CVGBM / CureVac - LARVOL DELTA

CureVac Announces Financial Results for the First Quarter of 2025 and Provides Business Updates (Yahoo Finance) - "CVGBM (glioblastoma): Data from Phase 1 Part B and the decision on advancing the program to Phase 2 remain on track for H2 2025. Enrolment was completed in Q1 2025 and data in H2 2025 is expected to include 20 patients with a follow up period of at least 6 months. CVHNLC (squamous non-small cell lung cancer): U.S. Phase 1 initiation anticipated in H2 2025 following receipt of FDA Investigational New Drug (IND) clearance; Clinical Trial Application (CTA) filed in Europe with decision expected Q2 2025. As previously communicated, first Phase 1 study with a personalized precision immunotherapy candidate expected to start in H2 2026."

New P1 trial • P1 data • Astrocytoma • Glioblastoma • Lung Non-Small Cell Squamous Cancer

Preliminary immunogenicity results from the dose escalation phase of a first-in-human study of the mRNA-based cancer vaccine CVGBM in patients with newly diagnosed MGMT-unmethylated glioblastoma (ITOC 2025) - "Materials and Methods Eligible patients were HLA-A*02:01-positive and had newly-diagnosed MGMT-unmethylated GBM (CNS WHO Grade 4) with a gross total or partial resection and completed radiotherapy with or without concomitant temozolomide. Innate immune cytokines were also transiently induced upon vaccination. Conclusions CVGBM was generally well tolerated up to a dose level of 100 µg and was able to induce antigen-specific T-cell responses in the vast majority of patients."

Clinical • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • HLA-A • MGMT

CV-GBLM-001: Safety and Tolerability of CVGBM in Adults with Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma (clinicaltrials.gov) - P1 | N=37 | Active, not recruiting | Sponsor: CureVac | Recruiting ➔ Active, not recruiting | N=16 ➔ 37

Enrollment change • Enrollment closed • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Clinical off-the-shelf program in glioblastoma (CureVac Press Release) - P1 | N=16 | NCT05938387 | Sponsor: CureVac | "CureVac presented the first clinical data from the Phase 1 study of CVGBM...in November at the Society for Immunotherapy of Cancer (SITC) and the Society for Neuro-Oncology (SNO) Congresses...In the fully enrolled dose-escalation Part A, CVGBM monotherapy induced cancer antigen-specific T-cell responses in 77% of 13 evaluable patients. Notably, 84% of these immune responses were generated de novo, inducing T-cell activity in patients without prior immunity to the encoded antigens. Among responding patients, 69% showed CD8+ responses, 31% had CD4+ responses, and 23% had both. 67% of responding patients showed immune responses against multiple antigens....The dose-expansion Part B of the study is ongoing at the recommended 100 µg dose. Initial data and a decision on advancing the program to Phase 2 are expected in the second half of 2025."

P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

First in human study of the mRNA-based cancer vaccine CVGBM in patients (pts) with newly-diagnosed and surgically resected MGMT-unmethylated glioblastoma (GBM): first results from the dose escalation phase (SNO 2024) - "This is an ongoing, first-in-human study evaluating the safety of CVGBM in pts with newly-diagnosed MGMT-unmethylated GBM.MethodsHLA-A*02:01-positive pts with newly-diagnosed MGMT-unmethylated GBM (CNS WHO Grade [Gr] 4) who had a gross total or partial resection and completed radiotherapy ± concomitant temozolomide received CVGBM on Days 1, 8, 15, 29, 43, 57 and 71 + 6 optional doses at 6-week intervals. The highest tolerated dose was not reached. Based on all available safety data, the selected dose for trial expansion was 100 µg."

