VBL Therapeutics Announces Enrollment of the First Patients in the Phase 2 Clinical Trial of VB-111 in Metastatic Colorectal Cancer
VBL Therapeutics (Nasdaq: VBLT) has commenced a Phase 2 clinical trial investigating the combination of VB-111 and nivolumab (Opdivo®) for metastatic colorectal cancer. The trial, part of a Cooperative Research and Development Agreement with the National Cancer Institute, aims to enhance immune responses against this prevalent cancer. The initial patient enrollment reflects progress despite COVID-19 challenges. VB-111, VBL's lead candidate, is already under study for other solid tumors, showcasing its potential in addressing unmet medical needs in oncology.
- Initiation of Phase 2 trial for VB-111 with nivolumab indicates progress in cancer treatment.
- First two patients enrolled, demonstrating commitment to ongoing research despite external challenges.
- Potential to address unmet medical needs in metastatic colorectal cancer, a significant market.
- Trial results are uncertain, and reliance on historical data may not predict future outcomes.
- Regulatory approvals and trial timelines remain subject to substantial risks and delays.
- Study to investigate for the first time a combination of VB-111 with the checkpoint inhibitor, nivolumab.
TEL AVIV, Israel, Sept. 10, 2020 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT) announced today that the first two patients have been enrolled in the Phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo®), an immune checkpoint inhibitor, for the treatment of metastatic colorectal cancer. The study is being conducted under a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute (NCI) and VBL.
“Colon cancer is one of the most common cancers worldwide, but immune-based approaches in gastrointestinal cancers have unfortunately been largely unsuccessful,” said Tim F. Greten, M.D., Deputy Branch Chief & Senior Investigator of the Thoracic and GI Malignancies Branch (TGMB), Co-Director of the NCI Center for Cancer Research (CCR) Liver Cancer Program, and the principal investigator of the study. “The reasons for this are unclear, but no doubt relate to the fact that, in advanced disease, GI cancer appears to be less immunogenic. The goal of this Phase 2 study is to investigate whether priming with VB-111 followed by the addition of nivolumab may induce anti-tumor immune response in metastatic colorectal cancer, for which there remains a major unmet need.”
“We are pleased to see beginning of enrollment in this study, despite the challenges of COVID-19,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “We look forward to collaborating with the NCI on investigating VB-111 for the potential benefit of patients with colorectal cancer.”
For additional information on the study refer to https://clinicaltrials.gov/show/NCT04166383.
For patients interested in enrolling in this clinical study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: https://trials.cancer.gov
About VBL
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 areas of unmet need in cancer and immune/inflammatory indications. VBL has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications. VBL’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 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in a VBL-sponsored “all comers” Phase 1 trial as well as in three VBL-sponsored tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a VBL-sponsored Phase 3 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 of clinical trials and expected announcement of data, therapeutic potential and clinical results, and our financial position and cash runway. 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, the impact of the COVID-19 pandemic on our business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines and clinical results, that our financial resources do not last for as long as anticipated, 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 our 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, 2019, 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.
INVESTOR CONTACT:
Michael Rice
LifeSci Advisors
mrice@lifesciadvisors.com
(646) 597-6979
FAQ
What is the purpose of the VBLT VB-111 and nivolumab trial?
When did VBL Therapeutics start the Phase 2 trial for VB-111?
What are the implications of the VBL-111 trial for colorectal cancer treatment?
How does the partnership with the National Cancer Institute benefit VBLT's trial?
