Category Archives: Immunology

Immunology

Key to Hepatitis A Replication Discovered – Technology Networks

The viral replication cycle is crucial for a virus to spread inside the body and cause disease. Focusing on that cycle in the hepatitis A virus (HAV), UNC School of Medicine scientists discovered that replication requires specific interactions between the human protein ZCCHC14 and a group of enzymes called TENT4 poly(A) polymerases. They also found that the oral compound RG7834 stopped replication at a key step, making it impossible for the virus to infect liver cells.

These findings, published in the Proceedings of the National Academy of Sciences, are the first to demonstrate an effective drug treatment against HAV in an animal model of the disease.

Our research demonstrates that targeting this protein complex with an orally delivered, small-molecule therapeutic halts viral replication and reverses liver inflammation in a mouse model of hepatitis A, providing proof-of-principle for antiviral therapy and the means to stop the spread of hepatitis A in outbreak settings, said senior author Stanley M. Lemon, MD, professor in the UNC Department of Medicine and UNC Department of Microbiology & Immunology, and member of the UNC Institute for Global Health and Infectious Diseases.

Lemon, who in the 1970s and 80s was part of a Walter Reed Army Medical Center research team that developed the first inactivated HAV vaccine administered to humans, said research on HAV tapered off after the vaccine became widely available in the mid-1990s. Cases plummeted in the 2000s as vaccination rates skyrocketed. Researchers turned their attention to hepatitis B and C viruses, both of which are very different from HAV and cause chronic disease. Its like comparing apples to turnips, Lemon said. The only similarity is that they all cause inflammation of the liver. HAV is not even part of the same virus family as hepatitis B and C viruses.

Hepatitis A outbreaks have been on the rise since 2016, even though the HAV vaccine is very effective. Not everyone gets vaccinated, Lemon pointed out, and HAV can exist for long periods of time in the environment such as on our hands and in food and water resulting in more than 44,000 cases, 27,000 hospitalizations and 400 deaths in the United States since 2016, according to the CDC.

Several outbreaks have occurred over the past several years, including in San Diego in 2017 driven largely by homelessness and illicit drug use, causing severe illness in about 600 people and killing 20. In 2022, there was a small outbreak linked to organic strawberries in multiple states, leading to about a dozen hospitalizations. Another outbreak in 2019 was linked to fresh blackberries. Globally, tens of millions of HAV infections occur each year. Symptoms include fever, abdominal pain, jaundice, nausea, and loss of appetite and sense of taste. Once sick, there is no treatment.

In 2013, Lemon and colleagues discovered that the hepatitis A virus changes dramatically inside the human liver. The virus hijacks bits of cell membrane as it leaves liver cells, cloaking itself from antibodies that would have otherwise quarantined the virus before it spread widely through the blood stream. This work was published in Nature and provided insight into how much researchers had yet to learn about this virus that was discovered 50 years ago and has likely caused disease dating back to ancient times.

A few years ago, researchers found that hepatitis B virus required TENT4A/B for its replication. Meanwhile, Lemons lab led experiments to search for human proteins that HAV needs in order to replicate, and they found ZCCHC14 a particular protein that interacts with zinc and binds to RNA.

This was the tipping point for this current study, Lemon said. We found ZCCHC14 binds very specifically to a certain part of HAVs RNA, the molecule that contains the viruss genetic information. And as a result of that binding, the virus is able to recruit TENT4 from the human cell.

In normal human biology, TENT4 is part of an RNA-modification process during cell growth. Essentially, HAV hijacks TENT4 and uses it to replicate its own genome.

This work suggested that stopping TENT4 recruitment could stop viral replication and limit disease. Lemons lab then tested the compound RG7834, which had previously been shown to actively block Hepatitis B virus by targeting TENT4. In the PNAS paper, the researchers detailed the precise effects of oral RG7834 on HAV in liver and feces and how the viruss ability to cause liver injury is dramatically diminished in mice that had been genetically modified to develop HAV infection and disease. The research suggests the compound was safe at the dose used in this research and the acute timeframe of the study.

This compound is a long way from human use, Lemon said, But it points the path to an effective way to treat a disease for which we have no treatment at all.

The pharmaceutical company Hoffmann-La Roche developed RG7834 for use against chronic hepatitis B infections and tested it in humans in a phase 1 trial, but animal studies suggested it may be too toxic for use over long periods of time.

The treatment for Hepatitis A would be short term, Lemon said, and, more importantly, our group and others are working on compounds that would hit the same target without toxic effects.

Reference: Lemon SM et al.The ZCCHC14/TENT4 complex is required for hepatitis A virus RNA synthesis. PNAS; 2022. doi:10.1073/pnas.2204511119

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Immunology

Inmagene and HUTCHMED Announce First Participants in Global Phase I Trial of IMG-007 – Yahoo Finance

SAN DIEGO and HONG KONG and SYDNEY, July 6, 2022 /PRNewswire/ --Inmagene Biopharmaceuticals ("Inmagene") and HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) announces today that the first participant, based in Australia, was dosed in a global Phase I trial of IMG-007, an investigational OX40 antagonistic monoclonal antibody.

