Immunology and Infectious Diseases Seminar Series
Thursday, Oct. 20, 12-1 p.m.
HSC-1M102
Natasha Norton, MSc Candidate
An intracellular transfer of telomeres rescues T cells from senescence and promotes long-term immunological memory
Presented by BioMedical Sciences
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Immunology and Infectious Diseases Seminar Series - Gazette
CONTACTLetisia Marquez626-476-7593lemarquez@coh.org
LOS ANGELES Alberto Pugliese, M.D., has joined City of Hope as the Samuel Rahbar Endowed Chair in Diabetes & Drug Discovery, chair of the Department of Diabetes Immunology, and director of The Wanek Family Project for Type 1 Diabetes within the Arthur Riggs Diabetes & Metabolism Research Institute.
Pugliese has dedicated his 35-year career to studying type 1 diabetes from the preclinical period to the clinical diagnosis and, afterward, the setting of transplantation. His work has contributed to a greater understanding of genetic and cellular mechanisms that regulate immunological self-tolerance, specifically to molecules targeted in diabetes. Pugliese has provided seminal contributions in the field of type 1 diabetes genetics, immunology, pathology and clinical trials, and his work has been published in major international journals.
City of Hope is fortunate to welcome Dr. Pugliese as he shares our dedication to advancing type 1 diabetes research through scientific excellence, open collaboration and the training of new investigators, said Debbie C. Thurmond, Ph.D., director of the Riggs Institute and Ruth B. & Robert K. Lanman Chair in Gene Regulation & Drug Discovery Research.
Pugliese comes to City of Hope by way of the University of Miami, where he served as The J. Enloe and Eugenia J. Dodson Chair in Diabetes Research. He was also a tenured professor of medicine, Division of Diabetes Endocrinology and Metabolism, and a professor of microbiology and immunology, as well as serving as deputy director for Immune Tolerance Research at the Diabetes Research Institute, Leonard Miller School of Medicine, University of Miami.
I am humbled and honored to join City of Hopes legendary diabetes research department that has made pivotal discoveries about diabetes for more than 50 years, Pugliese said. My team and I will continue and enhance that spirit of innovation and scientific pioneering, digging deeper into the secrets of genetics and the immune system, metabolism and diabetic complications.
A native of Italy, Pugliese earned his medical degree and postdoctoral research fellowship at the University of Palermo. He completed postdoctoral research fellowships at that university, and then trained with the late George Eisenbarth at the Joslin Diabetes Center at Harvard Medical School and the Barbara Davis Center for Childhood Diabetes at the University of Colorado Health Sciences Center.
Pugliese is a champion of collaboration and team-science approaches, which has been recognized by the Helmsley Charitable Trust with the George S. Eisenbarth nPOD Award for Team Science. He has served on research grant review committees of the National Institutes of Health (NIH), the JDRF and other funding organizations internationally. He also served as chair of the American Diabetes Associations Grant Review Panel. He has been a steering committee member of the Type 1 Diabetes TrialNet, a clinical trial network funded by the NIH, under which auspices he has chaired several committees and initiatives.
Pugliese is also executive co-director of the JDRF Network for Pancreatic Organ Donors with Diabetes (nPOD), a collaborative project that recovers tissues from organ donors with type 1 diabetes and distributes samples to investigators worldwide to support a comprehensive understanding of the disease.
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About City of HopeCity of Hope's mission is to deliver the cures of tomorrow to the people who need them today. Founded in 1913, City of Hope has grown into one of the largest cancer research and treatment organizations in the U.S. and one of the leading research centers for diabetes and other life-threatening illnesses. As an independent, National Cancer Institute-designated comprehensive cancer center, City of Hope brings a uniquely integrated model to patients, spanning cancer care, research and development, academics and training, and innovation initiatives. Research and technology developed at City of Hope has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. A leader in bone marrow transplantation and immunotherapy, such as CAR T cell therapy, City of Hopes personalized treatment protocols help advance cancer care throughout the world.With a goal of expanding access to the latest discoveries and leading-edge care to more patients, families and communities, City of Hopes growing national system includes its main Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California and Cancer Treatment Centers of America. City of Hopes affiliated family of organizations includes Translational Genomics Research Institute and AccessHopeTM. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, Instagram and LinkedIn.
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Alberto Pugliese, M.D., Joins City of Hope as Director of The Wanek Family Project for Type 1 Diabetes and Chair of the Department of Diabetes...
