An Immunogenicity Veteran Shares His Experiences

Robert Kubiak’s professional journey has taken him from the University of Illinois at Chicago to the labs at Johns Hopkins to his current role with MedImmune.  The next stop for Robert will be the 15^th Annual Immunogenicity for Biotherapeutics where he’ll be leading a workshop on the Fundamentals of Immunogenicity Assessment. 

Robert will be sharing his experiences in his current role acting as head of a research group focusing on validation of bioanlytical methods.  In addition, he’s worked on development and validation of immunoassays at Tandem Labs, PPD and Meso Scale Discovery as well.  You’ll find some of those experiences cited in the work below:

-   Correlation of screening and confirmatory results in tiered immunogenicity testing by solution-phase bridging assays, Journal of Pharmaceutical and Biomedical Analysis

Commented by Coleman, D., Hendricks, R., et al, in 2013 Letter to the Editor “Regarding confirmatory immunogenicity assays” J. Pharm. Biomed. Analysis

Kubiak et al. present experimental and theoretical evidence that correlation of the screening and confirmatory results may be a general feature of the tiered approach when the same test platform is used for both screening and confirmatory assays. Presence of such correlation suggests that one of the tiers is redundant and that a single tier (e.g. screening only) can potentially yield the same results as the two-tiered assay.

-   Is The Tiered Immunogenicity of Biologics the Adequate Approach in Prenatal Development?, FutureScience

Following the arguments by Kubiak et al., Sauerborn proposes replacing the current tiered approach to immunogenicity testing with risk-based approach that follows fit-for-purpose strategy.

-   Challenges in keeping pace with immunogenicity advances throughout the clinical development of a biological therapeutic, FutureScience

     Authors of this paper argue that many immunogenicity assays tend to yield screening and confirmatory cut point values that are not reflective of biological variability in the study population. Such cut points, while mathematically correct, tend to result in high number of confirmed positive classifications in drug-naïve populations.

Don’t miss your chance to hear from Robert at IIR’s Immunogenicity for Biotherapeutics event. Join us October 20 – 22 in Boston, MA. Download the agenda to see the list of industry leaders presenting at this year’s event.

SAVE $100. Register here and use code XP1938BLOG

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Improved Immunogenicity, Rapid Action of Anthrax Vaccine

Soligenix, a company developing vaccines for inflammatory diseases and biodefense, has released results demonstrating improved immunogenicity for VeloThrax™, the company’s anthrax vaccine.

VeloThrax™ is a proprietary recombinant Protective Antigen (rPA) vaccine of Soligenix.  It had been believed that VeloThrax™’s improved immunogenicity could result in a vaccine with the potential to be administered in fewer doses.  Recent results prove that this is in fact the case. 

Next generation anthrax vaccines had aimed for fewer vaccinations over a shorter period of time for both pre and post exposure use.  While the current vaccination requires as many as five administrations over an 18 month period, recent developments with VeloThrax™ show that it’s capable of producing the necessary immune response with only two doses in less than a month’s time.   

The enhanced vaccine was developed by stimulating receptor 4 (TLR-4) which plays an important role in the recognition of pathogens.  The stimulation of these receptors resulted in a boost to toxin neutralizing antibodies and triggered an elevation in immune responses in mice after just one immunization. 

The improved vaccine also proved to be stable at 40 degrees Celsius for up to three months as well as up to 70 degrees Celsius for one month.  This alleviates some of the burden in storing the vaccine. 

“We are very pleased that our enhanced anthrax vaccine, VeloThrax™, has demonstrated promising results indicative of rapid onset of protective immunity," explained Christopher J. Schaber, PhD, President & CEO of Soligenix. "These data demonstrate the potential of creating a rapidly acting anthrax vaccine with the ability to withstand temperature extremes thereby avoiding the need for cold chain management. We believe that stability at such elevated temperatures provides a distinct advantage over other anthrax vaccine technologies currently in development. Further, DNI rPA is highly immunogenic and offers the potential for complete immunization with just one or two doses.”

Schaber says he expects his company to continue to develop the vaccine.  The ultimate goal?  A position as an anthrax vaccine for “stockpiling by the US government”.

Want more on the latest in immunogenicity?  Join us at the Immunogenicity for Biotherapeutics conference this October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100. Register here and use code XP1938BLOG.

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Why are peptides attractive as immunotherapeutic agents?

Later this month, we're hosting the TIDES 2014 Event.  Over the next few days, we'll be going back and looking at some of the one on one interviews we conducted with our speakers.  We'll start out by looking at the conversation we had with Eric Von Hofe, President of Antigen Express.

We started out by asking Eric:

Why are peptides attractive as immunotherapeutic agents?

His answer:

The main reason they are so attractive is that they represent the minimal agent needed to
generate an immune response. So, that’s always important in that if you have a lot of extra
agents, there is a potential for getting some non-specific toxic effects. The immune systemworks really just by recognizing the minimal units. By using them you know that you can getthe specific response that you want and really minimize the potential for any sort of toxic sideeffects. The other reason is that they are fully synthetic. So, they are very easy to make, very rapid and easy to scale-up and they are off-the-shelf products.

Read Dr. Von Hofe's full interview here.

Dr. Von Hofe will present the case study Peptide-Based Vaccines in the New Era of Cancer Immunotherapy on Tuesday, May 13.  For more information on his presentation and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us May 12-15 in Providence, Rhode Island, you're eligible to save 20% off the standard rate!  Simply register to join us and mention priority code XB14180BLOG.  Have any questions?  Email Jennifer Pereira.

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