VINC Vincerx Pharma Inc.

6.95
+0.15  (+2%)
Previous Close 6.8
Open 6.7
52 Week Low 6.73
52 Week High 26.75
Market Cap $146,350,042
Shares 21,057,560
Float 17,654,481
Enterprise Value $27,723,042
Volume 157,303
Av. Daily Volume 105,444
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Drug Pipeline

Drug Stage Notes
VIP152
Chronic lymphocytic leukemia (CLL) / Richter syndrome (RS)
Phase 1/2
Phase 1/2
Phase 1 dose escalation trial initiated December 17, 2021. Phase 2 portion to be initiated in 2H 2022.
VIP152
MYC-driven lymphomas and advanced solid tumors
Phase 1b
Phase 1b
Phase 1b initiation of dosing announced June 3, 2021.

Latest News

  1. PALO ALTO, Calif., Dec. 17, 2021 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (NASDAQ:VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced that the first patient has been dosed in the Company's Phase 1 dose-escalation study of VIP152 in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or Richter Syndrome (RS).

    "The dosing of the first patient in Vincerx's Phase 1 dose-escalation study of VIP152 in R/R CLL or RS marks the initiation of the second Vincerx-sponsored clinical trial this year, less than one year after becoming a publicly-listed company," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "Our data recently…

    PALO ALTO, Calif., Dec. 17, 2021 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (NASDAQ:VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced that the first patient has been dosed in the Company's Phase 1 dose-escalation study of VIP152 in relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or Richter Syndrome (RS).

    "The dosing of the first patient in Vincerx's Phase 1 dose-escalation study of VIP152 in R/R CLL or RS marks the initiation of the second Vincerx-sponsored clinical trial this year, less than one year after becoming a publicly-listed company," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "Our data recently disclosed through an oral presentation at ASH demonstrated increased selectivity and potency of VIP152 when compared with other CDK9 inhibitors currently in development, leading to cytotoxic activity in primary CLL samples as well as improved survival in a mouse model of CLL. With this compelling preclinical proof-of-concept data in hand, we are focused on advancing VIP152 across challenging indications like R/R CLL and RS, where targeted CDK9 inhibition has the potential to bring meaningful patient benefit. We are continuing our momentum in the clinic and remain on-track to initiate Phase 2 studies of VIP152 in the second half of 2022."

    The Phase 1 study will evaluate VIP152 in patients with relapsed/refractory CLL who have failed a Bruton tyrosine kinase inhibitor (BTKi) and venetoclax and in patients with RS who have relapsed after, or been refractory to, at least one prior line of therapy for DLBCL and have MYC overexpression/amplification/translocation. A dose-escalation arm will be performed in R/R CLL before enrolling 20 additional patients in each of the CLL and RS cohorts.

    The Phase 1 dose-escalation in CLL and RS builds upon Vincerx's ongoing first-in-human (FIH) study (NCT04978779) in patients with advanced cancer, which consists of two expansion arms. Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, patients with mantle cell lymphoma who have failed a BTKi, as well as patients with any other type of lymphoma characterized by a MYC aberration. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

    About Vincerx Pharma, Inc.

    Vincerx Pharma, Inc. (Vincerx) is a clinical-stage life sciences company focused on leveraging its extensive development and oncology expertise to advance new therapies intended to address unmet medical needs for the treatment of cancer. Vincerx has assembled a management team of biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Vincerx's current pipeline is derived from an exclusive license agreement with Bayer and includes a clinical-stage and follow-on small molecule drug program and a preclinical stage bioconjugation platform, which includes next-generation antibody-drug conjugates and innovative small molecule drug conjugates. For more information, please visit www.vincerx.com.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to: Vincerx's business model, pipeline, strategy, timeline, product candidates, preclinical and clinical development and results and future capital requirements. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.

    Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, but are not limited to: general economic, financial, legal, political and business conditions and changes in domestic and foreign markets; the potential effects of the COVID-19 pandemic; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerx's in-licensing; failure to realize the benefits of Vincerx's license agreement with Bayer; risks related to the rollout of Vincerx's business and the timing of expected business milestones; changes in the assumptions underlying Vincerx's expectations regarding its future business or business model; Vincerx's ability to develop and commercialize product candidates; the availability and uses of capital; the effects of competition on Vincerx's future business; and the risks and uncertainties set forth in Forms 10-K, 10-Q and 8-K filed with or furnished to the SEC from time to time by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

    Contact Information

    Bruce Mackle

    LifeSci Advisors, LLC

    646-889-1200



    Primary Logo

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  2. VIP152 has increased selectivity and potency compared to other CDK9 inhibitors in development, consistent across DLBCL and CLL models of disease

    Vincerx hosting KOL webinar today, Saturday, December 11, 2021, at 7:30pm EST

    PALO ALTO, Calif., Dec. 11, 2021 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (NASDAQ:VINC) a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced data on VIP152, the Company's PTEFb/CDK9 inhibitor, in high-grade B-cell lymphoma (HGBL), formerly referred to as double-hit lymphoma (DHL), and chronic lymphocytic leukemia (CLL), in two presentations at the 63rd American Society of Hematology (ASH) Annual Meeting held December 11-14…

    VIP152 has increased selectivity and potency compared to other CDK9 inhibitors in development, consistent across DLBCL and CLL models of disease

    Vincerx hosting KOL webinar today, Saturday, December 11, 2021, at 7:30pm EST

    PALO ALTO, Calif., Dec. 11, 2021 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (NASDAQ:VINC) a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced data on VIP152, the Company's PTEFb/CDK9 inhibitor, in high-grade B-cell lymphoma (HGBL), formerly referred to as double-hit lymphoma (DHL), and chronic lymphocytic leukemia (CLL), in two presentations at the 63rd American Society of Hematology (ASH) Annual Meeting held December 11-14, 2021 in Atlanta GA.

    "The data presented at ASH show that VIP152 has increased selectivity and potency as compared with other CDK9 inhibitors in development across high-grade B cell lymphoma and chronic lymphocytic leukemia models of disease," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx, "The consistency of preclinical data are noteworthy, with robust effects on key biomarkers of CDK9 inhibition including the durable downregulation of RNA polymerase II as well as the sustained reduction, and near clearance of, MYC and MCL-1 mRNA and protein. These results also translate through to primary samples from patients, with VIP152 demonstrating cytotoxic activity that overcomes stromal protection in primary CLL samples, and pharmacodynamic effects on key transcriptional targets observed in blood of patients with HGBL treated with VIP152. These results suggest that the demonstrated effects of VIP152 may translate to the clinic to provide new treatment options for patients with MYC and MCL-1- driven malignancies. With these expanded mechanism data in hand, we are currently enrolling two studies, a Phase 1b expansion study in relapsed/refractory aggressive lymphoma and advanced solid tumors, and a Phase 1b dose-escalation in CLL relapsed/refractory to venetoclax and BTK inhibitors."   

    Key Presentation Highlights:

    Poster presentation, titled, "VIP152, a selective CDK9 inhibitor, induces complete regression of high-grade B-cell lymphoma (HGBL) models and depletion of short-lived oncogenic driver transcripts, MYC and MCL1, with a once weekly schedule" presented by Melanie Frigault, Ph.D., Vice President of Translational Medicine, Vincerx, include:

    • Compared with two oral CDK9 inhibitors in development, KB-0742 and atuveciclib, at equimolar concentrations, VIP152 demonstrated more potent and durable downregulation of phospho-Serine 2 on RNA polymerase II, a key biomarker for evaluating the mechanism of action of CDK9 inhibitors (50% reduction for 24–48 hours). Additionally, depletion of short half-life MYC and MCL-1 transcript levels up to 48 hours was observed.
    • VIP152 treatment conferred a shift in transcriptional program, supporting an oncogenic shock mechanism of action, and sustained robust reduction and near clearance of MYC and MCL-1 proteins in MYC overexpressing lymphoma cell lines.
    • Once weekly VIP152 treatment showed antitumor efficacy as demonstrated by dose-dependent tumor regression and tumor-outgrowth control in the SU-DHL-10 (a MYC overexpressing cell line) xenograft model.
    • The pharmacodynamic effect demonstrated in the blood of HGBL patients treated with VIP152 suggests that the effect may translate to the clinic. Tumor-based pharmacodynamic studies are planned to confirm these findings.
    • VIP152 is currently being evaluated in HGBL patients and other MYC expressing indications in the clinic (ClinicalTrials.gov Identifier: NCT02635672).

