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Thoughts on the new facilities?
It looks like a good move to me. A signal from the company that the trial is going well and they *may* need a production facility if/once they receive approval.
No sure thing. But trending in the right directionl
Nice article and nice info on the drug's effectiveness. There's no doubt in my mind that VB-111 works. Now, it's a matter of seeing how effective it is across the 100+ patients in the globe trial.
Here is the link to the article.
Forgot to add it in the original post.
I do not disagree with you. I think if the drug is fully realized (firstline treatment) then 100 (2.5 bil mkt cap) is low. But many things have to fall in place.
I am cautiously optimistic. More than anything, I want this to work for all the people suffering with GBM. If VB-111 works then it could open up millions in funding for research in this area.
davidal66 ... I think if that scenario played out 20s and 30s ($500-800 mil mkt cap) is realistic. Then it will continue to run up as more information comes out to confirm the drug's efficacy in other indications. jmho
What are your thoughts?
This is a must read Q&A with the CEO.
Lots of good info but this part summarizes upcoming key dates:
Q: What is your focus for the next 6-12 months?
- We expect to report full data from our Phase 2 trial of VB-111 in thyroid cancer, including Overall survival data by the end of 2016
- Plan to promote a potential-registration trial for VB-111 in ovarian cancer during 2017
- Expect interim data for the Phase 3 pivotal study in rGBM in 1H 2017
- Expect full data from the Phase 3 pivotal study at YE17/beginning of 2018.
Q: Can you tell us about your cash on hand, burn rate, upcoming rounds?
On June 30, 2016 we had $51.6M in cash, which takes us into 2019. This covers completion of the Phase 3 pivotal study in rGBM and the potential-registration trial for VB-111 in ovarian cancer.
Q: Can you tell us about the investment opportunity?
VBL is not actively seeking investments at this point, as we are well funded into 2019. That being said, we have many plans that we would like to implement, and we value smart-money and qualitative long-term investors.
In the 13D filing (page 4 of 7):
The obligations of Keffi VI and the other debtor under the notes issued to the Trust and Lee were secured by, among other things, a pledge of the Ordinary Shares of the Issuer owned by Keffi VI. In connection with such pledge, Keffi VI, Lee, the Trust and JPMorgan Chase Bank N.A. (the “Intermediary”) entered into a Securities Account Control Agreement dated May 4, 2015 which provides that at such time as Lee and the Trust send a Notice of Exclusive Control to the Intermediary, the Intermediary may thereafter honor solely the orders of Lee and the Trust concerning the account in which the pledged Ordinary Shares are held. On January 19, 2016, following a default under the Loans, Lee and the Trust delivered a Notice of Exclusive Control to the Intermediary which gives Lee and the Trust the right to direct the vote and disposition of the Ordinary Shares of the Issuer held in the account.
You can read the original Securities Account Control Agreement in the jpg files. In page 1, JPM is the intermediary, Thai Lee (and Trustee) is the lender and Keffi is the pledgor. This means that Keffi pledged its shares (in this case, VBLT) as collateral for the loan it received from Thai Lee. Keffi defaulted and lost its shares to Lee.
In this 20F filing (pg 84) it shows Keffi owning 4.8 mil shares (or 21.6%). These shares are now all owned by Lee.
The other link refers to the failed initial VBLT IPO (in August) because of funding issues with an investor. It didn't name the US investor, but this article does: "The IPO in August was canceled because one investor, US venture capital fund Keffi Group, headed by founder Jide Zeitlin, did not deliver its money at the closing." Jide Zeitlin sits on the VBL board.
This WSJ article goes into more details:
"People familiar with Keffi said the firm and Mr. Zeitlin believed that others would buy more stock than indicated in the prospectus, which would have reduced his obligation. But when it became clear that wasn't the case, he said he wouldn't fund its purchase, a person familiar with Keffi said.
Mr. Zeitlin was involved in a legal dispute in India, where a wireless company he started, Independent Mobile Infrastructure Ltd., was accused of not paying suppliers."
For me, the take away is that Keffi was a very bad investor -- from the IPO until now -- for VBL, which I think has very promising products. Now that Lee is replacing Keffi, perhaps we'll see a change in its performance.
