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Immunology

INmune Bio, Inc. Announces Two Presentations at the 2021 British Society of Immunology Congress and Provides 119-day data on First patient in MDS…

Boca Raton, Florida, Dec. 01, 2021 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the Company), a clinical-stage immunology company focused on developing treatments that harness the patients innate immune system to fight disease, today announced two poster presentations at the 2021 British Society of Immunology Congress, which was held November 28-December 1, in Edinburgh, UK.

Mark Lowdell, PhD, Chief Scientific Officer of INmune Bio, stated, Im delighted to have two of our team presenting our latest data on the mechanism of action of INKmune. These are the first comprehensive data showing that INKmune-mediated priming generates NK cells with memory-like phenotype (mlNK). Before this, mlNK cells could only be produced using multiple combinations of cytokines. These are the data which led us to the concept that INKmune is a pseudokine that provides multiple signals to NK cells, akin to the multi-cytokine cocktails used by others. We also show that INKmune priming promotes significant proliferation of mlNK cells in vitro. These in vitro data have been replicated in the first patient treated with three, weekly doses of INKmune for high risk MDS. At 119 days post first treatment, 60% of the patients NK cells showed the activated, tumor killing phenotype compared to fewer than 15% before INKmune therapy. The patient remains well and with a significantly improved ECOG status.

Details of the presentations are as follows:

Title: Tumor-priming generates memory-like natural killer cells with universal anti-tumor functions

Poster: P-107

Session: Poster session 1

Natural killer (NK) cells are innate lymphocytes that target virus-infected and tumor cells. NK cells are exciting candidates for cancer immunotherapy due to their fast-acting innate ability to mount anti-tumor responses and recently highlighted adaptive properties including priming and memory-like functions. Tumor-priming of NK cells through in-vitro exposure to tumor target cells pre-activates NK cells to demonstrate enhanced tumor cell lysis upon restimulation, generating long-term memory-like features. The generation of memory-like NK cells was previously reported following exposure to cytomegalovirus (CMV), interleukin (IL)-12/15/18 combinations or the tumor cell line NALM-16.

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Here, we report a novel type of tumor-induced memory-like (TIML) NK cell induced by the acute lymphoblastic leukemia (ALL) cell line, INB16. These TIML NK cells are generated in vitro over a period of seven days to show better expansion, survival, and proliferation relative to other memory-like NK cells, maintaining similar levels of enhanced NK cell anti-tumor functional abilities including tumor lysis, and pro-inflammatory cytokine secretion against a wide range of tumor targets. Their unique phenotypic and gene expression signatures suggest a novel and distinct form of memory-like NK cell governed by tumor-specific signaling pathways. The universal and wide-acting function of these highly expanded NK cells may have important implications in the clinical setting to better mitigate challenges in low NK cell number and lytic ability.

A link to the abstract can be found here.

Title: Tumor-priming defines an intermediate stage in natural killer cell activity between resting and lytic stages for enhanced NK cell function upon re-stimulation

Poster: P-597

Session: Poster session 1

Natural killer (NK) cells are critical effector cells of the innate immune system belonging to the family of group one innate lymphocytes (ILCs). They display direct cytotoxicity against sensitive tumor targets and secrete a wide array of cytokines that help mount an effective immune response against cancer development and progression, making them attractive candidates for cancer immunotherapy.

We previously reported a tumor-priming approach to NK cell activation, whereby exposure to the acute lymphoblastic leukemia cell line CTV-1 specifically activates NK cells to display more enhanced anti-tumoral functions. This has yielded encouraging results in clinical trials against acute myeloid leukemia and myelodysplastic syndrome. Other groups reported a similar tumor-priming strategy for specific activation of NK cell anti-tumor responses using NALM-16. Still, the mechanisms involved in tumor-priming of NK cells remain to be elucidated, and it is unclear how the primed state can be achieved for optimal clinical benefit.

