RedHill Biopharma to Provide Update on its COVID-19 and other Development Programs at MedInvest Virtual Infectious Diseases and Immunology Conference…

TEL-AVIV, Israel and RALEIGH, N.C., June 08, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (RedHill or the Company), a specialty biopharmaceutical company, today announced that Mr. Gilead Raday, RedHills Chief Operating Officer, will present the Companys development program with opaganib (Yeliva, ABC294640)1 for COVID-19, as well as the Phase 3 development program with RHB-204 for pulmonary nontuberculous mycobacteria (NTM) infections, at the MedInvest Virtual Infectious Diseases and Immunology Conference on Monday, June 15, 2020, at 12:40 p.m. EDT.

The presentation will be broadcast live and available via replay for 30 days on the Company's website, http://ir.redhillbio.com/events. Please access the website at least 15 minutes ahead of the presentation to register.

About RedHill BiopharmaRedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs Movantik for opioid-induced constipation in adults2, Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults3 and Aemcolo for the treatment of travelers diarrhea in adults4. RedHills key clinical late-stage development programs include: (i) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (ii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iii) RHB-102 (Bekinda), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) Opaganib (Yeliva), a first-in-class SK2 selective inhibitor, targeting multiple indications, with an ongoing Phase 1/2a study for cholangiocarcinoma and a development program for COVID-19; (v) RHB-106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at http://www.redhillbio.com.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words intends, may, will, plans, expects, anticipates, projects, predicts, estimates, aims, believes, hopes, potential or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Companys control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Companys research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Companys ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Companys receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Companys therapeutic candidates and Talicia; (v) the Companys ability to successfully commercialize and promote Talicia, and Aemcolo and Movantik; (vi) the Companys ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Companys therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Companys business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Companys expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Companys industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

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1 Opaganib is an investigational new drug, not available for commercial distribution.2 Full prescribing information for Movantik (naloxegol) is available at: http://www.Movantik.com.3 Full prescribing information for Talicia (omeprazole magnesium, amoxicillin and rifabutin) is available at: http://www.Talicia.com.4 Full prescribing information for Aemcolo (rifamycin) is available at: http://www.Aemcolo.com.

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European Academy of Allergy and Clinical Immunology: Launch of the EAACI Guidelines for the Use of Biologicals in Patients With Severe Asthma – PR…

ZRICH, June 8, 2020 /PRNewswire/ -- EAACI has launched its Guidelines for the use of Biologicals in Patients with Severe Asthma at the EAACI Digital Congress 2020.

Prof. Marek Jutel, EAACI President began by highlighting the significant burden of severe asthma on patients, families and healthcare systems. "Management of severe asthma proves to be difficult due to disease heterogeneity, coexisting comorbidities and especially because of complexities in care pathways and differences in national and regional healthcare systems. Better understanding of the mechanisms of the disease has enabled a stratified approach to the management of severe asthma, supporting the use of targeted treatments with biologicals. However, many unmet needs remain: how to select a certain biological as they all target overlapping disease phenotypes? How to enhance response? What are the best strategies to enhance the respondent's rate? What is the optimal duration of treatment and its cost-effectiveness? And what is the appropriate regimen - in the clinic or home-based?"

What is novel in the EAACI guidelines for the management of severe asthma is the inclusion of the GRADE approach in formulating recommendations for each biological and asthma outcome, separate recommendations for exacerbations, for lung function and more.

"It is clear that biologicals in the context of severe asthma is a very rapidly evolving field. After the first EAACI position paper on Biologicals and allergic diseases, these EAACI Guidelines for the use of Biologicals in Patients with Severe Asthma represent a desk reference tool of utmost importance for healthcare providers, patients, regulators and healthcare systems providing specific recommendations for each biological in the context of each independent outcome," saysProf. Oscar Palomares, Complutense University of Madrid, Past Chair of EAACI Biologicals Working Group, current EAACI ExCom member and Biologicals Guidelines Project Co-Chair.

A management algorithm for the use of biologicals in the clinic is further proposed, together with future approaches and research priorities. "EAACI advocates for a triple decision chart based on phenotypic traits, biomarkers and outcomes, added to this is shared decision making to reset individual goals and define response together with the patient. Efficacy is tested after 4-6 months - if there is a response, intervention is to be continued according to the preset target and while continuously monitoring for safety. Real life evidence must be collected through registries, real world trials and health economics indicators as the basis for the next steps. If the response is suboptimal it is important to look at the airway inflammation and to the airway hyperreactvity. If the eosinophilic inflammation persists, several factors can be improved, for example adherence to background controller treatment or other options can be considers such as switching to a biological targeting a different path, or checking for other immune mechanisms. If neutrophilic inflammation is present macrolides can be considered. If there is no inflammation non-T2 asthma approaches like dual bronchodilators and in very selective cases bronchial thermoplasty can be considered," says Prof. Dr. Ioana Agache, University of Brasov Romania, Biologicals Guidelines Project Co-Chair and EAACI Past President.

