Category Archives: Immunology

Immunology

Report resurrects false claim that coronavirus was bioengineered – WXII The Triad

Posted on Sept. 17, 2020We are collaborating with FactCheck.org, a project of the Annenberg Public Policy Center of the University of Pennsylvania, in an effort to identify misinformation and to ensure news consumers get the facts. This story first appeared on FactCheck.org.A long-circulating, unsubstantiated claim about the origins of the novel coronavirus resurfaced in recent days after a paper published online purported that SARS-CoV-2 was created in a lab.The baseless claim which we first addressed in the early days of the pandemic was further amplified when Fox News host Tucker Carlson featured an interview with one of the authors of the paper on his show on Sept. 15.That segment was viewed on YouTube nearly 2 million times and that link alone was shared by more nearly 50,000 users on Facebook, according to CrowdTangle analytics data, where other popular posts also repeated the allegations.But experts say the new paper, which has not been peer-reviewed, does not prove that the virus was created in a lab.The paper was uploaded to an open-access website Sept. 14 and was published by the Rule of Law Society & Rule of Law Foundation two related entities in New York tied to Steve Bannon, a former adviser to President Donald Trump. Bannon is listed as the chair of the Rule of Law Society in a registration document filed last year with the state.The organizations are connected to a partnership forged by Bannon and Guo Wengui, an exiled Chinese businessman, that has been described as being based on their shared disdain for the Chinese government. Guo is wanted in China on charges of bribery and fraud allegations he has denied according to The New York Times. Bannon announced in November 2018 that Guo would be setting up a $100 million Rule of Law fund in part to aid Chinese dissidents and their families.Guos work in the U.S., including consulting services from Bannon, has drawn the interest of federal investigators, The Wall Street Journal has reported.Rossen Reports: Busting COVID-19 myths with experiments you can try at homeThe new paper attempts to make the case that the novel coronavirus couldnt have come from nature and instead may have been created by altering a previously discovered bat coronavirus. But several of its main points rest on faulty conclusions.One of the studys main claims is that the genomic sequence of SARS-CoV-2 is suspiciously similar to that of a bat coronavirus discovered by military laboratories in China and therefore indicates that another coronavirus was used to create the novel coronavirus.Kristian G. Andersen, a professor of immunology and microbiology at Scripps Research who has studied the origins of the virus, said of the claim on Twitter: This simply cant be true there are more than 3,500 nucleotide differences between SARS-CoV-2 and these viruses.And Dr. Stanley Perlman, a professor of microbiology and immunology at the University of Iowa who studies coronaviruses, told us in an email that the coronavirus referenced ZC45 is only 89% related to SARS-CoV-2. In virology terms, that is very distant.Perlman said it would be nearly impossible to make the reverse genetics system needed to manipulate the virus and changing its sequence to arrive at SARS-CoV-2 would be virtually impossible since it would not be known how to manipulate the virus.Nevertheless, Dr. Li-Meng Yan one of the authors of the new paper and a virologist who has claimed she fled China to reveal the truth about COVID-19 doubled down on Carlsons show. She alleged a cover-up by the Chinese government and the scientific community.The paper goes on to suggest that SARS-CoV-2 contains a unique furin-cleavage site in its Spike protein which is completely absent in this particular class of coronaviruses found in nature and that, therefore, the virus was engineered.Susan R. Weiss, a University of Pennsylvania professor of microbiology who researches coronaviruses, told us in an email that that makes no sense in terms of what we know about coronaviruses.Among murine coronavirus strains there are viruses with the furin site and strains without closely related strains closer than SARS-1 and SARS-2 yet they are all virulent, Weiss said. So this observation says nothing to me about the virus being engineered.A furin site is a short protein sequence that can be recognized and cut by other proteins.Perlman also said furin sites are found in many coronaviruses and finding it does not surprise us in the field.The paper also argues a conspiracy is afoot by claiming that scientific journals wont publish the alternative theory that the virus may have come from a research laboratory.I dont believe that, Weiss said. It is just that the data is not compelling. I dont know any CoV researchers that believe this at all. There is no way anyone could figure out how to make a virus behave like SARS-2 asymptomatic spread for thing.In March, Andersen and other scientists concluded in an article in Nature Medicine that the novel coronavirus is not a laboratory construct or a purposefully manipulated virus. The authors said that the virus likely originated in one of two ways: natural selection in an animal host before zoonotic transfer, meaning before the spread of disease from animals to humans, or natural selection in humans following zoonotic transfer.The Nature Medicine article did say it couldnt rule out an accidental laboratory release of the naturally occurring virus, but its authors said they do not believe that any type of laboratory-based scenario is plausible.The new, dubious paper attempts to discredit those findings by saying the Nature Medicine studys authors show signs of conflict of interests, raising further concerns on the credibility of this publication.The supposed support for that allegation: that one of the authors, Columbia Universitys Dr. W. Ian Lipkin, received an award from China for his work on public health there following the 2003 outbreak of the coronavirus that causes severe acute respiratory syndrome, or SARS.The new paper also references the curriculum vitae of another author Edward C. Holmes, a researcher at the University of Sydney in Australia which shows that he has collaborated with scientists and organizations in China.espite the online lies and malicious editing of my Wikipedia page, I have never received any funds from China, personal or research, and have no grants with Chinese scientists. I do have some honorary appointments there and a nice certificate though, Holmes wrote on Twitter. I do work closely with some Chinese scientists and as that directly led to the first release of the genome sequence that might just perhaps possibly be argued to be a good thing.Andersen also said that the allegation about the authors being conflicted was wrong. y lab has never received funding from China and we have no collaborations with Chinese investigators. I have no financial interests in China, he said in a tweet. All our analyses are scientific and unbiased.Its worth noting that collaborations between researchers in the U.S. and China arent uncommon. A recent study published in Higher Education found that U.S. research output between 2014 and 2018 would have dropped without Chinese partnerships while Chinas output would have grown regardless of work with the U.S. he findings demonstrate that the USA has more to lose than gain in cutting ties with China, its authors wrote.Public health officials have also suggested the virus originated in bats.The Centers for Disease Control and Prevention has said: The SARS-CoV-2 virus is a betacoronavirus, like MERS-CoV and SARS-CoV. All three of these viruses have their origins in bats. The sequences from U.S. patients are similar to the one that China initially posted, suggesting a likely single, recent emergence of this virus from an animal reservoir. However, the exact source of this virus is unknown.And in April, the Office of the Director of National Intelligence said in a statement that the Intelligence Community also concurs with the wide scientific consensus that the COVID-19 virus was not manmade or genetically modified. The intelligence community, it said, will continue to rigorously examine emerging information and intelligence to determine whether the outbreak began through contact with infected animals or if it was the result of an accident at a laboratory in Wuhan.Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told National Geographic in a May interview, If you look at the evolution of the virus in bats and whats out there now, is very, very strongly leaning toward this could not have been artificially or deliberately manipulated.Everything about the stepwise evolution over time strongly indicates that evolved in nature and then jumped species, Fauci said.Jessica McDonald contributed to this article.Editors note: FactCheck.org is one of several organizations working with Facebook to debunk misinformation shared on social media. Our previous stories can be found here.

