data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor

VIP943: Preliminary data from P1 trial (NCT06034275) for advanced CD123+ hematologic malignancies in mid-2024 (Vincerx Pharma) - Corporate Presentation

P1 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Exploring Novel Mechanisms for Release of Different Payloads From ADCs & SMDCs: Discovery & Translational Aspects (ADC London 2024) - "Reviewing the tailored design of ADCs and SMDCs depending on the target biology • Evaluating legumain-cleavable linker and elastase-cleavable linker for intra- and extracellular payload release, respectively • Discussing the selection and advancement of SMDC VIP236 and ADC VIP943 to clinical trials"

ELANE • LGMN

Vincerx Pharma Announces Compelling Clinical Efficacy of Enitociclib in Combination with Venetoclax and Prednisone in Lymphoma (GlobeNewswire) - P1/2 | N=130 | NCT05371054 | "Vincerx Pharma...announced promising clinical results from a Phase 1 NIH-sponsored study of enitociclib in combination with venetoclax and prednisone for the treatment of relapsed/refractory lymphoma....'Outcomes for patients with PTCL are extremely poor, with median progression-free survival and overall survival of 3.1 and 5.5 months, respectively'....Investigators from the National Institutes of Health (NIH) report 2 partial responses (PR) in 3 peripheral T-cell lymphoma (PTCL) patients and 1 PR in 2 double-hit diffuse large b-cell lymphoma (DH-DLBCL) patients in ongoing dose-escalation trial of enitociclib in combination with venetoclax and prednisone. Vincerx remains on target to report early clinical data from lead VersAptx™ platform compounds, VIP236 (early 2024) and VIP943 (mid 2024)."

P1 data • Diffuse Large B Cell Lymphoma • Peripheral T-cell Lymphoma • Solid Tumor

Vincerx Pharma Presents Preclinical VIP943 and VIP924 Posters at ASH 2023 (GlobeNewswire) - "On-target selectivity and activity show that VIP943 is highly selective for the kinesin spindle protein (KSP) target, aka EG5, versus other members of the related KIF super family. This on-target activity translates to cell cycle arrest at the G2/M phase of mitosis, resulting in apoptosis in AML cell lines. In vitro cytotoxicity assays show that most hematologic cell lines (n=56) are sensitive to VIP943’s payload and that DNA alterations (including common AML mutations such as TP53) did not reduce its cytotoxicity."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Vincerx Pharma Reports Third Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "VIP943: CD123-KSPi ADC for leukemias and myelodysplastic syndrome...We will present new data on robust preclinical activity at the 65th American Society for Hematology Meeting (ASH 2023) in December. We expect to report preliminary clinical trial data in mid-2024. VIP236: SMDC with αvβ3 integrin binder linked to optimized CPT payload for solid tumors...We expect to report preliminary clinical trial data in early 2024."

P1 data • Preclinical • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Vincerx Pharma To Present Three Posters at ASH 2023 in December (GlobeNewswire) - "Vincerx Pharma, Inc...today announced that it will present three posters related to VIP943 (NCT06034275), VIP924 (in preclinical studies), and enitociclib (in collaboration with University of Calgary) at the 65^th American Society for Hematology Meeting (ASH), taking place in San Diego California from December 9 to 12, 2023...we show enitociclib’s preclinical activity in pediatric leukemia."

P1 data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Development of a CD123 Occupancy Assay to Support Dose Selection of VIP943, a Novel αCD123-KSP Inhibitor ADC (ADC-USA 2023) - "VIP943 is a novel αCD123-KSP inhibitor ADC in pre-clinical development with line of sight to AML in the clinic; Development of a CD123 occupancy assay for Phase 1 dose escalation first in human trial to support dose selection for expansion"

Acute Myelogenous Leukemia • CD123 • IL3RA

Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Vincerx Pharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Monotherapy • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • IL3RA

Phase 1 Dose Escalation Study for VIP943 Subjects With Advanced CD123+ Hematologic Malignancies (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Vincerx Pharma, Inc.

Metastases • Monotherapy • New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • IL3RA

Vincerx Pharma Doses First Patient in the Phase 1 Clinical Trial Evaluating VIP943 (GlobeNewswire) - "Vincerx Pharma, Inc...today reported that the first patient has been dosed in the Phase 1 trial evaluating VIP943 in patients with relapsed/refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia...'We look forward to evaluating the potential of VIP943 and expect to report preliminary safety and pharmacology data from our Phase 1 study in 2024.'....'Our team is excited to collaborate with Vincerx and begin enrolling patients in this Phase 1 dose escalation study.'"

P1 data • Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Vincerx Pharma Doses First Patient in the Phase 1 Clinical Trial Evaluating VIP943Phase 1 trial enrolling patients with relapsed/refractory AML, MDS and B-cell ALL (BioSpace) - P1 | N=36 | (NCT06034275) | Sponsor: Vincerx Pharma, Inc. | "Stephen A. Strickland...said, 'Despite there being new medicines for hematologic malignancies such as AML, MDS and B-cell ALL, outcomes for many patients have not improved and relapse rates remain high. The urgent need for more effective treatment options persists....Vincerx's preclinical data provides a strong rationale to support the evaluation of VIP943 in the setting of hematologic malignancies, with hopes of providing more effective and less toxic therapeutic options for patients.'"

Media quote • P1 data