Keffi Group VI LLC defaulted on their loan, and lost their shares to Thai Lee.
https://www.sec.gov/Archives/edgar/data/1677397/000161577416006946/0001615774-16-006946-index.htm
Keffi is the reason why the first VBLT IPO failed: http://www.law360.com/articles/566360/vascular-biogenics-ipo-undone-after-investor-fails-to-buy
Yes, there are some positive results and the rGBM patient population is cautiously optimistic. There are not a lot of options for this population so I think they are hoping that VB-111 is the first (of many) that can effectively help them.
Avastin is widely used but even on its website, it says, "The effectiveness of Avastin in rGBM is based on tumor response. Currently, no data have shown whether or not Avastin improves disease-related symptoms or survival in people with rGBM."
VB-111 will be a huge drug for these folks if phase 3 validates what prior trials have indicated.
Stanford, UCSF, UCLA among others recruiting for VB-111 in California ... not to mention Harvard/Dana Farber, MD Anderson .. pretty much a "Who's Who" of glioma research.
https://med.stanford.edu/neurology/divisions/neurooncology/clinicaltrials.html
https://clinicaltrials.gov/ct2/show/study/NCT02511405?show_locs=Y#locn
Two things I took away from the conf call:
1) Ovarian: "Additionally, 52% of the patient had tumors and had failed respond to prior anti-angiogenic agents including Avastin. Practically, most patients in Phase II trials has a better prognosis making this already a late trial. So while we design the trial primarily to look at safety, we were happy to see such significant efficacy."
2) RGBM: "We are saying that we are according to plan, but actually we are ahead of plan, but wanted to be very careful, because it goes month-by-month, but right now the excitement around the trial is quite big and we are recruiting very well."
Like Avastin, Cloughesy is the lead for VB-111. This guy is not going to risk his reputation on a "fraud" as the shorts claim.
Here's his background:
"Dr. Cloughesy’s research has focused on clinical trials in brain cancer using targeted molecular therapies with novel clinical trial design and biomarkers in brain cancer. He provided principal leadership for the approval of bevacizumab (Avastin®) for recurrent glioblastoma, which was the first drug approved in this disease setting in over 30 years. He is recognized as a world expert in brain cancer research and has led several first-in–human studies to treat glioblastoma. He has developed a brain cancer bioinformatics database that combines clinical outcomes, imaging, and molecular analysis to enhance translational research and has the goal of using biomarkers to provide individualized care for brain cancer patients. He has authored or co-authored over 270 peer-reviewed articles on brain cancer."
In regards to "patients will drop out of the placebo arm", one thing you can read into it is that patients do not have a lot of faith in Avastin (alone). Avastin has been used because in the past, there was no other option.
Good stuff, davidal66!
Good observation. Prior avastin trials had KPS median of 90, while VB-111 was 80. Even with better KPS, median survival was 32 weeks compared to VB-111's 59 weeks.
The CEO, Dror Harats, said that the recruiting criteria in phase 2 is similar to phase 3, and thus, provide a better indication of what to expect in the GLOBE trial.
Other companies recruit differently from phase 2 to 3 (like celldex), and that is the main reason for phase 2 success but phase 3 failure.
We will find out soon what caused today's move, imo. Only catalyst in Q3 is the FDA meeting on phase 2 Ovarian. I don't think that was the cause of today's move because the data has been published. Perhaps the phase 2 went well and VB-111 received fast track designation for ovarian?
The company is also actively looking for partners for its NASH products so that can happen at any time.
Someone knows something ... strong movement supported by over 2.5 million shares already.
Agree. Sales numbers seem low just for rGBM .. but that's ok. It will be higher as it is approved for other indications.
Exactly the way I feel about VBLT:
H.C. Wainwright’s Swayampakula Ramakanth believes if the VTS gene therapy platform is successfully developed by VBLT, it could revolutionize the multi-billion dollar angiogenesis inhibitor market.
“Currently, we expect VBL’s lead gene therapy product, VB-111, to reach the market in 2019 and achieve risk-adjusted annual sales of $386M by 2026,” Ramakanth stated.
International Thyroid Congress it at the end of October. This would correspond with full phase 2 data being available in Q4.
Agree that they'll probably be partnering to do the thyroid trial .. for NASH as well.
Thyroid Cancer Phase 2 study already met its primary endpoint of 6 month Progression Free Survival (“PFS”) with disease stabilization and safety, but we keep on following the patients for survival data, which we expect to report by the end of 2016.