Gritstone bio
-- Data to be presented from CORAL-BOOST and CORAL-CEPI trials evaluating Gritstones samRNA vaccine candidates against SARS-CoV-2 --
EMERYVILLE, Calif., Oct. 19, 2022 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the worlds most potent vaccines, today announced that it will host a webinar on October 25, 2022 to present data from its CORAL program and discuss the application of its self-amplifying mRNA (samRNA) vaccine platform for infectious diseases. During the webinar, lead investigators will present data from the ongoing Phase 1 CORAL-BOOST and CORAL-CEPI trials which are evaluating the companys samRNA vaccine candidates against SARS-CoV-2. Following the data presentations, Lawrence Larry Corey, M.D., an internationally renowned expert in virology, immunology and vaccine development, will speak to the potential application of samRNA vaccines against infectious diseases.
Presenters and Content
Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, will present data from CORAL-BOOST. This presentation will expand on study data being presenting at IDWeek 2022.
Professor Shabir Madhi, Dean of the Faculty of Health Sciences, Professor of Vaccinology at the University of the Witwatersrand, Johannesburg, South Africa, will present the interim data from CORAL-CEPI. This presentation will include data on virus-nave subjects.
Larry Corey, M.D., virology, immunology and vaccine development expert, former President & Director of Fred Hutchinson Cancer Center (Fred Hutch) and Board Member of Gritstone bio, will speak to the landscape and broad potential application of samRNA.
Company management will also provide an overview of self-amplifying mRNA (samRNA) as a novel vaccine platform for the prevention and treatment of infectious diseases.
The presentations will be followed by a Q&A session.
Webinar DetailsDate and time: 8:00 9:00am ET on Tuesday, October 25Link: To register for the webinar, please click here
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A replay of the webinar will be accessible for 30 days following the event on the events page of the companys website: https://ir.gritstonebio.com/investors/events.
About the CORAL ProgramGritstones CORAL program is evaluating the companys infectious disease approach, which is designed to drive both B cell and T cell immunity using a self-amplifying mRNA (samRNA) vector, against SARS-CoV-2. The program currently includes three ongoing Phase 1 trials: CORAL-BOOST, which is evaluating one construct in a boost setting (following primary series of currently-approved COVID-19 vaccines); CORAL-CEPI, which is evaluating multiple constructs in virus-nave, convalescent, and HIV+ subjects in South Africa; and CORAL-NIH, which is being run by the National Institute of Allergy and Infectious Disease (NIAID), is evaluating multiple constructs in previously vaccinated healthy volunteers. The program serves as proof-of-concept for the application of Gritstones platform against coronaviruses and other infectious diseases and is supported by theBill & Melinda Gates Foundation,NIAID and theCoalition for Epidemic Preparedness Innovations(CEPI).
About Gritstone bioGritstone bio, Inc. (Nasdaq: GRTS) is a clinical-stage biotechnology company that aims to create the worlds most potent vaccines. We leverage our innovative vectors and payloads to train multiple arms of the immune system to attack critical disease targets. Independently and with our collaborators, we are advancing a portfolio of product candidates to treat and prevent viral diseases and solid tumors in pursuit of improving patient outcomes and eliminating disease. http://www.gritstonebio.com
Gritstone Forward-Looking StatementsThis press release contains forward-looking statements, including, but not limited to, statements related to the potential of Gritstones therapeutic programs; the advancements in Gritstones ongoing clinical trials; the timing of data announcements related to ongoing clinical trials and the initiation of future clinical trials. Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstones research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including Gritstones programs clinical stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Gritstones ability to successfully establish, protect and defend its intellectual property and other matters that could affect the sufficiency of existing cash to fund operations. Gritstone undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Gritstones most recent Annual Report on Form 10-K filed on March 10, 2022, as well as Gritstones Quarterly Reports on Form 10-Q filed on May 5, 2022 and August 4, 2022 and any current and periodic reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Gritstone as of the date hereof. Gritstone disclaims any obligation to update any forward-looking statements, except as required by law.
Gritstone ContactsInvestors:George E. MacDougallDirector, Investor Relations & Corporate CommunicationsGritstone bioir@gritstone.com
Media:Dan Budwick1AB(973) 271-6085dan@1abmedia.com
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Gritstone to Host Data Update on CORAL and Discuss the Application of Self-amplifying mRNA (samRNA) in Infectious Diseases - Yahoo Finance
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SAN DIEGO & BASEL, Switzerland, Oct. 18, 2022 (GLOBE NEWSWIRE) -- Bright Peak Therapeutics, a privately held biotechnology company leveraging a revolutionary chemical protein engineering platform to develop next-generation multifunctional cytokine-based immunotherapies, today announced the formation of a Scientific Advisory Board ("SAB") comprised of world-renowned experts in immuno-oncology basic, translational and clinical research.
