Carditis

Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

Retrieved on: 
Monday, August 8, 2022
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The randomized, placebo-controlled, Phase 3 VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older.

Key Points: 
  • The randomized, placebo-controlled, Phase 3 VALOR study is planned to enroll approximately 6,000 participants 5 years of age and older.
  • As per the terms of the collaboration agreement between Pfizer and Valneva, Pfizer will make a $25 million milestone payment to Valneva upon initiation of the Phase 3 study.
  • VLA15 is the only Lyme disease vaccine candidate currently in clinical development.
  • This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.

Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15

Retrieved on: 
Monday, June 20, 2022
Heart, Fever, FDA, Fatigue, Senior, COVID-19, Arthralgia, Safety, Science, Erythema migrans, Vaccine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Arthritis, News, Company, Myalgia, Carditis, Euronext Paris, Human, Fast Track, LinkedIn, Infection, Saint-Herblain, Global Health, Disease, Joint, Vaccination, BLA, YouTube, VLA, Program, Bacteria, PFE, Nasdaq, Partnership, Borrelia burgdorferi, Twitter, Food, Facebook, Biologics license application, Chikungunya, Headache, NYSE, Valneva SE, Nervous system, Pharmaceutical industry, Security (finance), Ixodes, Lyme disease, Pfizer

Valneva is planning to use the proceeds from Pfizers equity investment to support its Phase 3 development contribution to the Lyme disease program.

Key Points: 
  • Valneva is planning to use the proceeds from Pfizers equity investment to support its Phase 3 development contribution to the Lyme disease program.
  • In addition, Valneva and Pfizer updated the terms of their collaboration and license agreement which they announced on April 30, 20201.
  • Valneva will now fund 40% of the remaining shared development costs compared to 30% in the initial agreement.
  • Pfizer will pay Valneva tiered royalties ranging from 14% to 22%, compared to royalties starting at 19% in the initial agreement.

Valneva and Pfizer Enter into an Equity Subscription Agreement and Update Terms of Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15

Retrieved on: 
Monday, June 20, 2022
Science, Biotechnology, Research, Pharmaceutical, Health, Infectious Diseases, Clinical Trials, Other Health, Science, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Euronext Paris, LinkedIn, Infection, Disease, BLA, Clinical trial, PFE, U.S. Securities and Exchange Commission, Chikungunya, Nervous system, Time, Heart, Fever, Patent, Arthralgia, News, Fast Track, Vaccination, YouTube, VLA, Intention, Bacteria, Nasdaq, Twitter, FDA, Fatigue, COVID-19, Achievement, Myalgia, Carditis, Global Health, Joint, Biologics license application, Multimedia, NYSE, Risk, Senior, Safety, Erythema migrans, Vaccine, Arthritis, Company, Human, Research, Program, Partnership, Borrelia burgdorferi, Food, Facebook, Headache, Pharmaceutical industry, Security (finance), Valneva SE, Ixodes, Lyme disease, Pfizer

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15.

Key Points: 
  • Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today announced that they have entered into an Equity Subscription Agreement and have updated the terms of their Collaboration and License Agreement for Lyme disease vaccine candidate VLA15.
  • Valneva is planning to use the proceeds from Pfizers equity investment to support its Phase 3 development contribution to the Lyme disease program.
  • In addition, Valneva and Pfizer updated the terms of their collaboration and license agreement which they announced on April 30, 20201.
  • Pfizer will pay Valneva tiered royalties ranging from 14% to 22%, compared to royalties starting at 19% in the initial agreement.

Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate

Retrieved on: 
Tuesday, April 26, 2022
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Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.

Key Points: 
  • Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.
  • Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial.
  • Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, Lyme disease affects all age groups, but with their affinity for being active outdoors, the pediatric population is at the greatest risk of Lyme disease.
  • In partnership with Pfizer, we are excited to further investigate our VLA15 vaccine candidate, which will hopefully help protect both adults and children against Lyme disease.

Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate

Retrieved on: 
Tuesday, April 26, 2022
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Pediatric population to be included in planned Phase 3 trial expected to start in Q3 2022, subject to regulatory approval

Key Points: 
  • Pediatric population to be included in planned Phase 3 trial expected to start in Q3 2022, subject to regulatory approval
    Saint-Herblain (France) and New York, April 26, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.
  • Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial.
  • Like in adults, the immunogenicity and safety data support a three-dose primary vaccination schedule in pediatric participants in the Phase 3 study.
  • In partnership with Pfizer, we are excited to further investigate our VLA15 vaccine candidate, which will hopefully help protect both adults and children against Lyme disease.

Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate

Retrieved on: 
Friday, February 4, 2022
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These data are consistent with the strong immunogenicity profile observed for this age group in previous Phase 2 studies.

Key Points: 
  • These data are consistent with the strong immunogenicity profile observed for this age group in previous Phase 2 studies.
  • In partnership with Pfizer, we are excited to further investigate this vaccine candidate, which will hopefully help provide protection against Lyme disease for both adults and children.
  • The continued positive data from the VLA15-221 trial support the ongoing development of this vaccine candidate, and we look forward to continuing to work with Valneva to potentially help protect people against Lyme disease.
  • This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.

Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate

Retrieved on: 
Tuesday, September 28, 2021
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Saint-Herblain (France) and New York (United States), September 28, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE), today announced further positive Phase 2 results, including booster response, for Lyme disease vaccine candidate VLA15.

Key Points: 
  • Saint-Herblain (France) and New York (United States), September 28, 2021 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE), today announced further positive Phase 2 results, including booster response, for Lyme disease vaccine candidate VLA15.
  • All participants seroconverted to anti-OspA IgG after the booster dose, meaning Seroconversion Rates (SCRs) were 100% for all OspA serotypes.
  • VLA15 is the only active Lyme disease vaccine candidate in clinical development.
  • Study centers are located in areas where Lyme disease is endemic; volunteers with a prior history of Lyme disease were also enrolled.

Cantargia presents new preclinical data showing unique improvement of heart function in myocarditis using antibody CAN10

Retrieved on: 
Monday, May 10, 2021
Medical specialties, Branches of biology, Heart diseases, Clinical medicine, Interleukins, Myocarditis, Interleukin-1 receptor, Inflammation, Carditis, Eosinophilic myocarditis, Galectin-3

These data demonstrate that the interleukin-1 receptor accessory protein (IL1RAP)-binding antibody CAN10 reduces inflammation and/or fibrosis in several disease models including myocarditis.

Key Points: 
  • These data demonstrate that the interleukin-1 receptor accessory protein (IL1RAP)-binding antibody CAN10 reduces inflammation and/or fibrosis in several disease models including myocarditis.
  • Favorable therapeutic effects were presented using a murine surrogate CAN10 antibody in multiple preclinical models of inflammatory or autoimmune diseases, including myocarditis.
  • In myocarditis, disease development is driven by inflammation and subsequent fibrosis of the myocardium, resulting in deterioration of the cardiac function.
  • CAN10 significantly reduced the development of inflammation and fibrosis in a preclinical model when treatment was given during five weeks after induction of disease.

Kiniksa Announces New England Journal of Medicine Publication of Rilonacept Phase 3 Data in Recurrent Pericarditis and Late-Breaking Science Presentation at American Heart Association Scientific Sessions 2020

Retrieved on: 
Tuesday, November 17, 2020
Medical specialties, Clinical medicine, Medicine, Immunosuppressants, Rilonacept, Pericarditis, Carditis

Additionally, the RHAPSODY data were presented at the late-breaking science session during the American Heart Association (AHA) Scientific Sessions 2020.

Key Points: 
  • Additionally, the RHAPSODY data were presented at the late-breaking science session during the American Heart Association (AHA) Scientific Sessions 2020.
  • The manuscript entitled Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis, is available on The New England Journal of Medicine website with open access for seven days.
  • Data were reported which showed that patients treated with rilonacept experienced a 96% reduction in risk of recurrent pericarditis events.
  • These data suggest that targeted immunomodulation with rilonacept may signal a paradigm shift in the management of patients with recurrent pericarditis.

Kiniksa Pharmaceuticals Announces Collaboration with the Myocarditis Foundation for the Pericarditis Community

Retrieved on: 
Monday, August 5, 2019
Medical specialties, Heart diseases, RTT, Medicine, Clinical medicine, Myocarditis, Pericarditis, Carditis

Kiniksa and the Myocarditis Foundation are working together to raise awareness about pericarditis, an underserved, painful and debilitating autoinflammatory cardiovascular disease.

Key Points: 
  • Kiniksa and the Myocarditis Foundation are working together to raise awareness about pericarditis, an underserved, painful and debilitating autoinflammatory cardiovascular disease.
  • The Myocarditis Foundation is providing information about pericarditis on its website as an educational reference for patients and caregivers.
  • In addition, the Myocarditis Foundation plans to launch a free online interactive community for pericarditis patients and caregivers to support and connect with each other.
  • We are excited to expand our capabilities for patients affected with pericarditis in collaboration with the team at Kiniksa.