The Phase I study is a multi-stage, double-blind, randomized, placebo-controlled, dose-escalation study in healthy volunteers, and a dose-escalation and parallel design, multiple-dose study in adult patients with moderate to severe atopic dermatitis. The study will be used to evaluate the safety, tolerability and efficacy of IMG-007 in patients with atopic dermatitis. Additional details will be found at clinicaltrials.gov, using identifier NCT05353972.

"Dosing the first participant is an important milestone for the IMG-007 program," said Dr Jonathan Wang, Chairman and Chief Executive Officer of Inmagene. "We hope the data will help us demonstrate that IMG-007 is one of the strongest OX40 antagonist drug candidates worldwide."

Dr Jean-Louis Saillot, Chief Development Officer of Inmagene, said, "IMG-007 blocks the OX40 activity and has demonstrated high potency in preclinical studies, indicating a best-in-class potential. We welcome the start of the IMG-007 clinical program with the hope of developing an innovative, safe and effective treatment option for patients with atopic dermatitis and other immunological diseases."

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said: "This is an exciting step towards taking our novel drug candidates into immunological diseases, where Inmagene has significant expertise, as we work to maximize the impact of our drug discovery engine."

About IMG-007

IMG-007 is a novel antagonistic monoclonal antibody targeting the OX40 receptor. It was originally discovered by HUTCHMED, with Inmagene assuming development responsibility at the candidate stage. Inmagene has an exclusive option to in-license IMG-007's global rights.

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About OX-40 and Atopic Dermatitis

OX40 is a costimulatory receptor member of the tumor necrosis factor receptor (TNFR) superfamily expressed predominantly on activated T cells. The ligation of OX40 by its ligand OX40L leads to enhanced T cell survival, proliferation, and effector functions. Preclinical research results show that IMG-007 can bind to human OX40 receptor with high affinity, thereby inhibit the binding of OX40 to OX40L, reducing OX40L-dependent downstream signaling and cytokine release by OX40+ T cells. By selectively shutting down OX40+ T cell function, IMG-007 may provide a treatment option for pathological OX40+ T cell-mediated immune diseases, such as atopic dermatitis.

Atopic dermatitis is a chronic inflammatory skin condition that is estimated to affect 8-19% of children and 2-5% of adults in US, Europe, and East Asia.[1],[2],[3]

About Inmagene

Inmagene is a global clinical-stage biotechnology company focused on developing novel therapeutics for immunology-related diseases. The company is building a robust pipeline of nearly twenty drug development programs.

Inmagene's most advanced drug candidate is IMG-020 (izokibep), which has successfully met the endpoints in global phase II studies for both psoriasis and psoriatic arthritis ("PsA"). It has received the IND approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for phase III studies in plaque psoriasis. Inmagene is working with its partners to conduct global phase II studies for multiple autoimmune diseases, including PsA, ankylosing spondylitis (AS) and uveitis. In addition, IMG-004 and IMG-007, both of which with global rights, are in global phase I studies.

Believing in "Borderless Innovation", the Inmagene team strives to integrate efficient resources worldwide to develop novel therapeutics for global patients. Based on its proprietary QuadraTek drug discovery platform, Inmagene is operating 12 "Smart Innovation" programs to create and develop drug candidates with global rights. Inmagene also in-licenses drug candidates and, together with its partners, carries out global development activities, including global multi-center clinical trials. Inmagene has formed strategic partnerships with multiple partners, such as HUTCHMED and Affibody AB, to develop highly innovative drug candidates. For more information, please visit: http://www.inmagenebio.com

About HUTCHMED

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has more than 4,900 personnel across all its companies, at the center of which is a team of over 1,800 in oncology/immunology. Since inception it has advanced 13 cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: http://www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Inmagene's and/or HUTCHMED's current expectations regarding future events, including expectations regarding the therapeutic potential of IMG-007 for the treatment of patients with atopic dermatitis and other immunological diseases, the further clinical development of IMG-007, expectations as to whether clinical studies of IMG-007 would meet their primary or secondary endpoints, and expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study's inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of IMG-007 to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of IMG-007 for a targeted indication; the sufficiency of funding; and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of various risks applicable to HUTCHMED, see HUTCHMED's filings with the U.S. Securities and Exchange Commission, on AIM and with The Stock Exchange of Hong Kong Limited. Neither Inmagene nor HUTCHMED undertakes to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

[1] Silverberg JI, Barbarot S, Gadkari A, et al. Atopic dermatitis in the pediatric population: A cross-sectional, international epidemiologic study. Ann Allergy Asthma Immunol. 2021;126(4):417-428.e2. doi:10.1016/j.anai.2020.12.020

[2] Barbarot S, Auziere S, Gadkari A, et al. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy. 2018;73(6):1284-1293. doi:10.1111/all.13401

[3] Stnder S. Atopic Dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911

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Inmagene and HUTCHMED Announce First Participants in Global Phase I Trial of IMG-007 - Yahoo Finance

Immunology

All-in-one vaccine will tackle future coronavirus threats – Innovation Origins

As of July 2022, uncertainty persists as waves of SARS-CoV-2 continue to emerge. Over time, new virus variants arise and threaten to reduce the impact of existing vaccine efforts. There is a clear need for strategies to both tackle emerging variants, and to protect populations against potential future threats to human health such as related bat viruses, writes the University of Oxford in a press release.

