Vincerx Reports Positive Initial Clinical Data from Ongoing VIP943 Phase 1 Dose-Escalation Study and Provides Pipeline and Corporate Updates
Vincerx Pharma (Nasdaq: VINC) reported positive initial clinical data from its ongoing VIP943 Phase 1 dose-escalation study in relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and B-cell acute lymphoblastic leukemia (B-ALL). The study has enrolled 22 patients to date, with two complete responses observed so far. VIP943 has shown favorable safety and tolerability, with no dose-limiting toxicities reported.
The company also provided updates on its VIP236 and enitociclib programs. VIP236 showed promising monotherapy duration of response in advanced cancer patients, while enitociclib demonstrated a 57% overall response rate in a Phase 1 study for relapsed/refractory lymphoma. Vincerx is focusing its resources on the continued development of VIP943 and expects its cash runway to extend into early 2025.
Vincerx Pharma (Nasdaq: VINC) ha riportato dati clinici iniziali positivi dal suo studio in corso VIP943 di fase 1 per l'escalation della dose, che riguarda leucemia mieloide acuta (AML) recidivante/rifrataria, sindrome mielodisplastica ad alto rischio (HR-MDS) e leucemia linfoblastica acuta a cellule B (B-ALL). Fino ad oggi, lo studio ha arruolato 22 pazienti, con due risposte complete osservate finora. VIP943 ha mostrato safety e tollerabilità favorevoli, senza toxicità limitanti legate alla dose riportate.
L'azienda ha anche fornito aggiornamenti sui suoi programmi VIP236 ed enitociclib. VIP236 ha mostrato una durata di risposta promettente in monoterapia nei pazienti con cancro avanzato, mentre enitociclib ha dimostrato un tasso di risposta complessivo del 57% in uno studio di fase 1 per linfoma recidivante/rifratario. Vincerx sta concentrando le sue risorse sullo sviluppo continuato di VIP943 e si aspetta che la sua disponibilità di cassa si estenda fino all'inizio del 2025.
Vincerx Pharma (Nasdaq: VINC) reportó dati clínicos iniciales positivos de su estudio en curso VIP943 de fase 1 sobre escalación de dosis en leucemia mieloide aguda (AML) recidivante/refractaria, síndrome mielodisplástico de alto riesgo (HR-MDS) y leucemia linfoblástica aguda de células B (B-ALL). Hasta la fecha, el estudio ha enrolado a 22 pacientes, con dos respuestas completas observadas hasta ahora. VIP943 ha mostrado seguridad y tolerabilidad favorables, sin toxicidades limitantes relacionadas con la dosis reportadas.
La empresa también proporcionó actualizaciones sobre sus programas VIP236 y enitociclib. VIP236 mostró una duración de respuesta prometedora en monoterapia en pacientes con cáncer avanzado, mientras que enitociclib demostró una tasa de respuesta global del 57% en un estudio de fase 1 para linfoma recidivante/refractario. Vincerx se está enfocando en el desarrollo continuo de VIP943 y espera que su capital disponible se extienda hasta principios de 2025.
Vincerx Pharma (Nasdaq: VINC)는 재발/내성 급성 골수 백혈병 (AML), 고위험 골수형성이상증후군 (HR-MDS) 및 B세포 급성 림프oblastic 백혈병 (B-ALL)에 대한 진행 중인 VIP943 1상 용량 증량 연구에서 긍정적인 초기 임상 데이터를 보고했습니다. 현재까지 연구에는 총 22명이 등록되었으며, 지금까지 두 가지 완전한 반응이 관찰되었습니다. VIP943는 유리한 안전성 및 내약성을 보여주었으며, 보고된 용량 제한 독성은 없습니다.
회사는 또한 VIP236 및 enitociclib 프로그램에 대한 업데이트를 제공했습니다. VIP236은 진행성 암 환자에서 유망한 단독 치료 반응 지속 기간을 보여주었고, enitociclib은 재발/내성 림프종을 위한 1상 연구에서 57%의 전체 반응률을 나타냈습니다. Vincerx는 VIP943의 지속적인 개발에 자원을 집중하고 있으며, 자금 조달이 2025년 초까지 이어질 것으로 예상하고 있습니다.