Here, we show that tumor-priming stimulates NK cells to a point along the lytic activation pathway for enhanced NK cell function upon re-stimulation. The primed state is achieved through exposure to less sensitive tumor targets that form fewer conjugates, and induce lower levels of avidity, degranulation, activation marker expression, pro-inflammatory cytokine secretion and lysis by NK cells. This tumor-primed state leads to enhanced NK cell function upon re-stimulation and potent NK cell killing of previously insensitive tumor targets. Interestingly, tumor-priming of NK cells is achieved in the presence of inhibitory signals and can be achieved using whole cell or cell lysate preparations, which generate differential activation signatures relative to cytokine stimulation.

This may have important implications in the clinic, where continuous cytokine exposure is associated with a dose-limiting toxicity in patients. These findings help define the tumor-primed NK cell activation state for the development of more optimal NK cell-based immunotherapeutic strategies in cancer.

A link to the abstract can be found here.

About INKmune

INKmune is a pharmaceutical-grade, replication-incompetent human tumor cell line (derived from CTV-1) which conjugates to resting NK cells and delivers multiple, essential priming signals akin to treatment with at least three cytokines in combination. INKmune is stable at -80oC and is delivered by a simple IV infusion. The INKmune:NK interaction ligates multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma, ovarian cancer, breast cancer.

About INmune Bio, Inc.

INmune Bio, Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has two product platforms that are both in clinical trials. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is in clinical trial to determine if it can treat cancer (INB03), Mild Alzheimers disease, Mild Cognitive Impairment and treatment resistant depression (XPro). The Natural Killer Cell Priming Platform includes INKmune aimed at priming the patients NK cells to eliminate minimal residual disease in patients with cancer. INmune Bios product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic malignancies, solid tumors and chronic inflammation. To learn more, please visit http://www.inmunebio.com.

Forward Looking Statements

Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03, XPro1595, and INKmune are still in clinical trials or preparing to start clinical trials and have not been approved and there cannot be any assurance that they will be approved or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Companys ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and, the Companys business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Companys filings with the Securities and Exchange Commission, including the Companys Annual Report on Form 10-K, the Companys Quarterly Reports on Form 10-Q and the Companys Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contact:

David Moss, CFO (858) 964-3720info@inmunenbio.com

Investor Contact: Chuck Padala LifeSci Advisors (646) 627-8390

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INmune Bio, Inc. Announces Two Presentations at the 2021 British Society of Immunology Congress and Provides 119-day data on First patient in MDS...

Immunology

Sanofi to acquire Origimm Biotechnology, gaining therapeutic acne vaccine candidate – BioPharma-Reporter.com

It marks Sanofis first move into skin immunology and the skin microbiome as it champions its strategy to build an industry-leading vaccines pipeline.

Founded in 2012, Origimm specializes in the discovery of virulent skin microbiome components and antigens from bacteria causing skin disease, such as acne. Its therapeutic vaccine candidate for acne vulgaris ORI-001, is based on recombinant proteins, and entered preliminary clinical studies in Q3 this year.

In parallel, Sanofi is working to develop additional antigen versions and expects to leverage its mRNA platform in a Phase 1/2 trial to start in 2023.

The acquisition of Origimm further broadens our vaccines R&D pipeline with a first vaccine candidate against acne, a high medical need for millions of teenagers and adults, says Thomas Triomphe, Executive Vice President, Global Head of Sanofi Pasteur.

Welcoming Origimm within Sanofi expands our area of expertise by bringing extensive know-how in the field of skin microbiome and skin immunology. We look forward to unlocking the full potential of this candidate.

Origimm develops preventive and therapeutic products that act against those skin-colonizing bacteria that can induce skin disease. Unlike acne treatments, its therapy would address the root cause of the disease, rather than treat the symptoms.

Diseases caused by skin microbes are more complex than classic infections because the same microbes that appear harmless, or even beneficial, on the surface of skin can become pathogenic under certain conditions.

Origimm has identified the proteins produced by bacteria when it reacts to an increase in sebum secretion from the skin's pores, thus creating a specific immune response for when the bacterium breaches the skin.

Recent scientific findings about the role ofPropionibacterium acnes (P. acnes)in acne vulgaris have opened the path for the development of a new, highly specific and efficacious acne therapy,"notes Origimm.

"Our therapeutic product is designed to support the human immune system in controllingthe growth ofP. acneson the skin and prevent it from damaging the cellular lining of the pores.

