Streptococcus

CDC’s ACIP Unanimously Votes to Provisionally Recommend Use of Merck’s VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) as an Option for Pneumococcal Vaccination in Infants and Children

Retrieved on: 
Wednesday, June 22, 2022

Additionally, the ACIP unanimously voted to include VAXNEUVANCE in the Vaccines for Children program.

Key Points: 
  • Additionally, the ACIP unanimously voted to include VAXNEUVANCE in the Vaccines for Children program.
  • VAXNEUVANCE is contraindicated for individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
  • Serotypes 3, 22F and 33F are responsible for more than a quarter of all invasive pneumococcal disease cases in children.
  • Vaccination of premature infants should be based on the infants medical status and the potential benefits and possible risks.

Affinivax Presents Data for Enhanced Protection Against Serotype 3 in Next-Generation Pneumococcal Vaccine

Retrieved on: 
Tuesday, June 21, 2022

These new data presented by Affinivax reveal that the inclusion of a new conserved pneumococcal fusion protein using our versatile MAPS technology has the potential for next generation MAPS pneumococcal vaccines to enable enhanced protection against this serotype and provide broader coverage to patients.

Key Points: 
  • These new data presented by Affinivax reveal that the inclusion of a new conserved pneumococcal fusion protein using our versatile MAPS technology has the potential for next generation MAPS pneumococcal vaccines to enable enhanced protection against this serotype and provide broader coverage to patients.
  • A highly lethal type 3 pneumococcal invasive disease model was developed to evaluate whether antibodies to the SPP2 protein provide enhanced protection.
  • These data indicate that SPP2 confers synergistic protection in a serotype 3 invasive pneumococcal disease model, where traditional conjugate vaccines fail.
  • The MAPS technology platform enables the inclusion of additional pneumococcal polysaccharides and conserved pneumococcal proteins into next generation MAPS pneumococcal vaccines.

Protara Therapeutics Announces Trials in Progress Poster Presentation for the ADVANCED-1 Trial in NMIBC at the 2022 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Thursday, May 26, 2022

The ADVANCED-1 study is evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC).

Key Points: 
  • The ADVANCED-1 study is evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC).
  • We look forward to continuing to advance this trial and exploring TARA-002s full potential in NMIBC.
  • In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002.
  • Bladder cancer is the 6th most common cancer inthe United States, with NMIBC representing approximately 80% of bladder cancer diagnoses.

Blue Water Vaccines Reports First Quarter 2022 Financial Results and Recent Business Developments

Retrieved on: 
Friday, May 13, 2022

Blue Water Vaccines is a pre-clinical stage biotechnology company developing vaccines against multiple infectious diseases, including influenza, norovirus, rotavirus, and acute otitis media (AOM) from Streptococcus pneumoniae colonization.

Key Points: 
  • Blue Water Vaccines is a pre-clinical stage biotechnology company developing vaccines against multiple infectious diseases, including influenza, norovirus, rotavirus, and acute otitis media (AOM) from Streptococcus pneumoniae colonization.
  • The first quarter of this year had several exciting updates for Blue Water Vaccines, most notably the successful closing of our initial public offering, said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water Vaccines.
  • We continue to advance our transformational vaccine pipeline to address significant global public health challenges and look forward to sharing additional developments throughout the rest of 2022.
  • In February 2022, the Company appointed James Sapirstein, R.Ph., M.B.A. to the Blue Water Vaccines Board of Directors.

Inventprise Inaugurates Manufacturing Facility for High-Capacity Supply of Pneumococcal Conjugate Vaccines

Retrieved on: 
Tuesday, May 10, 2022

Inventprise, a biotechnology company specializing in novel, affordable and impactful vaccines, today announced the inauguration of its new manufacturing facility for high-capacity supply of a 25-valent Pneumococcal Conjugate Vaccine (IVT-PCV-25) for low- and middle-income countries.

Key Points: 
  • Inventprise, a biotechnology company specializing in novel, affordable and impactful vaccines, today announced the inauguration of its new manufacturing facility for high-capacity supply of a 25-valent Pneumococcal Conjugate Vaccine (IVT-PCV-25) for low- and middle-income countries.
  • Bill Gates joined Inventprise leaders and employees to tour the new facility and deliver remarks at the inauguration ceremony.
  • The opening of Inventprises new facility marks an important step forward in increasing the supply of affordable vaccines.
  • IVT-PCV-25 is an investigational pneumococcal conjugate vaccine being developed by Inventprise, in collaboration with non-profit global health organization PATH.