The rising use of biologicals (monoclonal antibodies) in modern medicine, their remarkable potential and possible challenges were also discussed at the EAACI Digital Congress 2020 by its Special Guest, Sir Gregory Paul Winter, Nobel Prize Winner for Biochemistry in 2018.

"For inflammatory disease monoclonal antibodies are finding their place on the front line. Although inflammatory diseases such as severe asthma can be treated with chemical drugs such as corticosteroids their broad mechanism of action may also bring a range of undesirable side effects including fluid retention, hypertension and bone loss, particularly with extended use. Ideally treatments should have a more specific mode of action and avoid these side effects. That is why monoclonal antibodies which have such specific modes of action in blocking the interaction of key proteins or receptors are so attractive. And the availability of a range of therapeutic monoclonal antibodies against proteins involved in inflammation provides the opportunity to identify in the clinic those targets which are most relevant. Over the last 30 years biologicals have become increasingly important in medicine. The limitations in early use of biologicals were overcome by the recombinant DNA technology leading to a tsunami of therapeutic monoclonal antibodies. These biologicals are of high efficiency and exquisite specificity, they have a long half-life in serum and properties and functions can be tailored to order. Their impact has already been immense and likely to become greater still," says Sir Gregory Winter, University of Cambridge, Nobel Prize Laureate 2018.

Under these promising auspices, EAACI hopes its new Guidelines will be a cornerstone for clinicians, researchers, scientific societies and medical agencies in the years to come.

About EAACI:

The European Academy of Allergy and Clinical Immunology (EAACI) is an association of clinicians, researchers and allied health professionals founded in 1956. EAACI is dedicated to improving the health of people affected by allergic diseases. With more 12 000 members from 124 countries and over 75 National Allergy Societies, EAACI is the primary source of expertise in Europe and worldwide for all aspects of allergy.

Logo - https://mma.prnewswire.com/media/1177661/EAACI_Digital_Congress_2020_Logo.jpg

Contact:EAACI HeadquartersHagenholzstrasse 111, 3rd Floor 8050 Zurich CH- SwitzerlandTel: +41799561865communications@eaaci.orgwww.eaaci.org

SOURCE European Academy of Allergy and Clinical Immunology

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European Academy of Allergy and Clinical Immunology: Launch of the EAACI Guidelines for the Use of Biologicals in Patients With Severe Asthma - PR...

Harnessing the Power of T Cells To Fight Mosquito-borne Viruses – Technology Networks

Every year, more than 68,000 people end up with a clinical case of Japanese encephalitis. One in four of these patients will die. The mosquito-borne virus, which is most common in Southeast Asia, also causes severe neurological damage and psychiatric disorders.

There is no cure for Japanese encephalitis, but there are effective vaccines against Japanese encephalitis virus (JEV). The problem is that JEVs range is spreading, and more and more people at risk of the disease also live in areas where viruses like Zika are prevalent.

In a new study, published June 5, 2020, in the Journal of Experimental Medicine, scientists at La Jolla Institute for Immunology (LJI) shows that antibodies against JEV are cross-reactive and can also recognize Zika virus. Unfortunately, these antibodies can actually make Zika cases more severe. The research, conducted in mice, is the first to show that T cells can counteract this dangerous phenomenon.

This means we probably need to be developing a vaccine against both viruses that can elicit a good balance of antibodies and T cells, says Associate Professor Sujan Shresta, Ph.D., who co-led the study in collaboration with Jinsheng Wen, Ph.D., of Ningbo University and Wenzhou Medical University, and Yanjun Zhang, Ph.D., of Zhejiang Provincial Center for Disease Control and Prevention.

Zika, JEV, dengue, West Nile virus and yellow fever have spread in recent years as more people around the world have moved to cities and climate change has allowed the mosquitoes that carry these diseases to expand their habitat. People in many countries now live at risk of encountering multiple harmful flaviviruses in their lives.

Shresta has spent much of her career studying flaviruses, a family of viruses which includes Zika, JEV, dengue, West Nile virus and yellow fever. These diseases have spread in recent years as more people around the world have moved to cities and climate change has allowed the mosquitoes that carry these diseases to expand their habitat. People in many countries now live at risk of encountering multiple harmful flaviviruses in their lives.

The immune responses to these viruses are very cross-reactive, says Shresta. The problem is that the immune response can be both good and bad.

In some cases, antibodies against one flavivirus can make a future flavivirus infection even worse by allowing the virus to enter host cells. Shresta and investigators worldwide have shown this process, called antibody-dependent enhancement (ADE), during Zika and dengue infections in animal models that recapitulate severe dengue or Zika disease in individuals with prior exposure to dengue or Zika virus. However, ADE of Zika disease in cases of previous JEV exposure, and the interplay between antibodies and infection-fighting immune cells called CD8+ T cells, had not been studied before.