"Our intention is not just to provide a more effective treatment of acne, but also to prevent its formation in the first place, thereby avoiding any potential skin damage (scarring). Therefore, both therapeutic and prophylactic immunotherapymay be possible.

The acquisition is expected to close early December 2021.

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Sanofi to acquire Origimm Biotechnology, gaining therapeutic acne vaccine candidate - BioPharma-Reporter.com

Immunology

The Importance of Immunology by Joe Murphy, Hampton School – This is Local London

Due to a challenging winter in the presence of the COVID pandemic, new variants of concern such as Omicron and an increase in the number of colds and flu, immunology has never been more important; hence, there has been a large rise in interest in this area of science. Immunology is the study of the immune system and how it can protect us from disease. This brief article derives from an interview with Dr Robert Busch who is a Senior Lecturer from the School of Life and Health Sciences at the University of Roehampton, whose research focuses on the immune system.

Immunology is very important in current times as it is essential for maintaining general human health, responding to disease and also for developing COVID-19 vaccines that can make the virus more survivable and less transmissible. Dr Busch recognises this as a difficult and tragic time for many people, and knowledge of immunology is of great importance.

Dr Buschs current research is focused on tissue antigens, which are molecules that trigger immune responses by activating other cells of the immune system. In particular he studies how the immune system kicks in when it is faced with infection, but is quiet at other times so that the body doesn't fight itself. Tissue antigens vary from one person to the next and this variation can influence the risk of autoimmunity (when the immune system attacks the bodys own tissues).

Other research that Dr Busch conducts is on Vitamin D which is also important for immune regulation and can influence how many tissue antigens are produced and their ability to function in response to different diseases. Vitamin D has also been of interest in relation to COVID; however, so far results have been contradictory and no clear conclusions can be drawn.

Dr Busch stated, There is much to discover in the future, such as studying new and existing diseases and creating new vaccines. Another aspect of immunology that needs to be researched further is the question of how to turn off an immune cell once it has been activated, without compromising the immune systems ability to fight infections. Dr Busch describes this as the Holy Grail of immunology. Essentially, the more we know about how our immune system reacts, the better we can make the interventions that will combat viruses and protect people.

Immunology is important now and will remain so in the future, and scientists such as Dr Robert Busch are paving the way in helping broaden our understanding of the immune system so that we can fight disease and stay healthy.

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The Importance of Immunology by Joe Murphy, Hampton School - This is Local London

Immunology

Western News – Western researcher helping bring HIV cure within reach – Western News

At first, in the medical fight against AIDS, there was only uncertainty.

Then researchers brought hope in the form of life-saving treatment antiretrovirals that stop HIV from replicating in an infected person and reduce the risk of transmission.

Now, as the international community marks World AIDS Day on Dec. 1, a cure could be within REACH.

Western University researcher Jessica Prodger is a collaborator in Research Enterprise to Advance a Cure for HIV (REACH), an ambitious multi-institutional project funded through the U.S. National Institutes of Health (NIH).

HIV is resilient and has, so far, been resistant to a cure. One key issue is that some of the virus, as it integrates itself into human DNA, becomes invisible to the immune system if the infected cells go dormant.But the cells retain the viral DNA, and if a person stopped taking antiretroviral treatment, the infection would reactivate and the virus would again replicate.

The work of REACH focuses on understanding this latent reservoir of infected cells and figuring out how to eliminate it.

Prodger, a professor of immunology and microbiology at Westerns Schulich School of Medicine & Dentistry, is a co-lead investigator in Weill Cornell Medicines new five-year, US$28.5million Martin Delaney Collaboratory grant from the NIH.

This is a huge endeavour involving 37 co-investigators, all of us attacking HIV from one important angle, Prodger said. The NIH Martin Delaney funding removes competition between individual groups, allowing us to organize cure research into large, well-funded teams, and I think were going to make huge strides.

Her research includes a study group of HIV-positive women and men in Uganda who are receiving antiretroviral therapy.

Her team has been tracking and quantifying the HIV reservoir in this cohort, and has made important discoveries, such as that latent HIV is not as easily reactivated in females.