"Bright Peak is truly privileged and excited to have such an accomplished and dedicated group of scientific and clinical experts to advise on our discovery and clinical development programs," said Fredrik Wiklund, Chief Executive Officer of Bright Peak. "Their combined resume includes some of the most groundbreaking discoveries in immuno-oncology, from basic biology through clinical investigation." Jon Wigginton, M.D., President of Research and Development at Bright Peak added, "We are honored to welcome this outstanding group of investigators to the Bright Peak SAB and look forward to leveraging their expertise in our shared mission to develop transformative precision immunotherapies that address significant unmet needs for patients with cancer."
The members of Bright Peak's Scientific Advisory Board include:
Gordon Freeman, Ph.D., Professor of Medicine at the Dana-Farber Cancer Institute (DFCI) and Harvard Medical School, is renowned for discovering the PD-L1 and PD-L2 proteins. Dr. Freeman showed that PD-L1 and PD-L2 bound to PD-1 to turn off the immune response and that blockade of PD-L1/PD-1 enhanced immune responses. He further showed that PD-L1 is highly expressed on many tumors and allows these tumors to resist immune attack. Dr. Freemans work led directly to the development of a successful strategy for cancer immunotherapy - blocking the PD-1-ligand interaction. Dr. Freeman has published over 400 scientific papers and holds over 90 US patents on immunotherapies. He was elected to the National Academy of Sciences and the National Academy of Inventors, is a Fellow of the AACR and SITC Academies, and has received numerous awards, including the William B. Coley Award for Distinguished Research in Tumor Immunology, the Warren Alpert Foundation Prize, and the Richard Smalley, MD, Memorial Award. Dr. Freeman received his Ph.D. degree in Microbiology and Molecular Genetics from Harvard University.
Thomas Gajewski, M.D., Ph.D., is the AbbVie Foundation Professor in Cancer Immunotherapy, leader of the Immunology and Cancer program, and Director of Melanoma Oncology at the University of Chicago. Dr. Gajewski's notable discoveries includethe identification of the STING pathway and how it stimulates the body's innate immune system to attack cancer, downstream pathways including Wnt/-catenin that enable tumors to evade immune responses, and the connection between the immune system's response to cancer and the gut microbiota. An author of more than 250 manuscripts, Dr. Gajewski is past president of SITC, a founding editor of the Journal for Immunotherapy of Cancer, past chair of the Cancer Immunopathology and Immunotherapy grant review study section at the NIH, has served on the program committees for ASCO and AACR, a grant reviewer for the Melanoma Research Alliance and Cancer Research Institute, and editor for Cancer Research. Among numerous honors, Dr. Gajewski has received theWilliam B. Coley Awardfor Distinguished Research in Tumor Immunology, the ESMO award in Immuno-oncology, the American Cancer Society-Jules L. Plangere Jr. Family Foundation Professorship in Cancer Immunotherapy, and Distinguished Professor designation at the University of Chicago. He holds a B.S., Ph.D. in Immunology, and M.D. degrees from the University of Chicago where he also completed Internal Medicine Residency and Hematology/Oncology Fellowship.
Jason Luke, M.D., is the Director of the Immunotherapy and Drug Development Center at UPMC Hillman Cancer Center and Associate Professor at the University of Pittsburgh. Dr. Luke is an internationally recognized investigator in translational immuno-oncology, early phase drug development and the clinical management of cutaneous malignancies. Dr. Luke has designed and led two practice-changing studies in melanoma - the combination of anti-PD1 + low-dose anti-CTLA4 Ab in PD1 refractory disease, and establishing the role for, and FDA/EMA approval of, adjuvant anti-PD1 for stage IIB/C melanoma. More generally, Dr Luke has been a lead investigator for many first-in-human trials of novel immunotherapies and a major contributor toward the investigation of radiation, the microbiome and bioinformatic approaches in relation to cancer immunotherapy. Dr. Luke is an At Large member of the Board of Directors for SITC and has held leadership roles in SMR, AACR & ASCO. He is a member of the NCI Investigational Drug Steering Committee and the Immunotherapy Task Force co-Chair. He has received numerous awards including the Melanoma Research Foundation Humanitarian Award, ASCO Merit Award, and the NCI Cancer Clinical Investigator Team Leadership Award. Dr. Luke received an M.D. from Rosalind Franklin University of Medicine and Science/Chicago Medical School, completed Internal Medicine Residency at Boston University Medical Center and Medical Oncology Fellowship at Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical Center.