Vincerx Pharma (Nasdaq: VINC) a rapporté des données cliniques initiales positives de son étude en cours VIP943 de phase 1 sur l'escalade des doses pour la leucémie myéloïde aiguë (AML) récurrente/résistante, le syndrome myélodysplasique à haut risque (HR-MDS) et la leucémie aiguë lymphoblastique à cellules B (B-ALL). L'étude a actuellement recruté 22 patients, avec deux réponses complètes observées jusqu'à présent. VIP943 a montré une sécurité et une tolérabilité favorables, sans toxicités limitant la dose rapportées.
L'entreprise a également fourni des informations sur ses programmes VIP236 et enitociclib. Le VIP236 a montré une durée de réponse prometteuse en monothérapie chez les patients atteints de cancer avancé, tandis qu'enitociclib a démontré un taux de réponse global de 57 % dans une étude de phase 1 pour le lymphome récurrent/résistant. Vincerx concentre ses ressources sur le développement continu de VIP943 et s'attend à ce que ses liquidités s'étendent jusqu'au début de 2025.
Vincerx Pharma (Nasdaq: VINC) berichtete über positive erste klinische Daten aus seiner laufenden VIP943 Phase-1-Dosis-Eskalationsstudie bei rezidivierender/refraktärer akuter myeloischer Leukämie (AML), Hochrisiko-myelodysplastischem Syndrom (HR-MDS) und B-Zell-akuter lymphoblastischer Leukämie (B-ALL). Der Studie haben bisher 22 Patienten teilgenommen, mit zwei kompletten Ansprechen, die bis jetzt beobachtet wurden. VIP943 zeigte günstige Sicherheit und Verträglichkeit, ohne berichtete dosislimitierende Toxizitäten.
Das Unternehmen gab auch Updates zu seinen Programmen VIP236 und enitociclib. VIP236 zeigte eine vielversprechende Monotherapie-Reaktionsdauer bei fortgeschrittenen Krebspatienten, während enitociclib in einer Phase-1-Studie bei rezidivierendem/refraktärem Lymphom eine Gesamtansprechrate von 57% demonstrierte. Vincerx konzentriert seine Ressourcen weiterhin auf die Entwicklung von VIP943 und erwartet, dass die finanzielle Mittel bis Anfang 2025 reichen.
- Two complete responses observed in VIP943 Phase 1 study
- Favorable safety and tolerability profile of VIP943 with no dose-limiting toxicities
- 44% of patients receiving efficacious dose of VIP943 remain on study
- VIP236 showed 45% disease control rate in evaluable patients
- Enitociclib demonstrated 57% overall response rate in Phase 1 lymphoma study
- Cash runway extended into early 2025
- Seeking strategic partners for VIP236 and enitociclib programs
- Streamlining operations to focus on VIP943 development
Insights
The initial clinical data for VIP943 in the Phase 1 dose-escalation study is highly promising. Achieving two complete responses (CRi and CRL) in a hard-to-treat salvage population of AML and HR-MDS patients is remarkable for an early-stage trial. The 44% retention rate among patients receiving efficacious doses is encouraging.
The safety profile appears favorable, with no dose-limiting toxicities reported and only one drug-related serious adverse event. This could potentially allow for combination therapies or use in earlier treatment lines. The pharmacodynamic data showing 84% maximal receptor occupancy and concurrent decreases in CD123+ blasts provide strong evidence of the drug's mechanism of action.
The VersAptx platform's ability to create a stable linker with low payload release (<
Vincerx's focus on VIP943 development and pipeline prioritization is a strategic move that could extend their cash runway into early 2025. This approach allows the company to allocate resources efficiently towards their most promising asset.