Its one small, but vital, part in solving the larger HIV puzzle and finding a cure, said Prodger, who also holds a Canada Research Chair in genital immunology and prevention of sexually transmitted infections.

Burden of infection

Around the world, 38 million people live with human immunodeficiency syndrome (HIV) and require daily, lifelong medication.

In 2020 alone, about two million people contracted HIV and 690,000 died from AIDS-related illnesses, UNAIDS notes.

All told, 80 million people have contracted the virus; half of those have died from AIDS-related illnesses.

The heaviest burden of infection is still borne by people in low-income countries where different strains of HIV are in circulation, while most of the research is taking place in high-income countries among high-income populations with predominantly one HIV strain.

Shifting focus

But progress is taking place.

AIDS-related deaths have dropped by 64 per cent since the peak in 2004. Infection numbers last year were about half the number of infected in 1997.

Antiretrovirals and other medications are transforming HIV infection into a manageable chronic condition, and people who are on effective treatment cannot transmit the virus to others.

Scientists around the world, including many at Western, are working towards new treatments, cures and potential vaccines.

The focus of HIV research for the first 30 years (since HIV was first identified) was on treatment and prevention, to save lives and stop people from dying of AIDS.This has been hugely successful, Prodger said. The discovery of the reservoir came decades after the discovery of the virus, and the field has only just begun to focus on a cure, now that highly effective treatments have been developed.

The REACH team is composed of investigators with expertise in virology, immunology, clinical studies and community advocates.

With 18 different institutions involved, the REACH program is a model for harnessing the great power of many scientific communities and minds, said a news release from Weill CornellMedicine, based in New York.

The project team, led by Dr. Brad Jones,associateprofessor ofimmunology inmedicine in the Division of Infectious Diseases at Weill Cornell Medicine, received the Delaney Collaboratory grant in August 2021. The REACH Collaboratoryis co-led by Dr. Marina Caskey of The Rockefeller University.

This award represents a remarkable vote of confidence and recognition of Weill Cornell Medicine as an international hub of HIV cure research, Jones said in the news release. With this funding we will leverage novel technological and analytical methods to redefine how the immune system interacts with the HIV reservoir in people on therapy.

A cure either eradicating the virus in the body or suppressing the virus by boosting the immune system would end the need for lifelong medication.We believe that both of these outcomes are possible, but that they are complex andthere arechallenging problems to solve, Jones said.

Prodger emphasized its the collaboratorys collective work, not any one individuals, that will make the difference and, ultimately, lead to a cure.

Research is very much about building an enormous structure, brick by brick. You begin to see what an amazing thing this is when everyone adds their brick to the whole, she said.

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Western News - Western researcher helping bring HIV cure within reach - Western News

Immunology

UK professor impacted by Omicron travel restrictions – LEX18 Lexington KY News

LEXINGTON, Ky. (LEX 18) First detected in the United States Wednesday, Omicron has rapidly become the dominant variant of the coronavirus in South Africa, a country that has held a special place in Dr. Zach Porterfield's heart.

An assistant professor of immunology and infectious diseases at the University of Kentucky, Dr. Porterfield told LEX 18 he has lived in South Africa on and off over the last 21 years. He has studied as an HIV virologist in the country, where he said doctors and scientists have been doing exceptional work researching COVID-19.

"We probably found [Omicron] in South Africa because there was a concerted effort to look," Dr. Porterfield said. "We have the expertise and technology to do that [genetic] sequencing."

Dr. Porterfield said he was planning to travel to South Africa next week, before learning about new travel restrictions imposed on South Africa and seven other African countries.

"I still have an apartment in Durban and projects and laboratory collaborations in South Africa that I was planning to return and try and set right," he said.

Although his plans may have been upended, Dr. Porterfield said he understands why President Joe Biden's administration implemented the latest travel bans.

"I think the right thing to do is take a moment to pause and think through what does this mean," he said.

President Biden explained earlier this week that while travel restrictions will not prevent the arrival of the variant, they could buy the administration time to prepare.

Health experts around the world, including representatives from the World Health Organization, have criticized the restrictions, suggesting they are ineffective and punitive.