Ignacio Melero, M.D., Ph.D., is Co-Director of the Department of Immunology and Immunotherapy and Professor of Immunology at the Clinica Universidad de Navarra and at the Center for Applied Medical Research (CIMA) of the University of Navarra, Spain. Dr. Melero is an international leader in translational tumor immunotherapy research who focuses on cytokine gene therapy, immune-stimulatory monoclonal antibodies, and cell therapy for cancer. Dr. Melero is renowned for seminal discoveries in the function of NK cell inhibitory receptors (KIRs) and T-cell co-stimulation via CD137 (4-1BB). Dr. Melero has served as principal investigator in numerous clinical trials of cancer immunotherapy and has won multiple awards including the BIAL Prize of Medicine, the Conde de Cartagena Award from the Royal Academy of Medicine, Doctor Durantez LAIR Foundation Award and a Cancer Research Institute research award. Dr. Melero earned an M.D. degree from the University of Navarra School of Medicine, completed Residency in Immunology at the Hospital Universitario de la Princesa (Madrid) and earned a Ph.D. in Immunology at La Princesa Hospital, Autonomous University of Madrid, Spain.
Anthony Tolcher, M.D., is founder and CEO of NEXT Oncology, one of the most successful and respected Phase 1 programs in oncology research. Prior to founding NEXT Oncology, Dr. Tolcher was President and Co-Founder of START LLC, one of the world's largest Clinical Phase I and early drug development operations in cancer medicine. Dr. Tolcher is a medical oncologist with over 25 years' experience in early drug development and clinical trials and has been involved in more than 21 of the initial Phase 1 studies of new oncology agents that subsequently were FDA approved, including PD-(L)1 inhibitors, antibody-drug conjugates, anti-tumor-associated antigen antibodies, and numerous targeted therapies, and he is currently the principal investigator of over 20 Phase 1 studies. He has over 130 peerreviewed publications in scientific journals and has chaired the Developmental Therapeutics Review Committee for ASCO. Dr. Tolcher obtained his M.D. degree from the University of British Columbia and then completed Internal Medicine Residency at the University of Toronto, Oncology Fellowship at the University of British Columbia and a research fellowship at the NCI, Bethesda.
About Bright Peak TherapeuticsBright Peak is a privately held biotechnology company based in Basel, Switzerland and San Diego, CA. We are rapidly advancing a robust portfolio of next-generation, multi-functional, cytokine-based immunotherapies for the treatment of patients with cancer and autoimmune disease. We accomplish this by leveraging our world class protein engineering capabilities and our unique cell-free technology platform to chemically synthesize and conjugate novel protein therapeutics that reflect state-of-the-art insights into cytokine and immune checkpoint biology. Our pipeline stretches from discovery to IND-enabling and encompasses enhanced cytokines, antibody-cytokine conjugates and other novel formats. Bright Peak is funded by a syndicate of leading healthcare investors.
Contact:[emailprotected]
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Bright Peak Therapeutics Announces Formation of World Class Immuno-Oncology Scientific Advisory Board - StreetInsider.com
October 20, 2022
Amsterdam, the Netherlands argenx (Euronext & ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, October 27, 2022 at 2:30 pm CET (8:30 am ET) to discuss its third quarter 2022 financial results and provide a business update.
A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately one year following the presentation.
Dial-in numbers:
Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call.
Belgium 32 800 50 201United Kingdom 44 800 358 0970United States 1 888 415 4250All other locations 1 646 960 0294
About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., the EU and Japan. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit http://www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.
For further information, please contact:
Media:
Kelsey Kirk[emailprotected]
Investors:
Beth DelGiacco[emailprotected]
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argenx to Report Third Quarter - GuruFocus.com
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University failed to follow collective bargaining agreement when it ordered Kyle Anderson to cut employment references from his social profiles.
An arbitrator has ruled that the University of Saskatchewan never should have sent a letter telling an outspoken faculty member to remove references to his employment from his social media accounts.
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Lawyer Eric Cline presided over the labour board hearing between the university and its faculty association, which acted on behalf of Kyle Anderson, a tenured assistant professor in the College of Medicines department of biochemistry, microbiology and immunology.
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The decision, reached last month, outlines Andersons rise on social media during the early stages of the COVID-19 pandemic, to eventually being ordered to strip all references to his faculty positions from his public communications.
