Vascular Biogenics Ltd (VBLT)

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While we're waiting for the quarter and interim results, check out the patent filed in May 2016. A good read.

https://www.google.com/patents/US20160121001?cl=enAn

VB-111 and bevacizumab are both anti-angiogenic agents that target the tumor vasculature. However, they do so based on two distinct MOAs: Bevacizumab antagonizes VEGF while VB-111 directly disrupts the angiogenic vessels.

Expected Adverse Events with Bevacizumab
- Serious and sometimes fatal GI perforation occurs at a higher incidence in bevacizumab-treated patients compared to controls

Surgery and Wound Healing Complications
- The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in bevacizumab-treated patients

Additional patients were subsequently added to the study and the data were recalculated accordingly. Forty six patients aged 27-76 years at 4 medical centers in the US and Israel received up to 13 repeat doses of VB-111. Of these, 30 patients received the high dose (1×1013 VPs). There were 22 related adverse events, 19 CTCAE grade 1-2; grade 3 included pulmonary embolism, peri-tumoral edema and DVT. The median overall survival was 360 [range: 70-574] and 266 days [range: 28-664] for patients receiving at least one high dose vs. subjects who received lower doses, respectively (p NS). Progression free survival was 63 vs. 55 days for patients who received high vs. lower doses, respectively (p=0.01). Median follow-up was 232 days. Six patients had a partial response and/or prolonged disease stability (?180 days). Tumor growth rates showed a statistically significant dose response. Eleven patients received combination therapy of up to 4 doses of VB-111 together with bevacizumab after progression on VB-111 monotherapy. Median time to second progression was 93 days. These data are shown in FIG. 2. FIG. 3 provides an example of a patient who was treated with a combination of VB-111 and bevacizumab upon disease progression. VB-111 was safe and well tolerated both as monotherapy and combined therapy.

[0639]
Conclusions:
VB-111 was safe and well tolerated in patients with recurrent GBM with repeat doses of up to 1×1013 VPs. Tumor responses were seen. Overall survival was about 3 months longer compared to historical data in recurrent GBM including standard of care anti-angiogenic agents. Data suggests that VB-111 potentiates the response to bevacizumab given at further progression.