A new consortium aims to address these issues by establishing the first-in-human clinical proof of concept for a new vaccine design. The vaccine will target both SARS-CoV-2 and a number of related bat viruses which have the potential to spread to humans. It builds on technologies developed by the Molecular Immunology Group at the University of Oxford and by the Bjorkman Group based at Caltech led by Professor Alain Townsend at the MRC Human Immunology Unit and by Professor Pamela Bjorkman respectively.

In contrast to many existing vaccine designs that use mRNA or a viral vector to present sections of the spike protein of a single type of virus to the immune system, this new vaccine will use protein nanoparticles containing a protein glue to attach related antigenic sections of the spike proteins from eight different viruses. By incorporating a mosaic-8 vaccine design created at Caltech these nanoparticles would favour immune responses to the shared parts of each of the different types of coronaviruses within a single vaccine.

Evidence published today in Science by the researchers demonstrates that this vaccine technology not only elicits protective immune responses against SARS-like virusesbutalso against some coronaviruses not presented in the trial vaccine. This suggests that the technology could provide protection against future novel SARS-CoV-2 variants and as-yet-undiscovered coronaviruses with the potential to spill over from animal populations.

Using Artificial Intelligence to monitor and manage COVID-19

A study by researchers at the Universitat Politcnica de Valncia (UPV), part of BDSLab-ITACA group and the Institute of Pure and Applied Mathematics (IUMPA), has become an international benchmark for the reliable use of artificial intelligence in monitoring and managing COVID-19.

Alain Townsend, Oxford Lead of the consortium, Professor of Molecular Immunology at the MRC Weatherall Institute of Molecular Medicine, University of Oxford, said: The evolution of this consortium is an example of collaborative science at its best. We had been deeply impressed by the power of the glue for sticking proteins together developed by Mark Howarth (Biochemistry Oxford),and derived from his beautiful basic science investigations of the Streptococcus pyogenes bacterium.

Throughconnections made byIan Wilkinson (Absolute Antibody), we joined with colleagues at Ingenza and CPI who succeeded in making a fully functional version of the vaccine produced in microbes, thus reducing the cost of production. We have been collaborating with Prof. Pamela Bjorkman and the Caltech team, who had independently developed the brilliant concept of the mosaic version of the vaccine and are excited to continue working with this world-class consortium.

The consortium aims to commence a Phase 1 trial in 2024, led by the Oxford Vaccine Group.

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All-in-one vaccine will tackle future coronavirus threats - Innovation Origins

Immunology

Wheres the herd immunity? Our research shows why Covid is still wreaking havoc – The Guardian

We are all so very tired of Covid-19, and there are many other crises to wrestle with. This pandemic has been going on since the beginning of 2020, and a state of hypervigilance can only be maintained for so long. And yet, just live with it looks self-evidently too thin a recipe and, currently, not very workable or successful with the emergence of BA.4 and BA.5 Omicron subvariants.

According to the latest numbers, released today, the UK added more than half a million new Covid infections in the past week, and the estimated number of people with Covid in total was somewhere between 3% and 4% of the population.

Many have been rather unwell and off work or school, with the associated disruptions to education, healthcare and other vital services. These infections will also inevitably add to the toll of long Covid cases. According to ONS data, the supposedly mild waves of Omicron during 2022 have brought more than 619,000 new long Covid cases into the clinical caseload, promising an enduring and miserable legacy from this latest phase.

Rather than a wall of immunity arising from vaccinations and previous infections, we are seeing wave after wave of new cases and a rapidly growing burden of long-term disease. Whats going on? The latest scientific research has some answers.

During May and June two new variants, BA.4 and BA.5, progressively displaced the previous Omicron subvariant, BA.2. They are even more transmissible and more immune-evasive. Last week a group of collaborators, including me and a professor of immunology and respiratory medicine, Rosemary Boyton, published a paper in Science, looking comprehensively at immunity to the Omicron family, both in triple-vaccinated people and also in those who then suffered breakthrough infections during the Omicron wave. This lets us examine whether Omicron was, as some hoped, a benign natural booster of our Covid immunity. It turns out that isnt the case.

