VIP924 / Vincerx, Bayer - LARVOL DELTA

Comparison of the CXCR5-Antibody Drug Conjugate (ADC; VIP924) to a CD19-ADC and a CD79b-ADC in a Humanized Rec-1 Mantle Cell Lymphoma (MCL) Mouse Model (ASH 2023) - "Loncastuximab teserine had a deleterious effect on several hematologic parameters, which was not observed with VIP924 or polatuzumab vedotin. The efficacy and tolerability observed in this study with VIP924 suggests further testing in human clinical trials is warranted."

Preclinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD79B • CXCR5 • LGMN • PTPRC

Vincerx Pharma Reports Second Quarter 2024 Financial Results (GlobeNewswire) - "VIP924 can be evaluated in B-cell malignancies, including mantle cell lymphoma, follicular lymphoma, DLBCL, and chronic lymphocytic leukemia , as a monotherapy and in combination. IND application is anticipated in early 2026, pending funding."

IND • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update (GlobeNewswire) - "Vincerx presented a preclinical poster at the 2023 AACR Annual Meeting demonstrating the promise of VIP924, a first-in-class CXCR5-targeted ADC from the VersAptx platform....VIP924:...IND application anticipated in late 2025 or early 2026, pending funding."

IND • Preclinical • Oncology

VIP924: Regulatory submission in US for B-cell malignancies in 2025 (Vincerx Pharma) - Corporate Presentation

NDA • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Vincerx Pharma Presents Preclinical VIP943 and VIP924 Posters at ASH 2023 (GlobeNewswire) - "In vivo activity in a humanized mouse model shows that VIP924 demonstrates significant efficacy (i.e., tumor growth inhibition and increased survival) with no substantial change in body weight (an indication of safety). In comparison, the commercially available ADCs, Polivy and Zynlonta, show no improvement in tumor growth inhibition or survival in this setting....Complete blood counts (CBCs) show that VIP924 had minimal impact on the six elements of the CBC reported in these studies."

Preclinical • Hematological Malignancies • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • 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

CXCR5 is a very promising drug target for the development of antibody-drug conjugates to treat patients with lymphoma (AACR 2023) - "CXCR5 is a highly attractive target in hematological malignancies such as DLBCL, MCL, and FL due to high protein expression and almost no expression in healthy tissues. CXCR5-targeting ADC with KSPi payload showed high potency and superiority to other B-cell-targeted ADCs in vitro on a broad range of lymphoma cell lines. VIP924 with a novel legumain-cleavable linker showed activity in in vivo PDX models from lymphoma patients."

Clinical • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD70 • CD79B • CXCR5 • LGMN

Vincerx Pharma Presents Preclinical Data on VIP924, a First-in-Class Antibody-Drug Conjugate (ADC), at the 2023 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "VIP924 showed superior in vitro cytotoxicity across different non-Hodgkin lymphoma cell lines compared with other B-cell lymphoma targeting antibodies conjugated to the same effector chemistry including, CD19-KSPi, CD22-KSPi, and CD70-KSPi....VIP924 (10mg/kg) resulted in significant tumor growth inhibition in two DLBCL patient-derived tumor models: 68% in a low CXCR5-expressing model and 87% in a high CXCR5-expressing model." "

Preclinical • Oncology

Vincerx Pharma Reports Fourth Quarter and Full Year 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - "(i) VIP943, CD123-KSPi ADC:...IND-enabling studies continue to advance, with IND filing expected mid-2023; (ii) VIP924, CXCR5-KSPi ADC: IND-enabling studies continue to advance, with IND filing on track for mid-2024."

IND • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Vincerx Pharma Reports Third Quarter 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Based on discussions with the FDA, combination with Bruton tyrosine kinase (BTK) inhibitor in patients with high-risk CLL (NCT04978779) will start after assessing the safety of enitociclib monotherapy in patients with CLL and RS. Anticipated start of the combination study is early 2023; Targeting initiation of Phase 2 studies in prioritized enitociclib indications in 2023; IND submission for SMDC VIP236 on track by year end; IND filing for ADCs, VIP943 and VIP924, on track for 2H2023 and 1H2024, respectively."

IND • New P2 trial • Trial status • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Vincerx Pharma Reports Second Quarter 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Prioritized enitociclib indications expected to initiate Phase 2 studies in 2023; IND submission for SMDC VIP236 on track for 2H2022; IND filing for ADCs, VIP943 and VIP924, on track for 2H2023 and 1H2024, respectively"

IND • New P2 trial • Oncology

Vincerx Pharma Reports First Quarter 2022 Financial Results and Provides a Corporate Update (GlobeNewswire) - "...'This June, we are excited for our poster presentation at the annual European Hematology Association meeting, which will show data from patients with lymphoma treated with VIP152....We also remain on-target to file INDs in the second half of 2023 for our two initial antibody drug conjugates (ADCs), VIP943, an anti-IL3RA-KSPi, and VIP924, an anti-CXCR5-KSPi, both with a CellTrapper moiety'."

Clinical data • IND • Hematological Malignancies • Lymphoma • Oncology

Vincerx Pharma To Host Key Opinion Leader Webinar on Bioconjugation and CDK9 Inhibitors for the Treatment of Hematologic and Solid Tumors (Businesswire) - “Vincerx’s management team will discuss its poster titled, ‘A novel small molecule drug conjugate -αvβ3 integrin antagonist linked to a cytotoxic camptothecin derivative- for the treatment of multiple cancer types,’ which will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting, as well as the Company’s bioconjugation platform. Vincerx’s preclinical bioconjugation platform seeks to address the current limitations of small-molecule and antibody-drug conjugates in oncology and consists of VIP236, a small molecule drug conjugate (SMDC) targeting advanced and metastatic cancer, as well as VIP943 and VIP924, two ADCs targeting hematologic tumors.”

Preclinical • Hematological Malignancies • Oncology • Solid Tumor

Vincera Pharma, Inc Announces Exclusive License Agreement for Oncology Portfolio Including a Clinical-stage PTEFb/CDK9 Inhibitor and a Preclinical Bioconjugation Platform (GlobeNewswire) - “Vincera Pharma, Inc…announced the signing of an exclusive license agreement with Bayer AG for the development and commercialization of an early development oncology portfolio…Under the terms of the license agreement, Vincera will in-license VIP152 (formerly BAY 1251152)…Additionally, Vincera will receive assets and license technology for a preclinical bioconjugation platform to address the limitations of small-molecule and antibody-drug conjugates in oncology. The preclinical assets include: VIP236...targeting advanced and metastatic cancer; as well as VIP943 (formerly BAY-943) and VIP924 (formerly BAY-924), two antibody-drug conjugates (ADC) targeting hematologic tumors; and VIP217…’with proof-of-concept clinical data in hand, we are poised to execute on a strategic clinical development plan with the potential for multiple accelerated approvals in the U.S. Expansion of the current Phase 1b study to include these patient populations is expected to begin in 2021.’”

Licensing / partnership • New P1 trial • Hematological Malignancies • Oncology