Posted on Sept. 17, 2020

We are collaborating with FactCheck.org, a project of the Annenberg Public Policy Center of the University of Pennsylvania, in an effort to identify misinformation and to ensure news consumers get the facts. This story first appeared on FactCheck.org.

A long-circulating, unsubstantiated claim about the origins of the novel coronavirus resurfaced in recent days after a paper published online purported that SARS-CoV-2 was created in a lab.

The baseless claim which we first addressed in the early days of the pandemic was further amplified when Fox News host Tucker Carlson featured an interview with one of the authors of the paper on his show on Sept. 15.

That segment was viewed on YouTube nearly 2 million times and that link alone was shared by more nearly 50,000 users on Facebook, according to CrowdTangle analytics data, where other popular posts also repeated the allegations.

But experts say the new paper, which has not been peer-reviewed, does not prove that the virus was created in a lab.

The paper was uploaded to an open-access website Sept. 14 and was published by the Rule of Law Society & Rule of Law Foundation two related entities in New York tied to Steve Bannon, a former adviser to President Donald Trump. Bannon is listed as the chair of the Rule of Law Society in a registration document filed last year with the state.

The organizations are connected to a partnership forged by Bannon and Guo Wengui, an exiled Chinese businessman, that has been described as being based on their shared disdain for the Chinese government. Guo is wanted in China on charges of bribery and fraud allegations he has denied according to The New York Times. Bannon announced in November 2018 that Guo would be setting up a $100 million Rule of Law fund in part to aid Chinese dissidents and their families.

Guos work in the U.S., including consulting services from Bannon, has drawn the interest of federal investigators, The Wall Street Journal has reported.

Rossen Reports: Busting COVID-19 myths with experiments you can try at home

The new paper attempts to make the case that the novel coronavirus couldnt have come from nature and instead may have been created by altering a previously discovered bat coronavirus. But several of its main points rest on faulty conclusions.

One of the studys main claims is that the genomic sequence of SARS-CoV-2 is suspiciously similar to that of a bat coronavirus discovered by military laboratories in China and therefore indicates that another coronavirus was used to create the novel coronavirus.

Kristian G. Andersen, a professor of immunology and microbiology at Scripps Research who has studied the origins of the virus, said of the claim on Twitter: This simply cant be true there are more than 3,500 nucleotide differences between SARS-CoV-2 and these viruses.

This content is imported from Twitter.You may be able to find the same content in another format, or you may be able to find more information, at their web site.

And Dr. Stanley Perlman, a professor of microbiology and immunology at the University of Iowa who studies coronaviruses, told us in an email that the coronavirus referenced ZC45 is only 89% related to SARS-CoV-2. In virology terms, that is very distant.

Perlman said it would be nearly impossible to make the reverse genetics system needed to manipulate the virus and changing its sequence to arrive at SARS-CoV-2 would be virtually impossible since it would not be known how to manipulate the virus.

Nevertheless, Dr. Li-Meng Yan one of the authors of the new paper and a virologist who has claimed she fled China to reveal the truth about COVID-19 doubled down on Carlsons show. She alleged a cover-up by the Chinese government and the scientific community.

The paper goes on to suggest that SARS-CoV-2 contains a unique furin-cleavage site in its Spike protein which is completely absent in this particular class of coronaviruses found in nature and that, therefore, the virus was engineered.

Susan R. Weiss, a University of Pennsylvania professor of microbiology who researches coronaviruses, told us in an email that that makes no sense in terms of what we know about coronaviruses.

Among murine coronavirus strains there are viruses with the furin site and strains without closely related strains closer than SARS-1 and SARS-2 yet they are all virulent, Weiss said. So this observation says nothing to me about the virus being engineered.

A furin site is a short protein sequence that can be recognized and cut by other proteins.

Perlman also said furin sites are found in many coronaviruses and finding it does not surprise us in the field.

The paper also argues a conspiracy is afoot by claiming that scientific journals wont publish the alternative theory that the virus may have come from a research laboratory.

