Vincerx Pharma Presents Preclinical and Preliminary Clinical Data on PTEFb/CDK9 Inhibitor VIP152 in Gynecologic Malignancies at the American Association for Cancer Research (AACR) Annual Meeting 2022

VIP152 demonstrates antitumor responses in preclinical models of gynecologic malignancies

Preliminary monotherapy clinical results presented for VIP152-treated patients with gynecologic cancers

PALO ALTO, Calif., April 08, 2022 (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 a poster presentation of preclinical and preliminary clinical data on VIP152, the Company’s PTEFb/CDK9 inhibitor, in gynecologic cancer cell lines and in patients with gynecologic malignancies, respectively, at the 2022 American Association for Cancer Research (AACR) Annual Meeting, being held virtually and in New Orleans, Louisiana from April 8-13, 2022.

“The preclinical data presented at AACR demonstrate sensitivity of gynecologic cancer cell lines with MYC and/or MYCN genetic alterations to VIP152,” said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx, “Our findings demonstrate that VIP152 monotherapy inhibits tumor growth in an ovarian cancer xenograft model in mice. We believe these preclinical data are noteworthy and translate through to primary tissue samples from patients with ovarian or endometrial cancer showing significant reduction in MYC protein expression ex vivo, and, in the blood of patients with gynecologic cancer, a downregulation of CDK9-regulated genes MYC, MCL1, and PCNA mRNA expression after VIP152 treatment.”

“Additionally, our preliminary VIP152 monotherapy clinical results as of March 2022 demonstrated an early signal in patients with gynecologic malignancies who have had multiple lines of prior therapy,” continued Dr. Hamdy. “In our ongoing first-in-human study, 3 out of 3 patients with MYC-amplified gynecologic cancer had stable disease at first assessment, as well as 1 out of 4 patients with ovarian cancer unselected for MYC. These results, together with our findings presented at ASH last year, suggest that VIP152 has the potential to provide new treatment options for patients across various MYC and MCL-1- driven tumor types. We are continuing to enroll patients in our Phase 1b expansion study across multiple tumor types including hematologic malignancies.”   

Key Presentation Highlights:

Poster presentation, titled, “VIP152, a selective CDK9 inhibitor, demonstrates sensitivity in gynecologic cell lines that are cisplatin sensitive or resistant and delivers in vivo antitumor efficacy” presented by Melanie Frigault, Ph.D., Vice President of Translational Medicine, Vincerx, include:

• A 10-fold range of sensitivity to VIP152 was observed in cisplatin-sensitive and cisplatin-resistance ovarian, uterus, uterus/cervix, and vulva cancer cell lines demonstrating the cytotoxic effects of VIP152.
• High tumor mutation burden (TMB) is identified as a feature associated with VIP152 in the most sensitive quartile of gynecologic cell lines and will be validated in an independent cohort.
• Antitumor efficacy was observed following a single 17.5 mg/kg dose of VIP152 monotherapy as demonstrated by tumor growth inhibition in the A2780 ovarian cancer xenograft model.
• VIP152 treatment administered on an intermittent treatment schedule (once weekly), showed predictable pharmacokinetic properties and conferred a shift in transcriptional program, supporting an oncogenic shock mechanism of action, with significant reduction in MYC protein expression in patient-derived ovarian and endometrial cancer tissues samples as well as a downregulation of CDK9-regulated genes MYC, MCL, and PNCA mRNA expression in the blood of patients with gynecologic cancer.
• Four out of seven patients with gynecologic cancers treated with VIP152 had stable disease, including all 3 of the MYC-amplified patients, at their first assessment. One patient remains on treatment. Although duration on monotherapy treatment is short, we believe this is a signal that warrants further exploration including in combination studies.
• Neutropenia is an on-target (CDK9) toxicity via downregulation of MCL1 and is monitorable and manageable with supportive care. Once weekly dosing of VIP152 allows for recovery of neutrophils before the next dose.
• Data support the ongoing Phase 1 clinical trial of VIP152 (ClinicalTrials.gov Identifier: NCT02635672).

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 modular 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,” “suggest,” “seek,” “intend,” “plan,” “goal,” “potential,” “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 ongoing COVID-19 pandemic on Vincerx’s manufacturing, clinical trial and other business activities; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerx’s in-licensing; the risk that preliminary clinical results may not be predictive of, and may differ from, later results; 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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