FDA grants first COVID-19 antibody green light for at-home, fingerprick blood test

 Antibody testing just went DIY: The FDA has given the go-ahead to a COVID-19 test that can detect the virus’s antibodies in a dried blood spot sample taken at home and mailed to a lab.

The COVID-19 Self-Collected Antibody Test System, developed by Symbiotica Inc., is the first home-collected antibody test to receive the FDA’s emergency use authorization, though 75 other antibody tests have been approved for use on samples collected in point-of-care settings.

Once the test is prescribed, fingerstick blood samples can be taken from individuals as young as 5 years old (with help from an adult for anyone under the age of 18). The sample will be processed for evidence of COVID-19 antibodies at one of Symbiotica’s labs.

Symbiotica is a California-based clinical laboratory that both develops and processes a variety of at-home assays. Besides the antibody test, other tests in the company's portfolio detect active COVID infections, diseases like rheumatoid arthritis, celiac disease and lupus, and a variety of food and environmental allergies.

The presence of antibodies in a person’s blood points to a past COVID infection, but scientists still aren’t sure how long antibodies can stay in the bloodstream—and therefore how recent the infection was—nor whether the person is at risk for repeat infections.

“The authorization of the first prescription-use, home-collection antibody test will play an important role in helping healthcare professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in a release. “The FDA will continue to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options.”

Though the antibody test can’t diagnose a current case of COVID, the FDA has recently authorized a handful of other self-collected tests that can. So far, more than 40 COVID tests that use samples taken at home have been OK’d, including a mix of eight prescription and over-the-counter molecular and antigen tests that can also be processed in the home, rather than being sent to a lab.

Most recently, in early March, the FDA granted an emergency use authorization to the first at-home molecular test that can be taken and processed without a prescription. That kit, from Cue Health, includes a cartridge that analyzes nasal swab specimens for genetic material linked to the virus (instead of the proteins studied in an antigen test). Results are available in about 20 minutes via an accompanying mobile app.

https://www.fiercebiotech.com/medtech/symbiotica-s-self-collected-covid-19-antibody-test-becomes-first-to-receive-fda-emergency

AstraZeneca COVID-19 shot tagged with new warning in EU, highlighting rare blood clot risk

 Europe’s drug regulator has been probing cases of rare blood clots in AstraZeneca COVID-19 vaccine recipients since mid-March—and now it has confirmed a possible link. The agency stressed that the benefits of the shot still outweigh the risks.

Unusual blood clots with low blood platelets should be listed as a “very rare” side effect of the vaccine, the European Medicines Agency (EMA) said Wednesday. Incidents have mostly been reported within two weeks of vaccination in women below the age of 60. With cases piling up over the past month, several countries have stopped using the shot altogether.

The EMA's safety arm, the Pharmacovigilance Risk Assessment Committee (PRAC), specifically noted clots in the brain, abdomen and arteries associated with thrombocytopenia, or low levels of blood platelets.

As of March 22, PRAC had reviewed 62 cases of cerebral venous sinus thrombosis (CVST)—a type of rare brain blood clot—and 24 case of splanchnic vein thrombosis, or clotting in the abdomen, in connection with AstraZeneca’s vaccine. Eighteen of those cases were fatal.

On the heels of the EMA’s safety update, AstraZeneca said it has teamed up with regulators to update its product label and is “working to understand the individual cases, epidemiology and possible mechanisms that could explain these extremely rare events.”

It also pointed out that the World Health Organization has ruled a link between the vaccine and blood clots plausible, but not confirmed.

The reports mainly came through spontaneous reporting systems in the U.K. and Europe and were posted to the EU’s drug safety database EudraVigilance. At the time, around 25 million people had received the vaccine.

By April 4, EudraVigilance had reports on 169 total CVST cases and 53 cases of splanchnic vein thrombosis linked to the vaccine. At that point, some 34 million people in Europe and the U.K. had been vaccinated with AZ’s shot.

AstraZeneca’s isn’t the only vaccine to face clotting concerns, but it leads its competitors by a fair margin when it comes to CVST cases.

The EMA has identified 35 cases of brain blood clots in connection with Pfizer and BioNTech’s vaccine Comirnaty, out of some 54 million people vaccinated, according to Evaluate Vantage reporter Jacob Plieth.

