8-K: VBI Vaccines Announces Encouraging Interim Data for VBI-1901 in Recurrent Glioblastoma Trial

VBI Vaccines reports positive interim tumor response data from its Phase 2b study of VBI-1901 in recurrent glioblastoma, showing a 43% disease control rate compared to 0% in the control arm.

Summary

• VBI Vaccines has released interim data from its Phase 2b trial of VBI-1901, an immunotherapeutic cancer vaccine, for recurrent glioblastoma (rGBM).
• The study is a randomized, controlled trial comparing VBI-1901 to standard-of-care therapy.
• As of May 15, 2024, 23 patients were randomized, with 7 in the VBI-1901 arm and 6 in the control arm having evaluable data.
• The VBI-1901 arm showed a 43% disease control rate (DCR), with one partial response (PR) and two stable disease (SD) observations.
• The partial response demonstrated a 67% reduction in tumor size at week 6 after two doses of VBI-1901.
• In contrast, the control arm had a 0% DCR, with 5 out of 6 patients experiencing a 2-8x increase in tumor size.
• The company expects additional interim data, including survival data, in Q4 2024.
• The FDA has granted VBI-1901 Fast Track and Orphan Drug Designations for rGBM.

Sentiment

Score: 8

Explanation: The document presents positive interim results for VBI-1901, with a notable disease control rate and a partial response. The FDA designations and the potential for accelerated approval contribute to a positive outlook. However, the study is ongoing, and the results are preliminary, which tempers the overall sentiment.

Positives

• The VBI-1901 treatment arm showed a 43% disease control rate, indicating potential efficacy.
• One patient experienced a significant 67% tumor reduction, demonstrating a partial response.
• The FDA's Fast Track and Orphan Drug Designations could expedite the approval process.
• The company expects to release additional data in Q4 2024, including survival data, which could further validate the treatment's effectiveness.
• Patient enrollment is increasing, with 6 patients randomized in May.

Negatives

• The study is still in progress, and the results are based on a small sample size of 7 patients in the treatment arm.
• The control arm showed no tumor responses and significant tumor progression in most patients, highlighting the severity of the disease.
• The study is open-label, which could introduce bias in the assessment of outcomes.
• The study is still enrolling patients and is not expected to be fully enrolled until the end of 2024.

Risks

• The study results are preliminary and based on a small number of patients, so the final results may differ.
• The success of VBI-1901 is dependent on the continued pace of enrollment and the strength of the clinical data.
• There is no guarantee that the FDA will approve VBI-1901, even with Fast Track and Orphan Drug Designations.
• The company's ability to commercialize VBI-1901 depends on securing future funding and manufacturing capabilities.
• The company faces competition from other companies developing treatments for glioblastoma.

Future Outlook

VBI expects to release additional tumor response and initial survival data in Q4 2024 and plans to discuss an accelerated development and approval pathway with the FDA based on the strength of the clinical data.

Management Comments

• David E. Anderson, Ph.D., VBIs Chief Scientific Officer, stated that the tumor responses seen to date are incredibly encouraging.
• Jeff Baxter, VBIs President and CEO, said that the data represents a considerable advancement in their effort to make a difference in the fight against GBM.

Industry Context

The announcement is significant as there are limited effective treatments for recurrent glioblastoma, and the current standard of care has limited efficacy. VBI-1901's potential to improve outcomes could be a major advancement in the field.

Comparison to Industry Standards

• The control arm in the study showed a 0% disease control rate, which is consistent with the limited efficacy of current standard-of-care treatments for recurrent glioblastoma, such as carmustine or lomustine.
• The previous Phase 1/2a study of VBI-1901 showed a 44% disease control rate and a median overall survival of 12.9 months, compared to the 8-month median overall survival for standard-of-care chemotherapy, indicating a potential improvement over existing treatments.
• The 43% disease control rate in the current Phase 2b study is comparable to the 44% seen in the Phase 1/2a study, suggesting consistency in the treatment's effect.
• The partial response with a 67% tumor reduction is a notable result, as many treatments for recurrent glioblastoma struggle to achieve significant tumor reduction.

Stakeholder Impact

• Shareholders may view the positive interim data as a positive development for the company.
• Patients with recurrent glioblastoma and their families may see hope in the potential of VBI-1901.
• Healthcare providers may be interested in the potential of VBI-1901 as a new treatment option.
• Employees of VBI may be motivated by the progress of the clinical trial.

Next Steps

• The company will continue to enroll patients in the Phase 2b study, aiming for full enrollment by year-end 2024.
• Additional interim data, including survival data, is expected in Q4 2024.
• VBI plans to discuss an accelerated development and approval pathway with the FDA based on the clinical data.

Key Dates

Keywords

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