For the new study, Shresta and her colleagues took antibodies from JEV-infected mice or JEV-vaccinated people and injected them into healthy mice. The healthy mice were then exposed to Zika virus. These mice experienced ADE and had far more severe cases of Zika fever than mice with no antibodies against JEV.

Shresta and her colleagues next focused their attention on CD8+ T cells from JEV-infected mice. They found that CD8+ T cells primed to fight JEV could counteract the harmful effects of cross-reactive antibodies. These JEV-elicited T cells were indeed able to recognize and get rid of the Zika virus infection, says Shresta.

In short, the mouse survival rate went up and their viral load went down, thanks to the CD8+ T cells. A future JEV vaccine would need to prompt a similar response from CD8+ T cells to help a person avoid ADE of Zika infection.

Shresta says this work can help shed light on how to fight the whole family of flaviviruses, which includes over 70 different species, and many countries are increasingly dealing with cocirculation of multiple flaviviruses. Any of these viruses could cause a major, major outbreak, says Shresta. We need to look at deploying a combination Zika/JEV vaccine, and we may need to tailor vaccines to particular locations where we know both JEV and Zika pose a threat.

Shresta adds that research into cross-reactive antibodies and T cell responses is especially important today as scientists investigate whether exposure to common cold coronaviruses can leave a person with any immunity against SARS-CoV-2, the novel coronavirus.

This provides us with a really good model to learn about immune response, Shresta says.

ReferenceJapanese encephalitis virus-primed CD8+ T cells prevent antibody-dependent enhancement of Zika virus pathogenesis. Dong Chen et al.Journal of Experimental Medicine, https://doi.org/10.1084/jem.20192152.

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

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Harnessing the Power of T Cells To Fight Mosquito-borne Viruses - Technology Networks

AstraZeneca’s Acquisition of Gilead Would Create a COVID-19 Colossus — but Don’t Bet on Seeing It Happen – Motley Fool

Nothing should be absolutely shocking in the biopharmaceutical world. But I'll admit, the reports that surfaced over the weekend thatAstraZeneca (NYSE:AZN) was interested in acquiringGilead Sciences (NASDAQ:GILD) were surprising.

Bloomberg recently reported that AstraZeneca had reached out to Gilead last month about a potential deal, according to the always-intriguing sources of "people familiar with the matter." Should this acquisition actually move forward, it would be the biggest healthcare deal ever -- and there have been plenty of really big takeovers in the healthcare sector over the last few years.

The combination of AstraZeneca and Gilead would create a COVID-19 colossus, considering that both companies have leading coronavirus programs. But don't bet on seeing this deal ever happen.

Image source: Getty Images.

AstraZeneca's market cap currently stands at around $140 billion, while Gilead's market cap is around $96 billion. The combination of the two big drugmakers would create the world's third largest healthcare company, behind only Johnson & Johnsonand UnitedHealth Group.

As previously mentioned, the merger of AstraZeneca and Gilead would also result in a formidable player in the COVID-19 arena. AstraZeneca partnered with the University of Oxford on developing a COVID-19 vaccine that was reportedly selected by the Trump administration as one of the five vaccines most likely to be successful and worthy of U.S. government support. Gilead's antiviral drug remdesivir appears to be headed toward becoming the standard of care for treating COVID-19.

The two companies would bring different strengths to the table. AstraZeneca claims three core franchises: oncology, CVRM (cardiovascular, renal, and metabolism), and respiratory and immunology. Gilead's current drugs focus primarily on HIV, hepatitis C, and oncology.

There's not any significant overlap right now between the two drugmakers' current lineups, though, despite both targeting oncology. AstraZeneca's top oncology products are targeted therapies Tagrisso and Lynparza and immunotherapy Lynparza, all of which treat solid tumors. Gilead's Yescarta is a CAR-T cell therapy targeting certain types of blood cancers.

Gilead hopes to soon enter the immunology market with FDA approval pending for filgotinib in treating rheumatoid arthritis. The biotech also is evaluating the drug in several other immunology indications. However, Gilead's immunology efforts shouldn't clash much with AstraZeneca's respiratory & immunology programs, which focus primarily on asthma and COPD.

While the fit between AstraZeneca and Gilead might seem pretty good, it's still very unlikely that the acquisition will actually happen. For one thing, Gilead reportedly wasn't interested. And after the initial inquiries by AstraZeneca, the pharma company's executives ultimately decided a deal wasn't worth pursuing, according to sources interviewed by British newspaper TheTimes.

Gilead doesn't need to be acquired. The company appears to be ready to return to solid growth after several years struggling with declining hepatitis C virus (HCV) franchise sales. Gilead's Biktarvy looks to be on track to become the biggest-selling HIV drug ever. Its HIV pipeline is impressive. The biotech also, as previously mentioned, has solid opportunities in COVID-19 and in immunology.

