Nipocalimab shows promise in RA subgroups in phase 2a IRIS-RA study

Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology community. “Now, there are some highly respected physicians who’ve said, ‘This is a failed trial,’” said Dr. Peter Taylor, the Norman Collisson Professor of Musculoskeletal Sciences at the University of Oxford. “I think that’s an incorrect interpretation.”

Johnson & Johnson is also pursuing a host of other autoimmune indications for nipocalimab. The FDA has granted it Fast Track designation for hemolytic disease of the fetus and newborn (HDFN) and orphan drug status for HDFN while EMA granted it orphan medicinal product designation for HDFN.

Breaking down the data from IRIS-RA

Johnson …

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NKGen Biotech’s SNK01 ‘natural killer’ cell therapy for Alzheimer’s gets FDA nod for clinical trial

Santa Ana, California–based NKGen Biotech has received FDA clearance to begin a phase 1/2a trial for their “natural killer” cell therapy, SNK01, designed to treat Alzheimer’s Disease. The autologous, non-genetically modified natural killer (NK) cell therapy involves extracting a patient’s own cells through a blood draw, and then processing them to enhance their natural abilities in a laboratory setting before reinfusing them into the patient’s body.

NKGEN Biotech modifies NK cells to improve their cytotoxicity and their activating receptor expression, which helps them to identify and engage with target cells. This process imparts the NK cells with the ability to target and combat the specific cells associated with Alzheimer’s.

Early data are promising

Data from a phase 1, 3 + 3 dose-escalation trial found SNK01 to be well-tolerated. The drug candidate appeared to cross the blood-brain barrier to help reduce proteins and neuroinflam…

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Mirikizumab shows continued promise for ulcerative colitis after regulatory hiccup

Lilly has announced that its interleukin-23 blocker mirikizumab demonstrated promise in patients with moderately to severely active ulcerative colitis (UC) in the ongoing open-label LUCENT-3 extension study. The trial evaluated two-year efficacy and safety of the monoclonal antibody in patients who had previously undergone UC treatments, including biologics, that were ineffective, stopped working, or were intolerable.

In April, the company announced that it had received a complete response letter for mirikizumab for UC as a result of issues FDA identified related to the proposed manufacturing of the antibody. The agency noted no concerns about the clinical data package, safety, or label for the therapy.

After revealing the most recent LUCENT-3 data, Lilly plans on filing a marketing application for mirikizumab in Crohn’s disease to FDA. It intends to file paperwork with other regulatory agencies in 2024.  

Mirikizumab efficacy in LUCENT-3


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Two new SARS-CoV-2 antibodies could neutralize COVID-19 strains with high efficacy

This scanning electron microscope image shows SARS-CoV-2 in yellow. [Image courtesy of NIAID RML]

Researchers at Tel Aviv University have identified two monoclonal antibodies that are broadly effective against SARS-CoV-2 variants.

The researchers investigated the activity of nine anti-SARS-CoV-2 monoclonal antibodies (mAbs) against several variants of concern, including alpha, beta, gamma, delta and omicron.

The scientists at the Tel Aviv University’s Sackler Faculty of Medicine suspect that the antibodies may reduce the future need for regular boosters.

The research was published in Communications Biology.

Natalia Freund and doctoral students Michael Mor and Ruofan Lee at Tel Aviv University led the research in collaboration with Ben Croker of the University of California at San Diego. Other research partners included Ye Xiang, a professor at Tsinghua University in Beijing and professors Me…

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AstraZeneca paying up to $157M for broad-spectrum monoclonal antibodies against COVID

RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2.

“Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases,” said Hugo Fry, a former Sanofi executive who is CEO of RQ Bio.

“By combining our expertise and innovative excellence in core areas, we have created a smarter approach to antibody generation, making us uniquely positioned to deliver fast patient impact,” Fry said in a news release.

The agreement gives AstraZeneca an exclusive worldwide license to develop, manufacture and commercialize mAbs against SARS-CoV-2.

“The COVID-19 pandemic has changed the landscape for immune therapies, including the use of monoclonal antibodies to protect vulnerable patien…

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Lilly to supply up to 600,000 doses of investigational COVID antibody to U.S. government

Monoclonal antibodies were one of the first weapons to emerge in the battle against COVID-19, but only a single antibody therapy, sotrovimab from Vir Biotechnology and GSK, retains potency against the omicron variant. Two weeks ago, FDA recommended limited use of Eli Lilly’s (NYSE:LLY) bamlanivimab and etesevimab and Regeneron’s (NSDQ:REGN) REGEN-COV (casirivimab and imdevimab), given their diminished protection against omicron.