Anderson scored his first hit in August 2020 with a 50,000-view Facebook video calling for pool testing of schoolchildren. By December 2020, hed racked up about 1.2 million views on various posts about the pandemic. He was also getting favourable notes from his supervisors, and being tapped to do interviews when media called the university with questions about COVID-19.
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In a rancorous Twitter exchange in December 2020, Anderson hurled personal insults at an unnamed person who was reportedly posting misinformation about the pandemic. This led to his first brush with university authorities, who had a communications specialist from the medical school provide him with training on best practices for social media.
Andersons postings again came to the attention of university leadership when, on April 14, 2021, he tweeted a post critical of Premier Scott Moe, including the line It sounds like there are already plots and maneuverings in motion to take down the Mad King of Saskeros in reference to the Saskatchewan premier. This led the RCMP to question Anderson to ensure there was no threat to Moes safety.
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A tweet on April 22, 2021 drew the letter from the administration that was at the heart of Clines decision.
On that day, while advocating for tighter pandemic measures in schools, Anderson re-tweeted a post suggesting a maskless child repeatedly coming to school while infectious with COVID-19 was responsible for infecting a Moose Jaw educational assistant who later died from the disease. The information turned out to be inaccurate, prompting Anderson to later take it down.
The grievance before Cline concerned a letter sent to Anderson after the April 22 tweet, signed by the universitys president, vice-president academic and the dean of the College of Medicine. In the letter, the signees noted the university had received multiple complaints about Andersons post, describing it as hateful and unconscionable, and that it amounted to a targeted victimization of a vulnerable family for singling out a child who, it was subsequently revealed, had autism.
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The universitys letter went on to say that Andersons post was reflecting badly on the university, by virtue of him identifying himself as a faculty member. It ordered him to remove all references to his employment from his social media and public communications, or potentially face further discipline.
The faculty association argued the letter amounted to a disciplinary action against a member outside of whats prescribed in the collective agreement with the university.
Clines decision is in favour of the unions position, noting the university failed to follow a key section of the collective agreement by not bringing the complaints against Anderson to his attention before sending him the letter, and therefore denying him an opportunity to be heard.
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Cline acknowledged that Andersons re-posting of unverified, inaccurate information was wrong, and perhaps even reckless, but added that he also never heard any evidence from anyone who signed the letter, leaving him with no idea of the number or content of the complaints against Anderson, and no evidence to show Andersons tweets damaged the universitys reputation.
Cline ruled the letter was a disciplinary measure that is not allowed under the collective agreement, and ordered that it be removed from any university files.
The news seems to be flying at us faster all the time. From COVID-19 updates to politics and crime and everything in between, it can be hard to keep up. With that in mind, the Saskatoon StarPhoenix has created an Afternoon Headlines newsletter that can be delivered daily to your inbox to help make sure you are up to date with the most vital news of the day. Click here to subscribe.
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Tonix Pharmaceuticals Holding Corp.
CHATHAM, N.J., Oct. 19, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the ThinkEquity Conference on Wednesday, October 26, 2022, at 10:30 a.m. ET, and host investor meetings. The conference is being held at the Mandarin Oriental, New York in New York City.
Investors interested in arranging a meeting with the Companys management during the conference should contact the ThinkEquity conference coordinator. A webcast of the presentation will be available under the IR Events tab of the Tonix website at http://www.tonixpharma.com.
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonixs portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonixs CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonixs lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the first half of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonixs rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonixs immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonixs infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonixs vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonixs lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonixs recombinant pox live virus vector vaccine platform.
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*All of Tonixs product candidates are investigational new drugs or biologics and have not been approved for any indication.
This press release and further information about Tonix can be found at http://www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as anticipate, believe, forecast, estimate, expect, and intend, among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the SEC) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Contacts
Jessica Morris (corporate)Tonix Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Olipriya Das, Ph.D. (media)Russo PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo (investors)ICR Westwickepeter.vozzo@westwicke.com(443) 213-0505
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Tonix Pharmaceuticals to Present at the 2022 ThinkEquity Conference - Yahoo Finance
Newswise NEW YORK, October 11, 2022 The Cancer Research Institute (CRI) and Israel Cancer Research Fund (ICRF) have partnered to award and co-fund, respectively, a Clinic and Laboratory Integration Program (CLIP) grant to support the promising immunotherapy research of Yifat Merbl, PhD, of the Weizmann Institute of Science in Israel. The CLIP grant, providing $200,000 in research funding over two years, was established by CRI to support investigators who are studying critical topics at the intersection of laboratory and clinical research. This collaboration builds on another partnership that supported immunotherapy research conducted in Israel The Immunotherapy Promise betweenCRI, the leading funder of immunotherapy research internationally, and ICRF, North Americas largest nonprofit dedicated to supporting cancer research in Israel and the largest non-governmental funder of Israeli cancer research.