"Blanket travel bans will not prevent the international spread of Omicron," said Dr. Tedros Adhanom Ghebreyesus, the Director-General of the WHO. "And they place a heavy burden on lives and livelihoods."

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UK professor impacted by Omicron travel restrictions - LEX18 Lexington KY News

Immunology

Viral evolution in animals could reveal future of COVID-19 – Jill Lopez

When animals catch COVID-19 from humans, new SARS-CoV-2 variants can arise. To evaluate this phenomenon, an interdisciplinary team at the College of Veterinary Medicine and Biomedical Sciences systematically analyzed mutation types occurring in the virus after infection of cats, dogs, ferrets, and hamsters.

Confirmed COVID-19 cases in a variety of wild, zoo, and household animals demonstrate cross-species transmission, which is a rare occurrence for most viruses.

SARS-CoV-2, in the realm of coronaviruses, has a very broad species range, said Laura Bashor, one of the first authors and a doctoral student in the Department of Microbiology, Immunology and Pathology. Generally speaking, many types of viruses cant infect other species of animals, they evolved to be very specific.

Humans have so much exposure to many different animals which permitted this virus to have the opportunity to expose a variety of different species, said Erick Gagne, a first author and now an assistant professor of wildlife disease ecology at the University of Pennsylvania.

The global reach and spillover of the virus have given researchers a unique opportunity to investigate the viral evolution of SARS-CoV-2, including in University Distinguished Professor Sue VandeWoudes laboratory at Colorado State University.

These specialists in disease transmission in wild and domestic cats applied their experience in sequence analysis and studying a collection of genomes to SARS-CoV-2.The studywas recently published in PNAS, the official journal of the National Academy of Sciences.

Researchers in the VandeWoude lab worked with Assistant Professor Angela Bosco-Lauth and Professor Dick Bowen in the Department of Biomedical Sciences, who used their animal modeling expertise to develop a test for SARS-CoV-2 susceptibility of animal species.

Also key to the findings was a newer sequencing technique of the virus at different stages of the study, now common to detect variants in the human population. Mark Stenglein, associate professor in the Department of Microbiology, Immunology, and Pathology, provided computational skills in analyzing biological molecule sequences, known as bioinformatics, to the study.

We found there was evolution, we saw selection on the virus, and we saw a lot of variants emerge in the genome sequence of the virus, said Bashor.

To provide ample viral material for the study, Bosco-Lauth and Bowen cultivated a SARS-CoV-2 human sample in cells grown in the lab. Bashor and Gagne determined that multiple mutations developed, and became a greater percentage of the genetic population, at each step of this process.

Then the virus was introduced to the four household species, and samples of the virus were collected from their nasal passages after infection.

In the animals, the cell culture variants reverted back to the initial human type, which indicates that likely there is adaption occurring in that cell culture and environment that was selected for those variants, said Gagne.

Not all these mutations within the cell culture SARS-CoV-2 variant transferred in the new hosts. Instead, different mutations emerged within the virus shed by the live animals.

The initial viral sample in the study was isolated in early 2020. The team observed mutations that have since formed wide-spread SARS-CoV-2 strains in the human population at an accelerated rate throughout the study.

Among those were a number that weve since seen in humans in the alpha, beta, delta variants, said Dr. Sue VandeWoude, senior author. There were specific genetic code changes that mimicked what other scientists have reported in people.

Contact exposure between two cats demonstrated the SARS-CoV-2 variant can be transmitted with the possibility of producing a new strain within the species.

Thats what were seeing in people too, said Bosco-Lauth. Hosts that are really well adapted to support SARS-CoV-2 infection are also very good at allowing these mutations to stick and to be passed on.

Bashor did not anticipate studying SARS-CoV-2 when she came to CSU to begin her doctoral studies during the pandemic. However, it provided a unique opportunity to hit the ground running as a graduate student on a really cool and viable project in disease ecology and evolution.

Gagne was completing his postdoctoral research on cross-species transmission of feline retroviruses in the VandeWoude lab when the team launched the SARS-CoV-2 study. Now an assistant professor, he has continued to investigate SARS-CoV-2 spillover with the Wildlife Futures Program at the University of Pennsylvania.