    Oral presentation titled, "VIP152 Is a Novel CDK9 Inhibitor with Efficacy in Chronic Lymphocytic Leukemia" presented by Steven Sher, The Ohio State University Comprehensive Cancer Center, include:

    • VIP152 shows selective CDK9 inhibition with improved activity over other CDK9 inhibitors in development including dinaciclib, KB-0742 and atuveciclib.
    • VIP152 induces apoptosis in CLL cell lines and demonstrates cytotoxic activity that overcomes stromal protection of primary CLL samples.
    • VIP152 disrupts transcriptomics of patient samples after a two-hour treatment, alters cellular programming and disrupts binding of CDK9 to canonical binding partners, thereby inhibiting its function.
    • VIP152 weekly dosing decreases peripheral disease in a circulating tumor CLL mouse model and improves survival.
    • Data support the ongoing clinical trial in CLL (ClinicalTrials.gov Identifier: NCT04978779).

    Vincerx will be hosting a KOL webinar today, at 7:30pm Eastern Standard Time. The webinar will feature presentations from KOLs John C. Byrd, M.D. (University of Cincinnati) and Rosa Lapalombella, Ph.D. (The Ohio State University) who will discuss the current treatment landscape and unmet medical need in treating patients suffering from CLL and the VIP152 data presented earlier that day at the ASH Annual Meeting. Vincerx Pharma's Vice President of Translational Medicine, Melanie Frigault, Ph.D., will also discuss the VIP152 mechanism of action in lymphoma poster presented at ASH

    A live Q&A session will follow the formal presentations. To register for the webinar, please click here.

    The poster can be accessed on the presentations section of the Vincerx website.

    About Vincerx Pharma, Inc.

    Vincerx Pharma, Inc. (Vincerx) is a clinical-stage life sciences company focused on leveraging its extensive development and oncology expertise to advance new therapies intended to address unmet medical needs for the treatment of cancer. Vincerx has assembled a management team of biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Vincerx's current pipeline is derived from an exclusive license agreement with Bayer and includes a clinical-stage and follow-on small molecule drug program and a preclinical stage bioconjugation platform, which includes next-generation antibody-drug conjugates and innovative small molecule drug conjugates. For more information, please visit www.vincerx.com.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to: Vincerx's business model, pipeline, strategy, timeline, product candidates and preclinical and clinical development and results. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.

    Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, but are not limited to: general economic, financial, legal, political and business conditions and changes in domestic and foreign markets; the potential effects of the COVID-19 pandemic; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerx's in-licensing; failure to realize the benefits of Vincerx's license agreement with Bayer; risks related to the rollout of Vincerx's business and the timing of expected business milestones; changes in the assumptions underlying Vincerx's expectations regarding its future business or business model; Vincerx's ability to develop and commercialize product candidates; the availability and uses of capital; the effects of competition on Vincerx's future business; and the risks and uncertainties set forth in Forms 10-K, 10-Q and 8-K filed with or furnished to the SEC from time to time by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

    Contacts

    Bruce Mackle

    LifeSci Advisors, LLC

    646-889-1200



    Primary Logo

    View Full Article Hide Full Article
  3. PALO ALTO, Calif., Dec. 07, 2021 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (NASDAQ:VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced that the European Commission has granted Orphan Drug Designation to VIP152, the Company's PTEFb/CDK9 inhibitor, for the treatment of diffuse large B-cell lymphoma (DLBCL).

    "The granting of Orphan Drug Designation for VIP152 in DLBCL realizes another significant regulatory milestone for Vincerx," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "VIP152 has the potential to be an effective treatment for rare and highly refractory cancers, for which there is an unmet need in the current therapeutic…

    PALO ALTO, Calif., Dec. 07, 2021 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (NASDAQ:VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced that the European Commission has granted Orphan Drug Designation to VIP152, the Company's PTEFb/CDK9 inhibitor, for the treatment of diffuse large B-cell lymphoma (DLBCL).