Moderna’s rival mRNA shot has been linked to five CVST cases out of 4 million vaccinated. Meanwhile, Johnson & Johnson’s single-dose vaccine, cleared in Europe on March 11, has gone into the arms of around 4.5 million people. The EMA has connected it to three cases of blood clots with low platelets, Plieth reports.

As for AstraZeneca's shot, the EMA maintained that clotting events were uncommon and said the benefits outweigh potential risks. 

The agency pointed out that the unique combination of clotting with low blood platelets could stem from an immune response similar to heparin-induced thrombocytopenia, which can sometimes crop up in patients taking the popular blood thinner. PRAC says it has asked for new studies and updates to ongoing trials as it looks to gather more information.

Last month, EMA Executive Director Emer Cooke said the agency had reached a “clear scientific conclusion” that AZ's shot was safe and effective, stressing the importance of continued vaccination efforts. At the same time, the regulator admitted it couldn't rule out a possible link between the vaccine and clotting incidents. 

Meanwhile, AstraZeneca's native U.K. may become the latest country to limit the shot's use, the BBC reports. Following a review by the country's drug regulator, which found that 79 people had developed rare blood clots by the end of March, Britain's Joint Committee on Vaccination and Immunisation has recommended an alternative shot for people ages 18 to 29.

Out of those 79 cases, 19 people died, three of whom were below the age of 30. Nearly two-thirds of cases cropped up in women, and they all occurred after the first dose, the regulator said. The agency said it couldn't draw a link between the second dose because fewer people had completed their full vaccination regimen. 

U.K. health officials, like their EU counterparts, noted that the side effect was "extremely rare" and vouched for the continued use of the vaccine, recently dubbed Vaxzevria. 

Throughout all of this, AstraZeneca has maintained that patient safety is top of mind. 

"Regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes COVID-19 Vaccine AstraZeneca," a spokeswoman told Fierce Pharma last month. "The safety of the vaccine has been extensively studied in Phase III clinical trials and peer-reviewed data confirms the vaccine has been generally well tolerated."

https://www.fiercepharma.com/pharma/astrazeneca-s-covid-shot-should-list-blood-clots-as-rare-side-effect-ema-says

ImmunoPrecise Launches Antibody Program to Treat Cancer, Alzheimer’s

 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA) (TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, today announced that its subsidiary Talem Therapeutics LLC (“Talem”) has advanced development of a candidate panel of vetted, novel, therapeutic antibodies, collectively referred to as TATX-112, against an undisclosed target, into formal lead candidate characterization.

https://www.businesswire.com/news/home/20210408005485/en/ImmunoPrecise-Launches-TATX-112-Candidate-Antibody-Program-for-the-Treatment-of-Cancer-and-Alzheimer%E2%80%99s-Disease

uniQure Preclinical Data Huntington’s Show Safety, Widespread Long-Term HTT Lowering

  uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that three manuscripts on preclinical data from its gene therapy candidate AMT-130 in Huntington’s disease have been accepted for publication, in the journals Science Translational Medicine, Brain Science, and Brain Communications. The publications show the safety and efficacy of AMT-130 in the deep brain structures of a large animal model and outline a promising novel efficacy biomarker for AMT-130.

https://www.globenewswire.com/news-release/2021/04/08/2206570/0/en/uniQure-Announces-Publications-of-Preclinical-Data-for-AMT-130-in-Huntington-s-Disease-Showing-Safety-of-Administration-in-NHPs-and-Widespread-Long-Term-HTT-Lowering-in-the-Brain.html

New Roche data at 2021 AAN highlight expanding neuroscience portfolio

 -- EVRYSDI 2-year FIREFISH Part 2 data show improvement in motor function in

      infants with Type 1 spinal muscular atrophy (SMA) 
 
   -- OCREVUS data show its consistent benefit on slowing disease progression 
      in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS) 
 
   -- Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) 
      reinforce safety and efficacy, including in patients with concomitant 
      autoimmune diseases (CAIDs) 
 
   -- Data for investigational MS medicine fenebrutinib support its safety 
      profile and high potency 
 