Graduate students and early career scientists like Bashor and Gagne, have made meaningful contributions to SARS-CoV-2 research, said VandeWoude.

The team has continued their investigations to focus on cats, as they have shown higher susceptibility for COVID-19 spillover from humans and can produce variants of the virus and spread to other cats.

Bashor began analyzing SARS-CoV-2 genome sequences from a large pool of cat species all over the world, including tigers, lions and snow leopards. The publicly available data of infected cats could provide additional insights on the adaptability and mutability of COVID-19 within and among cat species.

There is not evidence of transmission from cats to humans. But cats continue to be susceptible to all variants of COVID-19 in the human population.

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Viral evolution in animals could reveal future of COVID-19 - Jill Lopez

Immunology

Analysis shows skin peanut allergy patch safe and well tolerated over 3-year period – Hospital Healthcare Europe

The use of Viaskin, an epicutaneous patch used for children with a peanut allergy appears to be safe and well tolerated according to a three-year analysis presented by at the American College of Allergy, Asthma and Immunology Conference, November 2021.

A peanut allergy is thought to affect around 2% of the general population and in a study of 3218 children, the incidence was found to be 24.8%. The presence of a peanut allergy is challenging for those affected and requires a high level of vigilance directed towards the avoidance of accidental ingestion of peanut-containing foods.

The use of viaskin represents epicutaneous immunotherapy and according to the manufacturer, DBV Technologies, is a proprietary technology platform that enables the delivery of biologically active compounds to the immune system through the skin.

The data presented at the American College of Allergy, Asthma and Immunology Conference was based on the REALISE trial, which included children with documented histories of peanut anaphylaxis and who were randomised, 3:1, to either viaskin peanut 250mcg (which contains 1/1000th of the protein found in a single peanut) or a placebo for a period of 6 months. Once this initial phase was completed, all subjects continued to receive the active treatment in an open-label extension, for a period of three years. For the REALISE study, the primary outcome was set as adverse Events (AEs), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study period.

The 6-month safety data for viaskin has already been published and showed that the patch was well-tolerated.

Findings

REALISE recruited 393 children with a median age of 7 years (gender not reported) of whom, 14 (3.6%) had a history of severe anaphylaxis. Throughout the study period, most subjects experienced at least one TEAE although these were reported as being mild (97.4%) or moderate (70.4%) in severity and commonly consisted of application site erythema and pruritus which fortunately decreased over time.

Overall, 16 children experienced a total of 17 anaphylactic reactions (none severe) considered to be due to viaskin. In addition, there were 2 serious that were viakskin-related TEAEs (2 anaphylactic reactions: one leading to permanent study discontinuation). No difference in TEAEs in subjects with severe anaphylaxis history was apparent.

The authors concluded that over 36-months, Viaskin Peanut was generally well tolerated, with decreasing frequency and intensity of local and systemic treatment-related AEs over time.

The product is yet to be approved by the FDA, which has requested more data or the EMA.

Citation

Brown-Whitehorn T et al. D030 REALISE (REAL-LIFE USE AND SAFETY OF EPIT) STUDY: 3 YEAR RESULTS IN PEANUT-ALLERGIC CHILDREN. Ann Allergy Asthma Immunol 2021

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Analysis shows skin peanut allergy patch safe and well tolerated over 3-year period - Hospital Healthcare Europe

Immunology

VBI Vaccines Announces FDA Approval of PreHevbrio for the Prevention of Hepatitis B in Adults – Yahoo Finance

- PreHevbrio is the only approved 3-antigen hepatitis B vaccine for adults in the U.S.

- Shareholder conference call to be held today, December 1, at 8:30 AM ET

CAMBRIDGE, Mass., December 01, 2021--(BUSINESS WIRE)--VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that the U.S. Food and Drug Administration (FDA) has approved PreHevbrio [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S.

"As we work to implement the ACIPs new universal hepatitis B vaccine recommendation for all adults ages 19-59, as voted on in November, we benefit from having more tools, including this newly approved 3-antigen hepatitis B vaccine," said Chari Cohen, DrPH, MPH, Senior Vice President of the Hepatitis B Foundation. "Having more vaccine options will help us effectively expand vaccine uptake, ensure more people are protected from hepatitis B infection, and reach the 2030 goal of eliminating hepatitis B in the U.S."