They are releasing phase 2 data in a few months. And yes, if the data is good and they move to phase 3, expect another round of financing for thyroid ... like ovarian ... like rGBM. So trade accordingly.
https://www.sec.gov/Archives/edgar/data/1603207/000119312516589621/d185043d6k.htm
That day will come. VBLT wants VB-111 to be first line treatment, but they need to conquer the rGBM beast first and show that VB-111 is well tolerated (which it is). If VB-111 is tolerated in the recurrent (less healthy) population, I would think it would be well tolerated in the healthier population.
Principal investigator is Dr. Tim Cloughesy. He is leading the phase 3 GLOBE study. The shorts' accusations about data all falls apart when you look at Cloughesy's background.
Cloughesy is one of the leaders in the area of malignant gliomas. He is the Director of the UCLA Neuro-Oncology Program. He's not going to put his reputation on the line for some biotech company if some of the stuff the shorts claim are true.
FDA reviews and verifies the data and will not approve a trial for a number of reasons, including improper (selective) censoring.
The shorts complained about rGBM data and said there was no way it would move to phase 3.
Data for rGBM and ovarian supports VB-111 effectiveness. But naysayers / shorts will claim that there's not enough data points and they're correct. Phase 3 will completely eliminate all doubts one way or another.
View today's presentation by registering here:
https://www.veracast.com/webcasts/bio/internationalconvention2016/01234284636.cfm
For partnerships, they would probably do one for their NASH products, VB-703 and VB-201. They don't have the resources to effectively do NASH in parallel with rGBM, ovarian and thyroid.
VB-111 would certainly quality for BTD based on early ovarian results. Their selection process gives me more confidence going to phase 3. They're not selecting patients that will give them positive outcomes ... they're using the same or tougher criteria as they would in phase 3.
Fast track designation for ovarian is absolutely possible. Accelerated approval won't happen until FDA sees enough data in phase 3, imo.
Accelerated approval may happen with rGBM, which is in phase 3, since ovarian data confirms rGBM data.
Median overall survival has been reached at 810 days. In the prior release mean OS was 19.9 months, which is 597 days. Great data, imo.
VB-111 Clinical Data Presented at ASCO Demonstrate Significant Increase in Overall Survival in Platinum-Resistant Ovarian Cancer
Date(s): 6-Jun-2016
For a complete listing of our news releases, please click here
VB-111 demonstrated a statistically significant increase in overall survival at therapeutic vs. low dose level (810 days vs. 172 days, p=0.042)
60% (9 of 15) durable response rate (as measured by reduction in CA-125) observed with VB-111, approximately 2x the historical response with Avastin® plus chemotherapy in ovarian cancer
Clinical data supported by immunotherapeutic effect observed in biopsies following treatment with VB-111
TEL AVIV, Israel, June 06, 2016 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced the presentation of updated clinical results from a Phase 1/2 trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer. The data are being presented today in a poster at the 2016 American Society of Clinical Oncology (ASCO) annual meeting, in Chicago. They demonstrate a median overall survival of 810 days in the VB-111 therapeutic dose arm, versus 172 days in the low dose arm, a result that was statistically significant. There was also a durable doubling in the response rate, as measured by a reduction in the CA-125 biomarker, compared to historical rates of Avastin plus chemotherapy in ovarian cancer. Durable RECIST responses and disease stabilizations were also observed.
"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, MD, MRCP, Associate Professor of Medicine, Harvard Medical School, Clinical Director of Medical Gynecologic Oncology, Massachusetts General Hospital, and Primary Investigator for this trial.
"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.
Twenty one patients with recurrent platinum-resistant Müllerian/ovarian cancer were enrolled at Massachusetts General Hospital and Dana Farber Cancer Institute, and received up to 7 doses of treatment. Patients were treated in two consecutive cohorts: Low Dose Treatment (n=4, 3x1012 VPs + 40mg/80 paclitaxel) or a Therapeutic Dose (n=17, 1x1013 VPs + 80 paclitaxel). All patients had measurable disease, with a grade at diagnosis of: 1A (1, 5%), 1B (1, 5%), 1C (1, 5%); IIIC (12, 57%); or IV (6, 29%). The patients included in the study were of particularly adverse prognosis as 48% of the patients were primary platinum refractory and 52% had tumors that failed to respond to prior anti-angiogenic agents, including Avastin®.