Professor Merbls project, Controlling Proteasomal Degradation for Enhancing Anti-Tumor Immunity, hopes to characterize the proteasome degradation landscape in melanoma, aiming to gain insight into the mechanisms of immune evasion and lack of patient response to immunotherapy. This approach should ultimately lead to a novel system to target proteasome degradation in order to improve cancer treatment. While immunotherapy first emerged as a form of FDA-approved cancer treatment in the late 1980s, it is only within the past decade that this class of therapy has begun to deliver significant survival benefit to more cancer patients, bringing it to the forefront of public attention. New immunotherapeutic approaches have been shown in clinical trials to effectively treat patients with bladder, head and neck, kidney, and lung cancers as well as leukemia, lymphoma, and melanoma, with clinical trials under way for more than 25 other types of cancer.
The Cancer Research Institute and Israel Cancer Research Fund have teamed up again to bring philanthropic support of immunology research to scientists in Israel who are working to harness the immune systems power to fight all types of cancer, and this latest joint initiative furthers our shared goal of finding effective answers to cancer to save more lives and cure as many patients as possible, said Jill ODonnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute.
Commenting on the partnership, David Abramson, president of ICRF said, We know how crucial immunotherapy is in the area of cancer research and our unique partnership with the Cancer Research Institute has the potential to yield breakthrough discoveries in the field. It is our hope that many more Israeli scientists will benefit from our collaboration with CRI.
About the Cancer Research InstituteThe Cancer Research Institute (CRI), established in 1953, is the worlds leading nonprofit organization dedicated exclusively to transforming cancer patient care by advancing scientific efforts to develop new and effective immune system-based strategies to prevent, diagnose, treat, and eventually cure all cancers. Guided by a world-renowned Scientific Advisory Council that includes four Nobel laureates and 27 members of the National Academy of Sciences, CRI has invested $500 million in support of research conducted by immunologists and tumor immunologists at the worlds leading medical centers and universities and has contributed to many of the key scientific advances that demonstrate the potential for immunotherapy to change the face of cancer treatment. To learn more, go to https://www.cancerresearch.org/.
About Israel Cancer Research FundICRF, a 501(c)(3) organization, is the largest charitable organization outside of Israel solely devoted to supporting cancer research in Israel. Grants issued by ICRF have gone to hundreds of researchers at two dozen leading research institutions, universities, and hospitals across Israel. The efforts of Israeli cancer researchers have resulted in significant cancer breakthroughs which were vital in the development of breakthrough cancer drugs, including Doxil, Gleevec, and Velcade. To learn more, go to https://www.icrfonline.org/.
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Cancer Research Institute and Israel Cancer Research Fund Announce Co-Funding of a Translational Immunotherapy Research Grant - Newswise
A team led by Scripps Research scientists has been awarded a contract by the U.S. Centers for Disease Control & Prevention (CDC) in support of one of the largest SARS-CoV-2 surveillance programs in the United States.
The two-year, $2.5 million contract will fund the large-scale, near real-time sequencing of SARS-CoV-2 isolates from hospitals and local public health agencies in San Diego and nearby northwestern Mexico, and the development of software for tracking the evolution and geographical spread of SARS-CoV-2 variants.
The contract, an extension of one originally awarded in 2020, will be carried out by the San Diego Epidemiology and Research for COVID Health (SEARCH) Alliance, which was co-founded by Scripps Research, the University of California San Diego (UC San Diego), and Rady Children's Hospital-San Diego.
CDC's support for SEARCH's genomic surveillance program has already led to significant COVID-19 public health advances as well as new science on SARS-CoV-2, and we expect much more progress in both areas as a result of this new award."
Kristian Andersen, PhD, Principal Investigator, Professor, Department of Immunology and Microbiology at Scripps Research
Since the start of the pandemic, SEARCH has been conducting genomic surveillance of SARS-CoV-2 using clinical samples collected at San Diego hospitals and from sources across the border in Baja California. SEARCH has also developed key protocols and analysis tools to track the emergence and spread of SARS-CoV-2 variants in wastewater. Moreover, SEARCH investigators are actively involved in understanding the emergence of SARS-CoV-2, and in several high-profile publications have found evidence for an initial spread from animals sold at the Huanan Market in Wuhan, China.