Jeff Baxter, VBIs President and CEO, commented: "We are proud to announce the approval of PreHevbrio, VBIs first FDA-approved vaccine. This is a substantial achievement that demonstrates the VBI teams ability to progress vaccine candidates from the clinic through to approval. This approval, however, is just the first step in our mission to provide broad access to our vaccine and to help strengthen the public health effort to put an end to adult HBV infections. We would like to thank the study participants, clinical site investigators, our employees, and all who contributed to this achievement, and we look forward to working with public health and advocacy organizations as we join the fight against hepatitis B."

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The approval of PreHevbrio was based on the results from two Phase 3 clinical studies, PROTECT and CONSTANT, data from which were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021. The pivotal studies compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. Data from the PROTECT study showed that PreHevbrio elicited higher rates of seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including in adults age 45+ (89.4% vs. 73.1%). The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue, all which generally resolved without intervention in 1-2 days.

VBI expects to make PreHevbrio available in the U.S. in the first quarter of 2022, and has partnered with Syneos Health for the past two years to ensure commercial readiness.

Outside of the U.S., VBI continues to support the European Medicines Agencys (EMA) ongoing review of the marketing authorization application for VBIs 3-antigen HBV vaccine. VBI expects to complete regulatory submissions to the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) and to Health Canada in 2022.

Conference Call Details

VBI Vaccines will host a conference call on Wednesday, December 1 at 8:30 AM ET. The live call can be accessed via the Events/Presentations page in the Investors section of the Companys website, or by clicking this link: https://viavid.webcasts.com/starthere.jsp?ei=1517423&tp_key=00a076a769.

A replay of the conference call will be archived on the Companys website following the live call.

To listen to the live conference call, please dial:

- Toll-free U.S. & Canada Dial-In: 877-705-6003

- International Dial-In: 201-493-6725

- Conference ID: 13725342

Indication and Use

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or http://www.vaers.hhs.gov

Please see full Prescribing Information.

About Hepatitis B

Hepatitis B is one of the worlds most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

Earlier in November 2021, the U.S. Centers for Disease Control and Preventions (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend universal HBV vaccination for adults age 18 to 59, and for adults age 60+ with risk factors for infection, expanding the addressable adult population that should be vaccinated.

About PreHevbrio

PreHevbrio is an adult hepatitis B vaccine that contains the three hepatitis B surface antigens of the hepatitis B virus S, pre-S1, and pre-S2. PreHevbrio is also approved for use and commercially available in Israel under the brand name Sci-B-Vac.

About VBI Vaccines Inc.

VBI Vaccines Inc. ("VBI") is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles ("VLPs"), including a proprietary enveloped VLP ("eVLP") platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

Website Home: http://www.vbivaccines.com/

News and Resources: http://www.vbivaccines.com/news-and-resources/

Investors: http://www.vbivaccines.com/investors/

Cautionary Statement on Forward-looking Information

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). The Company cautions that such statements involve risks and uncertainties that may materially affect the Companys results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Companys ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Companys products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Companys filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Companys Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211201005387/en/

Contacts

VBINicole AndersonDirector, Corporate Communications & IRPhone: (617) 830-3031 x124Email: IR@vbivaccines.com

See more here:
VBI Vaccines Announces FDA Approval of PreHevbrio for the Prevention of Hepatitis B in Adults - Yahoo Finance

Immunology

Everything We Know and Don’t Know About the Omicron Variant – WDET

This week, Michigan hit a dreadful milestone. The statehasthe highest numberof adults hospitalized with COVID-19 since the pandemic began, even as vaccines are widelyavailable.

I think its important for everyone to remember that we know so little right now. Adam Lauring, microbiologist at University ofMichigan

Now, many Michiganders and Americans are worried about anew variantthat has emerged and is spreading around theworld.

Adam Lauringis an associate professor of microbiology and immunology, and infectious diseases at the University of Michigan medical school. I think its important for everyone to remember that we know so little right now, hesays.

