Exhibit 99.1
Vincerx Pharma to Implement Cost-Controls to Support Advancing Phase 1 Study of VIP943
December 4, 2024
Also Exploring Strategic Alternatives to
Complement Fundraising Efforts
PALO ALTO, Calif., Dec. 04, 2024 (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 plans to implement cost-controls and explore strategic alternatives to support
advancing the Phase 1 study of VIP943, the Companys novel CD123-targeted antibody-drug conjugate (ADC) developed with the Companys next-generation VersAptx platform.
We believe VIP943 is a highly differentiated and valuable asset, and we remain fully committed to advancing this program, said Ahmed Hamdy, M.D.,
Chief Executive Officer. As we shared in October, the Phase 1 dose-escalation study of VIP943 has demonstrated encouraging safety, efficacy, and tolerability. Of nine evaluable patients, one patient whose acute
myeloid leukemia (AML) relapsed post-transplant achieved a CRi and one patient with higher-risk myelodysplastic syndrome (HR-MDS) achieved a CRL. Notably, since October, the patient with
CRi has continued to improve, with their most recent bone marrow results showing only 1% cancer cells. This patient has now been on the study for seven months and counting. Monotherapy responses in post-transplant patients are rare, so we believe
this type of response highlights the potential of VIP943 in this challenging population and supports the next-generation technology of our VersAptx platform.
Dr. Hamdy continued, Our immediate focus is to give the program time to generate more data, with results from additional cohorts expected by early
Q1 2025. To support this, we are implementing significant cost-cutting measures to focus resources on VIP943s advancement. Additionally, we will begin exploring strategic alternatives to complement our ongoing fundraising efforts, with the
goal of maximizing the value of the VIP943 program and our VersAptx platform.
As part of its review of potential strategic alternatives, Vincerx
will consider options such as out-licensing, merger and acquisition opportunities, including reverse mergers, sales of assets and technologies, and other transactions. To streamline operations and focus
resources, Vincerx will implement a significant reduction in force of approximately 55%. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such
agreements or transactions. The Company is in the process of engaging a financial advisor to assist in the strategic review process.
Vincerx has not set
a timetable for completion of the evaluation process and does not intend to disclose further developments or guidance on the status of its exploration of strategic alternatives unless and until it is determined that further disclosure is appropriate
or necessary.
As of October 31, 2024, the Company had approximately $8.4 million in cash, cash equivalents, and marketable securities.
About VIP943
VIP943, the first ADC from the VersAptx
platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with Vincerxs
CellTrapper technology. Vincerxs proprietary effector chemistry (linker + payload) was designed to reduce non-specific release of the payload
and ensure payload accumulation in cancer cells versus healthy cells. The increased therapeutic index has the potential to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities. VIP943 is being evaluated
in a Phase 1 dose-escalation trial in patients with relapsed/refractory AML, HR-MDS, and B-ALL who have exhausted standard therapeutic options (NCT06034275).
About VersAptx Platform
VersAptx is a versatile and
adaptable next-generation bioconjugation platform. The modular nature of this innovative platform allows the combination of different targeting, linker, and payload technologies to develop bespoke bioconjugates that address different cancer
biologies. With this platform, (i) antibodies and small molecules can be used to target different tumor antigens, (ii) linkers can be designed to reduce non-specific release of the payload, cleave
intracellularly or extracellularly, and conjugate to single or multiple payloads, and (iii) payloads can be designed with reduced permeability using our CellTrapper technology to ensure accumulation in cancer cells or to be permeable for
release in the tumor microenvironment. The VersAptx platform allows the development of bioconjugates designed to address the safety and efficacy challenges of historical ADCs.
About Vincerx Pharma, Inc.
Vincerx Pharma, Inc. is a
clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx has assembled a seasoned management team with a proven track record of successful
oncology drug development, approvals, and value creation. Vincerxs diverse pipeline consists of a next-generation antibody drug conjugate (ADC) VIP943, currently in Phase 1; a small molecule drug conjugate VIP236, which has completed its Phase
1; a CDK9 inhibitor enitociclib, which has completed a Phase 1 monotherapy study and continues in a Phase 1 study in collaboration with the NIH; a preclinical ADC VIP924; and VersAptx, a versatile, next-generation bioconjugation platform.
Vincerx is based in Palo Alto, California, and has a research subsidiary in Monheim, Germany.