SEARCH's efforts involve multiple collaborations, including with the CDC, San Diego County's Health & Human Services Agency, the California Department of Public Health, Sharp Health, Scripps Health, the viral surveillance company Helix, and the Salud Digna healthcare network in Mexico. Since the start of the pandemic, these efforts have yielded publications and analyses of more than 70,000 SARS-CoV-2 sequences.
Under the new contract, SEARCH will accelerate its virus-sequencing workflow to produce more timely and actionable information on local virus spread and evolution-;including the emergence of new variants and subvariants of concern.
"The current process of sampling, sequencing and analyzing a batch of virus samples from local hospital cases and wastewater treatment plants can take several weeks," says Mark Zeller, PhD, project scientist in the Andersen lab. "We're aiming to get that down to a matter of days, which would enable us to monitor the transmission chains in local outbreaks in near real-time."
Working with the County of San Diego, the state of California and Mexican public health labs, the researchers will also continue to analyze the transmission of SARS-CoV-2 across the busy California-Baja border. Additionally, they'll expand their genomic surveillance efforts to additional Mexican border states and popular tourist destinations, including Puerto Vallarta. The team will continue to post their analyses on SEARCH's online dashboards.
The project includes the further development of open-source software tools to support the tracking of local SARS-CoV-2 evolution and transmission.
"The tools we've developed in recent years are already being used widely by the public health community for SARS-CoV-2 sequencing and analysis," says Joshua Levy, PhD, postdoctoral research associate in the Andersen lab. "Under this new contract, we will be developing the technology to permanently transform how genomic surveillance will be used to strengthen our public health response."
These open-source software tools are available at https://andersen-lab.com/secrets/code/. The SEARCH Alliance's SARS-CoV-2 surveillance dashboards are at https://searchcovid.info/Dashboards/.
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$2.5 million CDC contract to fund one of the largest SARS-CoV-2 surveillance programs in the U.S. - News-Medical.Net
Evommune team/courtesy of Evommune
Evommunes novel human tissue-based assay system is proving to be a key differentiator as the company develops therapies to control chronic inflammation in autoimmune diseases.
Working with human tissue puts us closer to the target and yields a model that is much more predictive of outcomes in the human immune system, said Luis Pea, CEO of Evommune, in an interview with BioSpace.
Skin has all of the cell types that are needed to induce specific inflammatory pathways, said Eugene Bauer, M.D., CMO of Evommune. The companys human tissue model is an ex vivo system that uses living skin from human donors, allowing the model to reflect all the immune responses that occur across various tissues in the body that drive inflammation.
Consequently, in this context, it is more robust, predictive and relevant than animal modeling. This most closely mimics a real-time look at immune pathways and how to find the best way to target and modify inflammation. The miniaturized technology enables hundreds of assays to be conducted to study both systemic and topical therapies.
Evolving Immunology
In seeking to evolve immune therapy, Evommune is looking at the following opportunities in treating patients: early intervention in their disease state, improving efficacy, increasing response rates in patients and enhancing safety.
Autoimmune diseases are, in fact, systemic inflammatory conditions that are often associated with serious co-morbidities including infections, cardiovascular events, renal disease and mental health issues, making early intervention and preventing disease progression extremely important, Pea said. The entire body is in an accelerated immune-response mode. So, we are trying to modulate the immune system to dial down some of these responses.
Existing therapeutics have improved our ability to treat inflammatory conditions, but in most diseases, they still only elicit a response in about half the patients treated and achieve a great response rate in only one-third of those, he continued. Creating medicines that have better efficacy and that induce remission is the goal for us.
Improving the safety profile for drugs that treat autoimmune diseases could make a meaningful impact in this space. We want to develop therapies that improve patients quality of life without putting them at risk for other factors, Pea said.
Evommunes senior leadership and scientific teams are primed to do just that. Throughout their careers, they have helped bring more than 25 medicines to patients in need. As Pea noted, the combination of scientific insights, drug development expertise and building companies makes this team a unique group.
Accomplished Team of Experts
A testament to this is that Pea and Bauer were co-founders of Dermira, which Eli Lilly acquired for $1.1 billion to get the rights to lebrikizumab. The two had originally helped acquire this asset from Genentech, despite the drug having failed in prior Phase III trials for a different indication.
