CEPI

Gritstone to Host Data Update on CORAL and Discuss the Application of Self-amplifying mRNA (samRNA) in Infectious Diseases

Retrieved on: 
Wednesday, October 19, 2022
Fred Hutchinson Cancer Research Center, National Institute, U.S. Securities and Exchange Commission, RNA transfection, CEPI, Severe acute respiratory syndrome coronavirus 2, Annual report, Volunteering, CORAL, Infection, NIAID, Security (finance), Program, University of the Witwatersrand, University, Faculty, Immune system, UK, Epidemic, McMaster Faculty of Health Sciences, Degenerative disease, Virology, Q&A, Outline of health sciences, Bill & Melinda Gates Foundation, GLOBE, National Institute of Allergy and Infectious Diseases, COVID-19, COVID-19 vaccine, Pharmaceutical industry, Vaccine, Online shopping, Vaccine, Gritstone

EMERYVILLE, Calif., Oct. 19, 2022 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s 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 company’s 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.

Key Points: 
  • 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.
  • Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, will present data from CORAL-BOOST.
  • 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 forward-looking statements in this press release are based on information available to Gritstone as of the date hereof.

SK bioscience Appoints New Executives towards Global Business Growth

Retrieved on: 
Friday, October 21, 2022
Biochemistry, Bill, Doctor of Philosophy, Sanofi Pasteur, Therapy, Growth, CEPI, Akwa Ibom State Association of Nigeria, USA Inc., BMGF, Regulation of tobacco by the U.S. Food and Drug Administration, Electrical engineering, Biotechnology, HQ, BMS, OGD, Investment, VAX, Bristol Myers Squibb, University, Infection, Food, Epidemic, Coalition for Epidemic Preparedness Innovations, Company, Bill & Melinda Gates Foundation, Health, Industry, CDMO, SK Group, Plasma protein binding, CEO, Research, Virginia Tech, State university system, Head, Global Health, Coalition, Electricity, FDA, COVID-19, Pharmaceutical industry, Fine chemical, Pfizer, Microbiology

SK bioscience is accelerating its entry into the U.S. with the appointment of Dr. Harry Kleanthous.

Key Points: 
  • SK bioscience is accelerating its entry into the U.S. with the appointment of Dr. Harry Kleanthous.
  • The Company earlier appointed Dr. Hun Kim, Chief Technical Officer at SK bioscience, as Chief Executive Officer of SK bioscience USA, Inc., a new entity that will be established early next year.
  • The headquarters of SK bioscience USA, Inc. will be located in Boston, a vibrant center of biotechnology, large biopharma, and academia ecosystem.
  • SK bioscience is a global innovative vaccine and biotech company, committed to global pandemic preparedness in vaccine development and manufacturing for more equitable access.

Codiak Presents Preclinical Data Demonstrating its Pan Beta-Coronavirus Vaccine Elicits Broad Protective Immunity Against Known Variants of SARS-CoV-2 and Related Sarbecoviruses

Retrieved on: 
Wednesday, October 12, 2022
U.S. Securities and Exchange Commission, Infection, CD8, RNA transfection, Exosome, MGH, CEPI, Virus, APC, Â, Vaccine, Immunity, Biology, Epitope, Research, Security (finance), Neuro-oncology, Partnership, Nasdaq, Private Securities Litigation Reform Act, Radio, Epidemic, Harvard University, Ragon Institute, RBD, MIT, Polyvalency (chemistry), GLOBE, Coalition, Antigen, Human, Poster, Coalition for Epidemic Preparedness Innovations, Pharmaceutical industry, Severe acute respiratory syndrome coronavirus 2, VOC

CAMBRIDGE, Mass., Oct. 12, 2022 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (Nasdaq: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based candidates as a new class of medicines, today announced additional preclinical data from its pan beta-coronavirus vaccine program, which aims to protect against all SARS-CoV-2 variants of concern and potential future strains belonging to the beta-coronavirus family. The data, which are being presented today in a presentation and poster at the Vaccines Summit 2022 in Washington, DC, demonstrate the potential of Codiak’s exoVACC™ vaccine candidate, exoRBD, to protect against multiple known Variants of Concern (VoC) of SARS-CoV-2 and seven coronaviruses from the Sarbecovirus family that are currently in bats and may have a high potential to jump into humans.

Key Points: 
  • Vaccine and therapeutic development for SARS-CoV-2 has been impressive and life-saving, but the virus continues to mutate to evade vaccine protection.
  • At the same time, there remains the threat that another beta coronavirus or variant of concern could emerge.
  • Its clear that a vaccine offering comprehensive immunity across a range of coronaviruses would address this urgent need and represents an important advancement in combatting these viruses, said Sriram Sathyanarayanan, Ph.D., Chief Scientific Officer, Codiak.
  • This suggests that our exosome-based vaccine could limit the virus ability to mutate and evade protection.