We considered many facets of immunity, including the antibodies most implicated in protection (neutralising antibodies), as well as protective immune memory in white blood cells. The results tell us it is unsurprising that breakthrough infections were so common. Most people even when triple-vaccinated had 20 times less neutralising antibody response against Omicron than against the initial Wuhan strain. Importantly, Omicron infection was a poor booster of immunity to further Omicron infections. It is a kind of stealth virus that gets in under the radar without doing too much to alert immune defences. Even having had Omicron, were not well protected from further infections.

Also, to be added to the now complex mix is immune imprinting. This is the finding that our immune response to Covid is shaped very differently, depending on our prior exposures infection in one wave relative to another, plus vaccination. In our study, those whod been infected in the first wave and then again with Omicron had particularly poor T-cell responses and no boosting of antibodies. That is, some combinations of exposures may leave us poorly protected relative to others.

Contrary to the myth that we are sliding into a comfortable evolutionary relationship with a common-cold-like, friendly virus, this is more like being trapped on a rollercoaster in a horror film. Theres nothing cold-like or friendly about a large part of the workforce needing significant absences from work, feeling awful and sometimes getting reinfected over and over again, just weeks apart. And thats before the risk of long Covid. While we now know that the risk of long Covid is somewhat reduced in those who become infected after vaccination, and also less in those from the Omicron than the Delta wave, the absolute numbers are nevertheless worrying.

Not having got long Covid after a prior infection in the earlier waves offers no guarantee against getting it this time. As an immunologist struggling to decode long Covid mechanisms and potential treatments, it is both perplexing and not a little devastating that this mysterious, lingering disease finds a way to continue wreaking havoc in the face of a largely vaccinated population and a supposedly milder variant. Theres an ever-growing cohort of rather desperate long-haulers, many now affected for well over two years, starting to have difficult legal conversations about medical early retirement and personal independence payment support. They need answers, treatments and to know that we take the situation sufficiently seriously to stop creating more cases.

The first generation of vaccines served brilliantly to dig us out of the hole of the first year, but the arms race of boosters versus new variants is no longer going well for us. The UK has only offered a limited group fourth doses, and even then, uptake looks poor. Even if we had good vaccination coverage, we have entered a period of diminishing returns. A study reported in the BMJ last week showed us that the protection gained from a fourth booster dose likely wanes even faster than previous boosters. This leaves us between a rock and a hard place: continue to offer suboptimal boosters to a population who seem to have lost faith or interest in taking them up, or do nothing and cross our fingers that residual immunity might somehow keep a lid on hospitalisations (as happened in South Africa and Portugal).

There is massive activity to develop second-generation vaccine options that might do better including variant-specific vaccines or pan-coronavirus vaccines. While there are promising lab studies on these, we lack the evidence comparable to the huge, first-generation trials that inspired confidence during 2020. Conducting trials has become much harder as we struggle to keep pace with the emergence of new subvariants.

From where I stand, living with the virus is proving hard for many. This fight is far from over, and learning how to pull this off is an active process requiring considerable effort, intervention and ingenuity.

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Wheres the herd immunity? Our research shows why Covid is still wreaking havoc - The Guardian

Immunology

Immunic, Inc. Strengthens Its Board of Directors with the Appointment of Maria Trnsn – Yahoo Finance

Global Commercial Executive Brings 20 Years of Sales and Marketing Expertise Jan Van den Bossche Steps Down from Board After Six Year Tenure

NEW YORK, July 6, 2022 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX),a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, today announced the appointment of Maria Trnsn, an industry executive with 20 years of global commercial experience in U.S. and ex-U.S. markets, to its Board of Directors, effective July 5, 2022. The company also announced that Jan Van den Bossche has stepped down from the Board, effective July 5, 2022.

"Maria is a seasoned commercial executive, with 20 years of experience in sales and marketing as well as several operational and strategic leadership roles in the U.S., EMEA, and other global territories," stated Duane Nash, M.D., J.D., MBA., Chairman of the Board of Directors of Immunic. "Her expertise in scaling and optimizing commercial organizations to drive performance will be of tremendous value to the Board, as we continue to advance our three development programs, most notably, the phase 3 ENSURE program of lead asset, vidofludimus calcium, in patients with relapsing multiple sclerosis. I look forward to working with Maria and to leveraging her extensive knowledge and relationships."

"I would also like to take this opportunity to thank Jan for his dedication to Immunic and his invaluable input as a member of the Board of Directors over the last several years. We are very grateful for his contributions and offer him our best wishes in all future endeavors."