The results showed a significant increase in overall survival at the therapeutic dose of VB-111 vs. the low dose level (810 vs. 172 days, p=0.042). Nine of the 15 evaluable patients (60%) on the therapeutic dose had a response, as defined by a 50% reduction in CA-125. Durable RECIST responses and disease stabilizations were seen. This represents an approximate doubling in response rate, compared to historical data with ovarian cancer patients treated with a combination of Avastin® and chemotherapy in the AURELIA1 trial.
An immunotherapeutic effect was also observed in biopsies taken from patients. H&E and immunohistochemistry staining showed regions of apoptotic cancer cells and infiltration of cytotoxic CD8 T-cells following treatment with VB-111.
VB-111 was found to be safe and well tolerated. Toxicity was similar to what would be expected with antiangiogenics and taxanes in this patient population. Eight serious adverse events were reported, 2 were considered by the investigator to be possibly related to be VB-111. No dose limiting toxicities were reported at any dose level.
Title: Clinical Data Presented at ASCO Demonstrate Significant Overall Survival Benefit in rGBM Patients Receiving VB-111 Compared with Historical Avastin® Meta-analysis Data
Date(s): 3-Jun-2016
VBL's Phase 2 study in recurrent glioblastoma (rGBM) met the primary endpoint of statistically-significant increase in median overall survival, with 59 weeks in patients treated with continuous exposure of VB-111, compared to 32 weeks in patients with limited VB-111 exposure (p=0.048).
Median overall survival for patients on continuous exposure of VB-111 was 59 weeks, compared with 32 weeks in historical pooled Avastin trials (p= 0.0295).
12-Month overall survival was 57% in patients on continuous exposure of VB-111, compared with 24% in historical pooled Avastin trials (p=0.03).
TEL AVIV, Israel, June 03, 2016 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq:VBLT), today announced the presentation of new data comparing clinical outcomes with VB-111 with pooled data from 8 studies that investigated Avastin® (bevacizumab) in recurrent glioblastoma (rGBM). The data are presented at the 2016 American Society of Clinical Oncology (ASCO) annual meeting, taking place in Chicago.
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/a06ea8e4-2295-4ae2-ae38-9f08925037f3
The study, "VB-111, An Anti-Cancer Gene Therapy in Combination with Avastin Significantly Improves Overall Survival Compared to Avastin Monotherapy in Patients with rGBM: A Phase 2 Historically Controlled Trial," was based on a literature search of studies investigating Avastin in GBM patients, published during the period January 2005 to November 2015. Out of 662 abstracts and 53 full text articles assessed for eligibility, the independent academic investigators identified 8 studies for inclusion in a meta-analysis, outcomes were then compared with the VB-111 Phase 2 data in rGBM. Survival data from these studies was extracted based on tables giving individual patient data or directly from Kaplan-Meier curves using software which converted curves into numerical data.
In the Phase 2 VB-111 trial, the median overall survival of patients who received continuous exposure of VB-111 in combination with Avastin was 59 weeks. This is compared to 32 weeks in the pooled data from the 8 studies in the meta-analysis (p= 0.0295; Hazard Ratio 0.62, 95% CI: 0.40-0.96). Median survival ranged from 26.0 weeks to 45.7 weeks in the meta-analysis. Overall survival at 12 months for patients on continuous exposure of VB-111 was 57%, compared with 24% overall survival (range 16% - 38%) for the pooled Avastin® treated rGBM data (p= 0.03).
"This meta-analysis provides a large dataset from diverse sources, which is pooled together to provide a reliable historical control group; superiority of VB-111 continuous exposure over this control group supports our belief that VB-111 used in combination with Avastin can potentially prolong survival in rGBM compared with Avastin alone," said Yael Cohen, MD, Vice President of Clinical Development at VBL Therapeutics. "The ongoing Phase 3 randomized controlled GLOBE study of VB-111 in combination with Avastin, which is being conducted in the U.S., Canada and Israel, is proceeding on track and our goal is to conduct an event-driven interim analysis according to the study protocol. While the timing of the interim analysis depends on enrollment and VB-111 activity, we expect to conduct it in the first half of 2017."