The decision to seek strategic partners for VIP236 and enitociclib is prudent, potentially unlocking value while reducing burn rate. These assets have shown promising results, particularly enitociclib's 57% overall response rate in combination therapy for lymphoma, which could attract partnership interest.
Investor sentiment may improve with the positive VIP943 data, potentially supporting future financing rounds or partnerships. However, as a small-cap biotech (
VIP943 demonstrates promising safety and tolerability and achieves two complete responses to date in Phase 1 dose-escalation study, reinforcing the program’s potential and validating the VersAptx™ Platform technology
Vincerx focusing resources on continued development of VIP943
Expected cash runway into early 2025
Management to host webcast and Q&A today at 5:00 PM EDT to review pipeline and corporate updates, followed by commentary from key opinion leader Dr. M. Yair Levy
PALO ALTO, Calif., Oct. 07, 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, announced two complete responses in the ongoing first-in-human, Phase 1 dose-escalation study of VIP943, the Company’s next-generation antibody-drug conjugate (ADC) being evaluated in relapsed/refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndrome (HR-MDS), and B-cell acute lymphoblastic leukemia (B-ALL). The Company also provided pipeline and corporate updates.
VIP943 Data Highlights
The ongoing Phase 1 dose-escalation study of VIP943 has enrolled 22 patients to date across several escalating dose cohorts (0.2 to 1.3 mg/kg once weekly). These 22 patients represent a ‘hard-to-treat’ salvage population, which rarely responds to monotherapy. Nine patients (six AML; three HR-MDS) have received at least three doses of an efficacious dose of VIP943 (i.e., ≥1.0 mg/kg). Of these nine patients, four (
“We are excited by the emerging data from our Phase 1 study of VIP943, showing clinical responses in difficult-to-treat patients," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "We believe these promising clinical responses highlight the potential of VIP943 as a best-in-class therapy for CD123+ hematologic malignancies and validate our VersAptx platform’s ability to create safer, more effective bioconjugates by overcoming the challenges of historical ADCs.”
As of August 2024, VIP943 has shown favorable safety and tolerability, with no dose-limiting toxicities reported in 22 patients. Serious adverse events (SAEs) have been consistent with expectations for this patient population. The most common SAEs included pneumonia (three patients,
Target engagement (i.e., receptor occupancy) has been demonstrated by binding of VIP943 to CD123+ peripheral blood blasts from patients with AML from the Phase 1 study. Maximal receptor occupancy of
Dr. Hamdy continued, “Our initial clinical results demonstrate that VersAptx is a next-generation platform that overcomes key challenges associated with traditional ADCs. The PK profile shows that our linker is stable, cleaving exclusively inside cells without extracellular degradation. Our PD results coupled with clinical responses confirm the payload effectively kills cancer cells in peripheral blood and bone marrow without harming nearby healthy tissue. This innovative design with proof-of-concept in Phase 1 reinforces our confidence in VersAptx as a transformative platform for ADC development.”
The company anticipates providing another data update on the ongoing Phase 1 VIP943 study by the end of the year.
Dr. M. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology added, "Although this is still early data, VIP943 is clearly differentiated from other ADCs, particularly with its favorable safety profile. We’re not seeing neutropenia as a dose-limiting toxicity, which is encouraging and may allow the drug to move into earlier lines of therapy in combination. I look forward to the continued development of VIP943 and its potential to improve treatment options for patients with CD123+ malignancies.”
VIP236 Update
VIP236 is Vincerx’s first-in-class small molecule drug conjugate (SMDC) being evaluated in an ongoing first-in-human, Phase 1 dose-escalation study as a monotherapy in patients with advanced solid tumors. As of September 2024, 29 patients have been enrolled. Of these patients, 20 were evaluable per-protocol for response from the every 2- or 3-week schedule; nine of 20 patients had stable disease for a disease control rate of
Considering the promising VIP236 clinical data, the Company intends to pursue a strategic partner to champion its future development for the benefit of patients.