Eli Lilly, however, said it has found its investigational antibody bebtelovimab retains full neutralizing activity against the variant based on pseudovirus and authentic virus testing.

Lilly also noted that the antibody retains neutralization against the BA.2 subvariant.

Now, the company has reached an agreement with the U.S. government to supply up to 600,000 doses for a price tag of at least $720 million. The supply agreement asks for delivery of that number of doses by March 31. The U.S. has the option of purchasing an additio…

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Lonza bolsters drug manufacturing services in Switzerland

Contract development and manufacturing organization Lonza has announced a series of expansion projects during the pandemic. Most recently, the Basel-based company revealed plans to expand its drug product manufacturing services on its home turf in Switzerland.

Included in the expansion will be an installation of a new aseptic fill and finish line in the city of Stein in northern Switzerland. The filling line will enable the company to process various drug types such as monoclonal antibodies, bioconjugates and viral vectors. The company aims to finish the expansion by 2023.

The company is also beefing up its drug product services in nearby Basel. Specifically, its investments in Stücki Technologiepark in Basel will increase its offerings for early and late clinical stages. The expansion will also add to its capabilities related to integrated drug substances and drug products. Lonza aims to finish this expansion in 2024.

In late August, the company unveile…

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Regeneron exec shares how Ebola inspired COVID-19 treatment

The speed that pharmaceutical companies developed COVID-19 treatments and vaccines was “seemingly miraculous,” said Dr. George Yancopoulos, co-founder of Regeneron (NSDQ: REGN), in remarks when receiving a Titans of Global Health award.

“But these miracles were actually born many decades earlier,” he said at the virtual event ceremony from the American Friends of the Hebrew University.

NIAID director Dr. Anthony Fauci and fellow Regeneron co-founder Dr. Leonard Schleifer also were honored at the event. 

Scientists had been working on mRNA on vaccines for more than a decade before the emergency use authorizations of COVID-19 vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE). “Similarly, the technologies we use to develop our REGN-COV2 antibody cocktail were not available 10 or 20 years ago,” shared Yancopoulos, who is currently president and chief scientific officer of Regeneron. “We had to invent them and perfect them.” 

The antibody treat…

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FDA nixes EUA for Lilly’s bamlanivimab

On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone.

Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants.

Bamlanivimab, however, won’t be disappearing as a COVID-19 treatment but will be paired with another monoclonal antibody known as etesevimab.

Get the full story from our sister site, Drug Discovery & Development.

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U.S. government classifies threat levels of SARS-CoV-2 variants

Image courtesy of Wikipedia

The number of SARS-CoV-2 variants with enhanced transmissibility and resistance to antibodies is increasing, prompting the U.S. government to issue guidance on how to classify them.

The criteria divide variants into three categories including the following:

Variant of interest: This virus type has genetic markers that have been linked to a potentially increased risk. Examples include mutations that could change how the virus enters cells and responds to antibodies from vaccination or infection. Such a virus could also potentially enhance transmissibility or disease severity. Variant of concern: This class includes variants with evidence of increased transmissibility, severe disease or reduction in neutralization by antibodies from infection or vaccination. Such a variant may also pose a higher risk of eluding testing. See the table below for examples. Variant of high conseque…
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Lilly’s bamlanivimab and etesevimab cut COVID-19 hospitalization and deaths in study

A recent Phase 3 trial found that bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered jointly led to an 87% reduction in hospitalization and deaths in high-risk patients recently diagnosed with COVID-19.

The randomized, double-blind, placebo-controlled trial administered 700 mg of bamlanivimab (LY-CoV555) and 1400 mg of etesevimab (LY-CoV016) to 511 patients in the treatment arm. FDA granted emergency use authorization to the dosing regimen, which is also supported by the European Medicines Agency’s Committee for Medicinal Products for Human Use. A total of 258 patients in the cohort of the BLAZE-1 study received a placebo.

There were no deaths in the treatment arm but four deaths in the placebo arm. All of the deaths were considered related to COVID-19.

The BLAZE-1 trial has been ongoing for several months, giving Lilly the ability some indication that its monoclonal antibodies are effective against a range of SARS-CoV-2 varia…

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