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Vincerx Pharma to Implement Cost-Controls to Support Advancing Phase 1 Study of VIP943

Vincerx Pharma to Implement Cost-Controls to Support Advancing Phase 1 Study of VIP943

Vincerx Pharma將實施成本控制,以支持推進VIP943的1期研究。
GlobeNewswire ·  12/04 19:45

Also Exploring Strategic Alternatives to Complement Fundraising Efforts

還在探索戰略替代方案以補充籌款工作

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 Company's novel CD123-targeted antibody-drug conjugate (ADC) developed with the Company's next-generation VersAptx platform.

加州帕洛阿爾託,2024年12月04日(環球新聞稿)-- Vincerx Pharma, Inc.(納斯達克代碼:VINC),一家致力於通過變革性療法解決癌症患者未滿足醫療需求的生物製藥公司,今天宣佈計劃實施成本控制並探索戰略替代方案,以支持推進VIP943的第一階段研究,這是一種新型的CD123靶向抗體藥物偶聯物(ADC),由公司的下一代VersAptx平台開發。

"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."

"我們相信VIP943是一項高度差異化且有價值的資產,我們將全力推動這個項目,"首席執行官Ahmed Hamdy萬.D.說。"正如我們在十月份分享的,VIP943的第一階段劑量遞增研究顯示出了令人鼓舞的安全性、有效性和耐受性。在九名可評估患者中,一名急性髓性白血病(AML)移植後復發的患者達到了完全緩解的改良標準,而一名高風險骨髓增生異常綜合徵(HR-MDS)患者達到了部分緩解。值得注意的是,自十月以來,達到完全緩解的患者持續改善,最近的骨髓結果顯示只有1%的癌細胞。該患者已進入研究七個月,仍在繼續觀察。移植後患者的單藥治療反應罕見,因此我們認爲這種反應突顯了VIP943在這個具有挑戰性的人群中的潛力,並支持我們VersAptx平台的下一代科技。"

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 VIP943's 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."

Hamdy博士繼續說道:"我們現在的重點是給予該項目時間以生成更多數據,預計在2025年第一季度初將從其他隊列獲得結果。爲了支持此目標,我們正在實施顯著的削減成本措施,以集中資源推進VIP943的進展。此外,我們將開始探索戰略替代方案,以補充我們正在進行的籌款工作,目標是最大化VIP943項目和我們VersAptx平台的價值。"

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.

作爲對潛在戰略替代方案的審查的一部分,Vincerx將考慮如外許可、併購機會(包括反向併購)、資產和技術銷售及其他交易等選項。爲了簡化運營並集中資源,Vincerx將實施約55%的大規模裁員。不能保證戰略替代方案的探索將導致任何協議或交易,也無法保證任何此類協議或交易的時間。公司正在與金融顧問合作,協助進行戰略審查過程。

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.

Vincerx尚未設定評估過程的完成時間表,也不打算進一步披露其戰略選擇探索狀態的相關發展或指導,除非在確定進一步披露是適當或必要的情況下。

As of October 31, 2024, the Company had approximately $8.4 million in cash, cash equivalents, and marketable securities.

截至2024年10月31日,公司擁有約840萬美元的現金、現金等價物和可交易證券。

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 Vincerx's CellTrapper technology. Vincerx's 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).

關於VIP943
VIP943是VersAptx平台中首個ADC,包含抗CD123抗體、一種被legumain細胞內切割的獨特連接物以及一個由Vincerx的CellTrapper技術增強的新型肽酰蛋白酶A(KSPi)負荷。Vincerx專有的效應化學物質(連接物+負荷)旨在減少荷載的非特異性釋放,並確保荷載在癌細胞中與健康細胞相比的堆積。增加的治療指數有潛力解決許多ADC所面臨的挑戰,通過提高療效並減少嚴重毒性。VIP943正在接受在已耗盡標準治療方案的復發/難治性AML、HR-MDS和b-ALL患者中進行第一階段劑量遞增試驗的評估(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.