I dont believe that, Weiss said. It is just that the data is not compelling. I dont know any CoV researchers that believe this at all. There is no way anyone could figure out how to make a virus behave like SARS-2 asymptomatic spread for [one] thing.

In March, Andersen and other scientists concluded in an article in Nature Medicine that the novel coronavirus is not a laboratory construct or a purposefully manipulated virus. The authors said that the virus likely originated in one of two ways: natural selection in an animal host before zoonotic transfer, meaning before the spread of disease from animals to humans, or natural selection in humans following zoonotic transfer.

The Nature Medicine article did say it couldnt rule out an accidental laboratory release of the naturally occurring virus, but its authors said they do not believe that any type of laboratory-based scenario is plausible.

The new, dubious paper attempts to discredit those findings by saying the Nature Medicine studys authors show signs of conflict of interests, raising further concerns on the credibility of this publication.

The supposed support for that allegation: that one of the authors, Columbia Universitys Dr. W. Ian Lipkin, received an award from China for his work on public health there following the 2003 outbreak of the coronavirus that causes severe acute respiratory syndrome, or SARS.

The new paper also references the curriculum vitae of another author Edward C. Holmes, a researcher at the University of Sydney in Australia which shows that he has collaborated with scientists and organizations in China.

[D]espite the online lies and malicious editing of my Wikipedia page, I have never received any funds from China, personal or research, and have no grants with Chinese scientists. I do have some honorary appointments there and a nice certificate though, Holmes wrote on Twitter. I do work closely with some Chinese scientists and as that directly led to the first release of the genome sequence that might just perhaps possibly be argued to be a good thing.

Andersen also said that the allegation about the authors being conflicted was wrong. [M]y lab has never received funding from China and we have no collaborations with Chinese investigators. I have no financial interests in China, he said in a tweet. All our analyses are scientific and unbiased.

Its worth noting that collaborations between researchers in the U.S. and China arent uncommon. A recent study published in Higher Education found that U.S. research output between 2014 and 2018 would have dropped without Chinese partnerships while Chinas output would have grown regardless of work with the U.S. [T]he findings demonstrate that the USA has more to lose than gain in cutting ties with China, its authors wrote.

Public health officials have also suggested the virus originated in bats.

The Centers for Disease Control and Prevention has said: The SARS-CoV-2 virus is a betacoronavirus, like MERS-CoV and SARS-CoV. All three of these viruses have their origins in bats. The sequences from U.S. patients are similar to the one that China initially posted, suggesting a likely single, recent emergence of this virus from an animal reservoir. However, the exact source of this virus is unknown.

And in April, the Office of the Director of National Intelligence said in a statement that the Intelligence Community also concurs with the wide scientific consensus that the COVID-19 virus was not manmade or genetically modified. The intelligence community, it said, will continue to rigorously examine emerging information and intelligence to determine whether the outbreak began through contact with infected animals or if it was the result of an accident at a laboratory in Wuhan.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told National Geographic in a May interview, If you look at the evolution of the virus in bats and whats out there now, [the scientific evidence] is very, very strongly leaning toward this could not have been artificially or deliberately manipulated.

Everything about the stepwise evolution over time strongly indicates that [this virus] evolved in nature and then jumped species, Fauci said.

Jessica McDonald contributed to this article.

Editors note: FactCheck.org is one of several organizations working with Facebook to debunk misinformation shared on social media. Our previous stories can be found here.

See original here:
Report resurrects false claim that coronavirus was bioengineered - WXII The Triad

Immunology

Jim Broderick reels in a $100M Series B to explore a ‘new and big’ angle of immune regulation – Endpoints News

When Jim Broderick launched Massachusetts-based Palleon Pharmaceuticals in 2015, he had an office in Cambridges Kendall Square, a bit of seed money, and a blank canvas.

He set out to innovate within a new space in immunology, and recruited scientific co-founders Carolyn Bertozzi, a Stanford professor, and Paul Crocker, a professor and the head of the cell signaling and immunology division at the University of Dundee, Scotland, to help him do it.

When you start a new company in biotech, you need to be in something thats new and big, and you need to have the worlds best scientists behind you, Broderick, who was the first entrepreneur-in-residence at GSKs venture arm SR One, toldEndpoints News.

On Wednesday, the five-year-old company announced the completion of a $100 million Series B round to develop its pipeline of glyco-immunology therapies. Its lead program in oncology, an enzymatic sialoglycan degrader, is expected to hit the clinic next year.

Glycan-mediated immune regulation presents an enormous opportunity for novel therapeutics to treat a range of diseases characterized by immune system dysfunction, including cancer and inflammatory diseases, the CEO announced in a statement. Before Palleon, Broderick co-founded three other biotechs, including Ra Pharmaceuticals.

According to Broderick, its been known since 1959 that tumors have different glycan structures on their surfaces. But nobody could figure out what the glycans were doing, he said.

The answer, he added, was hiding in plain sight. But nobody could see it, because we didnt really have the lens to view the immune system in this way that we now do. The tumors, he said, use evolved glycan structures to hide from immune system attacks. And so Palleon is working on using cell surface sugar molecules to modulate immune activity.

In addition to its EAGLE platform, which uses enzymatic sialoglycan degradation to overcome intractable biological redundancy and enable a pan-immune anti-tumor response, the company also has its HYDRA platform, which characterizes cancer patients by their tumor surface glycan profile to identify which patients are most likely to respond. Palleon says its developing a broad pipeline of candidates that target individual Siglecs and other glycan-sensing receptors, which may be useful against inflammatory diseases like autoimmunity and fibrosis.

