CureVac Advances Cancer Vaccine Candidate CVGBM to Part B of Phase 1 Study in Patients with Resected Glioblastoma
CureVac N.V. (Nasdaq: CVAC) has advanced its cancer vaccine candidate CVGBM to Part B of a Phase 1 study for patients with resected glioblastoma. The first patient has been administered in this dose-confirmation phase, which is expected to include up to 20 patients. Part B aims to generate extended data on safety, tolerability, and immunogenicity of CVGBM.
CVGBM is CureVac's first investigational cancer vaccine based on its second-generation mRNA backbone. It encodes a single fusion protein with eight epitopes showing immunogenicity in glioblastoma. The study's Part A, involving 16 patients and testing doses from 12 to 100 μg, has been completed with no dose-limiting toxicities reported. A 100 μg dose was recommended for Part B.
Initial data from Part A will be presented at the ESMO Congress on September 13, 2024.
CureVac N.V. (Nasdaq: CVAC) ha portato avanti il suo candidato vaccino contro il cancro CVGBM alla Parte B di uno studio di Fase 1 per pazienti con glioblastoma rimosso chirurgicamente. Il primo paziente è stato trattato in questa fase di conferma del dosaggio, che si prevede includa fino a 20 pazienti. La Parte B mira a generare dati estesi su sicurezza, tollerabilità e immunogenicità di CVGBM.
CVGBM è il primo vaccino investigativo contro il cancro di CureVac basato su un backbone mRNA di seconda generazione. Codifica una singola proteina di fusione con otto epitopi che mostrano immunogenicità nel glioblastoma. La Parte A dello studio, che ha coinvolto 16 pazienti e ha testato dosi da 12 a 100 μg, è stata completata senza segnalazioni di tossicità limitante per il dosaggio. È stata raccomandata una dose di 100 μg per la Parte B.
I dati iniziali della Parte A saranno presentati al Congresso ESMO del 13 settembre 2024.
CureVac N.V. (Nasdaq: CVAC) ha avanzado su candidato a vacuna contra el cáncer CVGBM a la Parte B de un estudio de Fase 1 para pacientes con glioblastoma resecado. El primer paciente ha sido administrado en esta fase de confirmación de dosis, que se espera incluya hasta 20 pacientes. La Parte B tiene como objetivo generar datos ampliados sobre seguridad, tolerabilidad e inmunogenicidad de CVGBM.
CVGBM es la primera vacuna contra el cáncer en investigación de CureVac basada en un esqueleto de mRNA de segunda generación. Codifica una sola proteína de fusión con ocho epítopos que muestran inmunogenicidad en glioblastoma. La Parte A del estudio, que involucra a 16 pacientes y prueba dosis de 12 a 100 μg, se ha completado sin toxicidades limitantes de dosis reportadas. Se recomendó una dosis de 100 μg para la Parte B.
Los datos iniciales de la Parte A se presentarán en el Congreso ESMO el 13 de septiembre de 2024.
CureVac N.V. (Nasdaq: CVAC)는 수술로 제거한 교모세포종 환자를 대상으로 하는 1상 시험의 B파트로 암 백신 후보 CVGBM을 진행하고 있습니다. 이 용량 확인 단계에서 첫 번째 환자에게 치료가 시작되었으며, 최대 20명의 환자가 포함될 것으로 예상됩니다. B파트의 목표는 CVGBM의 안전성, 내약성 및 면역원성에 대한 데이터를 확장하는 것입니다.
CVGBM은 CureVac의 2세대 mRNA 백본을 기반으로 한 첫 번째 연구 중인 암 백신입니다. 교모세포종에서 면역원성을 나타내는 8개의 에피토프가 있는 단일 융합 단백질을 인코딩합니다. 12μg에서 100μg까지의 용량을 테스트한 16명의 환자가 포함된 A파트의 연구는 용량 제한 독성이 보고되지 않고 완료되었습니다. B파트를 위한 100μg의 용량이 추천되었습니다.
A파트의 초기 데이터는 2024년 9월 13일 ESMO 학회에서 발표될 예정입니다.
CureVac N.V. (Nasdaq: CVAC) a avancé son candidat vaccin anticancéreux CVGBM à la Partie B d'une étude de Phase 1 pour des patients ayant subi une résection de glioblastome. Le premier patient a été administré dans cette phase de confirmation de dose, qui devrait inclure jusqu'à 20 patients. La Partie B vise à générer des données étendues sur la sécurité, la tolérabilité et l'immunogénicité de CVGBM.
CVGBM est le premier vaccin anticancéreux en enquête de CureVac basé sur un backbone d'ARNm de deuxième génération. Il code une seule protéine de fusion avec huit épitopes montrant une immunogénicité dans le glioblastome. La Partie A de l'étude, impliquant 16 patients et testant des doses de 12 à 100 μg, a été complétée sans toxicités limitantes de dose rapportées. Une dose de 100 μg a été recommandée pour la Partie B.
Les données initiales de la Partie A seront présentées lors du Congrès ESMO le 13 septembre 2024.
CureVac N.V. (Nasdaq: CVAC) hat seinen Krebsimpfstoffkandidaten CVGBM in Teil B einer Phase-1-Studie für Patienten mit reseziertem Glioblastom vorangetrieben. Der erste Patient wurde in dieser Dosierungsbestätigungsphase behandelt, die voraussichtlich bis zu 20 Patienten umfassen wird. Ziel von Teil B ist es, umfassende Daten zur Sicherheit, Verträglichkeit und Immunogenität von CVGBM zu generieren.
