I'm blown away by the spectacular results of the RSV Phase II data that was just released. I'm not sure everyone really understood how great the results were. In my opinion, the proof-of-concept for RSV is completed. If we don't get a partner, that's just fine...and we will have a blockbuster on our hands. But I'm sure every scientists will understand the impact of the Phase IIb results. This is a fairly large 720 patient trial, so it bodes very very well for the next phases.
I will try to break down the results so everyone can understand clearly what is the implications:
"The RSV-F vaccine candidate was well-tolerated, with no vaccine-related serious adverse
events, at all doses and formulations. The safety profile was consistent with data from
prior Phase 1 and 2 studies."
So there are no SAE, so there is no risk at any dose.
"Significant increases in RSV-F antibody levels were observed across all doses and
formulations, consistent with prior studies. Peak RSV-F antibody levels were observed in
the group that received a single dose of vaccine containing 120 ug of antigen with one third of the aluminum phosphate dose used in prior studies"
Wow. This is the best case scenario for Novavax. In this trial, they wanted to reduce the alum adjuvant as much as possible because there might be questions on aluminum phosphate toxicity transfer to baby. And the fact that the highest response came from a single shot is also very good news for commercialization potential. A 2 shot regimen is not as favorable. Dose response is very good across all doses, this tells you the mechanism of action of the vaccine is on target for the disease.
I will continue in the next post...
"But I'm sure every scientists will understand the impact of the Phase IIb results." True, yet, we need the investment community to understand the results and that job is not getting done effectively. However, today marks a great move by NVAX management to change that by coupling the IIb news with a MERS announcement. Great move...keep it coming.
Flashback: William Tanner, Sept 2013...
"Novavax RSV-F vaccine is potentially one of the most under appreciated assets in the industry."
Can't wait to hear what Bill has to say now, after the mind-blowing RSV results...
Thanks for breakdown Bball! Pure awesomeness...
Excellent post bball…thanks
Amazing results… one shot! …Higher levels of palivizumab-like antibodies than any trial….
Most just don’t realize how clearly that translates to actual protection which means less babies in the hospital…Medimmune has already proved that to the FDA!...with a ton of data and with 10 times less antibody level!
And as good as these results are it could realistically result in protecting, at least most babies for the first 6 months…then it’s time for the next shot….then 1yr olds then 2 yr olds…etc…
As Glenn said….”the market is Prevnar-like”
And with no SAEs they can take the single high dose low alum forward in a clear straight forward fashion…this also clears the path for the Elderly/combo and pediatric trials to begin.
Yes, NVAX hit all of the marks needed to advance the program:
No SAE. This is critical if you want pregnant women to sign up for trial and eventually take this shot in their trimester. If you have any kind of SAE, it's over. And I think this was a very important criteria that most people took for granted. But in this population, this was a definite necessity. And they reduced the alum adjuvant usage to 1/3 of previous trial, further de-risking toxicity concerns. And highest antibody levels with 1 dose with quick ramp up in 14 days and last 90 days. And generating Synagis-like data that targets the same mechanism, so FDA can make the connection easier. The 1 dose is commercial friendly, and also lowers the COGS for NVAX to produce.
It does open up the whole market for different populations as ou mentioned. The future is bright for NVAX. I think PATH will continue their partnership, and hopefully support NVAX in their next trials to come.
Yes, bball...great results...and your breakdown is excellent...and it also exemplifies the trouble that I've had with management for years...they should be doing what you just did because few small investors understand the science...it has to be broken down into digestible pieces...(the news can't even get MERS facts straight)...we live in a world of hype... follow this board or any board for proof...hype is a tool...regardless of the bio sector going over a cliff, there was no attempt on the part of management to put on the brakes...the anticipation and expectations of these results is overshadowed by management's lack of public communication...it will be interesting to see how much play NVAX can get out of these long awaited results...also, where are new projects and products? Other bios with much less potential announce new products...it makes for news and brand building...I'm optimistic about long-term success for NVAX...but, people expecting a squeeze or huge jump right away in sp will be disappointed...
"Clear increases in RSV neutralizing antibodies were also shown across all doses and
formulations, and were strongest in women entering the study with the lowest baseline
levels, in confirmation of prior studies."
Dose response is very good, and the most benefit came from women with the least amount of antibody to begin with. Again, very favorable and consistent with previous studies. Repeatability in results is a very good sign.
"Vaccine-induced palivizumab-like antibody levels demonstrated strong concordance with
anti-RSV-F antibody responses. A single 120 µg antigen dose generated peak
palivizumab-like antibody levels of approximately 400 µg/mL, the highest levels seen in
Music to my ears, highest levels seen in any study. Amazing. And the vaccine is shown to target Synagis-like antibodies, this is critical to hitch onto the vast data from MedImmune for Synagis. Hello AstraZeneca!
"Kinetic analysis of the antibody responses showed rapid increases in antibody levels in
all vaccine formulations and dosing regimens. A single 120 µg antigen dose generated peak RSV-F and palivizumab-like antibody levels within 14 days of immunization, and high levels of both were sustained through the 91-day observation period"
So this is important because you need the antibodies in the mother to ramp up very quickly because ultimately you want inject the mother in the 3rd trimester and the antibody transfer to the unborn child at the peak. Additionally, you want the response to last at least 90 days because you want to protect the baby for several months...achieving the proof of concept that is needed for RSV maternal program.
Personally, I think this RSV program is completely de-risked at this point. The passive immunity is well documented with other vaccines like Pertussis, and it is well understood. I think PATH is going to be very happy with these unprecedented results. RSV is going to be going bye bye like the way of polio.
This is the data that seals this. The serum levels of Synagis like antibodies is impressive and makes the sales case that this is functional and predictive of the desired protective effects. Synagis is in trouble and NVAX just put on a fresh coat of paint for the for sale sign.