The Phase 2 trial was a multi-center study designed to determine the safety, tolerability and efficacy of VB-111 in patients with rGBM. A total of 46 patients were enrolled. In the first stage of the study, patients were treated with VB-111 alone. Upon disease progression, patients entered the second stage of the study, in which they received either Avastin alone as standard of care (limited exposure cohort) or VB-111 in combination with Avastin (continuous exposure cohort). The primary endpoint was overall survival (OS). VBL previously announced data from this study at the 2015 ASCO meeting and at the European Cancer Congress 2015.
VBL's ongoing pivotal Phase 3 GLOBE study in rGBM is comparing VB-111 in combination with Avastin to Avastin alone and is recruiting about 252 patients in the US, Canada and Israel. The study is proceeding under a Special Protocol Assessment (SPA) granted by the FDA, with full endorsement by the Canadian Brain Tumor Consortium (CBTC). VB-111 has received orphan drug designation in 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.
rGBM on Saturday and Ovarian on Monday. CEO stated that they will release updated data at ASCO so let's see what they release.
Upcoming Events
June 3 to June 7, 2016
The 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, which will take place June 3 to June 7, 2016 in Chicago
Ofranogene obadenovec (VB-111), an anti-cancer gene therapy in combination with bevacizumab to improve overall survival compared to bevacizumab monotherapy in patients with rGBM: A phase 2 historically controlled trial
Tumor responses and preliminary survival data in a phase 2 trial of ofranergene obadenovec (VB-111) combined with paclitaxel in patients with recurrent platinum resistant ovarian cancer
June 06, 2016 through June 09, 2016
2016 BIO International Convention, which will take place on June 6-9, 2016 at the Moscone Center, San Francisco, CA
This was Dror Harats response in the earnings call regarding ovarian patients:
=====
But more than this, we are going to show the type of patients that we are having in this trial and I urge you all to look very carefully at the characteristic of the patients, because in most trial doctors avoid taking patient what we called a primary platinum-refractory patients which are patient who never respond to platinum or that less than three months after responding to platinum already had a recurrent.
I don't want to say the number, but you will see it when we'll have the data at ASCO. I don't think that we put it at the abstract, but you will see it at ASCO itself and it’s a very high number. And the other point is that we are going to show that we have a very high number of patients that's already failed Avastin. So, to have 60% response rate in this type of population is actually a great indication that there is real response that we are seeing here.
=====
In the KOL event he compared VB-111 to Celldex, and also talked about how Celldex's phase 2 and 3 patient populations were different (as a possible reason for the drug's failure).
Celldex bellyflop has been discussed in the last two sessions. Check out:
1) Key Opinion Leader Meeting; and
http://lifesci.rampard.com/20160504/reg.jsp
2) Earnings q & a
http://seekingalpha.com/article/3974924-vascular-biogenics-vblt-ceo-dror-harats-q1-2016-results-earnings-call-transcript?part=single
It has to do with patient selection. Celldex selected patients to get favorable results in phase 2 and bombed in phase 3. VBLT phase 2 patient is the same as phase 3. No guarantee for success but higher chance at replicating success in phase 2.
Lower dose level was not successful (0% vs 60% at therapeutic dose) -- current treatment is at 31%
I read the "median OS not reached" to mean that patients are still alive and that data will be better at ASCO.
ASCO abstract 5551: VB-111 for ovarian
Background: Ofranergene obadenovec (VB-111) is a gene therapeutic consisting of a non-replicating adenovirus vector (Ad-5) with a modified murine pre-proendothelin promoter leading to apoptosis of tumor vasculature by expressing a Fas-chimera transgene in angiogenic endothelial cells. Over 170 patients have been treated with VB-111 across different cancer indications with evidence of anti-tumor activity with no significant safety issues. We report results of the phase II study of VB-111 in combination with paclitaxel in patients with recurrent müllerian cancers.
Methods: VB-111 was administered as intravenous infusion at escalating doses from 3x1012 (DL1&2) to 1x1013 viral particles (VPs) (DL3, therapeutic dose) every 2 months. Paclitaxel was given at 40 mg/m2 (DL1), and 80mg/m2 weekly (DL2-3). A phase 2 expansion cohort commenced at DL3 (therapeutic dose). Assessments included safety, tumor response (CA-125 and RECIST), histopathology, progression free survival (PFS) and overall survival (OS).