Meanwhile, AstraZeneca doesn't really need a big acquisition, either. The drugmaker continues to deliver solid growth thanks mainly to its strong oncology lineup. It also has a robust pipeline with 20 late-stage programs and over 50 life-cycle management (LCM) programs seeking additional indications for approved drugs.

There's also the matter of the size of any potential deal. AstraZeneca would almost certainly have to pay at least $130 billion (and probably more) to acquire Gilead. That large of an amount would require AstraZeneca to add a huge amount of debt since the company's cash position currently stands at around $4.2 billion.

The best bet for both AstraZeneca and Gilead is that both companies make smaller deals of their own, including both bolt-on acquisitions and collaborations.

Gilead has been much more active on this front over the last few years. The big biotech acquired Kite Pharma in 2017. More recently, it bought cancer-focused biotech Forty Seven for $4.9 billion earlier this year. Gilead also established a multi-year collaboration with Galapagoslast year with a price tage of $5.1 billion, including a $1.1 billion equity stake in the biotech.However, AstraZeneca's reported interest in Gilead could mean that the big drugmaker is ready to crank up its dealmaking.

My view is that AstraZeneca and Gilead are likely to strike a key deal in the not-too-distant future -- just not with each other.

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AstraZeneca's Acquisition of Gilead Would Create a COVID-19 Colossus -- but Don't Bet on Seeing It Happen - Motley Fool

More Than One Way to Fix Cat Allergy – Medscape

There is new hope for cat lovers who are allergic to their pets. Rather than desensitizing the human, researchers are working to eliminate the Feld1 protein, the primary allergen, from the cat, using CRISPR-Cas9 gene-editing technology.

"One of the benefits of CRISPR, compared to other methods of tackling this problem, is that you can permanently remove Feld1, compared with other techniques that only reduce the allergen," said Nicole Brackett, PhD, from Indoor Biotechnologies.

Previous attempts to remove the allergen have included feeding cats a specially formulated food that reduces Feld1 in the saliva, so less ends up on the dander when they lick themselves, as reported by Medscape Medical News.

"We hope to get to a point where we can offer an injection, or a series of injections, you would get at the vet, which would make the cat allergen-free," said Brackett, who presented the research in a poster at the European Academy of Allergy and Clinical Immunology 2020 Digital Congress.

When you're using this kind of technology, you are taking on a tremendous amount of responsibility.

About 10% of humans are allergic to cats, and we see the ones who are affected by their own cats, said Dean Mitchell, MD, an allergist and immunologist from Mitchell Medical Group in New York City.

"This research is interesting, but when you're using this kind of technology, you are taking on a tremendous amount of responsibility," he told Medscape Medical News.

"It's really an exciting technology, but I think it's scary, altering genes," he said. "You never know what you're going to change. Maybe we should use it to cure COVID first."

For their study, Brackett and her colleagues used discarded tissue samples from 50 spayed and neutered cats to collect genomic DNA from the Feld1 chains1 and 2.

The first goal was to see how similar genes were between cats, she explained. "We wanted to target a region in the gene that is well conserved something you would see in all cats not a random mutation."

The researchers were able to sequence a panel of 10 guide RNAs and use CRISPR Cas-9 to edit the genes. "We now have proof of principle in a cat cell line," Brackett told Medscape Medical News.

We still have a long way to go, but should have something we can test in a cat in a couple of years. But, she acknowledged, "we still don't know the role of the protein in the cat."

Feld1 expression differs from cat to cat, Brackett pointed out. "Some cats have an abundance and some have very little. The expression can vary, even within one cat."

Speculation on the function of Feld1 also varies. Because it's produced in the sebaceous gland, "it may serve as a way to coat, or protect, the skin. Or maybe it has something to do with chemical communication, maybe to communicate with other cats," she said. "But the fact that we see so much Feld1 variability with no obvious correlating behaviors makes us think it's not essential. One of the benefits of our study is we may figure that out."

Her lab is also looking at Feld1 expression in wild cats to determine its origin from an evolutionary standpoint. "We are curious to see how this allergen has evolved in different species of cats," she explained.

Cat allergies "rank number two in frequency and seriousness of allergies after food allergies, causing people to need to be on steroids or medications," Mitchell told Medscape Medical News. "Fifty percent of my immunotherapy practice is cat or dog allergy; it's a significant problem."

Young kids can't play at their friend's houses, relationships are affected, and families have to choose between their beloved cat and a healthy family member, he said.

Sublingual immunotherapy of Feld1 has been proven effective in clinical trials and is common in Europe, but "only about 100 allergists in the United States offer it," Mitchell said. "It's been a very underappreciated therapy, and I really don't know why; maybe because it's not patentable by a drug company."

Sublingual drops are not covered by insurance, and the therapy runs about $120 per month in the United States. "I've helped hundreds of patients with it," said Mitchell, and usually the therapy significantly improves patient quality of life.

The fact is, people make major life choices based on their cats, Mitchell explained.