The Series B, led by Matrix Capital Manaement, will help push that pipeline toward the clinic, Broderick said. Returning investors SR One, Pfizer Ventures, Vertex Ventures HC, Takeda Ventures, and AbbVie Ventures, and new investor Surveyor Capital also chipped in.

Its just a whole other angle of immune regulation You couldnt see it before and now when you see it, there seems to be a lot of opportunity, Broderick said.

See the article here:
Jim Broderick reels in a $100M Series B to explore a 'new and big' angle of immune regulation - Endpoints News

Immunology

Importance of exercise to boost the immune system – Excalibur Online

Sergiy Slipchenko | Sports Editor

Photo Credit: Mahdis Habibinia / Edited by: Bhabna Banerjee

Over the past decade exercise and physical activity have been related to various health benefitsimproved metabolic health and reducing age-related dysfunction are just some of the reported positive effects of exercise.

This field of study is called exercise immunology and the pandemic has shifted the focus on how exercise can help prevent contracting the infection, or help combat it once it is inside the body.

Exercise immunology has been gaining traction for the past three decades, but it exploded in popularity since the pandemic began as people flocked to the internet for answers on how to protect themselves.

The increased interest in this topic can be seen in the massive jump in sales of exercise equipmentdumbbells were nearly sold out all throughout North America.

Alongside the newfound enthusiasm for exercise came the question of its effectiveness against COVID-19. While many aspects of exercise immunology have been explored, a lot of focus has shifted to how significant physical activity is at boosting the immune system when confronted with the coronavirus.

Professor Richard J. Simpson from the University of Arizona wrote about how exercise can prevent viral infections: Each bout of exercise, particularly whole-body dynamic cardiorespiratory exercise, instantaneously mobilizes literally billions of immune cells, especially those cell types that are capable of carrying out effector functions such as the recognition and killing of virus-infected cells.

While exercise may not prevent us from becoming infected if exposed, it is likely that keeping active will boost our immune system to help minimize the effects of the virus, ameliorate our symptoms, expedite our recovery times.

In addition to combating viruses, exercise helps with the negative effects of isolation and confinement stress which affect how well your immune system can deal with infection.

Exercise should be coupled with stress management, regular sleep, healthy nutrition, and proper hygiene to improve resistance to infection.

However, an article published in the Journal of Sport and Health Science highlights several studies that show evidence that heavy exertion was associated with transient immune dysfunction, elevated inflammatory biomarkers, and increased risk of upper respiratory tract infections.

Exercise can have great effects on physical and mental health, however, it should be properly balanced. The World Health Organization recommends that adults should attempt to fit 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity exercise into their weekly routine.

Simpson wrote: While exercise may not prevent us from becoming infected if exposed, it is likely that keeping active will boost our immune system to help minimize the deleterious effects of the virus, ameliorate our symptoms, expedite our recovery times and lower the likelihood that we can infect others with whom we come into contact.

Exercise is not a cure-all for the COVID-19 virus and infection is still likely if in contact with an infected person. Social distancing and all preventative measures should continuously be practiced.

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Importance of exercise to boost the immune system - Excalibur Online

Immunology

Synthekine Launches with $82 Million Series A Financing to Advance Pipeline of Engineered Cytokine Therapeutics Optimized for Cancer and Autoimmune…

MENLO PARK, Calif.--(BUSINESS WIRE)--Synthekine Inc., an engineered cytokine therapeutics company, today announced the closing of an $82 million Series A financing. The financing was co-led by Canaan Partners, Samsara BioCapital and The Column Group, with participation from other undisclosed investors. Synthekine was founded by K. Christopher Garcia, Ph.D., to leverage discoveries showing that cytokines can be tuned to enhance their therapeutic effects.

Synthekine combines strengths in immunology, structural insights on cytokines and multiple engineering technologies to create optimized therapeutics against new and validated cytokine targets for the treatment of cancer and autoimmune disorders. Proceeds from this Series A financing will be used to advance Synthekines lead therapeutic programs into clinical studies, expand its discovery pipeline and hone its proprietary cytokine engineering platforms. The company currently has two lead programs in IND-enabling development: STK-012, an engineered Interleukin-2 (IL-2) partial agonist for the treatment of cancer, and the combination of STK-009 and SYNCAR-001, an orthogonal IL-2 ligand and a CD-19 CAR-T-cell therapy being studied in combination.

Cytokines have a fundamental role in the immune system and represent an enormous opportunity for innovative therapeutics. However, most cytokines broadly activate a wide range of cells that can simultaneously stimulate and suppress the immune system, making drug development against these targets challenging, said Debanjan Ray, chief executive officer of Synthekine. Chris Garcia has shown, for a wide range of therapeutically important cytokines, that cytokine efficacy and toxicity can be decoupled through structure-based protein engineering. These findings mean that many cytokines previously thought to be unsuitable as therapeutics can be transformed into safe and effective drugs. In addition to our highly differentiated IL-2-based programs, we have assembled multiple best-in-class technologies and an accomplished team to develop cytokine therapeutics by engineering them at the molecular level to enhance their activity and selectivity.

Unlocking cytokine therapeutics through unique structural biology insights

Cytokines are small, soluble proteins that are powerful regulators of the immune system and can stimulate a wide range of immune cells, primarily driven by their binding and interaction with cell surface receptors. Most cytokines are pleiotropic, meaning that a given cytokine can exert a range of responses across multiple cell types. Pleiotropy has proven to be a significant obstacle in the development of cytokine therapeutics. Existing cytokine therapeutics, such as aldesleukin (Proleukin) and interferons, demonstrate meaningful efficacy in cancer and other diseases but are limited by significant side effects.

