HIV vaccine readies for human trials

[JBeukema]

(originally found on slashnet)

Sumagen Canada announced this week it has submitted an Investigational New Drug application to the United States Food and Drug Administration to begin Phase 1 human trials for its SAV001 AIDS vaccine.

Since the AIDS virus was recognized in 1983, there have been numerous trials through pharmaceutical companies to develop vaccines; however, no commercialized vaccine has been developed to date.

If the vaccine is given the go-ahead to enter into human clinical trials, it will be at least four years before Kang expects to have statistically significant analysis, and possibly allow the vaccine to be marketed.

Through Western, Sumagen Canada has secured patents for the vaccine in over 70 countries in the world, including the United States, the European Union and Korea. According to the firm, animal testing has resulted in good antibody reactions in immunology tests, with no adverse effects or safety risks.

Western News - HIV/AIDS vaccine reaches milestone

 

[waltky]

Speeding up Vaccine Development with Test-tube Immune Systems...

Test-tube Immune Systems Can Speed Vaccine Development
July 24, 2017 | WASHINGTON — New technology allows scientists working on new vaccines to combat infectious diseases to test their products' effectiveness on a model immune system in a laboratory, without putting the upgraded vaccine into humans.

Researchers have begun building model immune systems using human cells, and this lab technique should make early vaccine trials quicker, safer and cheaper, according to scientists in the United States and Britain involved in this novel approach. The technology also has the potential to be used to mass produce antibodies in the lab to supplement real immune systems that are compromised, or battling pathogens like Ebola. A report announcing the new "in vitro booster vaccination" technique was published Monday in The Journal of Experimental Medicine, a prestigious peer-reviewed medical journal published by the Rockefeller University Press. The research project involved produced antibodies that attack strains of tetanus, HIV and influenza.

Selecting specific antibodies

When a pathogen invades the body, the immune system develops antibodies specific to that pathogen. The antibodies latch onto the pathogen and either flag it for destruction, disrupt the life cycle of the pathogen, or do nothing. Before now, when scientists tried to get immune cells in the lab to produce antibodies, the cells would do so indiscriminately, producing all sorts of antibodies, not just the relevant ones. Now scientists are able to get the antibodies they specifically desire by using nanoparticles that connect antigens, the active parts of a vaccine, with molecules that stimulate the immune system. "We can make these cells very quickly in vitro — in a Petri dish — to become antibody-producing cells," said a lead author of the new report, Facundo Batista. "This is quite important," he told VOA, "because until now the only way that this has been done is though vaccinating people."

A health agent prepares a vaccine during a campaign of vaccination against yellow fever in Rio de Janeiro, Brazil​

Batista was one of a number of scientists involved in the study from the Ragon Institute, established in the Boston area by experts from Massachusetts General Hospital, Harvard University and the Massachusetts Institute of Technology, with the goal of working toward development of an effective vaccine against HIV/AIDS. Others contributing to the new report were from the Francis Crick Institute in London and other institutions.

New technique saves time, money

The new laboratory technique will save time and money. After all the work of planning, funding and getting approval for a vaccine trial in humans, "you're talking at least about three years in a best-case scenario, if you have a very promising product," said Matthew Laurens, an associate professor of pediatrics and medicine at the University of Maryland who was not associated with the study. That lengthy process will now be shortened to a matter of months. This can eliminate, or at least greatly reduce, long and costly trials, and fewer volunteer subjects will be exposed to potentially dangerous vaccines. The ease of testing new vaccines will also allow scientists to tinker more and better understand how vaccines work. With better understanding, they may be able to develop more sophisticated vaccines that can be effective against more pathogens — those that differ as a result of genetic variations. This will be important in the fight against rapidly evolving pathogens like HIV, the virus that causes AIDS.

Outside of vaccine testing, immune systems in laboratories can lead to greatly improved methods for the mass production of antibodies. Scientists have been trying to identify antibodies that can attack all strains of the Ebola virus; this new technology will improve their chances of developing an effective therapy. Laurens, who studies malaria vaccine development at Maryland, called the research exciting. "This would allow vaccine candidates to be tested very early and very quickly," he told VOA, "with rapid turnaround and reporting of results to either advance a vaccine candidate or tell scientists they need to go back and look for other candidates."

Test-tube Immune Systems Can Speed Vaccine Development

See also:

Personalized Vaccines Hold Cancer at Bay in Two Early Trials
July 05, 2017 — A novel class of personalized cancer vaccines, tailored to the tumors of individual patients, kept disease in check in two early-stage clinical trials, pointing to a new way to help the immune system fight back.

Although so-called immunotherapy drugs from the likes of Merck & Co, Bristol-Myers Squibb and Roche are starting to revolutionize cancer care, they still only work for a limited number of patients. By adding a personalized cancer vaccine, scientists believe it should be possible to improve substantially the effectiveness of such immune-boosting medicines. Twelve skin cancer patients, out of a total of 19 across both the trials, avoided relapses for two years after receiving different vaccines developed by German and U.S. teams, researchers reported in the journal Nature on Wednesday.

Larger studies are next

The small Phase I trials now need to be followed by larger studies, but the impressive early results suggest the new shots work far better than first-generation cancer vaccines that typically targeted a single cancer characteristic. The new treatments contain between 10 and 20 different mutated proteins, or “neoantigens,” that are specific to an individual's tumour. These proteins are not found on healthy cells and they look foreign to the immune system, prompting specialist T-cells to step up their attack on cancer cells. One vaccine was developed at the U.S.-based Dana-Farber Institute and Broad Institute and the other by privately-owned German biotech firm BioNTech, which uses so-called messenger RNA to carry the code for making its therapeutic proteins.

Roche, the world's largest cancer drugmaker, is already betting on BioNTech's technology after signing a $310 million deal last September allowing it to test the German vaccine with its immunotherapy drug Tecentriq. BioNTech's co-founder and CEO Ugur Sahin told Reuters that combination trials using Roche's drug were due to start later this year against a number of different cancers. Rival biotech firm Neon Therapeutics, which was formed to exploit the U.S. research, initiated tests of its personalized neoantigen vaccine in combination with Bristol-Myer's Opdivo drug last year.

Expensive treatment

New drugs like Opdivo and Tecentriq that enlist the body's immune system are improving the odds of survival, but their typical price tag of more than $150,000 a year is controversial and adding a personalized vaccine will jack costs up further. Sahin acknowledged such vaccines would be expensive at first but said costs could be brought down by economies of scale and automation. “In the mid to long term the cost will fall dramatically ... it is an individual treatment but it is a universal process,” he said. “We are at a very early stage at the moment but in the long-run this approach could change everything.”

Potential confirmed