    "The granting of Orphan Drug Designation for VIP152 in DLBCL realizes another significant regulatory milestone for Vincerx," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "VIP152 has the potential to be an effective treatment for rare and highly refractory cancers, for which there is an unmet need in the current therapeutic landscape. We look forward to continued momentum with data presentations at the upcoming American Society of Hematology Annual Meeting, which include complete disease regression in DLBCL mouse models and modulation of key biomarkers in high-grade B-cell lymphoma cell lines and patients. In addition, we are presenting supportive preclinical mechanistic data in chronic lymphocytic leukemia."

    The European Commission grants orphan drug designation for medicinal products intended to treat life-threatening or chronically debilitating conditions that affect fewer than five in 10,000 people in the European Union and when no satisfactory method of diagnosis, prevention or treatment of the condition can be authorized. The designation provides certain benefits and incentives in the EU, including protocol assistance, fee reductions, and ten years of market exclusivity once the medicine is on the market.

    Vincerx is currently advancing Phase 1b studies of VIP152 in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors. The ongoing Phase 1b expansion, first-in-human (FIH) study is in patients with advanced cancer and consists of two expansion arms. Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and mantle cell lymphoma. Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration. All patients must have confirmed MYC overexpression or translocation.

    About Vincerx Pharma, Inc.

    Vincerx Pharma, Inc. (Vincerx) is a clinical-stage life sciences company focused on leveraging its extensive development and oncology expertise to advance new therapies intended to address unmet medical needs for the treatment of cancer. Vincerx has assembled a management team of biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Vincerx's current pipeline is derived from an exclusive license agreement with Bayer and includes a clinical-stage and follow-on small molecule drug program and a preclinical stage bioconjugation platform, which includes next-generation antibody-drug conjugates and innovative small molecule drug conjugates. For more information, please visit www.vincerx.com.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to: Vincerx's business model, pipeline, strategy, timeline, product candidates, preclinical and clinical development and results and future capital requirements. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.

    Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, but are not limited to: general economic, financial, legal, political and business conditions and changes in domestic and foreign markets; the potential effects of the COVID-19 pandemic; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerx's in-licensing; failure to realize the benefits of Vincerx's license agreement with Bayer; risks related to the rollout of Vincerx's business and the timing of expected business milestones; changes in the assumptions underlying Vincerx's expectations regarding its future business or business model; Vincerx's ability to develop and commercialize product candidates; the availability and uses of capital; the effects of competition on Vincerx's future business; and the risks and uncertainties set forth in Forms 10-K, 10-Q and 8-K filed with or furnished to the SEC from time to time by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

    Contact Information

    Bruce Mackle

    LifeSci Advisors, LLC

    646-889-1200



    Primary Logo

    View Full Article Hide Full Article
  4. PALO ALTO, Calif., Dec. 06, 2021 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (NASDAQ:VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced that it will host a key opinion leader (KOL) webinar to discuss the data presented on the Company's lead asset, VIP152, in chronic lymphocytic leukemia (CLL) and diffuse large B-Cell lymphoma (DLBCL) at the 63rd American Society of Hematology (ASH) Annual Meeting on Saturday, December 11, 2021 at 7:30pm Eastern Standard Time.

    The webinar will feature presentations from KOLs John C. Byrd, M.D. (University of Cincinnati) and Rosa Lapalombella, Ph.D. (The Ohio State University) who will discuss the current…

    PALO ALTO, Calif., Dec. 06, 2021 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (NASDAQ:VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced that it will host a key opinion leader (KOL) webinar to discuss the data presented on the Company's lead asset, VIP152, in chronic lymphocytic leukemia (CLL) and diffuse large B-Cell lymphoma (DLBCL) at the 63rd American Society of Hematology (ASH) Annual Meeting on Saturday, December 11, 2021 at 7:30pm Eastern Standard Time.