關於VersAptx平台
VersAptx是一種多功能且適應性強的下一代生物共軛平台。這一創新平台的模塊化特性允許結合不同的靶向、連接劑和載荷技術,開發定製的生物共軛物質,以應對不同的癌症生物學特徵。使用此平台,(i)可以利用抗體和小分子靶向不同的腫瘤抗原,(ii)連接劑可設計用於減少藥物的非特異性釋放,細胞內或細胞外裂解,並連接到單個或多個載荷,(iii)可使用我們的CellTrapper技術設計具有降低滲透性的載荷,以確保在癌細胞中積累或在腫瘤微環境中釋放。VersAptx平台允許開發旨在解決歷史ADC藥物的安全性和有效性挑戰的生物共軛物質。

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. Vincerx's 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.

關於Vincerx Pharma, Inc.
Vincerx Pharma, Inc.是一家臨床階段的生物製藥公司,致力於開發差異化和新穎的療法,以滿足癌症患者的未滿足醫療需求。Vincerx組建了一個經驗豐富的管理團隊,擁有成功的腫瘤藥物開發、批准和價值創造的良好記錄。Vincerx多樣化的產品線包括一個下一代抗體藥物偶聯物(ADC)VIP943,目前處於第1階段;一個小分子藥物偶聯物VIP236,已經完成第1階段;一個CDK9抑制劑enitociclib,已經完成第1階段單藥研究,並在與NIH的合作中繼續進行第1階段研究;一個臨床前ADC VIP924;以及VersAptx,一個多功能的下一代生物偶聯平台。

Vincerx is based in Palo Alto, California, and has a research subsidiary in Monheim, Germany.

Vincerx總部位於加利福尼亞州的帕洛阿爾託,並在德國的蒙海姆設有研究子公司。

Forward-Looking Statements

前瞻性聲明

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," "on-target," "on track," "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, plans, timing, and disclosure regarding strategic alternatives, product candidates and attributes, expectations regarding advancement, development, timing, and results of product candidates, and engagement of a financial advisor. 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, many of which are outside Vincerx's control.

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," "on-target," "on track," "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, plans, timing, and disclosure regarding strategic alternatives, product candidates and attributes, expectations regarding advancement, development, timing, and results of product candidates, and engagement of a financial advisor. 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, many of which are outside Vincerx's 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, Vincerx's capital requirements and availability and sufficiency of capital; Vincerx's ability to continue as a going concern; risks that Vincerx's activities to evaluate and pursue potential strategic alternatives may not result in a transaction that enhances stockholder value on a timely basis or at all; risks related to Vincerx's ability to reduce its expenses, and costs and expenses related to its streamlined operating plan; risks associated with clinical development of Vincerx's product candidates; general economic, financial, legal, political, and business conditions; and the risks and uncertainties set forth in the Form 10-Q for the quarter ended September 30, 2024 and subsequent reports filed with the Securities and Exchange Commission by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

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, Vincerx's capital requirements and availability and sufficiency of capital; Vincerx's ability to continue as a going concern; risks that Vincerx's activities to evaluate and pursue potential strategic alternatives may not result in a transaction that enhances stockholder value on a timely basis or at all; risks related to Vincerx's ability to reduce its expenses, and costs and expenses related to its streamlined operating plan; risks associated with clinical development of Vincerx's product candidates; general economic, financial, legal, political, and business conditions; and the risks and uncertainties set forth in the Form 10-Q for the quarter ended September 30, 2024 and subsequent reports filed with the Securities and Exchange Commission by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements.

Vincerx, the Vincerx logo, CellTrapper, and VersAptx are trademarks of Vincerx.

Vincerx、Vincerx標誌、CellTrapper和VersAptx是Vincerx的商標。

Contacts:
Gabriela Jairala
Vincerx Pharma, Inc.
gabriela.jairala@vincerx.com

聯繫人:
Gabriela Jairala
Vincerx Pharma,Inc.
gabriela.jairala@vincerx.com

Totyana Simien
Inizio Evoke Comms
totyana.simien@inizioevoke.com

託塔娜·西門
Inizio Evoke Comms
totyana.simien@inizioevoke.com


譯文內容由第三人軟體翻譯。


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