VBI Vaccines Presents Encouraging Early Tumor Response Data From Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma
VBI Vaccines Inc. presents promising early tumor response data from Phase 2b study of VBI-1901 in recurrent glioblastoma at World Vaccine Congress 2024
Positive
VBI-1901 treatment arm shows 40% disease control rate with stable disease observed in 2 out of 5 patients at week 12
Control arm sees 0% disease control rate with all patients experiencing tumor progression by week 6
FDA grants Fast Track Designation and Orphan Drug Designation to VBI-1901 in recurrent GBM
Interim data expected mid-year and year-end 2024 for ongoing Phase 2b study
Phase 1/2a study results show VBI-1901 improved median overall survival by ~5 months compared to historical controls
FDA has recognized improvement in overall survival as a key criteria for new oncology drug approval
The early data from VBI Vaccines Inc.'s ongoing Phase 2b study of VBI-1901 presents a notable development in the treatment of recurrent glioblastoma (rGBM), which historically has had limited effective treatment options. The observation of a 40% disease control rate (DCR) in the treatment arm, compared to a 0% DCR in the control arm, is significant in the context of rGBM's aggressive nature and poor prognosis. The FDA's Fast Track and Orphan Drug Designations highlight the potential of VBI-1901 as a treatment that addresses an unmet medical need.
From an investment perspective, these developments could impact VBI's stock value as they signify progress towards a potentially marketable product. The biopharmaceutical sector is highly sensitive to clinical trial outcomes due to the associated risks and costs of drug development. Positive interim data may lead to increased investor confidence and could drive up the company's market valuation. Conversely, any setbacks in later stages could have a detrimental effect. Therefore, monitoring upcoming interim data releases will be important for stakeholders.
The biotech industry relies heavily on the progression of clinical trials and regulatory milestones. VBI's announcement could serve as a positive signal to the market, potentially affecting not only their stock but also influencing the broader sector sentiment regarding cancer immunotherapies. The doubling of patient enrollment in Q1 2024 compared to Q4 2023 indicates operational efficiency and could be interpreted as a positive indicator of the company's ability to execute its clinical development plans.
However, investors should consider the inherent volatility of biotech stocks, especially those in the clinical stage. The long-term impact on VBI's business will depend on the completion of the Phase 2b study, subsequent regulatory approval processes and the ability to commercialize VBI-1901 effectively. Additionally, the competitive landscape, including the development of alternative treatments and the overall market demand for new rGBM therapies, will influence the potential market share and revenue generation for VBI.
In the field of oncology, the development of new therapies is particularly challenging due to the complexity of cancer biology. The early tumor response data for VBI-1901 is promising, especially considering the historical median overall survival (mOS) improvement seen in the Phase 1/2a study. However, the limited sample size and the early stage of reporting necessitate cautious optimism. The true efficacy and safety profile of VBI-1901 will only be ascertainable upon the completion of the Phase 2b study and subsequent data analysis.
Investors should be aware of the risk of extrapolating early data to predict long-term outcomes. The scientific community and the market will be looking for consistent data points that validate the initial findings. Furthermore, the impact on patients' quality of life and the reduction in corticosteroid use are important factors that will be closely scrutinized, as these are critical aspects of patient care in rGBM treatment.
04/03/2024 - 08:00 AM
Data highlighted in oral presentation at World Vaccine Congress 2024 on April 3, 2024
Early data from patients eligible for evaluation at week 12 show two observations of stable disease, indicating no tumor progression, in VBI-1901 treatment arm (n=2/5; 40% disease control rate [DCR])
By comparison, no tumor responses have been observed in the control arm to-date (n=0/6; 0% DCR), with all patients seeing a 2-8x increase in tumor size by week 6
FDA has granted both Fast Track Designation and Orphan Drug Designation to VBI-1901 in recurrent GBM following encouraging Phase 1/2a study results
Additional interim data expected mid-year and year-end 2024
CAMBRIDGE, Mass. --(BUSINESS WIRE)--
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present early tumor response data from the ongoing Phase 2b study of VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (rGBM) at the World Vaccine Congress Washington at 1:10pm ET on April 3, 2024. The multi-center, randomized, controlled, open-label study has been designed to evaluate overall survival, tumor response rates, and safety and tolerability of VBI-1901 as a monotherapy in rGBM patients.
Dr. Anderson commented: “In recurrent GBM, tumors typically double or triple in size within six weeks, with no effective treatments available to improve survival. 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. 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 – ~13 months vs. ~8 months1 – and achieved a 44% DCR.”
Based on the data seen in the Phase 1/2a study of VBI-1901 in rGBM patients, the FDA granted Fast Track Designation in June 2021 and Orphan Drug Designation in June 2022 .
Dr. Anderson’s presentation will be archived on the Events/Presentations page in the Investors section of VBI’s website.
Phase 2b Data Highlights
As of March 22, 2024, 17 patients have been randomized 1:1 to either the active, VBI-1901 treatment arm, or to the control, standard-of-care treatment arm (SoC).