Ms. Trnsn has served since July 2021 as Chief Commercial Officer at Passage Bio, where she is responsible for leading and building out the company's commercial organization and strategy, including determining product positioning and paths to commercialization. From 2019 to 2021, Ms. Trnsn served as Senior Vice President and General Manager of Sarepta Therapeutics' U.S. Commercial organization, including market access, trade & distribution, reimbursement, sales, patient services and marketing. From 2017 to 2019, she was Vice President, Global Therapeutic Area Head of rare neurological, metabolic and endocrine diseases at Sanofi Genzyme, where she managed a $1.6 B portfolio with five marketed and three pipeline products, and was commercial lead on multiple alliances. From 2011 to 2017, Ms. Trnsn held advancing commercialization roles in the endocrine and rare diseases groups at Shire, rising to the role of Vice President, Head of Endocrine Rare Disease Sales, U.S. Commercial. Earlier in her career, she gained experience in global marketing and as a Product Specialist at Merck KGaA and Eli Lilly, respectively.

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Ms. Trnsn earned a Master of Science (MSc) in International Business Administration from Lund University, Sweden.

About Immunic, Inc.Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases. The company is developing three small molecule products: its lead development program, vidofludimus calcium (IMU-838), a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH and exhibits a host-based antiviral effect, is currently being developed as a treatment option for multiple sclerosis, and primary sclerosing cholangitis. IMU-935, a selective inverse agonist of the transcription factor ROR/RORt, is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barr syndrome. IMU-856, which targets the restoration of the intestinal barrier function, is targeted for development in diseases involving bowel barrier dysfunction. For further information, please visit: http://www.imux.com.

Cautionary Statement Regarding Forward-Looking StatementsThis press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's three development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; the nature, strategy and focus of the company and further updates with respect thereto; expectations regarding the capitalization, resources and ownership structure of the company; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on February 24, 2022, and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

Contact Information

Immunic, Inc.Jessica BreuHead of Investor Relations and Communications+49 89 2080 477 09jessica.breu@imux.com

US IR ContactRx Communications GroupPaula Schwartz+1 917 322 2216immunic@rxir.com

US Media ContactKOGS CommunicationEdna Kaplan+1 617 974 8659kaplan@kogspr.com

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Immunology

Astria Therapeutics Presents New Preclinical Data Showing Differentiated Profile of STAR-0215, in Development for Treatment of Hereditary Angioedema -…

BOSTON--(BUSINESS WIRE)--Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for hereditary angioedema and focused on life-changing therapies for rare and niche allergic and immunological diseases, presented new preclinical data that demonstrate STAR-0215s rapid and durable inhibition of plasma kallikrein in cynomolgus monkeys, supporting the potential for once every three month or longer dosing in humans. The Flash Talks session entitled STAR-0215, a Long-Acting Monoclonal Antibody Plasma Kallikrein Inhibitor in Development for Treatment of HAE, Demonstrated Sustained Functional Inhibition in Subcutaneously Dosed Cynomolgus Monkeys was presented at the European Academy of Allergy and Immunology 2022 Hybrid Congress in Prague, Czech Republic.

These new preclinical results continue to support that STAR-0215 is a novel, potent, and selective inhibitor of plasma kallikrein, and demonstrate the potential for STAR-0215 to be dosed once every 3 months or longer, said Andy Nichols, Ph.D., Chief Scientific Officer at Astria Therapeutics. We expect to advance STAR-0215 into the clinic this year with our Phase 1a trial in healthy volunteers, which would bring us another step closer to our goal of developing the most patient-friendly treatment for HAE.

The study, conducted in cynomolgus monkeys, showed rapid inhibition of plasma kallikrein after subcutaneous administration. Inhibition of HMWK cleavage was rapid and sustained throughout an 84-day dose-free period in the extended portion of the study. These data confirm the long half-life of STAR-0215 and demonstrate prolonged pharmacological activity of STAR-0215 in circulation in cynomolgus monkeys.

STAR-0215 is a monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting, effective attack prevention for HAE with dosing once every 3 months or longer. The companys goal is to provide the most patient-friendly preventative treatment option for people living with HAE.

About Astria Therapeutics:Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in preclinical development for the treatment of hereditary angioedema. Learn more about our company on our website, http://www.astriatx.com, or follow us on Twitter and Instagram @AstriaTx and on Facebook and LinkedIn.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: the expected commencement of a Phase 1a clinical trial for STAR-0215; the potential attributes and differentiated profile of STAR-0215 as a treatment for HAE; and the Companys broader goal to meet the unmet needs of patients with rare and niche allergic and immunological diseases. The use of words such as, but not limited to, anticipate, believe, continue, could, estimate, expect, goals, intend, may, might, plan, potential, predict, project, should, target, will, or would and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Companys current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, future financial performance, results of pre-clinical and clinical results of the Companys product candidates and other future conditions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties: related to changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors, including the COVID-19 pandemic; risks inherent in pharmaceutical research and development, such as: adverse results in our drug discovery, preclinical and clinical development activities, the risk that the results of pre-clinical studies may not be replicated in clinical studies, the Companys ability to enroll patients in our clinical trials, and the risk that any of the Companys clinical trials may not commence, continue or be completed on time, or at all; decisions made by, or feedback received from, the U.S. FDA and other regulatory authorities, investigational review boards at clinical trial sites and other review bodies with respect to STAR-0215 and any future product candidates; the Companys ability to manufacture sufficient quantities of drug substance and drug product on a cost-effective and timely basis; the Companys ability to obtain, maintain and enforce intellectual property rights for STAR-0215 and any other future product candidates; competition with respect to STAR-0215 in HAE or with respect to any other future product candidates; the anticipated position and attributes of STAR-0215 in HAE based on its pre-clinical profile, pharmacokinetic modeling and other data; the Companys ability to manage its cash usage and the possibility of unexpected cash expenditures; the Companys ability to obtain necessary financing to conduct its planned activities and to manage unplanned cash requirements; general economic and market conditions; as well as the risks and uncertainties set forth under the caption Risk Factors in the Companys most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in the Companys subsequent filings with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. The Company may not actually achieve the forecasts or expectations disclosed in our forward-looking statements, and investors and potential investors should not place undue reliance on the Companys forward-looking statements. Neither the Company, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Companys views as of any date subsequent to the date hereof.

