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Cell Biology

Forma Therapeutics Announces Phase I Clinical Data for Investigational Agent FT-4202 in Sickle Cell Disease to be Presented at the Virtual Edition of…

Poster presentation to highlight the tolerability, pharmacokinetics and pharmacodynamics of FT-4202 in Phase I clinical trials of single and multiple ascending dose cohorts of healthy subjects, Phase I clinical trials of single dose of SCD patients

WATERTOWN, Mass.--(BUSINESS WIRE)-- FORMA Therapeutics, Inc.. (Forma), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that the company will present Phase 1 results from a study of FT-4202, Formas lead investigational agent currently in clinical development as a potentially disease-modifying treatment for sickle cell disease (SCD), at the Virtual Edition of the 25th European Hematology Association (EHA) Annual Congress taking place June 11-21, 2020.

The abstract, listed below, is currently available on the EHA website.

Poster Presentation Title: Phase 1 Single (SAD) and Multiple Ascending Dose (MAD) Study of the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of FT-4202, a PKR Activator, in Healthy and Sickle Cell Disease Subjects Abstract Number: EP1531Date and Time: Available on EHAs website beginning June 12, 2020, at 8:30 a.m. Central European Summer Time (CEST)Session Topic: Sickle Cell DiseasePresenter: Jeremie H. Estepp, M.D., St. Jude Childrens Research Hospital

The abstract and poster presentation will be available on Formas website upon presentation at the meeting. In addition, the e-Poster will be made available on the on-demand Virtual Congress platform as of Friday, June 12, at 8:30 CEST and will be accessible until October 15, 2020.

About FT-4202

FT-4202 is a novel, oral, once-daily pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy for the treatment of sickle cell disease (SCD). Early studies and trials have shown that FT-4202 works upstream by employing a multimodal approach and activating the red blood cells (RBC) natural PKR activity to decrease 2,3-DPG levels, which we believe leads hemoglobin to hold on to oxygen molecules longer to reduce RBC sickling. FT-4202 has also shown downstream activity by increasing ATP levels, the fuel that provides energy to cells, which we believe may improve RBC health and survival. Together, these effects have the potential to increase hemoglobin levels and decrease painful vaso-occlusive crises. In preclinical safety studies, FT-4202 did not inhibit aromatase activity, important biological processes responsible for sexual development.

About Forma Therapeutics

Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit http://www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.

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Forma Therapeutics Announces Phase I Clinical Data for Investigational Agent FT-4202 in Sickle Cell Disease to be Presented at the Virtual Edition of...

Immunology

Nimbus Therapeutics Announces Expansion of Its Drug Discovery Pipeline Across Oncology, Immunology and Metabolism – Business Wire

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, announced the expansion of the companys pipeline of small molecule candidates across a range of highly prevalent human diseases. These preclinical programs AMPK2 (AMP-activated protein kinase, 2 subunit), CTPS1 (CTP synthase 1), Cbl-b (Cbl proto-oncogene B), and WRN (Werner syndrome ATP-dependent helicase) represent promising targets across oncology, immunology and metabolism, for which Nimbus structure-based discovery approaches are uniquely suited.

The additional programs were unveiling today are a testament to Nimbus exceptional talent, the unwavering support of our investors, and the dynamic scientific collaborations we have built over the past decade, said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. Our prolific pipeline reflects the breadth of potential we see for our discovery engine going forward, and a new chapter in Nimbus leadership of structure-based drug discovery. We look forward to progressing these programs forward to the clinic within our development organization, which advanced our ACC inhibitor to an early proof of mechanism and is currently progressing our Tyk2 inhibitor toward Phase II.

With the addition of these targets, weve built a pipeline of promising therapeutics for the treatment of patients with diseases that have limited or no therapeutic options, said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. Each of these targets represents the sweet spot for Nimbus approach they are known to be fundamental drivers of highly prevalent diseases but have proven difficult for the industry to drug. As we have demonstrated with our progress on HPK1, which is being presented at AACR this month, we believe our structure-based drug discovery engine can generate the potent, selective small molecule therapeutics needed to move the needle on these targets.

A brief overview of our newly disclosed programs follows:

About Nimbus Therapeutics

Nimbus Therapeutics designs breakthrough medicines. Utilizing its powerful structure-based drug discovery engine, Nimbus designs potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. The companys LLC/subsidiary architecture enables diverse and synergistic partnerships to deliver breakthrough medicines. Nimbus is headquartered in Cambridge, Mass. http://www.nimbustx.com

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Nimbus Therapeutics Announces Expansion of Its Drug Discovery Pipeline Across Oncology, Immunology and Metabolism - Business Wire

Immunology

Soligenix to Present at the MedInvest Infectious Disease and Immunology Investor Conference – PRNewswire

PRINCETON, N.J., June 9, 2020 /PRNewswire/ --Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its Senior Vice President and Chief Scientific Officer, Oreola Donini, PhD, will deliver a presentation discussing Soligenix's vaccine efforts, including a COVID-19 vaccine development program, at the MedInvest Infectious Disease and Immunology Investor Conference, held virtually on June 15 and 16, 2020.

Oral Presentation:

Thermostabilized Protein Vaccines with Applications in Ricin Toxin, Filoviruses and Coronavirusespresented by Oreola Donini, PhD, Chief Scientific Officer, Soligenix on June 16 at 2:30 PM EDT. A question and answer period will follow the presentation.

A recording of the presentation will be available on the Soligenix website after June 16.

For more information about the MedInvest Infectious Disease and Immunology Investor Conference, please refer to the conference website at https://www.medinvestconferences.com.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

Our Public Health Solutions business segment includes active development programs for RiVax, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and our research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

For further information regarding Soligenix, Inc., please visit the Company's website at http://www.soligenix.com.

This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, such as experienced with the COVID-19 outbreak. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy, or any of our other clinical/preclinical trials. Despite the statistically significant result achieved in the SGX301 Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma, there can be no assurance that a marketing authorization from the FDA or EMA will be successful. Further, there can be no assurance that RiVax will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

SOURCE Soligenix, Inc.

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Immunology

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

Immunology

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...

Immunology

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

Immunology

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

Immunology

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

Immunology

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...

Immunology

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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More Than One Way to Fix Cat Allergy - Medscape