We saw that lebrikizumab had promise in atopic dermatitis. We believed lebrikizumab had been under-dosed in previous atopic dermatitis trials, mostly because of a focus on asthma, Pea explained. We adjusted the dose in a Phase II atopic dermatitis program and delivered strong data. Lilly bought us because of that drug and since then, lebrikizumab has had great data from their Phase III studies. We believe lebrikizumab will become a significant therapy for atopic dermatitis and the team at Evommune had the vision to make that happen, he said.
Before Dermira, Bauer was president and CMO of Peplin, Inc. (acquired by LEO Pharma) and shepherded Picato through a global submission, which included the FDA and resulted in an approval for actinic keratosis.
Additionally, the Evommune development team has been responsible for multiple new drug applications or biologics license applications, several investigational new drug applications and numerous other interactions with regulators, including four global clinical development programs.
That combination of intimate knowledge of both immunology and drug development is what separates Evommune from other companies in terms of our ability to move these novel therapies forward, Pea said.
Evommune is committed to this promise with the ongoing expansion of the team, including new management positions across R&D, CMC, legal, strategy and finance who also bring a wealth of diverse drug discovery and development expertise.
A Multifaceted Pipeline
Evommune currently has four programs in the pipeline.
"The goal for all of our programs is to be best in class, Pea said. EVO101 for atopic dermatitis is an IRAK4 inhibitor, which is a very novel target. A randomized, blinded, placebo-controlled Phase IIa clinical trial for patients with mild-to-moderate atopic dermatitis was initiated in Q3 2022.
We define mild-to-moderate atopic dermatitis as affecting between 4 and 12% of an individuals body surface area. For perspective, the palm of your hand is 1%, Bauer elaborated. Study participants will apply a 0.1% cream to the lesions twice daily for eight weeks. Results will be scored using the eczema area severity index (EASI), which measures redness, scaling and thickness of lesions, as well as the extent and severity of the disease.
In EVO101s development work, Evommunes human tissue model enabled researchers to recapitulate disease pathology and inflammatory mediators of atopic dermatitis. Adding low-, mid- and high-potency topical steroids (current standard-of-care therapeutics) to the human tissue model provided a control set of efficacy data a baseline by which we could then compare the performance of EVO101, Bauer explained.
EVO101, at the dosage being used for patients in the clinical trial, lowered inflammation levels to those comparable with doses of ultra-high potency steroids, but with high selectivity.
We believe this could become an alternative to standard-of-care therapies for atopic dermatitis, Bauer said, that may be used to treat both adult and pediatric patients.
In addition, we now have a development stage program that could potentially be a ground-breaking oral therapy for mast cell-mediated diseases, he said.
EVO756 is a completely novel compound that will target the treatment of mast cell-mediated diseases and inflammatory itch, Pea said. EVO756 targets MRGPRX2, a receptor that exists on mast cells and peripheral neurons and regulates mast cell degranulation. EVO756 is targeted for the treatment of mast cell-mediated disorders with highly prevalent populations such as chronic spontaneous urticaria, interstitial cystitis and hereditary alpha-tryptasemia.
In addition, preclinical data have shown that itch can be completely eliminated in mice: knocking out that receptor made it impossible to induce itch. For patients with inflammatory diseases, itch can be severe and have a significant, negative impact on a patients quality of life. We think EVO756 could be a great oral therapy, that can act quickly to relieve itch, Pea continued.
Another program, EVO390, is in development for the treatment of mild-to-moderate psoriasis in the hope of slowing or halting disease progression. This therapeutic agent targets RORt and has the potential to be best-in-class and the agent of choice for these patients. It may also serve as an adjunct therapy in more severe cases. We believe it could be a broadly used therapy for psoriasis, Pea added.
Our fourth program, currently in discovery, targets protein kinase C (PKC) theta, Pea continued. The company has identified several potent molecules that may have broad anti-inflammatory activity, highly targeted to T-effector cell inhibition and T-regulatory cell activation. This may have utility across a number of inflammatory conditions such as rheumatoid arthritis, IBD, atopic dermatitis and psoriasis. In addition, because it is highly targeted, it has the potential to be safer than the JAK inhibitors and other systemic anti-inflammatory agents.
As a company, we understand the importance of working on multiple targets and managing a portfolio of compounds. This approach provides the opportunity to work on different agents, impact many diseases and make a difference in patients lives, Pea said. The companys discovery engine is working to identify new targets so the team can extend its therapeutic impact.
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Evommunes Human Tissue-based Approach Enables Discovery and Development of Safer, Innovative Chronic Inflammation Therapies - BioSpace