Results: Nineteen patients at 2 US centers received up to 7 repeat doses of VB-111, 15/19 received the therapeutic dose. Median age was 65 (41-79) with a median of 3 prior lines of therapy. No DLTs were observed. VB-111 was associated with flu-like symptoms and mild infusion reactions; the drug was safe and well tolerated. In the therapeutic dose cohort, a 60% response rate (RR) was seen by the GCIG criteria (more than 50% reduction in CA-125), 93% had clinical benefit. The median OS was not reached, mean OS was 19.9 months. A dose-response was seen. Within the therapeutic dose cohort (n = 15), responses seen in 3 of the 5 patients who had received prior bevacizumab (RR 60%) and in 5 of the 9 pts with platinum refractory disease or progressive disease within 3 months of platinum (RR 55%). On study biopsies suggest that further to the anti-angiogenic mechanism of action VB-111 induced antitumor immune reaction.
Conclusions: VB-111 in combination with weekly paclitaxel was safe and well tolerated in ovarian cancer patients. Anticipated toxicities were observed. Tumor responses were seen and survival data is encouraging. Clinical trial information: NCT01711970
http://abstracts.asco.org/176/AbstView_176_167022.html
ASCO abstract 2074: VB-111 for rGBM
Background:
Ofranergene obadenovec (VB-111) is a gene-therapy specifically targeting angiogenic endothelial cells thereby leading to tumor starvation. Safety and efficacy of VB-111 in combination with bevacizumab (BEV) were evaluated in recurrent Glioblastoma (rGBM) patients in this Phase 2 study and were compared to pooled BEV data generated using meta-analysis.
Methods: VB-111 was administered at 1x1013 viral particles bimonthly until progression, followed by BEV standard of care (limited exposure cohort). The protocol was amended to add BEV 10mg/Kg biweekly combined with VB-111 bimonthly, until further progression (continuous exposure cohort). A systematic literature review identified reports of rGBM BEV monotherapy published between 1.1.2009 and 30.11.2015. Data were pooled in a meta-analysis and served as historical controls for comparison of VB-111 extended exposure cohort.
Results: 46 patients at 4 sites received up to 13 doses of VB-111. Upon further progression, 24 received VB-111 with BEV, 22 were treated with BEV as standard of care. VB-111 was safe and well-tolerated alone and combined with BEV. Median OS was 59 weeks for continuous exposure versus 33 weeks for limited exposure cohort (p = 0.048). Eight reports of BEV monotherapy were identified, with a total of 694 rGBM patients. VB-111 continuous exposure had superior OS compared to the pooled meta-analysis of BEV monotherapy, 59 versus 39 weeks (p = 0.0295, log-rank test), with a Hazard Ratio of 0.62 (95% CI: 0.40-0.96). Of 46 patients who received VB-111, 25 patients spiked a fever post- dosing of VB-111 at least once, which was associated with increased median OS of 64 weeks versus 34 weeks among patients without fever (p = 0.03).
Conclusions:
VB-111 was safe and well-tolerated alone and combined with BEV in rGBM patients. VB-111 continuous exposure significantly increased OS compared to a historical BEV meta-analysis controls, and compared to VB-111 limited exposure. Toxicities were as expected in this population. The GLOBE phase 3 randomized controlled trial of VB-111 in rGBM is currently underway. Clinical trial information: NCT01260506
http://abstracts.asco.org/176/AbstView_176_167566.html
Looking ahead to ASCO, VBLT has 2 abstracts - one for rGBM and one for ovarian:
Abstract 2074
Ofranogene obadenovec (VB-111), an anti-cancer gene therapy in combination with bevacizumab to improve overall survival compared to bevacizumab monotherapy in patients with rGBM: A phase 2 historically controlled trial.
Poster Board: #261
Andrew Jacob Brenner, MD, PhD - Presenter
The University of Texas Health Science Center at San Antonio
Abstract 5551
Tumor responses and preliminary survival data in a phase 2 trial of ofranergene obadenovec (VB-111) combined with paclitaxel in patients with recurrent platinum resistant ovarian cancer.
Poster Board: #374
Richard T. Penson, MD, MRCP - Presenter
Massachusetts General Hospital
VB-111 has 27 recruiting locations
https://clinicaltrials.gov/ct2/show/NCT02511405