CureVac Receives U.S. FDA IND Clearance to Initiate Phase 1 Clinical Trial for Novel mRNA-Based Precision Immunotherapy in Squamous Non-Small Cell Lung Cancer
CureVac (Nasdaq: CVAC) has received FDA clearance for its Investigational New Drug (IND) application to begin a Phase 1 clinical trial of CVHNLC in squamous non-small cell lung cancer (sqNSCLC) patients. CVHNLC is an mRNA-based precision immunotherapy encoding eight tumor-associated antigens.
The trial will evaluate CVHNLC in combination with pembrolizumab, featuring two parts:
- Part A: dose-escalation study (100μg to 400μg) as first-line maintenance treatment
- Part B: optional dose expansion testing CVHNLC with first-line chemotherapy and pembrolizumab
Primary endpoints include dose-limiting toxicities and treatment-related adverse events, while secondary endpoints cover overall response rate, progression-free survival, and disease control rate. Patient treatment is expected to begin in the second half of 2025, with additional oncology candidates planned for clinical trials in 2026.
CureVac (Nasdaq: CVAC) ha ricevuto l'autorizzazione dalla FDA per la sua richiesta di farmaco investigativo (IND) per iniziare un trial clinico di Fase 1 di CVHNLC in pazienti affetti da cancro polmonare non a piccole cellule squamoso (sqNSCLC). CVHNLC è un'immunoterapia di precisione basata su mRNA che codifica per otto antigeni associati ai tumori.
Il trial valuterà CVHNLC in combinazione con pembrolizumab, articolato in due parti:
- Parte A: studio di escalation della dose (da 100μg a 400μg) come trattamento di mantenimento di prima linea
- Parte B: espansione della dose opzionale testando CVHNLC con chemioterapia di prima linea e pembrolizumab
Gli endpoint primari includono tossicità limitanti della dose e eventi avversi correlati al trattamento, mentre gli endpoint secondari coprono il tasso di risposta complessivo, la sopravvivenza libera da progressione e il tasso di controllo della malattia. Si prevede che il trattamento dei pazienti inizi nella seconda metà del 2025, con ulteriori candidati oncologici previsti per trial clinici nel 2026.
CureVac (Nasdaq: CVAC) ha recibido la autorización de la FDA para su solicitud de medicamento en investigación (IND) para comenzar un ensayo clínico de Fase 1 de CVHNLC en pacientes con cáncer de pulmón no microcítico escamoso (sqNSCLC). CVHNLC es una inmunoterapia de precisión basada en ARNm que codifica ocho antígenos asociados a tumores.
El ensayo evaluará CVHNLC en combinación con pembrolizumab, con dos partes:
- Parte A: estudio de escalación de dosis (de 100μg a 400μg) como tratamiento de mantenimiento de primera línea
- Parte B: expansión de dosis opcional probando CVHNLC con quimioterapia de primera línea y pembrolizumab
Los objetivos primarios incluyen toxicidades limitantes de dosis y eventos adversos relacionados con el tratamiento, mientras que los objetivos secundarios abarcan la tasa de respuesta general, la supervivencia libre de progresión y la tasa de control de la enfermedad. Se espera que el tratamiento de los pacientes comience en la segunda mitad de 2025, con candidatos oncológicos adicionales previstos para ensayos clínicos en 2026.
CureVac (Nasdaq: CVAC)는 비소세포 폐암 (sqNSCLC) 환자에 대한 CVHNLC의 1상 임상 시험을 시작하기 위한 FDA의 승인을 받았습니다. CVHNLC는 여덟 가지 종양 관련 항원을 암호화하는 mRNA 기반의 정밀 면역 요법입니다.
이 시험은 pembrolizumab과 함께 CVHNLC를 평가하며, 두 부분으로 나뉩니다:
- 파트 A: 1차 유지 치료로서의 용량 증가 연구 (100μg에서 400μg까지)
- 파트 B: 1차 화학요법 및 pembrolizumab과 함께 CVHNLC를 시험하는 선택적 용량 확장
주요 목표는 용량 제한 독성과 치료 관련 부작용을 포함하며, 이차 목표는 전체 반응률, 무진행 생존 기간 및 질병 조절률을 포함합니다. 환자 치료는 2025년 하반기에 시작될 것으로 예상되며, 2026년에는 추가적인 종양학 후보가 임상 시험을 계획하고 있습니다.
CureVac (Nasdaq: CVAC) a reçu l'autorisation de la FDA pour sa demande de médicament expérimental (IND) afin de commencer un essai clinique de Phase 1 de CVHNLC chez des patients atteints de cancer du poumon non à petites cellules squameux (sqNSCLC). CVHNLC est une immunothérapie de précision basée sur l'ARNm codant pour huit antigènes associés aux tumeurs.