One of his pollen-allergic patients who loved both her cat and her cat-allergic boyfriend told him that her boyfriend wouldn't sleep over. "Can you help him?" she asked.

"The first day I see him, he's wheezing and can't breathe." Mitchell recalled. He treated the boyfriend with sublingual Feld1 immunotherapy. "After 4 or 5 months, he could go over to her house using inhalers on weekends sometimes. A year later, they moved in together and got married. The cat even slept on the bed at the end.

Mitchell discharged the boyfriend after 3 years of treatment. He ran into him on a New York sidewalk a couple of years later and asked how he was doing. It turned out the couple had gotten divorced.

"That's too bad, I told him. But at least you don't have to deal with the cat anymore," Mitchell recalled.

"Oh no, I liked the cat too much, he stayed with me," his patient told him.

Mitchell laughed. "You just can't make this stuff up!"

Brackett works for Indoor Biotechnologies as a scientist. Mitchell has disclosed no relevant financial relationships.

European Academy of Allergy and Clinical Immunology (EAACI) 2020 Digital Congress

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Bolt Biotherapeutics Announces Issuance of U.S. Patent for the Boltbody(TM) ISAC Technology and its Lead Development Candidate, BDC-1001 – Monterey…

REDWOOD CITY, Calif., June 9, 2020 /PRNewswire/ --Bolt Biotherapeutics, Inc., a private clinical-stage biotechnology company developing its Immune-Stimulating Antibody Conjugate (ISAC) platform technology to harness the power of the immune system to treat cancer, today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,675,358 entitled "Antibody Adjuvant Conjugates." The patent provides protection for immunoconjugates of a piperazinyl imidazoquinoline adjuvant bound to any antibody, including Bolt's BDC-1001 ISAC embodiment.

BDC-1001 is being developed as a monotherapy for patients with HER2-expressing solid tumors. BDC-1001 is an ISAC comprised of trastuzumab conjugated to a Bolt proprietary TLR7/8 agonist payload.

Michael N. Alonso, Ph.D., scientific co-founder and vice president of immunology and pharmacology of Bolt, stated "The development of Boltbody ISACs is motivated by the insatiable need to translate scientific discoveries into products that will help cancer patients become survivors. This patent issuance is an important milestone that provides protection for our BDC-1001 clinical asset and our Boltbody ISAC technology platform. Our dedicated and talented teams will continue to aggressively build a robust patent portfolio to protect our pipeline, our platform, and our commitment to patients."

About Bolt Biotherapeutics' Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology

The Boltbody platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of innate immune agonists to convert cold tumors into immunologically hot tumors thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients. The company's first Boltbody to enter clinical development, BDC-1001, is currently being evaluated in patients with HER2-expressing solid tumors.

About Bolt Biotherapeutics, Inc.

Bolt Biotherapeutics, based in the San Francisco Bay Area, is a private clinical-stage biotechnology company developing Boltbody Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics that have eliminated tumors following systemic administration in preclinical studies and results in the development of immunological memory, which may lead to more durable clinical responses for patients. Bolt's platform technology is applicable to a broad spectrum of antibodies targeting tumor antigens expressed on all types of cancer, including patients who are refractory to the current generation of checkpoint inhibitors. The company was founded by Dr. Ed Engleman, and its platform is based on technology exclusively licensed from Stanford University. The company is financed by world-class investors including Novo Holdings, Pivotal bioVenture Partners, Vivo Capital and Nan Fung Life Sciences. For more information about Bolt Biotherapeutics, please visit http://www.boltbio.com.

Media Contacts: Maggie Beller or David SchullRusso Partners, LLC646-942-5631maggie.beller@russopartnersllc.comdavid.schull@russopartnersllc.com

Investor Relations Contact: Sarah McCabeStern Investor Relations, Inc.212-362-1200sarah.mccabe@sternir.com

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Bolt Biotherapeutics Announces Issuance of U.S. Patent for the Boltbody(TM) ISAC Technology and its Lead Development Candidate, BDC-1001 - Monterey...

Experts present options to fully suppress COVID-19 while keeping the economy open – Newstalk

An immunologyexpert says Ireland can suppressthe coronavirus like New Zealand without further economic shutdowns.

It comes as more than 1,000 Irish scientists and doctors have warned that the country must completely eliminate COVID-19 before a return to normal life, with total suppression.

The widespread wearing of masks, faster testing and contact tracing, the testing of visitors at airport and a review the lockdown are all included to 'crush the curve'.

Dr Tomas Ryan is assistant professor at the school of biochemistry and immunology at Trinity College Dublin.

He told Pat Kenny: "I think we're certainly moving too fast, principally because our containment measures aren't in place.

"We are advocating for a scientific perspective in orientating our strategy for how we deal with COVID-19 in Ireland.

"But our motivation is to avoid lockdowns - what we want to do is avoid any further lockdowns so that we don't have more catastrophic economic consequences.