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Immunology

Tissue-Anchored Immune Cells Offer Unique Defenses Against Infections and Malignancies – Technology Networks

Scientists exploring how our immune system responds to pathogens and cancers have ramped up their attention to CD8+ T cells, which are deployed in response to infections and malignancies and equipped to remember the identities of malicious invaders.

While some of these critical memory cells circulate throughout the body, others are known to remain lodged within bodily organs to guard entry sites as part of an entrenched, long-term defense system. A new study led by biologists at the University of California San Diego offers fresh insights on these specialized cells, known as CD8+ tissue-resident memory T cells. Published June 27 in Nature Immunology, the study is led by Postdoctoral Scholars Max Heeg and John Crowl (now a scientist at Outpace Bio) in Professor Ananda Goldraths laboratory in UC San Diegos School of Biological Sciences and provides a framework for understanding how tissue-resident memory T cells adapt to distinct tissue environments. The researchers developed a new atlas that describes tissue-resident memory T cells in diverse tissue settings, boosting the prospects of the development of immune defense strategies to enhance immunity at sites vulnerable to infection.

By identifying the unique transcriptional pathways and regulators of tissue-resident memory T cells, we can discover novel targets that inform strategic design of vaccines to provide the greatest protection among first responders in the tissues where pathogens and tumors begin their expansion, said Goldrath, who holds the Tata Chancellors Endowed Professorship in the Department of Molecular Biology.

While several studies have examined memory cells as they either circulate or become entrenched in organ tissue, little had been known about the role that the surrounding tissue environments play in the process. When an infection takes hold, the immune system activates CD8+ T cells and directs them to infected tissues to survey cells for pathogens. Once the infection clears, the number of pathogen-specific CD8+ T cells declines, but a small number of cells remain as a type of long-term sentry system to bolster immunity against future infections.

The new study examined tissue-resident memory T cells residing in mouse organs such as the kidney, spleen, small intestine and liver. The collective results from across these disparate tissue environments generated insights into how each T cell population is governed by unique processes based on the tissue of residence.

Finally, the scientists raise the possibility that future extensions of this research could come in the form of customized engineered therapies: these findings collectively raise the possibility of programming tissue-tailored immune responses, where immune cells that promote or regulate inflammation could be transcriptionally engineered for trafficking to, retention in and function within a particular tissue.

Reference:Crowl JT, Heeg M, Ferry A, et al. Tissue-resident memory CD8+ T cells possess unique transcriptional, epigenetic and functional adaptations to different tissue environments. Nat Immunol. Published online June 27, 2022:1-11. doi:10.1038/s41590-022-01229-8

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Tissue-Anchored Immune Cells Offer Unique Defenses Against Infections and Malignancies - Technology Networks

Immunology

CAMI Set to Transform Immunotherapy Field Through Research – University of Arizona

When she was in her 30s, Molly Cassidy was handed a death sentence. Traditional treatments failed to fight the aggressive head and neck cancer that was running rampant through her body. Doctors were out of options, until a clinical trial at the University of Arizona Health Sciences offered a glimmer of hope and, eventually, a second chance at life thanks to immunotherapy.

Immunotherapy is a treatment that uses a person's own immune system to fight cancer, while molecular therapies use drugs and other substances to target specific molecules involved in disease progression. In Cassidys case, she received a personalized cancer vaccine in combination with an immunotherapy drug that helps the immune system fight certain kinds of cancer, and it worked. A year after the UArizona Cancer Center clinical trial ended, there were no traces of cancer left in her body.

Researchers and physician-scientists are increasingly using precision medicine to develop new cell- and gene-based therapeutical options for diseases, building on the idea that the most effective defense against health issues is the bodys natural immune system. At UArizona Health Sciences, the Center for Advanced Molecular and Immunological Therapies, or CAMI, is being developed to advance knowledge of the immunology of cancers, infectious diseases and autoimmune conditions to develop novel strategies for the diagnosis, prevention and treatment of diseases.