L'essai évaluera CVHNLC en combinaison avec pembrolizumab, comportant deux parties :
- Partie A : étude d'escalade de dose (de 100μg à 400μg) en tant que traitement de maintien de première ligne
- Partie B : expansion de dose optionnelle testant CVHNLC avec une chimiothérapie de première ligne et pembrolizumab
Les objectifs principaux incluent les toxicités limitantes de dose et les événements indésirables liés au traitement, tandis que les objectifs secondaires portent sur le taux de réponse global, la survie sans progression et le taux de contrôle de la maladie. Le traitement des patients devrait commencer dans la seconde moitié de 2025, avec d'autres candidats en oncologie prévus pour des essais cliniques en 2026.
CureVac (Nasdaq: CVAC) hat die Genehmigung der FDA für seinen Antrag auf ein investigational new drug (IND) erhalten, um eine Phase-1-Studie zu CVHNLC bei Patienten mit plättchenfreiem nicht-kleinzelligem Lungenkrebs (sqNSCLC) zu beginnen. CVHNLC ist eine mRNA-basierte präzise Immuntherapie, die acht tumorassoziierte Antigene kodiert.
Die Studie wird CVHNLC in Kombination mit Pembrolizumab bewerten und besteht aus zwei Teilen:
- Teil A: Dosissteigerungsstudie (100μg bis 400μg) als Erstlinien-Erhaltungstherapie
- Teil B: optionale Dosisexpansion, die CVHNLC mit Erstlinientherapie und Pembrolizumab testet
Die primären Endpunkte umfassen dosislimitierende Toxizitäten und behandlungsbedingte unerwünschte Ereignisse, während die sekundären Endpunkte die Gesamtansprechrate, das progressionsfreie Überleben und die Krankheitskontrollrate abdecken. Die Behandlung der Patienten wird voraussichtlich in der zweiten Hälfte von 2025 beginnen, mit weiteren onkologischen Kandidaten, die für klinische Studien im Jahr 2026 geplant sind.
- FDA clearance received for Phase 1 trial initiation
- Novel proprietary tumor antigens included in therapy design
- Second oncology program to enter clinical stage
- Multiple additional cancer programs planned for clinical trials in 2026
- Potential for expanded application in earlier disease settings
- Patient treatment not starting until second half of 2025
- Early-stage trial with no guaranteed success
- Complex trial design may extend development timeline
Insights
CureVac's FDA IND clearance for CVHNLC represents a significant regulatory milestone in their oncology pipeline development. This mRNA-based precision immunotherapy targeting squamous non-small cell lung cancer (sqNSCLC) demonstrates the company's strategic expansion beyond vaccines into cancer therapeutics.
The technology platform merits attention for two key innovations: First, CVHNLC employs dual mRNA constructs encoding eight tumor-associated antigens with prevalence across sqNSCLC patients. Second, it includes a novel class of tumor antigens identified through their proprietary whole genome-based discovery platform that haven't been previously tested in cancer immunotherapy trials.
The clinical development strategy is thoughtfully designed, combining CVHNLC with pembrolizumab - an established checkpoint inhibitor - to potentially amplify targeted anti-tumor immune responses. The trial's two-part structure allows for both dose optimization and exploration of combination therapy approaches.
For investors, this milestone validates CureVac's mRNA platform versatility beyond infectious diseases. However, with patient treatment not expected until H2 2025 and being a Phase 1 study primarily focused on safety and dosing, meaningful efficacy data and potential commercialization remain distant future events.
This represents CureVac's second oncology program to enter clinical development, with additional candidates expected to enter trials in 2026, indicating solid execution of their oncology pipeline strategy.
The FDA clearance for CureVac's CVHNLC trial addresses a critical unmet need in squamous non-small cell lung cancer (sqNSCLC), a disease with persistently poor prognosis despite recent therapeutic advances. The company's approach leverages a key biological insight: sqNSCLC exhibits high prevalence of shared tumor antigens across patients, creating an ideal target for off-the-shelf immunotherapy.
CVHNLC's mechanism of action aims to enhance the anti-tumor immune response when combined with pembrolizumab, potentially overcoming the efficacy seen with checkpoint inhibition alone. By encoding eight tumor-associated antigens, including novel ones discovered through their proprietary platform, the therapy could generate a more robust and targeted immune response.
The trial design is pragmatic and clinically relevant. The initial dose-escalation in maintenance therapy after first-line treatment allows for safety evaluation, while the planned expansion into first-line combination therapy addresses a key treatment window where improved outcomes could significantly impact patient survival.