Synthekine has licensed several cytokine programs and platforms from Stanford University. Research conducted in the Garcia lab at Stanford led to insights into the interaction of cytokines and their receptors, allowing researchers to engineer modified cytokines to deliver selective activity to particular cell types of therapeutic interest, giving them the potential for optimized efficacy, a larger therapeutic window and improved safety for patients. This research has been responsible for determining the three-dimensional structures for many different cytokine/receptor complexes, including IL-1, IL-2, IL-4, IL-6, IL-13, IL-15, IL-17, IL-23 and the three different classes of interferons.

A deep preclinical pipeline and proprietary platform

Synthekine is advancing several preclinical programs and innovative platform technologies. These include:

A collaborative company formation effort and seasoned leadership team

The founding members of Synthekines board of directors include Tim Kutzkey, Ph.D., managing partner of The Column Group; Srinivas Akkaraju, Ph.D., founding partner of Samsara BioCapital; and Julie Grant, general partner at Canaan Partners. Synthekine has also appointed biopharma veteran Nils Lonberg as an independent member of its board of directors.

Synthekines executive team is led by Debanjan Ray as chief executive officer. Mr. Ray was previously chief financial officer and head of business development at CytomX Therapeutics, where he was responsible for leading financing efforts and securing multiple strategic collaborations with major pharmaceutical companies that generated more than $400 million in upfront payments and up to $4 billion in milestones. The executive team also includes Martin Oft, M.D., as chief development officer, Rob Kastelein, Ph.D., as head of therapeutic discovery and Gregory Yedinak as senior vice president of technical operations.

Synthekines scientific advisory board is led by its founder, K. Christopher Garcia, Ph.D., professor of molecular and cellular physiology and structural biology at Stanford University School of Medicine, a Howard Hughes Medical Institute (HHMI) investigator and a member of both the National Academy of Sciences and the National Academy of Medicine.

About Synthekine

Synthekine is an engineered cytokine therapeutics company developing disease-optimized treatments. The company uses immunological insights to guide targeted protein engineering to generate transformative medicines for cancer and autoimmune disorders. Using the principles of cytokine partial agonism and immunological specificity, Synthekine designs differentiated therapeutics to be both safe and efficacious. Its lead programs have shown promising efficacy and tolerability in preclinical studies, and it is developing additional cytokine partial agonists that selectively modulate key pathways of the immune system. For more information, visit http://www.synthekine.com.

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Synthekine Launches with $82 Million Series A Financing to Advance Pipeline of Engineered Cytokine Therapeutics Optimized for Cancer and Autoimmune...

Immunology

CHMP Recommends Approval of Lilly’s Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis | Small Molecules | News…

DetailsCategory: Small MoleculesPublished on Sunday, 20 September 2020 11:23Hits: 231

Positive Opinion is the First Regulatory Action for Baricitinib as an Atopic Dermatitis Medicine

INDIANAPOLIS, IN, USA I Septemer 18, 2020 I Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

This opinion marks the first step toward European regulatory approval for baricitinib (marketed as OLUMIANT) for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. A final decision is expected from the European Commission in the next one-two months.

"Due to the limited treatment options currently available for adult patients with AD, we're excited to further explore baricitinib's potential benefit for patients,"said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "At Lilly, we aspire to elevate treatment standards for patients with dermatologic conditions. Today's CHMP opinion brings us closer to providing a new medicine for adults living with AD in Europe."

The positive opinion was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine's potential to treat AD including BREEZE-AD1 and BREEZE-AD2, monotherapy studies investigating the efficacy and safety of baricitinib in moderate to severe AD patients; BREEZE-AD4, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD who have failed or who are intolerant to, or have contraindications to cyclosporine; and BREEZE-AD7, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD.

"Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option," said Prof. Thomas Bieber, M.D., Ph.D., M.D.R.A., Professor of Dermatology and Allergy, University Hospital in Bonn, Germany.

OLUMIANT is already approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).

Lilly has exclusive worldwide development and commercialization rights for baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases under a license and collaboration agreement with Incyte.

Information on the previously approved EU OLUMIANT indication (Rheumatoid Arthritis) can be found here.

Indication and Usage for OLUMIANT (baricitinib) tablets (inthe United States) for RA patients

OLUMIANT(baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

About OLUMIANT

OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1OLUMIANT is approved in more than 70 countries. OLUMIANT is developed by Lilly under license from Incyte Corporation.

About Atopic DermatitisAtopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.3 AD is a heterogeneous disease both biologically and clinically, but may be characterized by chronic symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.4,5 AD affects approximately one-three percent of adults worldwide.6

Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.7 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8

About Lilly in DermatologyBy following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

AboutEli Lilly and CompanyLilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us atlilly.comandlilly.com/newsroom.

About IncyteIncyteis aWilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information onIncyte, please visit Incyte.com and follow @Incyte.

1 Olumiant Prescribing Information, 2020.2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.3 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.4Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.5 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.6 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.7 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.8 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

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SOURCE: Eli Lilly

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Immunology

Attempting to bounce back after mid-stage flop, Novus pivots to immunology with CD40L-focused acquisition of Anelixis – Endpoints News

Following a mid-stage failure of its acute otitis media candidate back in June that sent its shares deep into penny stock territory, Novus Therapeutics has found what it believes to be a new, exciting path forward in immunology.

The Irvine, CA-based company, originally called Tokai Pharmaceuticals, announced Monday afternoon the acquisition of Anelixis Therapeutics a biotech that was spun out of the ALS Therapy Development Institute in Boston in 2015 as well as $108 million in private placement funding led by BVF Partners. Anelixis lead program AT-1501, an anti-CD40L antibody, will be central to Novus new focus, and the company is bringing along David-Alexandre Gros to steer the ship as new CEO.