“We've made significant progress in identifying an effective dose and schedule. We believe it is now crucial to study VIP236 in the right patient population, which could include triple-negative breast cancer and gastric cancer, where camptothecins are used, especially in combination with other anticancer agents,” added Dr. Hamdy.
By transitioning VIP236 to a partnering asset, the Company plans to streamline its operations and focus its efforts on the continued development of its lead ADC, VIP943.
Enitociclib Update
Enitociclib, a highly selective CDK9 inhibitor, is currently being evaluated in a Phase 1 dose-escalation study in combination with venetoclax and prednisone for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL), in collaboration with the National Institutes of Health (NIH). As of September 2024, the study reported four partial responses (PRs) in seven patients (
Additionally, in a separate Phase 1 study of enitociclib as a monotherapy (30 mg), one patient with transformed follicular lymphoma achieved a metabolic PR. As of September 2024, this patient remains on enitociclib monotherapy after more than 26 months. Overall, these clinical results continue to show the promising safety, tolerability, and efficacy of enitociclib for the treatment of relapsed/refractory lymphoma. The Company is actively focused on finding a strategic partner to continue the development of this asset.
Corporate Webcast
Vincerx will host a corporate webcast today at 5:00 PM EDT. The webcast will provide a pipeline and corporate update, including discussing the initial clinical data from the Phase 1 dose-escalation study of VIP943, followed by commentary with key opinion leader, Dr. M. Yair Levy (Texas Oncology), and live Q&A with Vincerx leadership.
The webcast may be accessed through the “Corporate Overview & Events” in the Investors section of the Company’s website, located at investors.vincerx.com. An archived replay will be available shortly following the webcast.
About VIP236
VIP236, the first-in-class SMDC from the VersAptx Platform, consists of an αvβ3 integrin binder, a neutrophil elastase linker cleaved in the tumor microenvironment, and a camptothecin payload optimized for high permeability and low active efflux. VIP236 was designed to deliver its payload to advanced/metastatic solid tumors that express αvβ3. VIP236 is being evaluated in a first-in-human, Phase 1 dose escalation study in patients with advanced malignancies (NCT05712889).
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).
About Enitociclib
Enitociclib, a highly selective CDK9 inhibitor, is currently being evaluated in a Phase 1 dose-escalation study (NCT05371054) in combination with venetoclax and prednisone for DLBCL and PTCL, in collaboration with the NIH. Enitociclib has demonstrated favorable safety and PK, with significant clinical benefits across various indications, including durable complete metabolic remissions in patients with double-hit (DH)-DLBCL and stable disease in solid tumors, notably in ovarian cancer, suggesting promising potential for future combination studies.
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. Vincerx’s diverse pipeline consists of the next-generation antibody-drug conjugate, VIP943, in Phase 1; small molecule-drug conjugate, VIP236, in Phase 1; preclinical antibody-drug conjugate, VIP924; CDK9 inhibitor, enitociclib, in an NIH-sponsored Phase 1; and VersAptx, its versatile and adaptable, next-generation bioconjugation platform.
Vincerx is based in Palo Alto, California, and has a research facility in Monheim, Germany. For more information, please visit www.vincerx.com and follow Vincerx on LinkedIn.
Forward-Looking Statements
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, Vincerx’s business model, cash runway, pipeline, strategy, timeline, product candidates and attributes, platform benefits and attributes, and preclinical and clinical development, timing, 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, 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; risks associated with preclinical or clinical development and studies, 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 timing of expected business and product development milestones; changes in the assumptions underlying Vincerx’s expectations regarding its future business or business model; Vincerx’s ability to successfully develop and commercialize product candidates; Vincerx’s capital requirements, availability and uses of capital, and cash runway; and the risks and uncertainties set forth in the Form 10-Q for the quarter ended June 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 our trademarks.
Contacts
Gabriela Jairala
Vincerx Pharma, Inc.
gabriela.jairala@vincerx.com
Cassidy McClain
Inizio Evoke Comms
Cassidy.McClain@inizioevoke.com
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