   -- Additional presentations on investigational programmes, including 
      Alzheimer's disease and Huntington's disease, help advance scientific 
      understanding of neurological disorders 
 
 
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced 
that new data for its approved and investigational medicines for the 
treatment of neurological disorders will be presented at the 73rd 
American Academy of Neurology (AAN) Annual Meeting being held virtually 
April 17-22, 2021. These new data include 23 abstracts highlighting the 
expanding Roche neuroscience portfolio across six therapeutic areas, 
including EVRYSDI(TM) (risdiplam) for spinal muscular atrophy (SMA), 
OCREVUS(R) (ocrelizumab) in relapsing and primary progressive multiple 
sclerosis (RMS and PPMS), investigational Bruton's tyrosine kinase 
inhibitor (BTKi) fenebrutinib in Phase III trials for RMS and PPMS, 
ENSPRYNG(R) (satralizumab) in neuromyelitis optica spectrum disorder 
(NMOSD), and data from investigational programmes in Alzheimer's disease 
(AD) and Huntington's disease (HD). 
 
 
 
   "Following U.S. FDA and global approvals for our groundbreaking 
therapies in SMA and NMOSD, Roche's data at AAN reflect our continued 
commitment to meaningful therapeutic progress for people living with 
neurological disorders," said Levi Garraway, M.D., Ph.D., Roche's Chief 
Medical Officer and Head of Global Product Development. "We are proud to 
collaborate with patient advocates, academia, industry and the broader 
healthcare community through cutting-edge research and partnerships to 
advance the scientific understanding of neurological conditions, which 
have historically been among the hardest disorders to study, diagnose 
and treat." 
 
 
 
   Spinal Muscular Atrophy (SMA) 
 
   Roche will present data from five studies from the EVRYSDI clinical 
development programme, which was designed to represent a broad spectrum 
of people living with SMA. The programme includes infants aged 2 months 
to adults aged 60 years with varying degrees of disability, including 
people with scoliosis or joint contractures, and those previously 
treated for SMA with another medication. 
 
 
 
   New 2-year findings from Part 2 of the Phase II/III FIREFISH trial show 
longer-term efficacy and safety of EVRYSDI in infants with symptomatic 
Type 1 SMA treated with EVRYSDI. This includes the number of infants 
able to sit without support for 5 and 30 seconds, a key motor milestone 
not normally seen in the natural course of the disease, as well as data 
on event-free survival and reduced hospitalisations. 
 
 
 
   Additional data being presented across EVRYSDI's broad clinical trial 
programme include updated data from the JEWELFISH trial evaluating the 
safety, tolerability, pharmacokinetics and pharmacodynamics of EVRYSDI 
in patients previously treated with SMA targeting therapies, as well as 
updated pooled safety analyses from the FIREFISH, SUNFISH, RAINBOWFISH 
and JEWELFISH trials. 
 
 
 
   Multiple Sclerosis (MS) 
 
   Roche will be presenting data from its MS Franchise, including five 
presentations covering OCREVUS and results from studies on the 
investigational BTKi fenebrutinib. Real-world data continue to show the 
highest persistence and adherence to OCREVUS, the only MS therapy with a 
twice-yearly dosing schedule, over one year compared to other 
disease-modifying therapies (DMTs). Additionally, a post-hoc analysis of 
the ORATORIO Phase III PPMS study will be presented, which suggest 
OCREVUS significantly slowed atrophied T2-lesion volume accumulation, a 
subclinical measure of disease progression. Furthermore, interim 
analysis of the open-label Phase IIIb ENSEMBLE study shows OCREVUS 
treatment provided consistent benefit over one year in patients who were 
recently diagnosed with relapsing-remitting multiple sclerosis (RRMS) 
and had not received prior DMT. 
 
 
 
   Roche is continuing to advance the science in MS and is exploring the 
investigational medicine fenebrutinib. Data from fenebrutinib, a highly 
selective, non-covalent, reversible oral BTKi, support its safety 
profile in several autoimmune diseases and high potency, which is 
encouraging for the ongoing Phase III studies in RMS and PPMS. 
Fenebrutinib is a dual inhibitor of both B-cell and myeloid lineage-cell 
activation, which may offer a novel approach to slowing disease 
progression by targeting both acute and chronic inflammatory aspects of 
MS. 
 