"Currently, we are on path for a second surge - and that second surge may happen in mid-summer or it may happen in the autumn.

"That will lead to another lockdown; and we won't have herd immunity in Ireland unless we suffer four to seven, or maybe more, of these lockdowns so that we can build up 65% infections in the population.

"That's what we want to avoid, and we think there's a better way of handling COVID-19 in Ireland."

He outlined two options, one of which is to suppress the virus as we have been doing.

"That would mean we would keep it like South Korea - we would live with virus but keep a flat curve, no new lockdowns until we have a vaccine.

"But the other option, which is what we're advocating for in this letter, is to go to where New Zealand has gone [and] eliminate the virus".

"There's an argument that we couldn't do this in March because we didn't have enough advance warning, but we have a second chance now - because our infection numbers are back to where they were at March 11th.

"If we keep going the way we're going, we're going to be back into mid-March - we're going to get there a little bit more slowly because of social distancing, but we'll face a second surge.

"Or we can choose to aim for what New Zealand did.

"This is where there's a number of different ways where we could implement this.

"Some people are quite right to say we could do this with a very sharp lockdown - and by sharp I mean slightly more rigorous than what we've experienced, and maybe only for four weeks."

"It could [also] be done by a hybrid approach of careful social distancing, localised lockdowns where necessary, masks and rigorous test-trace-isolate.

"So we don't need to shut down the economy, necessarily, to eliminate the virus - we certainly do need to watch travel into the country."

On the border issue, he said: "I think we could achieve at least the South Korean level of suppression without Northern Ireland cooperation.

"But... if we want to get to the New Zealand level of complete nonality, we really do probably need an all-Ireland approach.

"But I'm not too worried about that because I think that if we lead, I think that they will follow and I think it's a much better approach than going with what's been happening in Great Britain".

"This is our opportunity, it's the summer - we've got everything under control, we don't want to be in a situation where we arrive into September, it gets more difficult to manage because of winter, because of flu season and we ask ourselves why didn't we do this four months ago.

"We can make hay now and we should".

Experts present options to fully suppress COVID-19 while keeping the economy open

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Experts present options to fully suppress COVID-19 while keeping the economy open - Newstalk

Is it bad allergies, the flu or the coronavirus? Heres how to tell – NBC4 WCMH-TV

COLUMBUS (WCMH)Allergy season is upon us. Toward the end of May and early June there is a one-two punch. Trees are still pollinating, and grass begins to also. This is sort of like a double whammy, because people can be somewhat confused about symptoms between allergies and COVID-19.

With Covid, were going more often to see fever and just the overwhelming fatigue, said Dr. Kara Wada, who is an allergy and immunology doctor at The Ohio State Universitys Wexner Medical Center. Feeling like you were hit by a truck, similar to what you feel like with the seasonal flu.

The similarities between having a virus and allergies are few. What separates them from each other is specific. Allergies typically have itchy throat, eyes, and nose. A virus, like COVID-19, typically can have a fever, aches, and fatigue.

Pollen will attach to you like a lost puppy, except it will wreak havoc on you if you are allergic. It will get on your clothing, skin, and hair. That means when you are finished with being outside, the pollen stays with you once you are inside.

I recommend rinsing off if youve been outside for any measurable amount of time, because the pollen can end up sticking to our hair, skin, our clothes, Dr. Wada advised during a Zoom interview. You dont neccessarily need to shampoo, but just rinse off can be really helpful to give your body a break before you go off sleep.

Should you have recurring allergies, Dr. Wada suggests meeting with your allergy/immunology doctor to figure out a personalized health strategy. She offers an injection free immunotherapy. That means no needles.

[We are] essentially treating patients with the substances they are allergic to in a formulation that goes under the tongue, she said. The nice thing about that is we see a response a little bit faster than traditional allergy shots.

She added that the treatment can be done at home rather than returning to the doctors office weekly.

Some of the things to prevent the spread of viruses, we already know, and those same ideas can help lessen your allergy symptoms. You can wear a mask, because pollen particles are huge compared to a virus and its difficult for them to get through the cloth. A mask can keep the pollen from getting into your nose and mouth. Good hygiene eliminate pollen from your hands, and of course, do not touch hour face, eyes, or mouth.

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Is it bad allergies, the flu or the coronavirus? Heres how to tell - NBC4 WCMH-TV

IsoPlexis Awarded $2 Million NIH Phase 2 SBIR Grant for Expanding Development of a Cellular Platform for Analyzing the Peripheral Immune Response in…

BRANFORD, Conn., June 9, 2020 /PRNewswire/ -- Isoplexis, the leader in functional single cell proteomics, announced today that it has been awarded a Phase 2 Small Business Innovation Research (SBIR) grant from the National Institute on Aging of the National Institutes of Health for $2 million to continue analyzing the highly multiplexed proteomic responses of trafficking leukocytes in patients with Alzheimer's disease, neuroinflammation, and related neurodegenerative diseases.

