Vascular Biogenics Ltd (VBLT)

[wcopeland]

I just had a chance to check out Jan2018 company presentation, and lots of interesting information.

One thought that is really standing out to me though: Bristol Myers Squibb (BMY) is a very legitimate suitor of VBLT, and the timeline for which VBLT might engage in a big transaction (partnership/acquire) is taking shape.

1. Several ex-BMY executives are now affiliated with VBLT:
Corrine and Rachel Humphrey (at least she was...) are at the top of that list. Successful transactions are much more likely to happen when entities have shared networks/connections.

2. They are using nivolumab (Opdivo) in their Ph1/2 NSCLC:

Remember, that their preclinical studies used an anti-PD-L1 which would have suggested that they purchased either Genentech or AstraZeneca's molecule. If they were playing it safe and conservative, why would they move away from the preclinical combination? It seems way too risky unless they were offered other significant benefits. Also, there were two anti-PD1 molecules: pembroluzimab (Keytruda; Merck) and nivolumab (BMY). Currently, Merck's pembroluzimab seems to have the slight edge in physician's perceptions. So once again, why nivolumab from BMY?

3. BMY is losing to Merck - at least in public perception:
Both have anti-PD1 drugs - which are all the rage as a foundational component of immunne therapy in cancer. In the past few months Merck has gained a significant advantage on BMY in NSCLC: Merck passed monotherapy trial while while BMY fails, Merck releases positive results on pembroluzimab + chemotherapy in first-line. It should be clear that BMY needs a win. And I would wager that after 18 months of losing, their win needs to show superiority rather than comparability.

4. The trial design gives hints that a big decision could be made around Q2-Q3 2019.
Look at Slide 25 of the 2018 deck. Even though BMY is "losing" to Merck, nivolumab is still an FDA-approved drug that many patients would sacrifice much to gain access to. I am believing that the efficacy of VB-111 will be justified by GLOBE by 3/31/18. Bottom line: patient recruitment should happen very quickly. Let's assume FSFV (first subject, first visit) is on March 31, 2018.

For the Ph1 safety run-in, lets say it takes 1 month to recruit the 12 patients, and that they want to see 2 doses of VB111+Nivo before proceeding. LSFV (last subject, first visit) is 5/1/2018. Confirmation of safety around Cycle 7 for Patient #12 puts us around 8/1/2018.

For the Ph2 portion, let say they recruit 33 patients per month (conservative). That would be 3 months to fully enroll. LSFV for Patient #112 would be around 11/1/2018. LSLV (last subject last visit) would be around 6 months later... around 5/1/2019.

At that point, VBLT and BMY will both have undisclosed knowledge of clinical outcomes. If VB111+Nivolumab results are impressive, BMY will have a short period to act.