The concept and discussions were around not only how to continue to move this asset forward in ALS, but also recognizing the broader potential of the CD40 ligand and beginning to think about how one could develop the asset more broadly, Gros, who joins the company after co-founding Imbria, told Endpoints News.

Novus new funding will get AT-1501 through four Phase II trials in renal transplantation, islet cell transplantation, autoimmune nephritis and ALS. Several other investors participated in the private placement, including Cormorant Asset Management, Ecor1, Logos, Fidelity Management and Research, Adage, Woodline, Ridgeback Capital, Janus Henderson, and Samsara BioCapital.

Joining Gros at Novus is Steven Perrin, the founder and CEO of Anelixis, who will work as the companys new president and CSO. When Anelixis was founded, the biotech spent its resources studying AT-1501s effect in the treatment of ALS, managing to complete a Phase I trial evaluating the compounds safety.

CD40 has a long history of research, Perrin said, and blocking the pathway can induce profound effects in the biology of both B cells and T cells, creating potential opportunities for drugs to treat a host of autoimmune disorders like multiple sclerosis, rheumatoid arthritis and type 1 diabetes. But in earlier efforts by companies to create anti-CD40 drugs, several instances of blood clots arose, putting early but exciting clinical programs on hold.

Prominently, in 2018, a UCB and Biogen anti-CD40L program designed to treat lupus flopped in a Phase IIb trial. Lupus, however, has been a challenging indication for years as the field has seen one FDA approval in GSKs Benlysta. AstraZeneca spinout Viela Bio is also working on an anti-CD40L in kidney transplant rejection, currently in a Phase II trial.

Novus hopes to set itself apart from the competition by focusing on the CD40 ligand, rather than the receptor, as part of an emerging new generation of transplant rejection therapies. The opportunity to join this pack is one of the main reasons why the program is being expanded from an initial ALS target into other indications, Perrin said.

The most important part of the historical data is that to this day, blocking CD40 ligand signaling is the most effective way to prevent transplant rejection in multiple animal models, Perrin said. Thats why theres been a long-term focus on this pathway; it could really be a transformational way to treat autoimmune indications and transplants.

From Anelixis business perspective, Perrin and his team decided to go against the traditional fundraising and eventual IPO route after wrapping up the programs Phase I at the end of 2019. Anelixis wanted to further AT-1501 development as the company was excited by their data, but needed more than just cash. Novus existing infrastructure, both from an administrative and operational standpoint, made the pairing a suitable match, Perrin said.

Next up are the Phase II trials, after which Novus will determine future steps.

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Attempting to bounce back after mid-stage flop, Novus pivots to immunology with CD40L-focused acquisition of Anelixis - Endpoints News

Immunology

Immunologists analyze types of immune response to predict an effective COVID-19 vaccine – News-Medical.Net

Reviewed by Emily Henderson, B.Sc.Sep 15 2020

Immune reactions caused by vaccination can help protect the organism, or sometimes may aggravate the condition. It is especially important now when multiple vaccines against COVID-19 are being developed. The top immunologists analyze types of immune response to predict what kind of vaccine would be the best.

The COVID-19 pandemic is still ongoing, and it is a major challenge for healthcare professionals worldwide.

Currently, there are several strategies of preventing the spread of the disease caused by the SARS-CoV-2 virus, including confinement or quarantine measures, social distancing, use of face masks, and good hygiene -- with frequent hand washing and application of antiseptics. However, it is clear that such restrictions affect our personal and professional lives.

This is why vaccines against SARS-CoV-2 are being developed across the globe, as vaccination could help stop the pandemic. But these vaccines can be designed in a number of ways, and immune responses may be different.

The recent keynote paper by Sechenov University scientists and their Swiss colleagues analyses which type of immune reaction would be more favorable so the vaccine could be effective. The study has been published in International Archives of Allergy and Immunology.

The vaccine, as expected, should efficiently induce high-affinity neutralizing antibodies which would target SARS-CoV-2. At the same time, there are concerns that infection after vaccination might lead to eosinophilic lung disease and eosinophil associated Th2 immunopotentiation.

Eosinophils are white blood cells involved in conditions such as bronchial asthma, eosinophilic oesophagitis, and hypereosinophilic syndromes. Currently, despite the limited available data, there is no indication that eosinophils play a protective or pathogenic role in COVID-19 infection.

However, eosinophils might still get involved when a person is vaccinated. For example, the research on potential vaccines against SARS-CoV-1, a closely related virus which caused an epidemic in 2002-2004, showed that pulmonary eosinophilia was induced in ferrets, monkeys, and mice after viral challenge.

This fact suggests that vaccines against SARS-CoV-2 could also cause a similar immunopathology. Another source of complications might be the induced antibodies that promote viral uptake via Fc receptors.

According to the authors of the study, the most advantageous strategy should focus on vaccines that would induce the production of high-affinity virus-neutralizing antibodies.

These antibodies should block the interaction of SARS-CoV-2 with its cellular receptor -- angiotensin-converting enzyme 2 (ACE2). Successful vaccines are expected to polarize the T-cell response towards type 1 immunity and prevent the stimulation of cytokines which induce T-helper 2 immunity.

From our experience with the SARS-1 vaccine, we know that mice which received the whole spike protein (responsible for ACE2 binding) exhibited some eosinophilic complications due to the Th-2 polarisation of the immune response."