Clinical • P1 data • Ataxia • Brain Cancer • Cardiovascular • CNS Disorders • CNS Tumor • Epilepsy • Fatigue • Glioblastoma • Hypertension • Movement Disorders • Oncology • Pain • Solid Tumor • HLA-A • MGMT

Preliminary immunogenicity results from the dose escalation phase of a first-in-human study of the mRNA-based cancer vaccine CVGBM in patients with newly diagnosed MGMT-unmethylated glioblastoma (SITC 2024) - P1 | "Methods Eligible patients were HLA-A*02:01-positive and had newly-diagnosed MGMT-unmethylated GBM (CNS WHO Grade 4) with a gross total or partial resection and completed radiotherapy with or without concomitant temozolomide. Preliminary results for CD4+/CD8+ responses and induction of cytokines and chemokines in the peripheral blood will be presented. Conclusions CVGBM was generally well tolerated up to a dose level of 100 µg."

Clinical • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • HLA-A • MGMT

CureVac to Present at the 12th International mRNA Health Conference (CureVac Press Release) - "CureVac N.V...announced that new and updated data will be shared in two oral presentations and four posters at the 12th International mRNA Health Conference, taking place in Boston, Massachusetts, November 12-14, 2024. More detailed preliminary safety, tolerability and immuno­genicity data from the dose escalation part of CureVac’s ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be shared in an oral presentation....A second oral presentation will cover CureVac’s approach to developing optimized LNP delivery, while posters shared at the meeting will provide additional data on how CureVac optimizes its mRNA platform with different approaches as well as highlighting new targets for future development programs."

Clinical • P1 data • Glioblastoma

Pre-clinical development of CVGBM: A therapeutic mRNA-based multiepitope vaccine for glioblastoma (ESMO 2024) - P1 | "These data supported the initiation of a phase I clinical trial (CV-GBLM-001; NCT05938387) evaluating CVGBM in HLA-A*02:01-positive patients with surgically resected MGMT-unmethylated glioblastoma (CNS WHO Grade 4)."

Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • HLA-A • MGMT

First in human study of the mRNA-based cancer vaccine CVGBM in patients (pts) with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma (GBM): First results from the dose escalation phase (ESMO 2024) - P1 | "We report first results from an ongoing, first-in-human study evaluating the safety of CVGBM in pts with newly diagnosed MGMT-unmethylated GBM. HLA-A*02:01-positive pts with newly diagnosed MGMT-unmethylated GBM (CNS WHO Grade [Gr] 4) who had a gross total or partial resection and completed radiotherapy ± concomitant temozolomide received CVGBM on Days 1, 8, 15, 29, 43, 57 and 71 + 6 optional doses at 6-week intervals. CVGBM was generally well tolerated with an acceptable safety profile. The highest tolerated dose was not reached. Based on all available safety data, the selected dose for trial expansion was 100 μg."

Clinical • P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • HLA-A • MGMT

CureVac's CVGBM Cancer Vaccine Induces Promising Immune Responses in Phase 1 Study in Glioblastoma Presented at the ESMO 2024 Congress (ACCESSWIRE) - P1 | N=16 | NCT05938387 | Sponsor: CureVac | "CureVac...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....Preliminary immunogenicity results demonstrate induction of cancer antigen-specific T-cell responses in 77% of evaluable patients following CVGBM monotherapy. 84% of immune responses were de novo, observed in patients without pre-existing. T-cell activity against encoded cancer antigens. CVGBM was generally well tolerated up to the highest tested dose level of 100 µg with no dose-limiting toxicities....100 µg was selected as the recommended dose for the dose expansion phase, which recently started enrollment."

P1 data • Glioblastoma

CureVac to Present First CVGBM Glioblastoma Cancer Vaccine Clinical Data at ESMO 2024 Congress (CureVac Press Release) - "CureVac...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). Clinical data will be presented as an oral presentation on Friday, September 13, along with a poster presentation of preclinical data supporting the program’s development....The Phase 1 study includes a dose-escalation part (Part A) and dose-expansion part (Part B). Results for Part A will be covered in the oral presentation, with safety and tolerability as well as initial immunogenicity data provided for all evaluable patients at dose levels of 12-100 µg. A summary of treatment-emergent adverse events (TEAEs), which were mostly Grade 1-2 and yielded no dose-limiting toxicities as confirmed by a Data Safety Monitoring Board, will also be provided."

