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Daily Brief: Janssen's HIV vaccine, Q2 results, Biogen's Alzheimer's data

News from pharma, biotech and healthcare


AIDS 2018: has Janssen cracked the HIV vaccine puzzle?

The AIDS 2018 congress gets underway today in Amsterdam, with all the main pharma players (ViiV, Gilead and Janssen) presenting new data this week.

One of the most eyecatching developments will be Janssen’s data on its preventative vaccine regimen against HIV-1, which is presented tomorrow.

While there has been great success in the development of antiretroviral therapy to suppress HIV in infected patients since the virus first emerged 35 years ago, there is still no viable vaccine.

At least four previous vaccine candidates have failed over the years, all of them unable to produce strong immune responses in health individuals and protect them from HIV infection, which has many different sub-types because of its highly mutable nature.

Janssen has developed what it calls a “global vaccine” with the aim of preventing HIV infections across this wide variety of HIV-1 subtypes which occur around the world.

Findings up to one year after last vaccination on safety and immunogenicity will be presented from the Phase 1/2a APPROACH study. Initial data from the study were published in The Lancet on 6 July, which showed a robust HIV immune response among a high percentage of healthy volunteers.

The vaccine will need to show sufficient levels of protection in those given the injection, as efficacy rates below a certain level would prove to be counterproductive and likely to leave patients unknowingly open to infection. A study of the vaccine in non-human primates (NHPs) found the most immunogenic mosaic-based vaccine regimen in humans demonstrated similar immune responses in NHPs and afforded 67% protection against an HIV-like virus.

A week of pharma Q2 results

This week will see dozens of pharma and biotech companies reporting their third quarter results, with Biogen and Lilly kicking things off tomorrow.

Biotech investor Brad Loncar has compiled a full rundown of all the big presentations this week.

Could this be an Alzheimer’s turning point? Biogen’s big reveal

Another major data readout this week is from Biogen and Eisai and their Alzheimer’s candidate BAN2401.

The company unveiled positive topline results from its phase II trial of BAN2401 in patients with early Alzheimer's Disease (AD) in 5 July, and is following this up on Wednesday with a full data presentation.

Earlier this month it revealed the drug had hit its secondary endpoints at 18 months in slowing the progression of AD, and in reducing amyloid beta accumulation in the brain on the highest treatment dose.

However, there remains some deep scepticism about the likelihood of the drug proving to be a genuine step forward against the disease.

One reason is that these new results are a turnaround compared to the failure reported last year.

Analysts have also raised specific doubts around the study design. These include Biogen’s decision to change its statistical measure methodology, as well as the validity of the new ADCOMS endpoint, devised by Eisai.

That’s why there will be a lot of scrutiny of the data on Wednesday. If the drug hits primary endpoints, it will bring to an end years of repeated failures in the Alzheimer’s drug development field.

Biogen also have aducanumab in its late stage pipeline, which has also shown a statistically-significant improvements in cognition and beta-amyloid levels, backed up by a dose-response relationship.

Article by
Andrew McConaghie

23rd July 2018

From: Research



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