Immunotherapy is one of the most promising approaches to cancer treatment, as it has the potential to sidestep the effects of therapies that can compromise patients long-term health and wellness. But cancer isnt the only target researchers, including bioengineer Michael Kuhns, PhD, have in their sights.

Bioengineers solve fundamental problems with technologies that can have many applications, said Dr. Kuhns, associate professor in the UArizona College of Medicine Tucson and member of the BIO5 Institute. If you can make something run more efficiently in certain circumstances for example, make T cells in the immune system more effective at combating a particular disease then the only limit to immunotherapy is your imagination.

Dr. Kuhns research in the Department of Immunobiology focuses on engineering chimeric antigen receptors, or CARs, a relatively new type of gene therapy. He built a biomimetic five-module chimeric antigen receptor, or 5MCAR, to direct killer T cells to target and destroy autoimmune T cells. When tested in a non-obese diabetic mouse model, the 5MCAR T cells recognized and destroyed pathogenic T cells, effectively preventing Type 1 diabetes.

The Center for Advanced Molecular and Immunological Therapies will focus on developing precision therapies that stimulate or suppress the immune system to fight diseases including cancers, infectious diseases and autoimmune conditions.

This technology has clear implications for autoimmune disease, but also for cancer, said Dr. Kuhns, who serves on the 21-member CAMI Advisory Committee. This technology emerged from basic science, is taking hold in the laboratory and is showing promise to go to the clinic. This is a prime example of what we can do.

CAMI will build on UArizona Health Sciences expertise in basic science, translational medicine and investigator-initiated clinical trials to advance immunotherapies research in four areas: cancer, infectious diseases, autoimmune diseases and real-time immune system monitoring.

Other examples of potential research include identifying biomarkers for response to immunotherapy that may help determine the precise drugs to fight specific cancers in individual patients, understanding individual immune responses to autoimmune diseases such as lupus, rheumatoid arthritis or Crohns disease, and creating ways to analyze immune health at the cellular level to identify how individuals might respond to a disease and to predict their health outcomes.

CAMI will serve as the anchor for an innovation district that aims to differentiate Phoenix from other emerging life sciences hubs, establishing the Phoenix Bioscience Core as a center of cell and gene therapy research, startup activity and corporate engagement. Its location is expected to facilitate strong connections with partners such as Arizona State University, Northern Arizona University, the Mayo Clinic and the Translational Genomics Research Institute, among others.

We expect CAMI to be nothing short of a national biomedical research hub, said Michael D. Dake, MD, senior vice president for UArizona Health Sciences. CAMI will be a beacon for people who are involved in this type of research to work, collaborate and engage on the Phoenix Bioscience Core.

The research will take place in connected buildings that are being designed to include laboratories to support translational research, clinical research space and startup incubator space to create a synergistic environment for commercialization opportunities. Student education will be prioritized in learning spaces dedicated to academic programs that will allow CAMI faculty and researchers to mentor and train the next generation of scientists.

There is not a field with more explosive growth than immunotherapy. There is rapid growth in research investment and increased formation of academic and industry partnerships around the world, Dr. Dake said said during a Tomorrow is Here Lecture Series presentation in Phoenix. My hopes are that CAMI is going to provide opportunities to accelerate the development and delivery of revolutionary treatments for the management of cancer, autoimmune and infectious diseases.

We are going to see diversification of drug classes and different types of combination therapies, delivery mechanisms and monitoring, he added. Going forward, I think were going to see a wide array of therapies that are going to be vastly different than any past generations ever had. Suffice it to say, in the future, pills and syringes are going to be obsolete.

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CAMI Set to Transform Immunotherapy Field Through Research - University of Arizona

Immunology

Locum Consultant in Paediatric Immunology job with Cambridge University Hospitals NHS Foundation Trust | 156644 – The BMJ

Applications are invited for the post of Locum Consultant in Paediatric Clinical Immunology at Cambridge University Hospitals NHS Foundation Trust to commence from 27 June 2022 until 25 June 2023 to cover sabbatical leave.

The Paediatric Immunology Service provides a regional service focused on diagnosis and management of immune deficiency in children presenting with severe, frequent, or atypical infection and autoimmune or autoinflammatory diseases. Additional to providing a consult service within the hospital, the post holder will run regular outpatient immunology clinics taking referrals from across region, and support multidisciplinary clinics for 22q11 deletion syndrome, respiratory complications of immune deficiency, complex haematological syndromes and rheumatic diseases.

The post holder will work closely with Great Ormond Street Clinical Immunologist, providing shared care as clinically indicated.

Main duties of the job

You will be fully registered with the GMC and have CCT in Paediatrics with a specialist interest in Paediatric Immunology and Infectious Diseases or be within six months of award of CCT at the time of interview. Applications are welcomed from those unable to work full time for personal reasons or those wishing to job-share.