Alexander Karaulov, Study Author and Head of the Department of Clinical Immunology and Allergology, Sechenov University

'At the same time, if the injected vaccine contained not the whole spike protein, but rather its receptor-binding domain which is directly involved in interactions with ACE2, immune-mediated pathologies (hypereosinophilic syndrome) could be avoided because of the high immunogenicity and high antibody titre. I believe this to be an important aspect, which remains poorly investigated'.

The article is the result of a collaboration between Sechenov University and the University of Bern (Switzerland).

Source:

Journal reference:

Simon H.-U., et al. (2020) Strategies to Prevent SARS-CoV-2-Mediated Eosinophilic Disease in Association with COVID-19 Vaccination and Infection. International Archives of Allergy and Immunology. doi.org/10.1159/000509368.

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Immunologists analyze types of immune response to predict an effective COVID-19 vaccine - News-Medical.Net

Immunology

Antibiotic Molecule Enables HIV Infected Cells To Be Killed by the Immune System – Technology Networks

Ever since the first cases of a mysterious disease in the early 1980s exploded into the HIV/AIDS pandemic, researchers have been searching for ways to outsmart the deadly virus. Now thanks to anti-retroviral therapy, people living with HIV can live relatively normal lifespansas long as they take their medications every day.

If they ever stop, in short order the virus rebounds and resets at the high levels seen before starting and that seems to be the case even after decades of therapy, says Mark Painter, Ph.D., a graduate student in the University of Michigan Medical Schools department of microbiology and immunology.

The reason is that HIV can hide inside the human genome, lying dormant and ready to emerge at any time. Because of this, a true cure for HIV relies on waking the latent virus and eliminating it before it has a chance to again take hold of the bodys cells, an approach known as shock and kill.

Working with a team under the direction of Kathleen Collins, M.D., Ph.D., they set out to find a weapon to kill HIV by targeting a protein called Nef. In 1998, Collins, who is a professor of internal medicine and microbiology and immunology, discovered that HIV uses Nef to evade the bodys immune system by overriding the functioning of a protein on a cells surface that lets immune cells know that the cell is infected and in need of elimination. By disabling this protein, called MHC-I, infected cells are able to proliferate.

The research tried determine if there was an FDA-approved drug or molecule already on the market that could override Nef, restore the functioning of MHC-I and allow the bodys own immune system, specifically cells known as cytotoxic T lymphocytes, to recognize the HIV-infected cells and destroy them.

We started out screening a library of 200,000 small molecules and found none inhibited Nef, says Painter. Undeterred, they approached David Sherman, Ph.D. of the U-M Life Sciences Institute, whose lab studies the biosynthesis of natural products from microbes, such as cyanobacteria.

Often synthetic molecules have quite a low molecular weight, meaning they are fairly small. And if you need to disrupt a large protein surface or interface, such as with Nef, a small molecule wont work well or at all, explains Sherman. A natural products library like the one at the LSI, on the other hand, is going to have molecules with a large range of weights and sizes.

After screening approximately 30,000 molecules, they discovered that a class of antibiotic molecules called pleicomacrolides inhibited Nef.

Pleicomacrolides are widely used in lab experiments when you want to shut down the lysosome. Because of this, they are considered toxic and risky to use as drugs, says Painter. The lysosome is an essential cell organelle used to break down worn out cell parts, viruses and bacteria.

However, the team determined that a pleicomacrolide called concanamycin A inhibits Nef at much lower concentrations than those needed to inhibit the lysosome. As a lead compound for drug development, its fairly exciting because we can use a very low dose, and inhibit Nef without short-term toxicity to the cells, said Painter.

In a proof of concept experiment, they treated HIV-infected, Nef expressing cells with concanamycin A and found that cytotoxic T cells were able to clear the infected T cells.

Its been extremely gratifying for this project, which began in my lab over a decade ago to finally come to fruition. I had hoped we would find something that worked as well as this compound does but it was never a guarantee that we would actually be successful. This type of research is risky but extremely important because of the potential reward, says Collins. But, she adds, the molecule is not yet ready to be used as a drug for treatment of HIV infected people. More research will be needed to optimize the compound. We will need to further separate the potent Nef inhibitory activity from the more toxic effect on lysosomal function to make it a viable therapy.

Collins, Painter and their colleagues are continuing work on refining the chemistry of concanamycin A to make it even more viable as a potential therapy. When combined with ART and future treatments that shock latent HIV awake, Painter notes the therapy could be used to clear any remaining virus, essentially curing HIV.

ReferencePainter M et al. Concanamycin A counteracts HIV-1 Nef to enhance immune clearance of infected primary cells by cytotoxic T lymphocytes, PNAS. September 11, 2020. https://doi.org/10.1073/pnas.2008615117

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Antibiotic Molecule Enables HIV Infected Cells To Be Killed by the Immune System - Technology Networks

Immunology

Experts Urge Those with Asthma to Take Extra Care as Wildfires Burn in Western U.S. – Newswise

Newswise ARLINGTON HEIGHTS, Ill. (September 15, 2020) As wildfires continue to burn across western U.S. states with smoke spreading across a large portion of the country, those with respiratory illnesses such as asthma need to be alert to the effects of smoke on their breathing.

Allergist J. Allen Meadows, MD, president of the American College of Allergy, Asthma and Immunology, says its important for everyone but especially children and those who suffer from asthma and other respiratory illnesses -- to stay indoors in order to not be exposed to smoke from the fires.

According to Dr. Meadows, Smoke from fires is a dangerous irritant to the eyes and respiratory system. It can make heart conditions and lung diseases like asthma worse. Children are especially vulnerable because their lungs are less developed, and they are closer to the ground, and thus more likely to take in more smoke.

