Vincerx Pharma Presents Data on PTEFb/CDK9 Inhibitor VIP152 in DLBCL and CLL at the 63rd American Society of Hematology Annual Meeting

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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.

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Forward-looking statement, Cancer, Failure, KOL, DHL, RNA, MYC, Poster, Clinical trial, Drug Quality and Security Act, RNA polymerase II, Securities Exchange Act of 1934, Eastern Time Zone, Translational medicine, Nasdaq, Biomarker, Immortalised cell line, 8-K, Form 10-K, COVID-19, Securities Act of 1933, Survival, Ohio State University, Lists of people executed in the United States, University of Cincinnati, Neoplasm, Patient, Disease, Therapy, DLBCL, BTK, University, GLOBE, ASH, Chronic lymphocytic leukemia, Blood, Apoptosis, CDK9, EST, MCL1, Q&A, Society, Pharmaceutical industry, Fine chemical, Vaccine, Risk management, Bayer, CLL
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CINCINNATI
Summary
Key Points: 
  • The pharmacodynamic effect demonstrated in the blood of HGBL patients treated with VIP152 suggests that the effect may translate to the clinic.
  • VIP152 is currently being evaluated in HGBL patients and other MYC expressing indications in the clinic (ClinicalTrials.gov Identifier: NCT02635672).
  • VIP152 induces apoptosis in CLL cell lines and demonstrates cytotoxic activity that overcomes stromal protection of primary CLL samples.
  • Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.



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
[email protected]


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