    The webinar will feature presentations from KOLs John C. Byrd, M.D. (University of Cincinnati) and Rosa Lapalombella, Ph.D. (The Ohio State University) who will discuss the current treatment landscape and unmet medical need in treating patients suffering from chronic lymphocytic leukemia (CLL) and the VIP152 data presented earlier that day at the ASH Annual Meeting.

    Vincerx Pharma's Vice President of Translational Medicine, Melanie Frigault, Ph.D., will also discuss the VIP152 mechanism of action in lymphoma poster presented at ASH. VIP152 is a potent and highly selective CDK9 inhibitor optimized for intermittent intravenous treatment. VIP152's differentiated profile for selectivity, potency, and durability has translated to early signals of clinical activity in Phase 1, notably in patient populations with high unmet medical needs including double-hit DLBCL. In addition, VIP152 has demonstrated on-target disruption of PTEFb function with durable reductions in kinase activity, mRNA and protein levels of key oncogenes including MYC and MCL-1.

    A live Q&A session will follow the formal presentations. To register for the webinar, please click here.

    John C Byrd, M.D. is the Chairman of the Scientific Advisory Board of Vincerx and an internationally known researcher and clinical specialist in leukemia and other hematologic malignancies. Dr. Byrd is currently the Department Chair, The Gordon and Helen Hughes Taylor Professor, University of Cincinnati. Previously, he was the D Warren Brown Chair of Leukemia Research at the Ohio State University College of Medicine.

    Dr. Byrd's research has shown that therapeutic agents such as rituximab, idelalisib, ibrutinib and acalabrutinib are effective against chronic lymphocytic leukemia (CLL) and has led efforts to understand how resistance develops to these agents. Dr. Byrd continues to study novel immune-based therapies for CLL. However, five years ago, he transitioned much of his experimental therapeutics effort toward acute myelogenous leukemia (AML); where he has been attempting to identify genomic-specific targeted therapies in the laboratory and translate them to clinical trials. He serves as the chief medical officer for Beat AML, a precision medicine effort.

    Dr. Byrd received his medical degree in 1991 from the University of Arkansas for Medical Sciences. He completed his internship and residency in internal medicine at the Walter Reed Army Medical Center in Washington, D.C., and then completed a fellowship at Walter Reed in hematology, oncology and bone marrow transplantation. Dr. Byrd also received a year of translational laboratory training at Johns Hopkins University.

    Rosa Lapalombella, Ph.D. is Professor with Tenure at The Ohio State University (OSU) where she also serves as the Associate Director for Basic Research in the Division of Hematology.

    Dr. Lapalombella has a strong history of translational medical research. Her research focus is on epigenetic alterations of cancer cells and the development of experimental therapeutics for hematologic disease. Her work has contributed to the translation of five therapeutic agents into clinical trials for CLL and has been reported in more than 60 articles in Cancer Discovery, Cancer Cell, Journal of Clinical Oncology, Leukemia and Blood. Dr. Lapalombella earned her Ph.D. from the University of Bologna, Italy and completed four years of postdoctoral training at the Ohio State University before joining the Faculty at OSU.

    Melanie Frigault, Ph.D. is the Vice President of Translational Medicine of Vincerx. In the year before joining Vincerx, Dr. Frigault was the U.S. head of Translational Medicine at AstraZeneca with a strategic focus on precision medicine and accelerating clinical development using novel biomarker-based endpoints in hematologic malignancies and solid tumors. From 2016 to 2020, Dr. Frigault established a translational science department at Acerta Pharma in South San Francisco, CA to support development of CALQUENCE® in mantle cell lymphoma (2017) and chronic lymphocytic leukemia (2019) with clinical biomarker data. Dr. Frigault held positions of increasing responsibility at AstraZeneca from 2011 to 2016 where she inserted science into the development of the portfolio ranging from target selection to phase 3 pivotal trials including biomarker discovery and companion diagnostic development. Dr. Frigault began her clinical research career at Novartis Institute of Biomedical Research in Cambridge, MA where she developed biomarkers and drove preclinical collaborations to inform clinical development.

    Dr. Frigault obtained her Ph.D. in Biochemistry from McGill University, Québec, Canada.

    About Vincerx Pharma, Inc.