 
 
   Neuromyelitis Optica Spectrum Disorder (NMOSD) 
 
   Roche will present five sets of data on adults living with NMOSD. Data 
from the Phase III SAkuraStar and SAkuraSky clinical trials reinforce 
the favourable safety and efficacy of this therapy for those living with 
NMOSD, including patients with concomitant autoimmune diseases (CAIDs). 
 
 
 
   New longitudinal, observational data from the CIRCLES study, conducted 
in collaboration with the Guthy-Jackson Charitable Foundation, a patient 
advocacy organisation dedicated to funding research on NMOSD 
epidemiology, pathogenesis and treatment, will also be presented. The 
CIRCLES study explored factors that influence treatment change in people 
living with NMOSD, including those who have experienced only one 
relapse. 
 
 
 
   Alzheimer's Disease (AD) 
 
   Roche will present data on the increased use of home nursing 
capabilities in the Phase III GRADUATE studies of gantenerumab during 
the COVID-19 pandemic, which enabled home-bound trial participants to 
continue dosing to maintain medicine exposure. 
 
 
 
   Gantenerumab is a late-stage investigational anti-beta-amyloid antibody 
being evaluated in two Phase III studies (GRADUATE I and II), which are 
the only late-stage AD clinical trials to offer subcutaneous 
administration. We expect data from the studies in 2022. 
 
 
 
   Huntington's Disease (HD) 
 
   Roche will also present an analysis of the Enroll-HD study and REGISTRY 
database, which will highlight the role that genetic factors and medical 
history may have in predicting the rate of disease progression in HD. 
These data may help advance the understanding of HD and inform future 
treatment approaches for this rare, neurological condition. 

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Press-Release-nbsp-New-Roche-data-at-2021-AAN-highlight-impact-and-breadth-of-expanding-neuroscien-32910531/

Bristol Opdivo, Yervoy Show Positive Phase 3 Results for Additional Application

 Bristol Myers Squibb Co. said Thursday that a Phase 3 trial testing the use of its Opdivo and Yervoy medications to treat unresectable advanced or metastatic esophageal squamous cell carcinoma showed positive results.

The trial tested the efficacy of two treatments: Opdivo plus chemotherapy, and Opdivo plus Yervoy.

Opdivo plus chemotherapy met its primary and secondary endpoints of providing a benefit both to patients whose tumors express PD-L1, and in the all-randomized population. The combination also met its primary endpoint of progression-free survival by blinded independent central review in patients whose tumors express PD-L1.

Opdivo plus Yervoy also demonstrated improvement in overall survival in patients whose tumors express PD-L1 and in the all-randomized population. It didn't meet the other primary endpoint of progression-free survival by BICR in patients whose tumors express PD-L1.

The drugs' safety profiles were consistent with prior research, the company said.

Dr. Ian Waxman, Bristol Myers Squibb's development lead for gastrointestinal cancers, said the results could lead to new treatment options for patients with esophageal cancer.

https://www.marketscreener.com/quote/stock/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-s-Opdivo-Yervoy-Show-Positive-Phase-3-Results-for-Additional-Application-32914091/

COVAX vaccines reach over 100 countries, despite supply hits: GAVI/WHO

 The COVAX vaccine facility has delivered nearly 38.4 million doses of COVID-19 vaccines to more than 100 countries and economies across six continents as of Thursday, six weeks after it began to roll out supplies, a statement said.

Despite being hit by reduced supply availability in March and April, and higher demand in India where much of its main jab AstraZeneca is made, it expects to deliver doses to all economies that have requested them in the first half of 2021, the GAVI vaccine alliance and World Health Organization said.

“According to its latest supply forecast, COVAX expects to deliver at least 2 billion doses of vaccines in 2021,” it said. Its portfolio, currently relying on AstraZeneca and the Pfizer and BioNTech shots, would be diversified.

https://www.reuters.com/article/us-health-coronavirus-vaccines-covax/covax-vaccines-reach-more-than-100-countries-despite-supply-hits-gavi-who-idUSKBN2BV1PK