Vincerx Pharma Announces First Patient Dosed in Phase 1b Study of VIP152 in MYC-Driven Relapsed or Refractory Aggressive Lymphomas and Advanced Solid Tumors

First patient dosed by Vincerx marks significant milestone in Company’s developmentPALO ALTO, Calif., June 03, 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 1b study of VIP152 in MYC-driven relapsed or refractory (R/R) aggressive lymphomas and advanced solid tumors. “Vincerx has achieved a significant milestone with the first dosing of a patient in a Vincerx-sponsored clinical trial,” said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx. “This trial builds upon the encouraging signals of monotherapy activity observed in the dose-escalation study and exploratory cohort in double-hit lymphoma, which includes clinically significant monotherapy activity in patients with advanced malignancies and a favorable safety profile. We believe our comprehensive clinical strategy, which explores the potential of potent and specific PTEFb/CDK9 inhibition with VIP152 in MYC-driven indications, positions us to pursue multiple registration paths. We look forward to the continued expansion of our strategic clinical programs with the initiation of our Phase 1 dose escalation study in CLL relapsed/refractory to venetoclax and BTK inhibitors in the second half of this year.” 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 30 patients with relapsed/refractory aggressive lymphoma, including DLBCL, transformed follicular lymphoma, and blastoid 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. Previously, early signs of clinical activity at higher dose levels were observed with durable disease control in individual patients with pancreatic cancer and salivary gland cancer (~10 and ~17 months of treatment, respectively). Of the 31 subjects dosed, a patient with double-hit lymphoma (DHL) from the 30-mg cohort achieved a complete metabolic response (CMR) followed by the enrollment of an additional 6 DHL patients in an exploratory cohort with a CMR observed in 29% (2 of 7) patients. Due to the COVID pandemic, the patients with CMR withdrew consent after 3.7 and 2.3 years, respectively, of treatment. Both patients were in CMR at study exit. 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. Cautionary StatementThis 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 conducted prior to Vincerx’s in-licensing; failure to realize the anticipated benefits of the business combination with LifeSci Acquisition Corp.; failure to realize the benefits of the Bayer license; 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 reports on 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 MackleLifeSci Advisors, [email protected]