VBI Vaccines Announces Initiation of Phase 1 Study of Multivalent Coronavirus Vaccine Candidate, VBI-2901

Retrieved on: 
Thursday, September 29, 2022
Biotechnology, FDA, Other Health, Health, Pharmaceutical, Oncology, Research, Infectious Diseases, Science, COVID-19, Clinical Trials, Government of Canada, Middle East respiratory syndrome–related coronavirus, Trial of the century, Safety, COVID-19, Virus, Severe acute respiratory syndrome coronavirus 2, Nature, VLP, Company, GBM, Private Securities Litigation Reform Act, Hepatitis B, Industry, Mouse, ISED, Glioblastoma, Coalition for Epidemic Preparedness Innovations, MERS, Epidemic, NRC, Health Canada, CEO, SARS, Technology, Vaccine, Annual report, Nasdaq, Omicron, Coronavirus, VBI, Government, Economic development, Infection, Research, Cytomegalovirus, National Research Council, SEC, Immune system, Disease, CMV, Coalition, CEPI, Pharmaceutical industry, Science, Lambda

As we work to develop a vaccine capable of providing broad protection against known, emerging, and as-yet-unknown COVID-19 and coronavirus strains, we believe this study initiation is a meaningful step toward that goal.

Key Points: 
  • As we work to develop a vaccine capable of providing broad protection against known, emerging, and as-yet-unknown COVID-19 and coronavirus strains, we believe this study initiation is a meaningful step toward that goal.
  • Each participant must have received their previous dose of a licensed COVID-19 vaccine at least six months prior to study enrollment.
  • VBI Vaccines Inc. (VBI) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease.
  • VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.

Emergent BioSolutions Initiates Phase 1 Study Evaluating Lassa Virus Vaccine Candidate

Retrieved on: 
Tuesday, September 6, 2022
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GAITHERSBURG, Md., Sept. 06, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that it has dosed the first participant in its Phase 1 study evaluating the safety and immunogenicity of EBS-LASV, a recombinant VSV-vectored Lassa virus vaccine candidate being developed for prevention of disease caused by Lassa virus infection.

Key Points: 
  • GAITHERSBURG, Md., Sept. 06, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that it has dosed the first participant in its Phase 1 study evaluating the safety and immunogenicity of EBS-LASV, a recombinant VSV-vectored Lassa virus vaccine candidate being developed for prevention of disease caused by Lassa virus infection.
  • This Phase 1 study, a randomized, placebo-controlled, dose-escalation study, will evaluate the safety and immunogenicity of Emergents rVSV-vectored Lassa virus vaccine in approximately 36 healthy adults at the Navrongo Health Research Centre and Kintampo Health Research Centre in Ghana.
  • Lassa virusa single-stranded RNA virus belonging to the family Arenaviridaecan cause the acute viral hemorrhagic illness known as Lassa fever.
  • In 2018, Emergent acquired development rights to the Profectus Lassa vaccine candidate now named EBS-LASV.

Codiak BioSciences Announces Program Reprioritization and Corporate Restructuring

Retrieved on: 
Tuesday, August 30, 2022
Neoplasm, Partnership, Security (finance), CEO, U.S. Securities and Exchange Commission, Program, Research, HCC, NASDAQ, Coalition, CEPI, SEC, Infection, Goal, Acceleration, Antibody, GLOBE, Pharmacology, Biology, Liver disease, Company, Exosome, Tams, Epidemic, Private Securities Litigation Reform Act, Colorectal cancer, AAV, Patient, Pharmaceutical industry, Risk management

CAMBRIDGE, Mass., Aug. 30, 2022 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, today announced a reprioritization of its clinical and research initiatives, an acceleration of discussions related to potential strategic corporate and program-based partnerships, and a restructuring of operations to support a streamlined set of priorities.

Key Points: 
  • We are also accelerating strategic and collaborative discussions at both the corporate level and for specific clinical candidates and engEx platform programs, said Douglas E. Williams, Ph.D., President and CEO of Codiak.
  • Codiak announced last month a new partnership with CEPI (Coalition for Epidemic Preparedness Innovations) to advance its exoVACC pan betacoronavirus program.
  • Codiaks team will continue to advance this program toward generation of in vivo proof-of-concept data later this year.
  • I would like to personally thank every Codiak employee for their trailblazing work, particularly those who are impacted by todays announcement.

