VIP236 / Vincerx - LARVOL DELTA

Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Vincerx Pharma, Inc. | Recruiting ➔ Completed | Trial primary completion date: Mar 2024 ➔ Oct 2024

Metastases • Monotherapy • Trial completion • Trial primary completion date • 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…Provides Pipeline and Corporate Updates (GlobeNewswire) - P1 | N=24 | NCT05712889 | Sponsor: Vincerx Pharma, Inc. | "VIP236 Update:...As of September 2024, 29 patients have been enrolled. Of these patients, 20 were evaluable per-protocol for response from the every 2- or 3-week schedule; nine of 20 patients had stable disease for a disease control rate of 45%. In addition, one of these subjects has been on treatment for over 300 days and four additional patients were on study for more than 120 days, demonstrating promising monotherapy duration of response in patients with advanced cancer. VIP236 continued to show a favorable safety and tolerability profile in these 29 patients, with no instances of the dose-limiting side effects commonly associated with camptothecins, such as life-threatening diarrhea, severe stomatitis/mucositis, or interstitial lung disease."

P1 data • Solid Tumor

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, and pharmacokinetics of VIP236 monotherapy in patients with advanced cancer. (ASCO 2024) - "VIP236 outperformed an anti-HER2 ADC, trastuzumab deruxtecan, in all three models. 3) Cohorts 1, 2a, 3a, 2b, 3b and 4b have been completed. Enrollment continues in the Q3W cohorts."

Clinical • Metastases • Monotherapy • P1 data • PK/PD data • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ELANE

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

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=24 | NCT05712889 | Sponsor: Vincerx Pharma, Inc. | "Results of the Q3W schedule (n=15) show: The patient population is typical of a Phase 1 study with heavily pretreated patients and a wide range of tumor types. 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. Importantly, no severe or life-threatening diarrhea has been observed, validating the purposeful design of VIP236’s optimized camptothecin payload. Dose escalation continues on the Q3W schedule. Vincerx anticipates presenting additional Phase 1 data for VIP236 later this summer."

P1 data • Oncology • Solid Tumor

Vincerx to Host Virtual Investor Event Reviewing Preliminary Phase 1 VIP236 Data Presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 (GlobeNewswire) - "Vincerx Pharma, Inc...will host a virtual investor event reviewing preliminary clinical data from its Phase 1 dose-escalation study of VIP236 and provide an update on pipeline progress on Monday, April 8, 2024, at 2 PM PT. This will follow the poster presentation of the VIP236 clinical data at the AACR Annual Meeting 2024."

P1 data • Oncology • Solid Tumor

Vincerx to Present Three Posters at the American Association for Cancer Research (AACR) Annual Meeting 2024 (GlobeNewswire) - "Vincerx Pharma...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. The poster will summarize preliminary safety, efficacy, and pharmacokinetic results from this first-in-human, dose-escalation study (NCT05712889)."

P1 data • Preclinical • Solid Tumor

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

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 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

Preclinical characterization and prediction of human pharmacokinetics and efficacious dose for VIP236, a novel alpha V beta 3 binding small molecule-drug conjugate (SMDC). (AACR-NCI-EORTC 2023) - No abstract available

PK/PD data • Preclinical • Oncology

Discovery of VIP236, an αvβ3-Targeted Small-Molecule-Drug Conjugate with Neutrophil Elastase-Mediated Activation of 7-Ethyl Camptothecin Payload for Treatment of Solid Tumors. (PubMed, Cancers (Basel)) - "Treatment with VIP236 resulted in long-lasting tumor regression in subcutaneous patient-derived xenograft (PDX) models from patients with non-small-cell lung, colon, and renal cancer as well as in two orthotopic metastatic triple-negative breast cancer PDX models. In these models, a significant reduction of brain and lung metastases also was observed."

Journal • Breast Cancer • Cholangiocarcinoma • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • ELANE

Discovery of VIP236, an αvβ3-Targeted Small-Molecule–Drug Conjugate with Neutrophil Elastase-Mediated Activation of 7-Ethyl Camptothecin Payload for Treatment of Solid Tumors (Multidisciplinary Digital Publishing Institute) - "Treatment with VIP236 resulted in long-lasting tumor regression in subcutaneous patient-derived xenograft (PDX) models from patients with non-small-cell lung, colon, and renal cancer as well as in two orthotopic metastatic triple-negative breast cancer PDX models."

Preclinical • Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

Vincerx Pharma Announces FDA Clearance of IND for VIP943 (GlobeNewswire) - "Vincerx Pharma, Inc...reported that it has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VIP943. Vincerx expects to enroll the first patient in the study early in the fourth quarter of 2023....'Looking ahead, in addition to beginning our Phase 1 trial for VIP943, we also expect to provide preliminary results for VIP236 by late 2023 or early 2024'."