Active Study Arm: VBI-1901 + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
9 patients have been randomized and 5 of those patients are currently evaluable for tumor response assessment (n=5)
2 stable disease (SD) have been observed in the VBI-1901 arm to-date
40% (n=2/5) early disease control rate achieved
Control Study Arm: Standard-of-Care (SoC) Therapy – Carmustine or Lomustine
8 patients have been randomized and 6 of those patients are currently evaluable for tumor response assessment (n=6)
No tumor responses have been observed in the SoC arm
0% (n=0/6) disease control rate
All evaluable patients have experienced tumor progression and have been taken off study protocol
Phase 2b Patient Enrollment Update
14 leading neuro-oncology centers are actively recruiting patients across the United States
2 new clinical sites were activated in March 2024, with a third site expected to come online in April
Patient enrollment in Q1 2024 was double the enrollment rate observed in Q4 2023
Phase 1/2a Study Data Highlights – VBI-1901 10µg + GM-CSF Study Arms
(n=16)
44% disease control rate achieved (n=7/16) – disease control rate is defined as stable disease (SD) + partial tumor response (PR) + complete tumor response (CR)
2 partial responses (PR) were observed – 1 patient was on treatment for more than 28 months (2.33 years), surviving at least 40 months (3.33 years) as of August 1, 2023, with a maximum tumor reduction of 93% relative to baseline
5 additional patients demonstrated stable disease (SD) for a sustained period of time
All patients with a tumor response (PR or SD) (n=7/16) reached a minimum survival of 12 months
Median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care1
Phase 2b Study Design
Multi-center, randomized, controlled, open-label study in up to 60 patients with first recurrent GBM
Patients will be randomized in a 1:1 ratio across two study arms:
Intradermal VBI-1901 + GM-CSF: 10 µg dose every 4 weeks until clinical disease progression
Monotherapy standard-of-care: either intravenous carmustine or oral lomustine, every 6 weeks until disease progression or intolerable toxicity
Endpoints include:
Safety and tolerability
Overall survival (OS) – median and overall
Tumor response rate (TRR)
Progression-free survival (PFS)
Immunologic responses
Reduction in corticosteroid use relative to baseline
Change in quality of life compared to baseline
The U.S. Food and Drug Administration (FDA) has considered demonstration of a statistically significant improvement in overall survival relative to a randomized control arm to be clinically significant and has recognized this as criteria to support the approval of new oncology drugs.2
For more information about the Phase 2b study, visit clinicaltrials.gov and reference trial identifier: NCT03382977.
About GBM and VBI-1901
Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 14,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.
VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. The FDA has granted VBI-1901 Fast Track Designation and Orphan Drug Designation for the treatment of recurrent glioblastoma. These designations are intended to provide certain benefits to drug developers, including more frequent meetings with the FDA, and Accelerated Approval and Priority Review, if relevant criteria are met, among other benefits.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology and a proprietary mRNA-launched eVLP (“MLE”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts , with research operations in Ottawa, Canada , and a research and manufacturing site in Rehovot, Israel .
Website Home: http://www.vbivaccines.com/
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References
Taal W, Oosterkamp HM, Walenkamp AME, et al. Single-agent bevacizumab or lomustine versus a combination of bevacizumab plus lomustine in patients with recurrent glioblastoma (BELOB trial): a randomized controlled phase 2 trial. Lancet Oncol. 2014; 15: 943-953
Oncology Center of Excellence, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics; Guidance for Industry. FDA.gov. December, 2018
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such forward-looking statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the Company’s ability to regain and maintain compliance with the listing standards of the Nasdaq Capital Market, the Company’s ability to satisfy all of the conditions to the consummation of the transactions with Brii Biosciences, the Company’s ability to comply with its obligations under its loan agreement with K2 HealthVentures, the impact of general economic, industry or political conditions in the United States or internationally; the impact and continuing effects of the COVID-19 epidemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 13, 2023, and filed with the Canadian security authorities at sedar.com on March 13, 2023, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
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VBI
IR@vbivaccines.com
Source: VBI Vaccines Inc.
What data was highlighted at the World Vaccine Congress 2024 regarding VBI-1901?
Early tumor response data from Phase 2b study in recurrent glioblastoma.
What is the disease control rate observed in the VBI-1901 treatment arm at week 12?
40% disease control rate with stable disease in 2 out of 5 patients.
What designations has the FDA granted to VBI-1901 in recurrent GBM?
Fast Track Designation and Orphan Drug Designation.
What are the expected timelines for additional interim data from the ongoing Phase 2b study?
Mid-year and year-end 2024.
How did VBI-1901 perform in the Phase 1/2a study in terms of overall survival improvement?
Improved median overall survival by ~5 months compared to historical controls.
What criteria does the FDA consider for supporting the approval of new oncology drugs?
Demonstration of a statistically significant improvement in overall survival relative to a randomized control arm.