Clover’s COVID-19 Booster Vaccine Candidate Demonstrates Robust Neutralization of Dominant Omicron BA.5

Retrieved on: 
Tuesday, August 30, 2022
LINK, European Medicines Agency, COVID-19, Public health, Vaccination, Development, GMT T1XX platform, Vaccine, National Medical Products Administration, Omicron, Coalition, Aluminium, CEPI, Severe acute respiratory syndrome coronavirus 2, GLOBE, CpG, Therapy, Population, World, Epidemic, SCB-2019, 1018, Forward-looking statement, Coalition for Epidemic Preparedness Innovations, World Health Organization, Pharmaceutical industry, Clover, Trimer

SHANGHAI, China, Aug. 30, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutics, today announced positive Phase 2/3 clinical trial data demonstrating that its lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), elicited a robust immune response to Omicron BA.5 subvariant, the dominant SARS-CoV-2 variant circulating globally today, building upon previously announced results for neutralization against Omicron BA.2 [LINK] and BA.1 [LINK]. This new positive data adds to the growing body of consistent evidence supporting the potential use of SCB-2019 (CpG 1018/Alum) as a universal COVID-19 booster vaccine to address the variant of SARS-CoV-2 most relevant today.

Key Points: 
  • It builds upon the full breadth of our development of SCB-2019 (CpG 1018/Alum) as a universal booster demonstrating broad neutralization against the most current Omicron lineages and all Variants of Concern to date.
  • In this Phase 2/3 trial, a homologous booster dose of SCB-2019 (CpG 1018/Alum) in individuals who previously received two doses of SCB-2019 (CpG 1018/Alum) induced a robust and rapid neutralizing antibody immune response (using validated live SARS-CoV-2 virus neutralization assays).
  • Together, this data supports the potential of SCB-2019 (CpG 1018/Alum) as a broadly neutralizing vaccine against divergent lineages of the Omicron variant.
  • Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavaxs (Nasdaq: DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

Clover Announces Positive Phase 2/3 Results in Adolescents for its COVID-19 Vaccine

Retrieved on: 
Thursday, August 25, 2022
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SHANGHAI, China, Aug. 25, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced positive data from a global Phase 2/3 trial evaluating Clover's COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), in adolescents (aged 12 to 17 years). The study successfully met the primary endpoint and demonstrated that vaccination with SCB-2019 (CpG 1018/Alum) elicited approximately 2-fold higher neutralizing antibody titers in adolescents compared to young adults (aged 18 to 25 years), a population where SCB-2019 (CpG 1018/Alum) had previously been demonstrated to be highly protective against COVID-19. Clover plans to submit the data and seek licensure in adolescents from global regulatory authorities, in addition to its ongoing submissions to the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA), and the World Health Organization (WHO) for use in adults and elderly, to broaden the potential use of SCB-2019 (CpG 1018/Alum) across age groups and as a universal COVID-19 booster vaccine.

Key Points: 
  • We are highly encouraged by these positive pivotal Phase 2/3 trial data in adolescents.
  • The Phase 2/3 trial in adolescents enrolled 1,278 participants and evaluated the immunogenicity, safety, and efficacy of SCB-2019 (CpG 1018/Alum) vaccine, administered as 2 doses given 21 days apart.
  • These study results will contribute to the SCB-2019 (CpG 1018/Alum) data package and the licensure pathway for Clovers COVID-19 vaccine candidate in adolescents.
  • Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavaxs (Nasdaq: DVAX) CpG 1018 advanced adjuvant and aluminum hydroxide (alum).

Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot Chikungunya Vaccine Candidate

Retrieved on: 
Thursday, August 18, 2022
FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nausea, Biologics license application, Ageing, Public health, LMIC, Mortality, Genome, Trial of the century, Population, European Medicines Agency, Saint-Herblain, CHIKV, Priority, Rash, Lyme disease, European, Fever, CEPI, Euronext Paris, Marketing, COVID-19, Company, Infection, Program, VLA, Vaccine, Fast track (FDA), Disease, Aedes, Headache, Low, BLA, Nasdaq, Human, MD, Food, File, EMA, Alphavirus, Person, Pharmaceutical industry, Chikungunya

Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease.

Key Points: 
  • Chikungunya is a major public health threat that continues to grow, and no vaccine or specific treatments are currently available for this debilitating disease.
  • This rolling BLA submission is part of the accelerated approval pathway agreed upon with the FDA in 20204.
  • Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
  • VLA1553 is a live-attenuated, single dose investigational vaccine candidate targeting the chikungunya virus, which has spread to over 120 countries.

Codiak BioSciences Reports Second Quarter 2022 Financial Results and Operational Progress

Retrieved on: 
Thursday, August 4, 2022
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CAMBRIDGE, Mass., Aug. 04, 2022 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, today reported second quarter 2022 financial results and recent operational progress.

Key Points: 
  • During the second quarter we made strong progress supporting our approach and making advancements across our pipeline.
  • Total revenues for the quarter ended June 30, 2022, were $13.1 million, compared to $0.9 million for the same period in 2021.
  • Research and development expenses were $12.8 million for the quarter ended June 30, 2022, compared to $15.4 million for the same period in 2021.
  • As of June 30, 2022, Codiak had cash, cash equivalents, and marketable securities of approximately $41.8 million.