Week 48: Universal flu vaccine updates, Bayer making big moves, while Cornell vet school replaces traditional canine cadavers for synthetics

Posted on December 4, 2018 in Uncategorized

Universal Flu Vaccine May Be Out of Reach

Science reports that a vaccine to cover multiple strains of influenza and last many years, if not for life, remains “an alchemist’s dream.” This quote came from a virologist at a meeting organized by the non-profit Human Vaccines Project based in New York City.

The state of the situation indicates that while researchers at times feel as if they have gained ground against the virus, the fight for a universal flu vaccine is at the same place they were decades ago. The difference in viruses from season to season is what’s making this universal vaccine such an enigma. Each season, the virus changes and renders any protection the previous season’s virus can offer is inconsistent, between 20% to 60% effective in providing protection from the strain people actually contract.

The change between seasonal viruses can be attributed to the epitopes present. If these structures change, the virus becomes less viable. The piece of the virus that can illicit an immune response and protect people from contracting it remains elusive. Researchers are trying to go after the epitopes located on the “stem” of the virus that seem to differ between each virus subtype, but the vaccines derived from utilizing these structures have missed their mark.

Another consideration that has left scientists perplexed is the immune phenomena called imprinting. This happens when children are exposed to a pathogen and develop a strong immune response against it, then get exposed to a different subtype and cannot generate an immune response against it. The example given looks at the Influenza Epidemic of 1918. The age group with an unexpected high mortality rate was young adults. This group proved to fall victim easier to the virus responsible for the outbreak- H1N1. Experts theorize that imprinting may have played a role in this, thinking that the virus these adults were exposed to as a child was likely a different subtype (H3N8, for example). When encountering it, the immune response against it was greater. While this might initially give hope for immune coverage, scientists believe that this actually worked against the body and incited an immune response great enough to destroy memory B cells responsible for fighting off the virus.

Researchers at the National Institute for Allergy and Infectious Diseases would like to study subjects from infancy to 7 years old, vaccinating them with a mix of common human subtypes of the virus and monitor how their immune system responds later as adults. This may be a step in the right direction for a universal flu vaccine.

Fusion Antibodies to Integrate Artificial Intelligence and Machine Learning

In a collaboration with Analytics Engines, the hope is to bring a level of humanization to manufacturing and increase product quality through Fusion Antibodies’ CDRx platform. This platform has been designed to incorporate artificial intelligence (AI) and machine learning (ML) to analyze and evaluate certain panels of antibodies to determine what is needed to develop further. The goal of this partnership is to reduce production costs and improve developmental timelines. Read more on Outsourcing-Pharma’s coverage here.

ADHD Genetic Risk Variants Discovered for the First Time

GEN has reported on a genomic-wide association study where twelve loci were discovered to contribute to ADHD in patients across the globe. Because these loci overlap with loci that contribute to other diseases, such as depression and type 2 diabetes, it may indicate there is a significant relationship between ADHD and other common diseases. Some of the loci in question control brain signaling and speech. Due to complexity of ADHD, researchers state that while this sheds light on the origins of this common disorder, there is still much to learn and study.

Pall, Cobra, and CGTC receive Innovate UK Grant

BioPharma-Reporter has covered the collaboration between the contract development and manufacturing organization (Cobra Biologics), biotechnology vendor (Pall Biotech), and independent research and technology organization (Cell and Gene Therapy Catapult, CGTC) have been formed. The companies will share a $1.9M grant to research the efficient production of adeno-associated viruses (AAV) and their applications in gene therapy. The goal is to produce AAVs with stronger process results and lower cost via reduced time and consumables needed through an advanced purification process.

New Competition for Mylan, EpiPen

An Israeli company, Teva, will release new generic to EpiPen with the intention to increase competition with Mylan. Mylan is currently the only company who makes the epinephrine auto-injector for the treatment of anaphylactic reactions, both brand and generic versions. After a shortage in supply led regulatory bodies to extend the expiration dates on existing products, Teva will debut their version at the same price of Mylan’s generic ($300/pack of two injectors) but has not disclosed the quantity it intends to place into the market. Approval for manufacturing was made in August of this year and will be the first generic outside of Mylan’s own to reach the market. Between 2007 and 2016, the EpiPen company had increased product price by 548%. Other epinephrine injection alternatives have also reached the market. Read more from in-Pharma Technologist.

Bayer Making Big Moves

BioPharma-Reporter has covered the German company’s announcement regarding a plan to divest its Animal Health division and sell off the Coppertone and Dr. Scholls Consumer Brands, and their 60% share of chemicals business, Currenta. The company has also announced the shutdown of their Germany-based facility that produces a hemophilia A treatment.

This comes in the wake of the monumental merger with Monsanto, valued at $62.5bn, earlier this year, and is claimed to be a refocus on the life sciences business. Unfortunately for Bayer, lawsuits quickly followed regarding Monsanto’s weed killers created with glyphosates and the negative effects it has on human health.

Significant write-offs and losses will be accounted for, as well as a subsequent significant reduction in staff. The entirety of this plan would start in 2019 and effectively reduce staff by 12,000 by the conclusion of 2021.

Cornell University has Adopted the Use of Synthetic Canine Cadavers

American Veterinarian covered this emerging story how Cornell’s vet school has replaced traditional canine cadavers with synthetic ones. Though some universities have replaced or supplemented their cadavers with 3D printed parts or specific organs, this can get costly to replace printed parts, while traditional cadavers take precision to defrost properly.

The synthetic cadavers come from SynDaver Labs, a company that has been making human replicas and has sold other animal versions to different vet schools. The cadavers are composed of fiber, water, and salt, with the outer layer having the ability to be patched and internal organs to be replaced after multiple uses. The company’s mission is to help improve the skills of novice surgeons without putting live animals at risk, and to reduce the use of traditional cadavers.