Nabriva Extends Exclusive Agreement to Promote and Distribute SIVEXTRO® (tedizolid phosphate) in the U.S. Through the End of 2026

Retrieved on: 
Thursday, May 5, 2022

Nabriva has been marketing and distributing SIVEXTRO in the United States and certain of its territories as part of an exclusive agreement executed in July 2020 with Merck.

Key Points: 
  • Nabriva has been marketing and distributing SIVEXTRO in the United States and certain of its territories as part of an exclusive agreement executed in July 2020 with Merck.
  • The term of the agreement can be further extended by an additional three-year period, subject to mutual agreement.
  • Ted Schroeder, Chief Executive Officer of Nabriva, commented, We are excited to announce the extension of our agreement with Merck to promote and distribute SIVEXTRO for at least an additional three years.
  • This is a testament to our successful and collaborative relationship with Merck, and our strong commercial performance with SIVEXTRO.

Merck Announces U.S. FDA has Granted Breakthrough Therapy Designation for V116, the Company’s Investigational 21-Valent Pneumococcal Conjugate Vaccine, for the Prevention of Invasive Pneumococcal Disease and Pneumococcal Pneumonia in Adults

Retrieved on: 
Thursday, April 14, 2022

Full results from the V116-001 study are planned for presentation at the upcoming International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in June.

Key Points: 
  • Full results from the V116-001 study are planned for presentation at the upcoming International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in June.
  • V116 is specifically designed to address strains of disease-causing pneumococcal bacteria that are most prevalent in adults, reflecting our population-specific approach to developing pneumococcal conjugate vaccines.
  • The Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of products intended for serious or life-threatening conditions.
  • 1Centers for Disease Control and Prevention, IPD serotype data 2019, as compiled from data provided through Active Bacterial Core surveillance (ABCs).

ProBioraKids®, the First Probiotic Specially Formulated to Support Kids' Oral and Overall Health, Launches in the U.S.

Retrieved on: 
Monday, April 4, 2022

TAMPA, Fla., April 4, 2022 /PRNewswire/ -- Caries, also known as cavities or tooth decay, is one of the most common yet preventable childhood diseases. According to the Centers for Disease Control and Prevention (CDC), 52 percent of U.S. kids have experienced a cavity by age eight, and 90 percent of people age 20+ have experienced one or more cavities.

Key Points: 
  • To best support their oral health, kids also need to repopulate the "good bacteria" native to the mouth, helping to fight against the pathogenic bacteria brushing and flossing can't reach.
  • Only by fighting the harmful bacteria and adding back in the good bacteria is a child's oral health best supported.
  • When taken daily, the good bacteria in ProBiora helps to rebalance the mouth's oral biome, which leads to improved oral health.
  • The ProBiora line of oral-care probiotics is the original dental probiotic clinically designed specifically for oral health.

Vaxcyte Doses First Participants in Phase 2 Portion of Ongoing VAX-24 Phase 1/2 Clinical Proof-of-Concept Study in Adults

Retrieved on: 
Monday, April 4, 2022

SAN CARLOS, Calif., April 04, 2022 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, announced today that the first participants were dosed in the Phase 2 portion of its ongoing Phase 1/2 clinical study evaluating VAX-24 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults. The initiation of the Phase 2 portion of the study in healthy adults 50 to 64 years of age occurred after the independent Data Monitoring Committee completed a prespecified review of Phase 1 safety and tolerability data and recommended that the study progress as planned. The Company expects to announce topline safety, tolerability and immunogenicity results from both the Phase 1 and Phase 2 portions of the VAX-24 study by the end of 2022.

Key Points: 
  • The Company expects to announce topline safety, tolerability and immunogenicity results from both the Phase 1 and Phase 2 portions of the VAX-24 study by the end of 2022.
  • Moving forward with the larger Phase 2 portion of the VAX-24 Phase 1/2 study is an exciting step toward delivering potential clinical proof-of-concept data for our lead, 24-valent PCV candidate, said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte.
  • The VAX-24 Phase 1/2 clinical proof-of-concept study is a randomized, observer-blind, dose-finding, controlled study designed to evaluate the safety, tolerability and immunogenicity of VAX-24 in healthy adults (NCT05266456).
  • Readers should not rely upon the information in this press release as current or accurate after its publication date.

Protara Therapeutics Doses First Patient in ADVANCED-1 Phase 1 Study of TARA-002 in Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Thursday, March 24, 2022

In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002.

Key Points: 
  • In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002.
  • Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses.
  • NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.
  • Protara is committed to identifying and advancing transformative therapies for people with cancer and rare diseases with limited treatment options.