Dr. Meadows points out that if you smell smoke you should do your best to stay inside. If you have asthma, make sure you are keeping it under control with proper use of your medications, and consult your allergist if are having difficulty breathing. He also recommends that, if you are still able to grocery shop,buy groceries you wont need to cook. Frying or grilling especially can make indoor air pollution worse.

If you must go outside, the Centers for Disease Control and Prevention (CDC) says you shouldnot rely on dustmasks or clothmasks for protection. Paper comfort or dust masks commonly found at hardware stores trap large particles like sawdust and arent useful against smoke. In addition, the cloth masks many people are using as a safeguard from COVID-19 will not protect your lungs from smoke. An N95 mask, properly worn, will offer some protection.

For those near areas where wildfires are burning, keep a supply of your asthma medications ready to go with you. For those who need to evacuate from home and go to a shelter, be sure to let officials know about anyone in your family who has asthma.

Once the wildfires and smoke have been controlled, continue to watch for any asthma symptoms. Contact your healthcare provider if you have trouble breathing, shortness of breath, a cough that wont stop, or other symptoms that do not go away. Call 9-1-1 or go right away to an emergency department for medical emergencies.

About ACAAI

The ACAAI is a professional medical organization of more than 6,000 allergists-immunologists and allied health professionals, headquartered in Arlington Heights, Ill. The College fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy, and research. ACAAI allergists are board-certified physicians trained to diagnose allergies and asthma, administer immunotherapy, and provide patients with the best treatment outcomes. For more information and to find relief, visitAllergyandAsthmaRelief.org.Join us onFacebook,PinterestandTwitter.

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Experts Urge Those with Asthma to Take Extra Care as Wildfires Burn in Western U.S. - Newswise

Immunology

Partner Therapeutics (PTx) Announces the Appointment of Ed Rock as Chief Medical Officer – BioSpace

LEXINGTON, Mass., Sept. 15, 2020 /PRNewswire/ --Partner Therapeutics, Inc. (PTx), Inc. (PTx), a commercial biotechnology company, announced today its appointment of Edwin Rock, MD, PhD to serve as the company's Chief Medical Officer. In his role as CMO, Dr. Rock will oversee clinical development activities for PTx, as well as serve on the Company's executive leadership team.

Dr. Rockhas 16years of leadership experience in the biopharmaceutical industry.Most recently, Edwas Clinical Project Leader and Vice President of Clinical Research at MacroGenics where he led the project team tocompletePhase 3 SOPHIA trialenrollment, to analyzethe studyandthen to write and defend the margetuximab BLA. Prior to MacroGenics, Edserved as Executive Director at Astex Pharmaceuticals where he led the team togenerate theASTRAL-1 guadecitabinetrial protocol, initiatesites in 24 countries, and complete enrollment of 815 patients in21 months.

Prior to Astex, Edwas Senior Director at Otsuka Pharmaceutical Development and Commercialization (OPDC) where he led,oversaw, or defended at Advisory Committeediverse first-in-humanthroughPhase 4 trials of Busulfex,Inqovi, Jynarque, Sprycel,and multiple pre-market new chemical entitiesand biologics. Prior to OPDC, Edwas Medical Director at GSK where he led or served as medical monitor for diverse biologic study products in Phase 1, 2, and 3 trials, including Nucala.

Before GSK, Ed served as a Medical Officer inoncology drug review at the US Food and Drug Administrationwhere he completed 3 NDA reviews and had clinical responsibility for up to 80 INDs. Edholds a B.A. in Biology and Economics fromSwarthmore College, as well as PhD (Microbiology and Immunology,Mark Davis lab)and MD degrees from the Stanford University School of Medicine.He completed medical residency training at Brigham and Women's Hospital in Boston, MA, a medical oncology fellowship at the University of Pennsylvania, and a postdoctoral fellowship in vaccine engineering at Stanford.Following medical residency, Ed worked as a biotech buyside analyst at Leerink Swann and Company.

"We are very happy to welcome Ed to our team to lead clinical development activities," said Debasish Roychowdhury, PTx's Chief Technology Officer. "Ed's expertise in immunology, drug development and regulatory experience will be critical in the ongoing development of Leukine, that is showing tremendous potential in immunomodulation and application across a gamut of diseases."

"I am excited to join the PTx team to strengthen and expand the Leukine franchise and to identify additional products that can benefit from the Company's expertise", said Dr. Rock. "Leukine is an exciting drug that may have therapeutic utility in multiple life-threatening diseases, including cancer, COVID-19 and neurodegeneration, among others. I see tremendous potential for Leukine to help patients across diverse indications with high unmet medical need."

ABOUT LEUKINELEUKINE(sargramostim)is a recombinant yeast derived human granulocyte-macrophage growth factor (rhuGM-CSF) that stimulates the differentiation, maturation and mobilization of cells involved in the innate and adaptive immune response.It is an important immune modulator that has been shown to facilitate cellular signaling, epithelial repair, and other critical processes that enhance the immune response and help defend the body against infection and cancer. Partner Therapeutics acquired the rights to Leukine in 2018. Leukine is held by the U.S. Government in the Strategic National Stockpilefor use during public health emergencies. Leukine is available outside of the United States through a Named Patient Program administered by Tanner Pharma Group.

ABOUT PARTNER THERAPEUTICSPTx is an integrated biotechnology company focused on the development and commercialization of late-stage therapeutics that improve health outcomes in the treatment of cancer and other serious diseases. The company believes in delivering products and supporting medical teams with the purpose of achieving superior outcomes for patients and their families. Visit http://www.partnertx.com

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SOURCE Partner Therapeutics, Inc.

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