Radiographic Analysis of VB-111 Phase 2 and 3 Clinical Trials in Recurrent Glioblastoma Shows Survival Benefit Associated with Objective Responses and Distinct Signature of VB-111 Activity
TEL AVIV, Israel, June 03, 2019 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT), today announced that MRI data from VB-111 Phase 2 and Phase 3 studies in recurrent GBM (rGBM), presented yesterday at the 2019 American Society of Clinical Oncology (ASCO) annual meeting, showed a survival benefit associated with objective responses to the compound and a distinct signature of VB-111 activity. The data were presented by Dr. Benjamin M. Ellingson, Ph.D., from the UCLA Brain Tumor Imaging Laboratory (BTIL), Department of Radiological Science.
The UCLA analysis compared data from VBL's Phase 2 study of VB-111, which met the primary endpoint of OS benefit with a median OS (mOS) of 414 days, to MRI data from the treatment arm in the GLOBE Phase 3 study, which had a mOS of 6.8 months, despite similar baseline tumor volume between patient cohorts. The goal of the analysis was to investigate the difference between the trial outcomes, using quantitative radiographic tools.
There was a notable difference in the regimens between the studies: in the Phase 2 study, VB-111 was administered first as a single agent therapy (`priming`), with bevacizumab added to VB-111 upon further progression; in contrast, the GLOBE Phase 3 study regimen included co-administration of VB-111 and bevacizumab (Avastin®) from the start of study therapy without any VB-111 monotherapy `priming` period.
“Our analyses revealed that responders to VB-111 monotherapy or combination therapy after priming with VB-111 exhibited characteristic, expansive areas of necrosis in areas of initial disease, which are related to the VB-111 mechanism of action,” said Dr. Ellingson. “Some patients had clear evidence of response to VB-111 while others showed pseudo-progression, potentially linked to edema and local immune response induced by VB-111, which may have been misinterpreted as disease progression. The data show that responders to VB-111 treatment had a statistically significant survival advantage compared to non-responders.”
“This analysis provides independent, quantitative evidence that priming with VB-111 has clinically-meaningful activity in rGBM, which can be seen by MRI signature, and is correlated with a statistically significant survival advantage,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “We believe this work supports our view that VB-111 has therapeutic potential in rGBM and other difficult to treat and aggressive cancers. The VB-111 program in rGBM is now being advanced in an investigator-sponsored study at leading neuro-oncology centers in the U.S. VBL is also conducting a potential registration study of VB-111 in ovarian cancer, OVAL.”
For additional information see: ASCO poster
About VB-111 (ofranergene obadenovec)
VB-111, a potential first-in-class anticancer therapeutic candidate, is the Company’s lead oncology product currently being studied in the OVAL potential-registration Phase 3 pivotal trial for ovarian cancer (ClinicalTrials.gov Identifier: NCT03398655). VB-111 has received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. In addition, VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970). VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission.
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a potential registration trial for platinum-resistant ovarian cancer.
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding our programs, including VB-111, including their clinical development, such as the timing thereof, therapeutic potential and clinical results, and the scope and protection of our intellectual property rights. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical clinical trial results may not be predictive of future trial results, and that we may not realize the expected benefits of our intellectual property protection. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission, including in our annual report on Form 20-F for the year ended December 31, 2018, and subsequent filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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