P1 data • Preclinical • Astrocytoma • Glioblastoma

CureVac Advances Cancer Vaccine Candidate CVGBM to Part B of Phase 1 Study in Patients with Resected Glioblastoma (ACCESSWIRE) - "CureVac...announced the start of the dose-confirmation Part B of its ongoing Phase 1 study in patients with resected glioblastoma....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....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."

DSMB • P1 data • Trial status • Astrocytoma • Glioblastoma

CV-GBLM-001: Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: CureVac | Active, not recruiting ➔ Recruiting

Enrollment open • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Proffered Paper: Pre-clinical development of CVGBM: A therapeutic mRNA-based multiepitope vaccine for glioblastoma (EACR 2024) - P1 | "This demonstrated correct translation and processing of the CVGBM-encoded fusion protein and presentation of the encoded peptides.To test potential anti-tumor efficacy of such a vaccine, a murine surrogate multiepitope mRNA encoding 10 epitopes derived from the murine B16.F10 tumor model and an additional synthetic T-helper epitope was tested in B16.F10 tumor-bearing mice. The surrogate mRNA vaccine demonstrated anti-tumoral immune responses by significantly extending the median survival time of mice.Conclusion These data supported the initiation of a first-in-human, phase 1 trial (CV-GBLM-001; NCT05938387) assessing CVGBM in HLA-A*02:01-positive patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma (CNS WHO Grade 4)."

Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • HLA-A • MGMT

Phase 1 dose-finding study to evaluate safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma. (ASCO 2024) - P1 | "In addition to the primary safety objectives, secondary objectives of efficacy (progression-free survival, overall survival) and patient-reported quality of life outcomes will be assessed. Trial sponsor: CureVac SE, Germany."

Clinical • P1 data • Tumor mutational burden • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • HLA-A • MGMT • TMB

Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: CureVac | Recruiting ➔ Active, not recruiting | N=54 ➔ 16

Enrollment change • Enrollment closed • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2023 and Provides Business Update (Issuer Direct) - "The open-label study evaluates the safety and tolerability of CVGBM in up to 54 patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM features a single unmodified mRNA encoding eight epitopes derived from known tumor-associated antigens with demonstrated immunogenicity in glioblastoma. A first data readout is expected in the second half of 2024."

P1 data • Astrocytoma • Glioblastoma

TRIAL IN PROGRESS: PHASE 1 DOSE-FINDING STUDY TO EVALUATE SAFETY AND TOLERABILITY OF CVGBM IN PATIENTS WITH NEWLY DIAGNOSED AND SURGICALLY RESECTED MGMT-UNMETHYLATED GLIOBLASTOMA (EANO 2023) - "In addition to the primary safety objectives, secondary objectives of efficacy (progression-free survival, overall survival) and patient-reported quality of life outcomes will be assessed. Trial sponsor: CureVac SE, Germany."

Clinical • P1 data • Tumor mutational burden • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • HLA-A • MGMT • TMB

CureVac Announces Financial Results for the Second Quarter and First Half of 2023 and Provides Business Update (Issuer Direct) - "The open-label study evaluates the safety and tolerability of CVGBM in up to 54 patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. The study is being conducted in Germany, Belgium and the Netherlands....A first data readout is expected in the second half of 2024."

P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: CureVac

New P1 trial • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

CureVac Doses First Patient in Phase 1 Study of Cancer Vaccine Candidate for Surgically Resected Glioblastoma (Issuer Direct) - "CureVac N.V....announced that it has dosed the first patient with its investigational cancer vaccine CVGBM in a Phase 1 study. CVGBM is based on CureVac's proprietary second-generation mRNA backbone and features a single mRNA, encoding eight epitopes derived from known tumor-associated antigens with demon­strated relevance in glioblastoma. A first data readout is expected in the second half of 2024....The open-label study evaluates 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....The Phase 1 proof-of-principle study of CVGBM is currently being conducted in Germany, Belgium and the Netherlands."

P1 data • Trial status • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor