South Korea to begin offering COVID-19 vaccine booster shots in October

 South Korea plans to begin giving out COVID-19 booster shots from October, joining several countries that have approved such doses amid resurgent infections and concern that vaccine protection wanes over time.

The plan will kick in once an October target for full vaccination of 70% of the population is achieved, as authorities aim to boost the rate above 80% with coverage for pregnant women and minors aged between 12 and 17 in the fourth quarter.

Initial booster doses will go to those with weakened immune systems or deemed to be at high risk. Others will receive them six months after full vaccination, the Korea Disease Control and Prevention Agency said.

"We will start with booster shots for high-risk groups such as the elderly and virus-prevention, medical personnel and gradually expand inoculation in line with expert recommendation and decisions by health authorities," President Moon Jae-in told his top aides on Monday.

Although the World Health Organization has repeatedly urged a delay in booster doses, arguing that the world's most vulnerable people should be fully vaccinated first, several countries have approved them, citing data on waning protection.

Vaccine booster doses will be made widely available to Americans in September, while nations from France and Germany to Israel have decided to offer them to older adults and those with weak immunity.

Evidence is growing that protection from COVID-19 vaccines ebbs after six months or more, especially in older people with underlying health conditions.

In June, South Korea said it planned to secure more mRNA vaccines https://www.reuters.com/world/asia-pacific/skorea-secure-more-mrna-vaccines-covid-19-booster-shot-2021-06-29 for booster doses next year for the entire population, on top of its already agreed 106 million doses from Pfizer/BioNTech / and Moderna.

South Korea has struggled to rein in daily COVID-19 cases as it battles its worst wave of infections since early July.

Monday's 1,372 new cases take its tally of infections to 251,421, with a death toll of 2,285.

By Monday, at least 56.5% of the population of 52 million had received at least one vaccine dose, while 29.6% had completed the inoculation

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-South-Korea-to-begin-offering-COVID-19-vaccine-booster-shots-in-October-36282156/

ANI Pharmaceuticals : FDA Accepts Application for Cortrophin Gel Revival

 ANI Pharmaceuticals Inc. on Tuesday said the U.S. Food and Drug Administration has accepted its application to reintroduce its Cortrophin Gel treatment for patients with chronic auto-immune disorders.

The Baudette, Minn., pharmaceutical company said the agency set a target action date of Oct. 29 for the potential competitor to Mallinckrodt PLC's Acthar Gel.

The FDA originally approved Cortrophin Gel in 1954, but it was last used in patients in the 1980s. The product has more than 54 indications on its previously approved label, including the treatment of acute exacerbations of multiple sclerosis, rheumatoid arthritis and nephrotic syndrome.

ANI, which acquired Cortrophin Gel from Merck in early 2016 and spent more than $100 million to re-establish the product, last year filed for FDA approval to reintroduce it to the U.S. market.

However, the agency turned the application away, citing concerns related to chemistry, manufacturing and controls section. ANI resubmitted the application in June.

https://www.marketscreener.com/quote/stock/ANI-PHARMACEUTICALS-INC-13658425/news/ANI-Pharmaceuticals-FDA-Accepts-Application-for-Cortrophin-Gel-Revival-36286343/

Teva, MedinCell Say FDA Accepts NDA for Schizophrenia Treatment

 

 Teva Pharmaceuticals and MedinCell on Tuesday said the U.S. Food and Drug Administration accepted their new drug application for TV-46000/mdc-IRM to treat schizophrenia.

The companies said the acceptance of TV-46000/mdc-IRM, or risperidone extended-release injectable suspension for subcutaneous use, was based on Phase 3 data from two studies which "evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia." The companies said the results will be shared "at future scientific conferences and in peer-reviewed publications."

Teva will continue to lead the clinical development and regulatory process and will be responsible for commercialization, while MedinCell will be eligible for certain milestones and royalties, the companies said.

Teva Pharmaceuticals is a U.S. affiliate of Teva Pharmaceutical Industries Ltd.

https://www.marketscreener.com/quote/stock/TEVA-PHARMACEUTICAL-INDUS-40246797/news/Teva-MedinCell-Say-FDA-Accepts-NDA-for-Schizophrenia-Treatment-36292737/

Walmart says ready to administer millions of COVID-19 vaccine boosters

 

Walmart Inc on Tuesday became the latest U.S. retailer to say that it is ready to administer millions of COVID-19 booster vaccine doses this fall if U.S. health officials endorse such a shot to improve fading immunity against the coronavirus.

Rivals CVS Health Corp and Kroger Co earlier this month had announced plans to make booster shots available at their stores, pending regulatory guidance.

U.S. health regulators have authorized a third dose of the vaccines made by Pfizer and partner BioNTech as well as Moderna for those with weak immune systems, and the government has said it plans to make booster doses available to more Americans in September.

The need for boosters, however, has not yet been recommended by health regulators.

The U.S. Centers for Disease Control and Prevention (CDC) on Monday said it may be difficult to determine at this point whether immunity from prior vaccination is waning over time or if the vaccines are just less able to prevent infection by the highly-transmissible Delta variant.

Walmart, which runs one of the largest U.S. pharmacy chains, and its Sam's Club pharmacies are currently administering the third dose to immunocompromised individuals.

https://www.marketscreener.com/news/latest/Walmart-says-ready-to-administer-millions-of-COVID-19-vaccine-boosters--36292804/

Amulet confers good fortune on Abbott

 Superiority Abbott needed, and superiority Abbott got. Full data from the head-to-head trial comparing Abbott’s Amplatzer Amulet left atrial appendage occluder versus the established product in this space, Boston Scientific’s Watchman, put Amulet ahead – though only on one of the trial’s primary endpoints. The results, presented yesterday at the European Society for Cardiology meeting, show Amulet’s noninferiority to Watchman across four endpoints, but its superiority on just one: the rate of successful LAA closure at 45 days. Amulet was approved mid-month for use in atrial fibrillation patients at increased risk of stroke on the strength of these data. And Amulet will be better able to treat patients at high risk of bleeding, since only 20% of recipients required anticoagulant therapy, versus 82% on Watchman. But there is a reason for caution: the comparator was an earlier version of Watchman that Boston has now phased out, so doctors have no definitive data on how Abbott’s newly available device compares against Watchman FLX, the version currently on the market. A cross-trial comparison might give a hint. On the measure of complete LAA closure Amulet achieved 60% versus Watchman’s 46%, but in a separate study Watchman FLX managed 90%. 

Amulet trial data
Outcome	N (%)		P value for noninferiority	P value for superiority
	Amulet	Watchman
Primary mechanistic endpoint* at 45 days	792 (98.9)	767 (96.8)	<0.001	0.003
Primary safety endpoint** at 12mth	131 (14.5)	130 (14.7)	<0.001	0.47
Primary effectiveness endpoint† at 18mth	25 (2.8)	24 (2.8)	<0.001	0.5
Stroke, systemic embolism, CV or unexplained death at 18mth	50 (5.6)	67 (7.7)	<0.001	0.09
*Successful LAA occlusion (residual jet around the device ≤5mm); **composite of procedure-related complications, all-cause death, or major bleeding; †composite of ischaemic stroke or systemic embolism. Source: ESC 2021 & Circulation. https://www.evaluate.com/vantage/articles/news/snippets/amulet-confers-good-fortune-abbott

AC Immune claims a tau win in Alzheimer’s

 These days mixed data in Alzheimer’s disease are enough to send a company’s stock rocketing. Today, AC Immune was the beneficiary after claiming a win in the phase 2 Lauriet trial of its tau-targeting agent semorinemab.

A closer look shows that the results are far from convincing. The placebo-controlled study, in mild-to-moderate Alzheimer’s patients, hit one primary endpoint but failed the other, and also missed its secondary efficacy endpoints. Perhaps this is enough to warrant further investigation, but pushing straight into a large phase 3 trial might be a rash move.

Another reason for caution is that semorinemab has already flunked a different mid-stage trial, Tauriel, in prodromal-to-mild patients.  

AC Immune, to its credit, was up front about the equivocal Lauriet results. The group has not laid out its next steps, aside from saying that its partner Roche would continue analysing the results, and that an open-label portion of the study would continue as planned.

Still, the news was enough to send the group’s stock up 72% at the open this morning.

Lauriet

Lauriet had two co-primary endpoints: change in Adas-Cog11, which measures cognitive function, and change in ADCS-ADL, which measures functional capacity, at week 49. It hit only the first of these, with semorinemab showing a 44% reduction in Adas-Cog11 versus placebo.

Secondary endpoints included the mini-mental state examination (MMSE) and clinical dementia rating-sum of boxes (CDR-SB).

AC Immune’s chief executive, Andrea Pfeifer, noted that this was the first time an anti-tau monoclonal antibody had shown a therapeutic effect; however, she also acknowledged that the group was “still cautious about what this may mean for patients” given the miss on other endpoints.

Topline data are set to feature at the Clinical Trials on Alzheimer's Disease conference in November.

AC Immune is particularly invested in tau, with three other projects in clinical development. Other companies in this space have not fared well lately, with Biogen discontinuing gosuranemab in June, and Abbvie using its second-quarter earnings to disclose that it had dropped ABBV-8E12 after that project disappointed in phase 2.

But Biogen has other clinical-stage irons in the tau fire too, the table below shows, as well as the preclinical project ST-501, licensed from Sangamo.

Perhaps AC Immune’s result will give the other players here a boost, but it seems premature to declare the tau hypothesis back on just yet.