CVGBM ist der erste experimentelle Krebsimpfstoff von CureVac, der auf einem mRNA-Rückgrat der zweiten Generation basiert. Er kodiert ein einzelnes Fusionsprotein mit acht Epitopen, die im Glioblastom Immunogenität zeigen. Teil A der Studie, an der 16 Patienten beteiligt waren und Dosen von 12 bis 100 μg getestet wurden, wurde ohne gemeldete dosierungsbegrenzende Toxizität abgeschlossen. Eine Dosis von 100 μg wurde für Teil B empfohlen.
Die ersten Daten aus Teil A werden auf dem ESMO-Kongress am 13. September 2024 präsentiert.
- Successful completion of dose-escalation Part A with no dose-limiting toxicities
- Advancement to dose-confirmation Part B of the Phase 1 study
- Data Safety Monitoring Board approval to proceed with Part B
- Selection of 100 μg as the recommended dose for Part B
- None.
Insights
The advancement of CureVac's CVGBM cancer vaccine to Part B of the Phase 1 study is a significant milestone in glioblastoma treatment research. This mRNA-based vaccine, encoding eight epitopes in a single fusion protein, shows promise in its novel approach. The absence of dose-limiting toxicities in Part A is particularly encouraging, suggesting a favorable safety profile up to
CureVac's progress with CVGBM represents a potential breakthrough in the competitive landscape of mRNA-based cancer vaccines. The company's focus on glioblastoma, a high unmet medical need area, could position them favorably if successful. The advancement to Part B, involving up to 20 patients, will provide important data on immunogenicity, which is key for vaccine efficacy. Investors should note that while this news is positive, it's still early-stage research. The ESMO presentation in September could be a significant catalyst for the stock. However, it's important to consider that success in early-phase trials doesn't guarantee late-phase success or market approval. The mRNA therapeutics field is rapidly evolving and CureVac's progress here could strengthen its position among competitors like Moderna and BioNTech in the oncology space.
The ethical implications of CureVac's CVGBM trial are noteworthy. The focus on MGMT-unmethylated glioblastoma patients, who typically have a poorer prognosis, addresses a critical need in neuro-oncology. The trial design, administering the vaccine after standard treatments, aligns with ethical guidelines by not withholding established therapies. However, it's important to manage patient expectations, as early-phase trials primarily assess safety, not efficacy. The open-label design raises potential bias concerns, though it's common in oncology trials. As the trial progresses, maintaining transparency in data reporting and ensuring informed consent are paramount, especially given the vulnerable nature of the patient population. The ethical conduct of this trial could set important precedents for future mRNA-based cancer vaccine studies.
First patient administered in dose-confirmation Part B of Phase 1 study with mRNA-based, multiepitope cancer vaccine candidate CVGBM
Part B expected to include up to 20 patients to generate extended data on safety, tolerability, and immunogenicity of CVGBM
TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / August 15, 2024 / CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the start of the dose-confirmation Part B of its ongoing Phase 1 study in patients with resected glioblastoma. CVGBM is CureVac's first investigational cancer vaccine based on its proprietary second-generation mRNA backbone. It encodes a single fusion protein comprising eight epitopes with demonstrated immunogenicity in glioblastoma.
"After successful completion of the dose-escalation part A of this clinical study with CVGBM, the dose expansion part B is important to confirm that we have selected the appropriate dose based on safety and immunogenicity for further studies in patients suffering from glioblastoma," said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. "Importantly, the review by the Data Safety Monitoring Board confirmed there have been no dose-limiting toxicities to date in Part A with the four doses tested, and have enabled us to move forward to this next part of the study."
The open-label study is evaluating the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM is administered as a monotherapy after surgical resection and completion of radiotherapy with or without chemotherapy. The study consists of two parts, a dose-escalation part (Part A) and a dose-expansion part (Part B). Part A has successfully been completed and involved 16 patients, testing doses in the range of 12 to 100 µg. A review of the safety data from Part A by the Data Safety Monitoring Board (DSMB) confirmed no dose-limiting toxicities. A 100 µg dose was recommended for Part B of the study.
Initial data on the dose-escalation Part A will be presented in an oral presentation at the European Society for Medical Oncology Congress (ESMO) on September 13, 2024.
More information can be found at clinicaltrials.gov ( NCT05938387 ).
About CVGBM
Based on CureVac's proprietary second-generation mRNA backbone, designed for improved mRNA translation and increased as well as extended protein expression, CVGBM encodes a single fusion protein comprising eight epitopes derived from tumor-associated antigens (TAA) with relevance in glioblastoma, including HLA class I epitopes presented on HLA A0201 and class II epitopes. The applied epitopes have been previously shown to induce immune responses in glioblastoma patients when administered as peptide vaccines with adjuvants. CVGBM applies unmodified mRNA and is formulated within lipid nanoparticles (LNPs). The Phase 1 proof-of-principle study of CVGBM is currently being conducted in Germany, Belgium and the Netherlands.
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 vaccine 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 Contact
Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
M: +49 151 14 115247
patrick.perez@curevac.com
CureVac 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 CureVac
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SOURCE: CureVac
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FAQ
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