Clinical data • IND • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Vincerx Pharma Reports Second Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "Vincerx Pharma, Inc...today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update...'We currently expect to dose our first patient with VIP943 in the fourth quarter.'...'Encouragingly, VIP236 preclinical data shows enhanced efficacy—independent of HER2 status— in patient-derived xenograft (PDX) and cell line-derived gastric cancer models compared with the ADC ENHERTU®. Given the first-in-class nature of this program, we are evaluating several dosing approaches and expect to provide preliminary results by late 2023 or early 2024'...IND for VIP943 filed; anticipate enrolling the first patient in a Phase 1 dose escalation study in Q4 2023....Vincerx had approximately $27.4 million in cash, cash equivalents and marketable securities as of June 30, 2023, as compared to approximately $52.5 million as of December 31, 2022."

Commercial • New P1 trial • P1 data • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Vincerx Pharma Reports First Quarter 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "First Quarter 2023 Corporate Highlights: (i) VIP236, an αvβ3 integrin binder linked to an optCPT payload SMDC:...Dosed the first cohort of the ongoing Phase 1 first-in-human dose-escalation study with VIP236 monotherapy in the first quarter 2023 (ClinicalTrials.gov NCT05712889); (ii) Enitociclib, Positive Transcription Elongation Factor b (P-TEFb)/CDK9 inhibitor: First patient dosed in National Institutes of Health collaborative Phase 1 combination study with venetoclax and prednisone (VVIP) in diffuse large B-cell lymphoma (ClinicalTrials.gov NTC05371054)."

Trial status • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

VIP236: A small molecule drug conjugate with an optimized camptothecin payload has significant activity in patient-derived and metastatic cancer models (AACR 2023) - "In summary, VIP236 monotherapy efficacy in NSCLC, gastric, TNBC, RCC, CRC, and metastatic TNBC in vivo cancer models provides a rationale for clinical investigation in advanced metastatic solid tumors. In gastric cancer, VIP236 showed improved efficacy compared with the approved ADC, trastuzumab deruxtecan, regardless of HER2 expression. These results warrant further evaluation in clinical trials."

Clinical • Metastases • Preclinical • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer • ELANE • HER-2 • TOP1

Vincerx Pharma Presents Preclinical Data on VIP236, a First-in-Class Small Molecule Drug Conjugate (SMDC), at the 2023 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "In an orthotopic metastatic breast cancer PDX model, immunohistochemistry analysis revealed an increase of αvβ3 and elastase staining after VIP236 treatment, while TOP1 expression remained stable. These results suggest VIP236 has potential antineoplastic activity across various advanced and metastatic cancers...VIP236 was efficacious in a PDX non-small cell lung cancer (NSCLC) model, with durable CRs. Partial responses and stable diseases were observed in PDX colon, renal, and TNBC models. Additionally, VIP236 treatment induced significant tumor growth inhibition in a PDX CRC liver metastatic model and significant reduction in lung and brain metastasis in a PDX orthotopic TNBC model. The reduction of brain metastases suggests successful VIP236 penetration of the blood-brain barrier."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Vincerx Pharma Announces Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2023 (GlobeNewswire) - "Vincerx Pharma...announced four poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, being held virtually and at the Orange County Convention Center in Orlando, Florida from April 14-19, 2023."

Preclinical • Oncology

Vincerx Pharma Reports Fourth Quarter and Full Year 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - "...'To date, we have generated robust preclinical results demonstrating how VIP236 can deliver up to 40 times more drug to the cancer, while sparing the surrounding tissues and normal organs. We look forward to sharing preclinical data at the upcoming AACR meeting, highlighting how VIP236 showed monotherapy efficacy in non-small cell lung cancer (NSCLC), gastric cancer, triple negative breast cancer (TNBC), renal cell carcinoma (RCC), colorectal cancer (CRC), and metastatic TNBC in vivo cancer models. Additionally, we will share exciting preclinical data in gastric cancer, where VIP236 showed improved efficacy in vivo compared with ENHERTU®, an approved ADC'....Initiated dosing the first cohort of the Phase 1 first-in-human dose-escalation study with VIP236 monotherapy in the first quarter 2023..."

Preclinical • Trial status • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Vincerx Pharma, Inc.

Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor

Vincerx Pharma Announces FDA Safe to Proceed Letter for Investigational New Drug (IND) Application for its αVβ3 Small Molecule-Drug Conjugate (SMDC) VIP236 (GlobeNewswire) - "Vincerx Pharma, Inc...today announced that the U.S. Food and Drug Administration (FDA) has provided a safe to proceed letter and cleared the IND application for VIP236, the Company’s front-runner SMDC for the treatment of advanced solid tumors....We will be pushing the VIP236 program forward into Phase 1 with our existing capital and continue to expect our cash runway to lead us into late 2024.'"

IND • New P1 trial • Oncology • Solid Tumor