The funds from this Phase 2 SBIR grant will be used by IsoPlexis to expand the development of a functional proteomic platform to determine effects of the inflammatory immune response on Alzheimer's progression. The IsoPlexis system will allow for the sensitive detection of responses from various immune cells such as peripheral monocytes, highly polyfunctional secretomic T cell types, and microglia, as biomarkers for early stage diagnosis and monitoring of inflammatory neurodegenerative diseases. This unique approach is non-invasive and should have broad impact and unique value for pre-clinical and clinical use.

"Immune-driven neuroinflammation is a significant contributor to the pathogenesis of diseases such as Alzheimer's. There is an urgent ongoing need for the accelerated development of novel therapeutics and diagnostics. We're excited to be developing solutions to better understand the functional mechanisms behind neuroinflammation," says Sean Mackay, CEO of IsoPlexis.

The IsoLight system is used globally by leading biotech, pharma, and academic medical centers to solve critical challenges in inflammatory diseases, infectious diseases, cell therapy, cancer immunology, and more.

IsoPlexis' functional cellular proteomics platform improves upon existing solutions by providing highly multiplexed, functional, secreted protein readouts, at the single-cell level and in very small sample volume bulk analysis, to advance detection of important drivers of immune system activity. IsoPlexis' technology has been used for precision drug discovery, as well as biomarker discovery in oncology, highlighting critical proteomic pathway changes that are often missed with traditional systems.

ABOUT ISOPLEXIS:

IsoPlexis (www.isoplexis.com) is dedicated to accelerating the fight against cancer and a range of the world's toughest diseases with its uniquely correlative, award-winning, cellular proteomics systems. By revealing unique immune biomarkers in small subsets of cells, we are advancing immunotherapies and targeted therapies to a more highly precise and personalized stage. Our integrated systems, named #1 innovation by the Scientist Magazine and Fierce, are used globally to advance the field of immune biology and biomarkers as we generate solutions to overcome the challenges of complex diseases.

ISOPLEXIS MEDIA CONTACT:

Jon ChenSenior Director of Marketinginfo@isoplexis.com

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IsoPlexis Awarded $2 Million NIH Phase 2 SBIR Grant for Expanding Development of a Cellular Platform for Analyzing the Peripheral Immune Response in...

With an Internet of Animals, Scientists Aim to Track and Save Wildlife – The New York Times

The International Space Station, orbiting some 240 miles above the planet, is about to join the effort to monitor the worlds wildlife and to revolutionize the science of animal tracking.

A large antenna and other equipment aboard the orbiting outpost, installed by spacewalking Russian astronauts in 2018, are being tested and will become fully operational this summer. The system will relay a much wider range of data than previous tracking technologies, logging not just an animals location but also its physiology and environment. This will assist scientists, conservationists and others whose work requires close monitoring of wildlife on the move, and provide much more detailed information on the health of the worlds ecosystems.

The new approach, known as ICARUS short for International Cooperation for Animal Research Using Space will also be able to track animals across far larger areas than other technologies. At the same time, ICARUS has shrunk the size of the transmitters that the animals wear and made them far cheaper to boot.

These changes will allow researchers to track flocks of birds as they migrate over long distances, for instance, instead of monitoring only one or two birds at a time, as well as far smaller creatures, including insects. And, as climate change and habitat destruction roil the planet, ICARUS will allow biologists and wildlife managers to quickly respond to changes in where and when species migrate.

Its a new era of discovery, said Walter Jetz, a professor of ecology and evolutionary biology at Yale, whose center is working with the project. We will discover new migration paths, habitat requirements, things about species behavior that we didnt even think about. That discovery will bring about all sorts of new questions.

As an added bonus, people all over the world will one day be able to log on with a smartphone app to whats known as the internet of animals to follow their favorite bird or tortoise or fish as it migrates and is tracked by the space station practically in real time.

The science of wildlife tracking, known as bio-logging, has come a long way in recent years. In the 1990s, researchers were still tracking large mammals using devices the size of lantern batteries. The technology has grown smaller since then, but many collars and tags are still too big for some three-quarters of the worlds wild creatures.

This space-based approach to uncovering the hidden lives of animals is led by Martin Wikelski, the director of migration research at the Max Planck Institute for Animal Behavior in Germany, who pursued it with a passion for years to overcome gaps and drawbacks in current technologies. It has been funded primarily by DLR, the German space agency.

ICARUS combines off-the-shelf technology, which includes solar and GPS units, and new communication technology that was developed for this mission, and specifically designed for tracking small animals.

On the ground, researchers will attach solar-powered bio-loggers that are far smaller than other technology the size of two fingernails. They weigh less than three grams, about one-tenth of an ounce, and technicians say they will soon have one gram trackers.

