I think we will get more color on the GLOBES trial on March 15'nth. The company is at an inflection point. The question needs to be raised is VB111 strong enough to produce meaningful changes in survival; i.e.. were the phase II trials accurate? If you look at the ovarian cancer trial, there were only like 4 patients? in the lower dose cluster. My question is this: is that enough to justify POC? in light of the GLOBES failure. There is biomarker CA125 showing substantial reductions with VB111 as proxy for meaningful effect, but will that translate into/justify a phase III trial that may enroll very slowly.
One could make an argument for stopping VB111--or at least modifying the ovarian into a more robust phase II trial to establish meaningful POC. In light of the GLOBES(and my reading of the ovarian), I'm not sure it makes sense.
Alternatives? there are, I believe, backup compounds to VB111 which may be more potent--that's the real issue is strength of effect. In my exhaustive due diligence, one of the things that worried me was in the animal models, the potency/effect was not that dramatic. Another consideration is their preclinical program with MOSIP which looks to be very, very attractive, a true immune target. With their case, they could develop this technology, a true platform technology with autoimmune conditions such as MS.
Is there an argument to be made with stopping the ovarian trial until they can establish POC. All three of their phase II studies were flawed in this respect... low dose/high dose, changes in the trial structure in rGBM, a puny cohort for comparison in thyroid and ovarian. If I were CEO, I'd shelve future dollars on VB111 and move forward on their unique preclinical asset... MOSIP. I would buy back in on speculation would the CEO signal he's open minded on VB111. Look, Dror H. is a brilliant guy and an ethical guy, but sometimes you can be married to a particular asset and one can become blinded.... as an investor, as a doctor, or as a CEO.