Laurings lab uploads the second most variant data in Michigan behind the state lab. He says some viral mutations are much more important than others, which is contingent upon how quickly the new virus spreads and the lethality that it brings withit.

WDET strives to make our journalism accessible to everyone. As a public media institution, we maintain our journalistic integrity through independent support from readers like you. If you value WDET as your source of news, music and conversation, please make a gift today.

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Continued here:
Everything We Know and Don't Know About the Omicron Variant - WDET

Immunology

Letter to the editor | In support of Hakeem Jefferson and the Early Career Black Faculty Group – The Stanford Daily

To our Stanford Community,

In response to the recent racist attacks on Professor Hakeem Jefferson and the open letter published in The Stanford Daily from the Early Career Black Faculty Group, we, the chairs of the Basic Bioscience Departments in the Stanford Schools of Medicine, Humanities and Sciences, and Engineering, the directors of the Biosciences Institutes and the directors of the Interdisciplinary Biosciences Programs, express our support for Professor Jefferson and the requests made in the open letter. We condemn the coordinated, racist attacks against Professor Jefferson and call on ourselves, our community and our University to help protect and defend our Black colleagues in response to these attacks. We commit to developing proactive strategies, in coordination with our Black faculty, to prevent these attacks in the future, and when we cannot prevent them, to respond to them quickly and to mitigate their negative impacts. We hope that we can help Stanford become a community where all of our members feel safe and included as we pursue our scholarly endeavors and career aspirations.

Chairs of Basic Biomedical Science Departments in the Schools of Medicine, Engineering,and Humanities and Science, directors of the Biosciences Institutes and the directors of the Interdisciplinary Biosciences Programs

Stephen A. Baccus Chair, Department of Neurobiology

Melissa L. Bondy Chair, Department of Epidemiology and Population Health

James K. Chen Chair, Department of Chemical and Systems Biology

Jennifer R. Cochran Chair, Department of Bioengineering

Martha S. Cyert Chair, Department of Biology

Miriam B. Goodman Chair, Department of Molecular and Cellular Physiology

Sherril L. Green Chair, Department of Comparative Medicine

Theodore S. Jardetzky Chair, Department of Structural Biology

Paul S. Mischel Vice Chair for Research, Department of Pathology

Thomas Montine Chair, Department of Pathology

Douglas K. Owens Chair, Department of Health Policy

Sylvia K. Plevritis Chair, Department of Biomedical Data Science

David S. Schneider Chair, Department of Microbiology and Immunology

Michael Snyder Chair, Department of Genetics

AaronF. Straight Chair, Department of Biochemistry

Anne Villeneuve Chair, Department of Developmental Biology

Steven Artandi Director, Stanford Cancer Institute

Carolyn Bertozzi Director, ChEM-H Institute

Mark M. Davis Director, Institute for Immunity, Transplantation, and Infection

Mary Leonard Director, Maternal and Child Health Research Institute

Crystal Mackall Director, Parker Institute for Cancer Immunotherapy

William Newsome Director, Wu Tsai Neuroscience Institute

Carla Shatz Director, Bio-X Program

Irving Weissman Director, Institute for Stem Cell Biology and Regenerative Medicine

Joseph C. Wu Director, Cardiovascular Institute

Olivia Martinez Director, Immunology Interdisciplinary Graduate Program

K.C. Huang Director, Biophysics Interdisciplinary Graduate Program

Tushar Desai Co-Director, Stem Cell Biology and Regenerative Medicine Interdisciplinary Graduate Program

Gerald Spangrude Co-Director, Stem Cell Biology and Regenerative Medicine Interdisciplinary Graduate Program

Julien Sage Co-Director, Cancer Biology Interdisciplinary Graduate Program

Laura Attardi Co-Director, Cancer Biology Interdisciplinary Graduate Program

Justin Gardner Co-Director, Neurobiology Interdisciplinary Graduate Program

Merritt Maduke Co-Director, Neurobiology Interdisciplinary Graduate Program

Link:
Letter to the editor | In support of Hakeem Jefferson and the Early Career Black Faculty Group - The Stanford Daily