Once secured an easy process that seldom harms the animal the sensors will hitch a ride on an array of animals and insects, like locusts, songbirds and baby tortoises. Most current wildlife tracking technologies cant be attached to creatures that weigh less than 100 grams, or about three and a half ounces. And while the new sensors are smaller and lighter, their advanced design will allow them to collect far more data by monitoring an animals physiology, including skin temperature and body position, and external conditions like weather metrics.

The technology can also be used to accomplish a range of goals beyond wildlife studies.

Dr. Wikelski has studied the ability of cows, domestic goats and sheep in Italy to sense earthquakes and volcanic eruptions hours before they happen. Behavioral changes can be picked up by the sensors, he said, so herd behavior may provide an early warning.

We think something smells wrong to them and there is static in the air, he said. So they move into wooded areas where they have shelter.

Why the animals react is not yet known.

Icarus could also help track elephants vulnerable to poaching in Africa, or keep tabs on species of bats, pangolins and other animals that have played a role in viral epidemics.

With skin temperature we can see in the ducks in China whether the next avian influenza is starting, Dr. Wikelski said.

The power of this new approach is partially based on the fact that the space station can pick up the signals of these animals almost anywhere on the planet (the station does not pass over Earths polar regions, however). And while other conservation projects have tracked sharks, birds and other migratory species with satellites, this one aims to be useful for a wide range of species that researchers can ask to have added.

The sensors it relies on, at about $500 each, are a fraction of the price of other widely used tags.

They can last an animals lifetime and even be reused. They are able to store up to 500 megabytes, an entire lifetime of data on an animal. A researcher need not retrieve the tag; its data can be downloaded with a computer or a smartphone.

ICARUS will truly change the study of animal migration, said Nathan Senner, a biologist at the University of South Carolina. He plans to use it for a study tracking the Hudsonian godwit, a shorebird that makes one of the worlds longest migrations, from southern Chile to Alaska.

We could get location estimates that are much more precise and help us develop targeted on the ground conservation measures, Dr. Senner said.

In Europe, studies show some 30 percent of migratory songbirds, or about 420 million, have disappeared. ICARUS may give a much more detailed answer to where and why the animals are dying and guide conservation measures.

Dr. Wikelski said he was asked by a farmer in the German village where he grew up why there were no swallows this year.

Its hard to say, Dr. Wikelski said. Did they die on the way south? Were they eaten in the Mediterranean? Were they hunted in North Africa? Were they poisoned in the Sahel? Was the weather really bad? Those are the kinds of things we will find out.

ICARUS will provide data on an individual bird, as well as a collective. In a study by Dr. Wikelski and others at Max Planck Institute, researchers are tagging 1,200 blackbirds in the hopes of better understanding the timing and route of their travels and where and why their numbers are declining.

In the Galpagos Islands, sensors will be used on baby tortoises to track their migration, a project of the Galpagos Tortoise Movement Ecology Programme.

No one knows how the hatchlings survive, said Dr. Wikelski, who works with the program. Those are the lost years of the sea turtles. Knowing where they go will allow us to protect them better.

Because ICARUS has the capability of tagging many more animals than other technologies do, Dr. Wikelski likened it to a smartphone traffic app that can track many cars on a highway at once. One phone can provide a lot of information about one car, but many phones sending information to one app can offer information about traffic patterns.

One of the goals of the project, Dr. Wikelski said, is to help conservation managers respond to a changing world. Protected areas like wildlife parks and forest preserves are defined by fixed boundaries. But many species are on the move as climate and other changes cause shifts, and protecting them will require an understanding of where they are going and where new protected areas and corridors may need to be created.

The system will be open to researchers around the world to use for research. And the data, with some exceptions, will be accessible to everyone. Dr. Wikelski said readings from ICARUS could be combined with other kinds of information, such as the eBird database, to make the data even more robust.

Another ambition of ICARUS is to allow anyone with a smartphone to follow tagged migrating animals. One app, called Animal Tracker, already exists as a way to tap into ground-based wildlife tracking systems.

Dr. Wikelski hopes that connecting people to a single charismatic animal whose movements they can follow will build support for conservation. If people hear Cecil the lion died its very real to them, he said, referring to a lion in Zimbabwe that was killed by an American hunter in 2015. But if you say 3,000 lions died nobody cares.

Mark Hebblewhite, a wildlife biologist at the University of Montana who has used wildlife tracking technology for decades, said ICARUS would have the capacity to fill in many gaps in our knowledge of the natural world.

Well get a lot of things from ICARUS we cant get any other way, he said. Its exciting.

But technology has downsides as well, he said. Birds may suddenly and unpredictably change their migration, for example, after years of traveling the same way, and Dr. Hebblewhite said there was a danger that conservation decisions could be made by people who dont know anything about birds except dots on a map.

Some might say nature should maintain a degree of mystery from an all-seeing eye in the sky, but Dr. Wikelski, not surprisingly, doesnt agree.

These animals are providing really important information, maybe for survival of humankind, he said. We should have this information.

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With an Internet of Animals, Scientists Aim to Track and Save Wildlife - The New York Times