Selected tau-targeting projects in clinical development
Project	Company	Description	Note
Phase 3
LMTM/TRx0237	Taurx Pharmaceuticals	Tau aggregation inhibitor	Lucidity trial completes Jun 2022
Phase 2
Semorinemab/RG6100	Roche/AC Immune	Anti-tau MAb (targets N-terminus)	Sep 2020: failed Tauriel in prodromal/mild Alz; Aug 2021: met one co-primary in Lauriet in mild/moderate Alzh
Zagotenemab/LY3303560	Lilly	Anti-tau MAb (targets N-terminus)	Early Alz study completed Aug 2021
Bepranemab/UCB0107	UCB/Roche	Anti-tau MAb (targets central region)	MCI/mild Alz study started Apr 2021; first data due H1'25
AADvac1	Axon Neuroscience	Anti-tau vaccine	Further development planned despite failure of ph2 Adamant trial
Phase 1/2
BIIB080/ IONIS-MAPTRx	Biogen/Ionis Pharmaceuticals	Tau antisense oligonucleotide RNAi therapeutic	Mild Alz study; part 1 showed safety/tolerability, part 2 ongoing
ACI-35.030	AC Immune/Johnson & Johnson	Anti-tau vaccine	Interim data from early Alz study reported Feb 2021; high-dose data due Q4'21
JACI-35.054	AC Immune/Johnson & Johnson	Anti-tau vaccine	Early Alz study; higher dose started
Phase 1
PNT001	Pinteon Therapeutics	Anti-tau MAb (targets cis-pT231 tau)	Healthy volunteer study reported Feb 2021; acute brain injury study initiated
ACI-3024	AC Immune/Lilly	Tau aggregation inhibitor	Ph1 completed; focus now on rare tauopathies
BIIB076	Biogen/Eisai	Anti-tau MAb (targets central region)	Healthy volunteer/Alz pts study completed Mar 2020; still in Biogen's pipeline
E2814	Eisai	Anti-tau MAb (targets microtubule binding region)	Healthy volunteer study completes Sep 2021; selected for Dian-Tu tau study Mar 2021
BEY2153	Beyondbio	Beta-amyloid & tau aggregation inhibitor	Healthy volunteer study completes Oct 2021
Lu AF87908	Lundbeck	Anti-tau MAb (targets C-terminus)	Healthy volunteer/Alz pts study recruiting
PRX005	Prothena/Bristol Myers Squibb	Anti-tau MAb (targets microtubule binding region)	Ph1 begun & Bristol opt-in June 2021
Source: EvaulatePharma & clinicaltrials.gov. https://www.evaluate.com/vantage/articles/news/trial-results/ac-immune-claims-tau-win-alzheimers

J&J's HIV vaccine fails phase 2b, extending long wait for an effective jab

 The wait for an HIV vaccine goes on. Johnson & Johnson, having seen peers including Merck swing at HIV and miss, has reported the failure of a vaccine based on similar technology to its COVID-19 jab to protect women from infection with the virus. 

Investigators randomized around 2,600 young women across five countries in sub-Saharan Africa to receive four doses of the vaccine or placebo over one year. The researchers calculated the efficacy of the vaccine in the phase 2b clinical trial by looking at the number of HIV cases in each cohort from Month 7, one month after the third dose, to Month 24. 

The analysis revealed 63 cases in the placebo arm and 51 cases in the slightly smaller vaccine cohort. J&J calculated the efficacy to be 25.2%, with a lower confidence interval of below 0%. While J&J said the vaccine was generally well tolerated, the efficacy data were too weak to support further study.

While J&J is stopping the study, a phase 3 trial of a related vaccine regimen is continuing. The phase 3 study is testing a different composition of the HIV vaccine regimen and enrolling men who have sex with men and transgender individuals in the Americas and Europe, where the circulating strains are different than in sub-Saharan Africa. The differences between the trials led to the continuation.

J&J is continuing to analyze data from the failed phase 2b study. One outstanding question is why the high levels of protection seen in animals shrank in humans. J&J moved the candidate into advanced clinical trials on the strength of evidence it slashed infection rates in animals. 

The continuation of the phase 3 trial, which has a primary completion date in 2024, gives J&J another crack at providing protection against HIV. Other vaccine developers are tackling the challenge, too, with Moderna set to start testing a mRNA candidate imminently.

Moderna’s approach is different from what has gone before. While J&J’s study looked at whether non-neutralizing antibodies can induce protection against HIV, Moderna is trying to use mRNA to generate broadly neutralizing antibodies against the virus. Neutralizing antibodies could prevent HIV from entering cells.

https://www.fiercebiotech.com/biotech/j-j-s-hiv-vaccine-fails-phase-2b-extending-long-wait-for-effective-jab