    Vincerx Pharma, Inc. ("Vincerx") is a clinical-stage life sciences company focused on leveraging its extensive development and oncology expertise to advance new therapies intended to address unmet medical needs for the treatment of cancer. Vincerx has assembled a management team of biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Vincerx's current pipeline is derived from an exclusive license agreement with Bayer and includes a clinical-stage and follow-on small molecule drug program and a preclinical stage bioconjugation platform, which includes next-generation antibody-drug conjugates and innovative small molecule drug conjugates. For more information, please visit www.vincerx.com.

    Contact Information

    Bruce Mackle

    LifeSci Advisors, LLC

    646-889-1200



    Primary Logo

    View Full Article Hide Full Article
  5. Advancing Phase 1b study of VIP152 in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors

    Phase 1b dose escalation study of VIP152 in patients with CLL relapsed/refractory to venetoclax and BTK inhibitors on track to initiate in 2H2021

    Strengthened balance sheet with $50M private placement

    PALO ALTO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) --  Vincerx Pharma, Inc. (NASDAQ:VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "Our Phase 1b study of VIP152 continues to enroll across diverse indications per our development…

    Advancing Phase 1b study of VIP152 in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors

    Phase 1b dose escalation study of VIP152 in patients with CLL relapsed/refractory to venetoclax and BTK inhibitors on track to initiate in 2H2021

    Strengthened balance sheet with $50M private placement

    PALO ALTO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) --  Vincerx Pharma, Inc. (NASDAQ:VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.

    "Our Phase 1b study of VIP152 continues to enroll across diverse indications per our development plan. Despite the recent COVID surge, we remain on-track with our goal to initiate Phase 2 studies in the second half of 2022," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. "We are also on-track to expand our clinical program with the initiation of our Phase 1 dose escalation study in patients with CLL relapsed/refractory to venetoclax and BTK inhibitors and Richter Syndrome by the end of the year."

    Dr. Hamdy continued, "Our balance sheet, strengthened by the proceeds from our recent private placement, provides us with additional resources to execute on our upcoming clinical and regulatory milestones, which will include the further diversification of our clinical pipeline with planned combination regimen studies to enable our entry into earlier lines of therapy. In parallel, we continue to progress our earlier stage bioconjugation programs and, with IND-enabling work ongoing, expect our small molecule drug conjugate (SMDC) candidate, VIP236, to enter first-in-human studies in the second half of 2022."

    Recent Highlights

    • Advanced Phase 1b study of VIP152, a potent and selective inhibitor of CDK9, in MYC-driven relapsed or refractory aggressive lymphomas and advanced solid tumors. Ongoing Phase 1b expansion, first-in-human study is in patients with advanced cancer and consists of two expansion arms:
      • Arm 1 will enroll up to 40 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and mantle cell lymphoma.
      • Arm 2 will enroll up to 40 patients with advanced solid tumors, including patients with ovarian cancer, triple negative breast cancer, castration-resistant neuroendocrine prostate cancer, and any other solid tumor with MYC aberration.
      • The Company is also evaluating the safety of pembrolizumab in combination with VIP152 in patients with advanced solid tumors. Other combinations studies are in planning.
    • Announced upcoming presentations at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition.



    • Advanced SMDC and antibody drug conjugate (ADC) bioconjugation pipeline manufacturing capabilities. Toxicology and Investigational New Drug (IND)-enabling studies are ongoing for VIP236, which selectively targets the tumor microenvironment and is activated by the tumor stroma, with an IND filing with U.S. Food and Drug Administration expected in the second half of 2022.



    • Strengthened balance sheet with $50 million private placement led by new and existing investors, with proceeds intended to support the clinical evaluation of VIP152 in additional indications and combination regimens, as well as, to advance the Company's bioconjugation platform.

    Third Quarter 2021 Financial Results

    • Vincerx Pharma ended the third quarter with $122.8 million in cash and cash equivalents, which includes the proceeds from the private placement completed in September, compared to $61.8 million at December 31, 2020.



    • Net loss for the third quarter ended September 30, 2021, was $24.5 million, or $1.39 per share, basic and diluted. The third quarter net loss includes a charge of $6.6M related to the change in fair value of its warrant liabilities.