Working for our organisation

The applicant must have demonstrable skills in listening, reading, writing and speaking in English that enable effective communication about medical topics with patients and colleagues, as set out in the GMCs Good Medical Practice (2013). Non-UK applicants must possess the IELTS/OET exam before obtaining a GMC licence to practice.

Applications from job seekers who require skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information please visit the UK Visas and Immigration website.

It is a requirement for skilled worker applicants, applying for entry clearance into the UK, to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) will also be subject to this requirement.

Cambridge University Hospitals NHS Foundation Trust is an Equal Opportunities Employer.

Job description and main responsibilities

Please refer to the Job description and Person specification attached for further details on the main responsibilities and duties for this post.

Additional contact information

Visiting the Department should be arranged through Ms Tracey White, PA/Paediatric Medical Secretary via email attracey.white@addenbrookes.nhs.ukor by telephone on 01223 256291.

Informal enquiries about this post should be addressed to Dr Donna McShane, Consultant in Paediatric Respiratory Medicine via email atdonna.mcshane@addenbrookes.nhs.uk

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Locum Consultant in Paediatric Immunology job with Cambridge University Hospitals NHS Foundation Trust | 156644 - The BMJ

Immunology

New textbook addresses the timely topic of molecular immunology – EurekAlert

The recent experience of the COVID-19 pandemic and the ensuing vaccine development have drawn our attention to the system that keeps us alive: immunity. However, our immune system does more than fight against microbes. The new textbook Molecular Immunology: How Science Works by Professor Carsten Carlberg and Dr Eunike Velleuer provides an essential background in molecular immunology. This includes the basic principles and underlying processes of immunity against bacteria and viruses, immune responses to cell and organ transplants, the overboarding immune activation in allergies and autoimmune reactions, as well as the way how a properly functioning immune system protects us against cancer.

Understanding these mechanisms will highlight that a fight against viruses uses the same mechanisms as the battle against thousands of transformed cancer cells arising every day in each of us, the authors remark.

Our immune system is composed of biological structures like the lymphatic system and bone marrow, as well as cellular immunity mediated by cell types such as leukocytes and humoral immunity mediated by proteins such as antibodies and complement proteins. The perfect balance of these components protects us against infectious diseases and cancer. Molecular immunology aims to understand the collective and coordinated response of these cells and proteins to substances that are foreign to our body. The main purpose of this immune response is the fight against microbes, such as viruses, bacteria, fungi and parasites. However, the example of allergic reactions, which nowadays are getting continuously more common, demonstrates that also non-microbial molecules can induce a strong reaction of our immune system. Moreover, incorrect reactions of the immune system can lead to autoimmune diseases, such as type I diabetes and multiple sclerosis. Immune responses can cause tissue injuries that are more harmful than the effects of pathogenic microbes. These collateral damages may be even fatal, such as in the case of bacterial sepsis or strong responses to SARS-CoV-2 infections.

The different chapters of the book explain the cellular basis of immunology, the key molecules mediating the effector functions of B and T cells, and how molecular immunology is associated with infections caused by bacteria and viruses, organ transplantation, allergy and autoimmunity as well as different types of cancers.

We hope that readers will enjoy this rather visual book and get as enthusiastic as the authors about life and its protection reflected in the fine-tuned molecular immunology.

Molecular Immunology: How Science Works is the fifth textbook in the series How Science Works co-authored by Professor Carlberg. The earlier books in the undergraduate book series are Cancer Biology: How Science Works, Mechanisms of Gene Regulation: How Science Works, Human Epigenetics: How Science Works and Nutrigenomics: How Science Works. They are linked to the lecture courses in Molecular Immunology, Molecular Medicine and Genetics, Cancer Biology and Nutrigenomics given by Professor Carlberg at the University of Eastern Finland in Kuopio. The book series now covers each lecture course.

Carsten Carlberg graduated in 1989 with a PhD in biochemistry at the Free University Berlin. After positions as postdoc at Roche in Basel, group leader at the University of Geneva and docent at the University of Dsseldorf, he is since 2000 full professor of biochemistry at the University of Eastern Finland in Kuopio. His work focuses on the mechanisms of gene regulation by nuclear hormones, in particular on vitamin D. At present, Professor Carlbergs projects focus on the epigenome-wide effects of vitamin D on the human immune system in the context of cancer.

Eunike Velleuer graduated in 2006 as MD at the University of Dsseldorf and specialized in 2016 in pediatric hemato-oncology. At present, she serves as senior physician at the Helios Childrens Clinic Krefeld as well as a research associate at the University of Dsseldorf. Her special clinical focus is the cancer predisposition syndrome Fanconi anemia. Herein, her research interest is early detection and prevention of oral squamous cell carcinoma and identifying patients with Fanconi anemia at risk. Furthermore, Dr. Velleuer is interested in increasing patients resilience and finding alternative ways for long-lasting empowerment.

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New textbook addresses the timely topic of molecular immunology - EurekAlert