This section highlights FDA-related milestones and regulatory updates for drugs developed by CureVac (CVAC).
Over the past two years, CureVac has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CVGBM, CVHNLC, and H5N1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CVGBM ( CureVac Advances Cancer Vaccine Candidate ) - FDA Regulatory Timeline and Events
CVGBM ( CureVac Advances Cancer Vaccine Candidate ) is a drug developed by CureVac for the following indication: In patients with resected glioblastoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CVGBM ( CureVac Advances Cancer Vaccine Candidate )
- Announced Date:
- September 13, 2024
- Indication:
- In patients with resected glioblastoma.
Announcement
CureVac N.V. today presented compelling data from the dose-escalation Part A of its ongoing Phase 1 CVGBM cancer vaccine study in patients with glioblastoma at the European Society for Medical Oncology (ESMO) Congress.
AI Summary
CureVac N.V. presented promising results from the dose-escalation Part A of its Phase 1 CVGBM cancer vaccine study at the European Society for Medical Oncology (ESMO) Congress. The study, conducted in glioblastoma patients after chemo-radiation therapy, showed that 77% of evaluable patients developed cancer antigen-specific T-cell responses. Notably, 84% of these responses were de novo, meaning that the vaccine successfully triggered new T-cell activity in patients who had no pre-existing immune response against the cancer antigens.
The CVGBM vaccine was also found to be safe and well tolerated, with no dose-limiting toxicities observed up to the highest tested dose of 100 µg. Mild to moderate side effects such as headache, fever, and chills were reported, but they resolved within 1-2 days after injection. Based on these encouraging findings, the 100 µg dose has been chosen for the next phase of the study.
Read Announcement- Drug:
- CVGBM ( CureVac Advances Cancer Vaccine Candidate )
- Announced Date:
- September 9, 2024
- Indication:
- In patients with resected glioblastoma.
Announcement
CureVac N.V. announced that the first clinical data from CureVac's ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be presented at the European Society for Medical Oncology (ESMO) Congress (Barcelona, Spain, September 13-17, 2024).
AI Summary
CureVac N.V. announced that the first clinical data from its ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be presented at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, scheduled from September 13 to 17, 2024. The data will be shown through an oral presentation on September 13, along with a poster presentation of supporting preclinical data. In the study’s dose-escalation phase (Part A), investigators are reporting on the safety, tolerability, and initial immunogenicity of the CVGBM vaccine at various dose levels. Early findings indicate mostly low-grade adverse events without any dose-limiting toxicities, as verified by an independent Data Safety Monitoring Board. This breakthrough approach uses CureVac’s advanced mRNA technology to target aggressive brain cancer, offering new hope in the potential development of effective cancer vaccines.
Read Announcement- Drug:
- CVGBM ( CureVac Advances Cancer Vaccine Candidate )
- Announced Date:
- August 15, 2024
- Indication:
- In patients with resected glioblastoma.
Announcement
CureVac N.V. announced the start of the dose-confirmation Part B of its ongoing Phase 1 study in patients with resected glioblastoma.
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CVHNLC - FDA Regulatory Timeline and Events
CVHNLC is a drug developed by CureVac for the following indication: In patients with squamous non-small cell lung cancer (sqNSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CVHNLC
- Announced Date:
- April 7, 2025
- Indication:
- In patients with squamous non-small cell lung cancer (sqNSCLC).
Announcement
CureVac N.V 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).
AI Summary
CureVac N.V. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to start a Phase 1 clinical study of its investigational therapy, CVHNLC, in patients with squamous non-small cell lung cancer (sqNSCLC). CVHNLC is an mRNA-based precision immunotherapy that encodes eight tumor-associated antigens discovered using CureVac’s proprietary whole-genome platform. The study will assess the safety and tolerability of CVHNLC when used in combination with pembrolizumab, a checkpoint inhibitor, to potentially enhance targeted anti-tumor immune responses. Patient treatment is anticipated to begin in the second half of 2025. This IND clearance marks a significant step in the company’s ongoing expansion of its oncology pipeline, confirming its commitment to advancing innovative therapeutic strategies for challenging cancer types.
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H5N1 - FDA Regulatory Timeline and Events
H5N1 is a drug developed by CureVac for the following indication: Avian Influenza.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- H5N1
- Announced Date:
- April 24, 2024
- Indication:
- Avian Influenza
Announcement
CureVac announced the start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A (H5N1) pre-pandemic vaccine candidate developed in collaboration with GSK.
AI Summary
CureVac has begun the Phase 1 portion of a combined Phase 1/2 study for its investigational influenza A (H5N1) vaccine candidate. Developed in partnership with GSK, the monovalent vaccine leverages CureVac’s proprietary second-generation mRNA backbone to encode the influenza A H5-antigen. The study addresses pandemic preparedness against the highly pathogenic H5N1 virus, which has shown the ability to cross from birds to humans and is seen as a potential future pandemic threat.
The trial will initially focus on evaluating the vaccine's safety, reactogenicity, and immunogenicity in healthy individuals, including both younger adults (ages 18 to 64) and older adults (ages 65 to 85). Up to five different dose levels will be tested against a placebo control in a dose-escalation format. This milestone marks a significant step in using mRNA technology for infectious diseases and enhances efforts to prevent future pandemics.
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