    • Research and development (R&D) expenses were $12.2 million for the quarter ended September 30, 2021, consisting primarily of $2.7 million in headcount related costs, $5.5 million of third party preclinical, clinical and manufacturing services in connection with its preclinical studies and clinical trials and $4.0 million in stock-based compensation expense.



    • General and administrative (G&A) expenses were $5.7 million for the quarter ended September 30, 2021, consisting primarily of $2.1 million in headcount related costs, $1.5 million of outside services in support of its operations as a public company and $2.1 million in stock-based compensation expense.

    About Vincerx Pharma, Inc.

    Vincerx Pharma, Inc. (Vincerx) is a clinical-stage life sciences company focused on leveraging its extensive development and oncology expertise to advance new therapies intended to address unmet medical needs for the treatment of cancer. Vincerx has assembled a management team of biopharmaceutical experts with extensive experience in building and operating organizations that develop and deliver innovative medicines to patients. Vincerx's current pipeline is derived from an exclusive license agreement with Bayer and includes a clinical-stage and follow-on small molecule drug program and a preclinical stage bioconjugation platform, which includes next-generation antibody-drug conjugates and innovative small molecule drug conjugates. For more information, please visit www.vincerx.com.

    Cautionary Statement

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to: Vincerx's business model, pipeline, strategy, timeline, product candidates, preclinical and clinical development and results and future capital requirements. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.

    Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, but are not limited to: general economic, financial, legal, political and business conditions and changes in domestic and foreign markets; the potential effects of the COVID-19 pandemic; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerx's in-licensing; failure to realize the benefits of Vincerx's license agreement with Bayer; risks related to the rollout of Vincerx's business and the timing of expected business milestones; changes in the assumptions underlying Vincerx's expectations regarding its future business or business model; Vincerx's ability to develop and commercialize product candidates; the availability and uses of capital; the effects of competition on Vincerx's future business; and the risks and uncertainties set forth in Forms 10-K, 10-Q and 8-K filed with or furnished to the SEC from time to time by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

    Contact Information

    Bruce Mackle

    LifeSci Advisors, LLC

    646-889-1200

    Vincerx Pharma, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

     September 30,

    2021
     December 31,

    2020
     (Unaudited)  
    ASSETS   
    Current assets:   
    Cash and cash equivalents$122,796 $61,792
    Prepaid expenses 452  1,104
    Other current assets -  214
    Total current assets 123,248  63,110
    Right-of-use assets 4,169  -
    Property plant and equipment 250  -
    Other assets 1,758  82
    Total assets$ 129,425  $ 63,192
        
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities   
    Accounts payable$2,259 $505
    Accrued expenses 4,668  -
    Lease liability 532  -
    License payable -  5,000
    Common stock warrant liabilities 17,703  32,308
    Total current liabilities 25,162  37,813
    Lease liability, net of current portion 3,637  -
    Total liabilities 28,799  37,813
        
    Total stockholders' equity 100,626  25,379
    Total liabilities and stockholders' equity$ 129,425  $ 63,192

    Vincerx Pharma, Inc.

    Condensed Consolidated Statements of Operations

    (unaudited)

    (in thousands, except per share amounts)

     For the three months ended For the nine months ended
     September 30, September 30,
      2021   2020   2021   2020 
    Operating expenses:        
    General and administrative$5,720  $305  $17,206  $342 
    Research and development 12,211   -   27,743   - 
    Total operating expenses 17,931   305   44,949   342 
    Loss from operations  (17,931)  (305)  (44,949)  (342)
    Other income (expense)        
    Change in fair value of warrant liabilities (6,606)  -   12,102   - 
    Other income (expense) 13   (2)  13   (2)
    Total other income (expense) (6,593)  (2)  12,115   (2)
    Net loss $ (24,524) $ (307) $ (32,834) $ (344)
            
    Net loss per common share, basic and diluted$(1.39) $(0.06) $(2.06) $(0.07)
    Weighted average common shares outstanding, basic and diluted 17,694   5,076   15,941   5,018 
            

     



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