Vascular Biogenics Ltd [linkme to=”VBLT”] is a publicly traded, late-stage clinical Biopharmaceutical company focused on the discovery, development and commercialization of first in class treatments for cancer.
Vascular Biogenics ‘s clinical pipeline is based on two distinct, proprietary platform technologies that leverage the body’s natural physiologic and genetic regulatory elements. To date, Vascular Biogenics has developed two programs based on these platforms – an oncology program and an anti-inflammatory program.
Shares of Vascular Biogenics have fallen by 15% on heavy trading volume Tuesday morning. This may have been caused after their stock price suddenly rose by 75% on Monday due to a market overreaction following positive trial results for the company’s ovarian cancer treatment.
The results for the VB-111 drug, which treats patients with recurrent platinum resistant ovarian cancer, were statistically significant. The results demonstrated a median overall survival of 810 days in the drug dose arm compared to 172 days in the low dose arm, according to a company statement.
The Company’s lead oncology product candidate, VB-111, is a gene-based biologic that is initially being developed for recurrent glioblastoma, or rGBM, an aggressive form of brain cancer. Phase 2 interim data show overall survival benefit for VB-111 in rGBM, providing proof-of-concept, with good safety and tolerability. VB-111 has received orphan drug designation in both the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation. VBL Therapeutics’ pivotal Phase 3 GLOBE trial of VB-111 in rGBM is ongoing under a special protocol assessment granted by the FDA.
Vascular Biogenics’s oncology program is based on the Company’s proprietary Vascular Targeting System or VTS platform technology which utilizes genetically targeted therapy to destroy newly formed or angiogenic blood vessels.
VBL has also developed a proprietary platform of small molecules, Lecinoxoids, for the treatment of chronic immune-related indications.
“The demonstration of improved overall survival with the therapeutic dose, in combination with 60% durable response rate, is particularly impressive, given this trial focused on women with poor prognosis disease,” said Richard Penson, a well qualified person who is an MD, MRCP, Associate Professor of Medicine, Harvard Medical School, Clinical Director of Medical Gynecologic Oncology, Massachusetts General Hospital, and Primary Investigator for this trial.
[adv_smv1 link=”9″] “We are excited by this data set from our Phase 1/2 ovarian cancer trial which show durable disease control and responses with VB-111,” said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. “The data reinforce our confidence in VB-111 as, together with the positive data we have generated in GBM, this is the second cancer indication in which we have observed a significant survival benefit. We are now preparing for an end-of-Phase 2 meeting with the FDA which will guide the next steps in our ovarian cancer clinical program.”
This trial was designed as a Phase 1/2 dose escalation study. The primary objectives were to evaluate the safety and tolerability and identify dose limiting toxicity in combination of VB-111 and weekly paclitaxel; and explore the efficacy in an expanded cohort of the optimally tolerated dose of combination VB-111 and weekly paclitaxel, based on RECIST response, CA-125 response, progression free survival (PFS) and overall survival (OS) in patients with recurrent platinum-resistant ovarian cancer.
[must_read] About 10.8 million shares of Vascular Biogenics have been traded so far today, well above the company’s average trading volume of roughly 89,862 shares per day.