8-K: VBI Vaccines Announces Encouraging Early Data for VBI-1901 Glioblastoma Treatment

VBI Vaccines reported early positive tumor response data from its Phase 2b study of VBI-1901 in recurrent glioblastoma, showing a 40% disease control rate in the treatment arm compared to 0% in the control arm.

Summary

• VBI Vaccines presented early data from its Phase 2b study of VBI-1901, a cancer vaccine immunotherapeutic, for recurrent glioblastoma (rGBM).
• The study is a multi-center, randomized, controlled, open-label trial evaluating overall survival, tumor response rates, and safety of VBI-1901.
• As of March 22, 2024, 17 patients were randomized, with 5 evaluable in the VBI-1901 arm and 6 in the control arm.
• The VBI-1901 treatment arm showed a 40% disease control rate (2 out of 5 patients with stable disease) at week 12.
• The control arm showed a 0% disease control rate, with all 6 evaluable patients experiencing tumor progression.
• In a previous Phase 1/2a study, VBI-1901 improved median overall survival by approximately 5 months compared to historical controls (13 months vs. 8 months) and achieved a 44% disease control rate.
• The FDA has granted Fast Track Designation and Orphan Drug Designation to VBI-1901 for recurrent GBM.
• Additional interim data from the Phase 2b study is expected mid-year and year-end 2024.

Sentiment

Score: 7

Explanation: The document presents positive early data for VBI-1901, with a clear improvement over the control arm. However, it is still early in the Phase 2b study, and there are risks associated with clinical trials and regulatory approvals. The sentiment is cautiously optimistic.

Positives

• The VBI-1901 treatment arm in the Phase 2b study showed a 40% disease control rate, indicating potential efficacy.
• The control arm had no tumor responses, highlighting the potential benefit of VBI-1901.
• The Phase 1/2a study demonstrated a significant improvement in median overall survival with VBI-1901 compared to standard-of-care.
• Patient enrollment in the Phase 2b study is accelerating, with Q1 2024 enrollment doubling Q4 2023.
• The FDA's Fast Track and Orphan Drug Designations for VBI-1901 could expedite its development and approval.

Negatives

• The Phase 2b study is still in its early stages, and the results are based on a small number of evaluable patients.
• All patients in the control arm experienced tumor progression, which is expected but highlights the need for effective treatments.
• The study is open-label, which could introduce bias in the assessment of outcomes.

Risks

• The early data from the Phase 2b study may not be indicative of final results.
• The study is ongoing, and there is a risk that the positive trends observed may not continue.
• The company faces risks related to clinical trials, regulatory approvals, and commercialization of its products.
• The company's ability to maintain compliance with Nasdaq listing standards is a risk.

Future Outlook

Additional interim data from the Phase 2b study is expected mid-year and year-end 2024.

Management Comments

• Dr. Anderson commented: 'In recurrent GBM, tumors typically double or triple in size within six weeks, with no effective treatments available to improve survival.'
• Dr. Anderson stated: 'Early indications from this ongoing study suggest tumor growth behavior in-line with expectations for both the standard-of-care arm and the VBI-1901 arm, based on positive data seen from the Phase 1/2a study.'
• Dr. Anderson said: 'While early, I am very excited by these results and hope to see the trends continue to confirm the results seen in earlier studies, where VBI-1901 improved median overall survival by ~5 months compared to historical controls.'

Industry Context

The announcement is significant in the context of glioblastoma treatment, where there is a high unmet need for effective therapies. The positive early data for VBI-1901 could position VBI Vaccines as a key player in this space.

Comparison to Industry Standards

• The control arm in the Phase 2b study used standard-of-care treatments like carmustine or lomustine, which have limited efficacy in recurrent glioblastoma, with a median overall survival of approximately 8 months.
• The Phase 1/2a study of VBI-1901 showed a median overall survival of 12.9 months, which compares favorably to the standard-of-care.
• The 40% disease control rate in the VBI-1901 arm of the Phase 2b study is a positive signal compared to the 0% in the control arm, suggesting a potential improvement over existing treatments.
• The study references a Lancet Oncology study (Taal et al., 2014) which showed that single-agent bevacizumab or lomustine had limited efficacy in recurrent glioblastoma, highlighting the need for new treatment options.

Stakeholder Impact

• Shareholders may react positively to the encouraging early data from the Phase 2b study.
• Patients with recurrent glioblastoma may benefit from the development of VBI-1901.
• The company's employees may be motivated by the progress of the clinical trial.
• The company's partners and collaborators may be encouraged by the positive results.

Next Steps

• The company will continue to enroll patients in the Phase 2b study.
• Additional interim data from the Phase 2b study is expected mid-year and year-end 2024.
• The company will continue to pursue regulatory approvals for VBI-1901.

Key Dates

Keywords

VBI-1901, glioblastoma, cancer vaccine, immunotherapy, tumor response, disease control rate, clinical trial, Phase 2b, FDA, Fast Track Designation, Orphan Drug Designation