CyanVac LLC | MedPath

Blue Lake Biotech's Intranasal RSV Vaccine Shows Promise in Pediatric Trial

5 months ago

• Blue Lake Biotechnology's BLB201, an intranasal RSV vaccine, demonstrated an 80% reduction in symptomatic RSV infections in infants and young children compared to placebo. • The Phase 1/2a trial (NCT05655182) reported no vaccine-related medically-attended adverse events or serious adverse events, highlighting the vaccine's safety profile. • BLB201 elicits mucosal and cellular immune responses, suggesting a distinct mechanism of protection compared to traditional injectable RSV vaccines. • The ongoing study is set to enroll up to 137 participants, with continued monitoring for safety, tolerability, immunogenicity, and symptomatic RSV infection rates.

CyanVac's Intranasal COVID-19 Vaccine Candidate, CVXGA, Enters Phase 2b Trial

5 months ago

• CyanVac's CVXGA, an intranasal COVID-19 vaccine, has dosed its first participant in a Phase 2b clinical study. • The trial, supported by Project NextGen, will compare CVXGA to an FDA-approved mRNA vaccine targeting the Omicron KP.2 variant. • Approximately 10,000 adults will be enrolled, with initial safety data reviewed before broader enrollment proceeds. • The study will assess CVXGA's efficacy in preventing symptomatic and asymptomatic SARS-CoV-2 infections over 12 months.

Blue Lake and CyanVac's Intranasal COVID-19 Vaccine Shows Promise in Phase 2a Trial

6 months ago

• Blue Lake and CyanVac reported positive Phase 2a clinical trial data for their intranasal COVID-19 vaccine candidate, CVXGA, demonstrating safety and efficacy. • The trial showed a 78% reduction in the risk of symptomatic COVID-19 infection in participants who received CVXGA compared to the placebo group. • CVXGA induced S-protein specific serum antibody responses in both younger (18-64 years) and older adults (65+ years), with good tolerability. • The PIV5-vectored vaccine showed no significant difference in adverse reactions compared to placebo, suggesting a safe and well-tolerated profile.

FDA Approves Pfizer's Abrysvo RSV Vaccine for Adults 18-59 at Increased Risk

7 months ago

• The FDA has approved Pfizer's Abrysvo vaccine for adults aged 18-59 at increased risk of RSV-related lower respiratory tract disease (LRTD). • Abrysvo is now the only RSV vaccine approved for this younger adult population, expanding its existing indications for older adults and pregnant women. • The approval was based on data from the Phase 3 MONeT trial, which demonstrated the vaccine's safety, tolerability, and immunogenicity in at-risk adults. • Common side effects in adults aged 18-59 include pain at the injection site, muscle pain, joint pain, and nausea, consistent with previous studies.

Blue Lake and CyanVac Present Promising Intranasal Vaccine Data at ISV Annual Congress

7 months ago

• Blue Lake Biotechnology and CyanVac presented positive interim Phase 1/2a data for BLB201, an intranasal vaccine candidate against respiratory syncytial virus (RSV), in RSV-seropositive children. • Phase 1 data for CVXGA, the companies’ intranasal vaccine candidate against COVID-19, demonstrated systemic and mucosal antibody responses and T cell-mediated responses. • Preclinical data on a PIV5-based vaccine for Lyme disease, a collaboration with Immuno Technologies, showed protection against multi-strain _Borrelia burgdorferi_ in mice.