Louis Fries on neuraminidase...
"Q - In the Vaccine paper, it was very interesting how you do the -- maybe the cross reactivity, especially with the N protein, the neuraminidase protein. Do you see moving forward, do you get sort of a broader response by focusing on the neuraminidase response because it's less mutatable than H protein?
Louis Fries -
Yes, this is Lou Fries again. We think that we believe that our antigen, and there's published data to this effect, that our antigen has the potential for a considerable breadth of response. And let me take up 2 different points there. First of all, we do build neuraminidase into the construct. As you know, neuraminidase is in some of the licensed vaccines now but it is a passive by stander and there's no strategy to actively include it.
It's a difficult molecule to quantitate and work with but we're gaining experience, we're building a set of assays that are going to allow us to understand the level of control of neuraminidase and more importantly, the level of the immune responses to it and we've been able to show immune responses to it. You correctly point out that neuraminidase evolves less rapidly than does hemagglutinin and so there is an opportunity there for cross-reactive immunity.
We've already shown in animals that our neuraminidase alone in the absence of a homologous hemagglutinin can provide protection against lethal disease. So yes, we are focusing on the opportunity of neuraminidase and actively working on that.
I also point out that in some of our prior publications about H5N1, we've been able to show that our construct elicits immune responses to concerned parts of the hemagglutinin that are not elicited by the egg-derived vaccines. And so we have actually several different specificities to our immune response that can serve to distinguish us from the existing vaccines."
Strategic and technological tools to unlock remaining ‘blockbuster’ unmet medical needs
9.00 Chair’s introduction
Case studies: Analyzing the latest development strategies behind candidate vaccines for unmet needs that represent potential billion-dollar markets - comparing notes from clinical successes and failures to date
The RSV F nanoparticle vaccine: Viral pathophysiology points the way to antigen design and clinical strategy
Dr Gregory M. Glenn, Senior Vice President & Chief Medical Officer, Novavax
Emerging pathogens: How to face the latest wave of ID threats with the benefit of past experience?
(NOTE! The content of this session in particular will alter as the situation concerning H7N9 becomes clear over the coming months)
2.30 Chair’s introduction
Dr Robert Huebner, Acting Director, Influenza & Emerging Diseases Division, Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), US Department of Health and Human Services (HHS)
2.35 Government, regulator and industry perspectives, followed by roundtable discussion Middle East respiratory syndrome coronavirus (MERS-CoV) – defining the potential threat to global public health moving forward, and the market opportunities (or lack of them) for the vaccine industry
- Industry perspective: Lessons learned from SARS vaccine development on the pros and cons of pursuing novel pathogens H7N9 – how to ensure a speedy and effective response on a global basis?
- Reviewing responses worldwide to date since the strain’s emergence
How has the community countered the problem of a lack of clinical data?
- How have lessons from recent pandemics been applied worldwide, particularly in terms of:
the clinical development model?
the adoption of novel technologies (eg. manufacturing platforms, adjuvants) and their efficient integration into the overall response?
- How will the linking of Pandemrix with increased risk of narcolepsy affect regulators’ attitudes – and the future for novel adjuvanted vaccines - in the US and Europe alike?
- What role will universal influenza vaccines play in addressing H7N9 and future potential pandemic strains?
How to respond to emerging pathogens for which there is
Dr Marion Gruber, Director, Vaccines Research & Review, US FDA
Dr Gregory M. Glenn, Senior Vice President & Chief Medical Officer, Novavax
Dr Richard Kenney, CMO, Immune Design
Andrew Geall, PhD, RNA Vaccine Platform Novartis
Thanks... also you may have seen this press release from Cadila last month...
" In addition, CPL Biologicals has set up manufacturing facility at Dholka, Ahmedabad in the state of Gujarat, to develop, produce and sell products such as seasonal influenza vaccine and potentially other novel vaccines against dengue fever and chikungunya fever based on Novavax’s virus-like-particle (VLP) vaccine technology."
Oct7 pr was the turn down...IMO...when PATH was not included in the trial ...shorts have had no reason to cover...along with weakness in the sector...
Well said max....
and that's why Gale Smith makes more from his patent royalties than Novavax could pay him... having him on the call was a great decision...
"HHS awards flu antigen contract to CSL
September 12, 2012
Australia-based vaccine maker CSL Biotherapies secured a contract with the U.S. government to strengthen the country's supply of pre-pandemic and pandemic vaccine antigens in the event of an outbreak.
The contract between CSL and the U.S. Department of Health and Human Services (HHS) is worth about $1.5 billion, according to CSL. The Australian speculates that about one-third of the figure will be spent on pre-pandemic planning, with the rest going toward pandemic demand (if one actually occurs).
CSL will manufacture and store antigens that can be used against influenza strains with pandemic potential. The vaccine maker will also be asked to develop virus "seeds" for other manufacturers, and to formulate, fill and finish bulk stored antigen, as requested by the national government."
Q4 Events-probable and possible
1)NVAX RSV Phase II Trial in Woman start
2) Isconova Rabies Trial Results with Matrix-M
3) Genocea begins Phase I Pneumococcal vaccine with Matrix-M
4) NVAX Q3 Results Conference Call
5) Lazard 10th Annual Healthcare Conference
6) 25th Annual Piper Jaffray Healthcare Conference
7) NVAX MERS Pre-clinical results
8) NVAX Phase I H7N9 Human Trial Results
9) RSV Vaccine for the World Conference
10) Cadila Rabies Phase I Trial start
11) Jenner malaria Vaccine mixed with Matrix-M Phase I results
Novavax may be the next big player... :)
from what I've seen GSK uses AS03 adjuvant...Squalene based
Novartis uses MF59....Squalene based adjuvant
Sanofi uses AF03...Squalene based adjuvant
it may be GSK uses a more toxic mix from the rest...but I'm glad now that Novavax uses it's saponin based Matrix-M and not squalene oil emulsion...
Steven Burrill is biotech’s unofficial spokesperson. Involved in creating industry stalwarts such as Genentech, Amgen and Chiron, he’s expanded his influence through a $1B+ venture capital fund and a successful merchant bank.
you may right b.....since the FDA only has the pandemic stockpile to worry about it's not as urgent as it is for the U.K. where they used it in the population.
But it may play a role in the decisions going forward regarding H7N9...this includes the biggest players...GSK, Sanofi and Novartis...
we'll see if it's only the 'apples' that contain squalene...
this is what I based it on... from March 2013 article...
"The FDA is facing calls to reconvene an advisory panel to review a GlaxoSmithKline vaccine in light of data linking an adjuvant to narcolepsy. And the outcome could have implications for other next-generation adjuvants pharma hopes will supercharge vaccines."
and this was before the U.K. decision...
with the headline..."U.K. gov makes U-turn on link between GSK vaccine and narcolepsy"...
it seems the FDA will have to follow....
"...Europeans have received AS03 and MF59 as part of seasonal and pandemic flu vaccines, but both have been involved in controversies over the past year. Novartis' adjuvanted seasonal flu vaccine, Fluad, was briefly banned in several countries over concerns about protein aggregation. The ban was lifted quickly after independent tests confirmed the safety of the vaccine. GSK, however, is still dealing with concerns about its adjuvant, which studies have linked to increased risk of narcolepsy."
this should shake up the pandemic landscape...I understand Sanofi was planning to test with GSK adjuvant as well...