Most intriguing is CureVac's stated goal to eventually move this combination therapy into earlier disease settings, where the impact on patient outcomes could be even more substantial. While early-stage (Phase 1), this approach represents a scientifically sound strategy with clear differentiation from existing immunotherapies for sqNSCLC.
Significant Regulatory Milestone: U.S. FDA cleared IND application for CVHNLC, CureVac's investigational therapy targeting squamous non-small cell lung cancer
Proprietary Epitopes: CVHNLC encodes novel tumor epitopes identified through proprietary whole genome-based discovery platform
Enhanced Combination Therapy: CVHNLC to be tested in combination with pembrolizumab, aiming to amplify targeted anti-tumor immune responses
Clinical Progress: Patient treatment anticipated to start in the second half of 2025
Pipeline Advancement: IND clearance highlights CureVac's continued oncology pipeline growth, with more candidates planned to enter the clinic in 2026
TÜBINGEN, GERMANY AND BOSTON, MA / ACCESS Newswire / April 7, 2025 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biotech company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1 clinical study of CVHNLC in patients with squamous non-small cell lung cancer (sqNSCLC). CVHNLC is CureVac's investigational mRNA-based precision immunotherapy consisting of two different mRNA constructs encoding eight tumor-associated antigens (TAAs) with prevalence across sqNSCLC patients. Encoded antigens include a novel class of TAAs that have not been previously tested in cancer immunotherapy trials.
The phase 1, dose-finding, open-label study will assess the safety and tolerability of CVHNLC plus pembrolizumab in patients with advanced sqNSCLC. The study comprises a dose-escalation part (Part A) of first-line maintenance treatment after either chemotherapy combined with pembrolizumab or pembrolizumab monotherapy. This is followed by an optional dose expansion part (Part B) in which CVHNLC is tested in combination with first-line chemotherapy and pembrolizumab.
"Immune checkpoint blockade has become a new standard of care for patients with metastatic squamous non-small cell lung cancer; however, overall prognosis still remains poor in advanced as well as in early settings of this disease, highlighting the urgent need for new therapeutic options," said Dr. Myriam Mendila, CureVac's Chief Scientific Officer. "Squamous non-small cell lung cancer exhibits a high prevalence of shared tumor antigens among patients, presenting a unique opportunity for developing targeted off-the-shelf mRNA immunotherapies. We believe by administering CVHNLC with checkpoint inhibition, we will trigger an amplified and targeted immune response, thereby increasing the efficacy against the cancer. Our goal is to take this combination also into earlier setting of the disease."
In Part A, patients with metastatic Stage IV sqNSCLC, who have received at least three cycles of pembrolizumab, either as monotherapy or in combination with chemotherapy, will be enrolled. CVHNLC doses between 100µg and 400µg plus pembrolizumab maintenance therapy for up to 12 months or until disease progression or undue toxicity occurs, will be administered with dose escalation. Primary endpoints include incidence of dose-limiting toxicities and treatment-related and emergent adverse events; secondary endpoints include overall response rate, progression-free survival, duration of response, and disease control rate.
"CVHNLC is our second oncology program to enter the clinical stage, highlighting the continued progress we are making with our mRNA-based precision immunotherapies. Importantly, we have been able to design CVHNLC using both known, shared tumor antigens and novel proprietary antigens discovered using our differentiated in-house technology platform," said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "We are leveraging this approach in the design of multiple novel cancer mRNA programs in our collaboration with MD Anderson Cancer Center, which we anticipate entering the clinic in the next 18-24 months."
About CVHNLC
CVHNLC has been built on CureVac's advanced second-generation mRNA backbone, featuring two different constructs utilizing unmodified mRNA formulated in lipid nanoparticles (LNPs). Its multi-epitope design encodes eight shared antigens, four of which are well-known with established relevance in solid tumors. The other four antigens are a novel class of TAAs uniquely derived from CureVac's proprietary whole-genome discovery platform.
About Squamous Non-Small Cell Lung Cancer
In the U.S., there are approximately 225,000 new cases of lung cancer each year,
About CureVac
CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer immunotherapy product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.
CureVac Media and Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com
Forward-Looking Statements of CureVac
This press release contains statements that constitute "forward looking statements" as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company's vaccine and treatment candidates and the timing of programs entering the clinic. In some cases, you can identify such forward-looking statements by terminology such as "anticipate," "intend," "believe," "estimate," "plan," "seek," "project," "expect," "may," "will," "would," "could," "potential," "intend," or "should," the negative of these terms or similar expressions. Forward-looking statements are based on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
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SOURCE: CureVac
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FAQ
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