Chronic pulmonary heart disease

ATHENS, Ga. & SAN JOSE, Calif.--(BUSINESS WIRE)-- Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company developing parainfluenza virus 5 (PIV5)-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases, today announced preliminary data from the first two cohorts of a Phase 1/2a clinical trial studying BLB201, the company’s investigational vaccine against severe respiratory syncytial virus (RSV) disease. The data show that BLB201 is immunogenic and well tolerated, with no significant safety events reported to date following a single intranasal dose in RSV seropositive children 18-59 months of age. The ongoing trial is currently enrolling both RSV seropositive and RSV seronegative children as young as eight months of age. “Given the challenges of developing an RSV vaccine for children, it is highly encouraging that BLB201, our intranasal RSV vaccine candidate, has been well tolerated in this age group so far,” said Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology. “It is also very exciting to see RSV-specific immune responses to our vaccine in children who have previously been exposed to RSV. We are eager to generate more data in younger children, including infants who have not had prior exposure to RSV, and to develop a highly effective and safe vaccine to protect this vulnerable population from RSV.” Among the initial 10 participants ages 18-59 months who received BLB201 study vaccine in this Phase 1/2a study (NCT05655182), there have been no serious vaccine-related safety signals reported to date. In the five participants who received the higher dose of 107 PFU of BLB201, prominent increases in RSV neutralizing antibody (nAb) responses were observed at four weeks post-vaccination, with 80% having a 3.6- to 57-fold rise in nABs over baseline. RSV-specific mucosal IgA antibody and cellular immune responses were also observed. “For the first time, an RSV vaccine candidate has been shown to generate increases in anti-RSV antibody responses in RSV-seropositive children, suggesting that BLB201 could be effective even in infants who have pre-existing anti-RSV antibodies,” continued Dr. He. “This is particularly encouraging given that the target population of our vaccine includes infants under eight months old who may already have passive immunity to RSV from maternal antibodies or exogenously administered anti-RSV antibodies.” About RSV Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus and one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people, it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, up to 80,000 children under five years old and up to 160,000 older adults are hospitalized per year because of RSV infection in the US, with up to 10,000 deaths each year. While there are approved antibody drugs and a maternal RSV vaccine that can provide passive immunity against RSV to infants, there is no approved vaccine for generating prophylactic immunity against RSV in infants and children. Such a vaccine is needed to fully protect young populations at significant risk from severe RSV disease. About BLB201 BLB201 is an RSV vaccine candidate that is currently in Phase 1/2a clinical testing in children ages eight to 59 months of age. It has received Fast Track designation from the US Food and Drug Administration for the prevention of RSV-associated acute respiratory disease in adults (>60 years) and pediatric populations (<2 years). BLB201 encodes the RSV F protein and uses a proprietary PIV5 vector, which is not known to cause human disease. PIV5 has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. Blue Lake Biotechnology is developing BLB201 as an intranasal vaccine to prevent acute and severe disease associated with RSV infection. Phase 1 clinical trial results demonstrate BLB201's safety and ability to induce antibody and cell-mediated immune responses, positioning it as a promising candidate in the fight against RSV. About CyanVac and Blue Lake Biotechnology CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and durability with few vaccine-related side effects. Learn more at Blue Lake Biotechnology.

Despite the Centers for Disease Control and Prevention warning this year will be potentially dangerous for respiratory illnesses, a third of Americans are not concerned about the threat, according to a new national survey. Despite the Centers for Disease Control and Prevention warning this year will be potentially dangerous for respiratory illnesses, a third of Americans are not concerned about the threat, according to a new national survey by The Ohio State University Wexner Medical Center. The survey found that while the majority of those polled (87%) said they do everything they can to avoid spreading seasonal viruses, one-third think their vaccine decision doesn't affect others and that they don't need vaccines for the flu or COVID-19 if they're not at high risk. "Unfortunately, respiratory viruses can cause really severe and life-changing disease for some people, even among the young and very healthy. The best way to help prevent a virus from really upending your life or others is to get vaccinated. Our vaccines are safe and very effective in preventing you from getting very sick and that's an important outcome," said Megan Conroy, MD, a pulmonologist and critical care specialist at the Ohio State Wexner Medical Center and clinical assistant professor in the College of Medicine. Along with the flu and respiratory syncytial virus (RSV), COVID-19 has become part of the respiratory virus season, resulting in strain on the healthcare system. The CDC projects the total number of hospitalizations will be higher this year than in seasons before the COVID-19 pandemic. "Unfortunately, the flu kills tens of thousands of Americans every year. We get an idea of how bad a respiratory illness season the U.S. will have by looking at what happened in the southern hemisphere where flu season is during our summer. Australia had almost a record setting influenza season. That's concerning and a sign that we may have higher flu numbers than average and certainly higher than in recent years since universal masking has gone by the wayside," Conroy said. Who should get a vaccination When it comes to flu and COVID-19 vaccinations, it's recommended everyone 6 months and older get both vaccines every season with rare exceptions. It's safe to get both at the same time, and clinical trials are underway on whether both vaccines can be combined into a single shot, Conroy said. For RSV, the recommendation is vaccination for adults age 60 and older and those pregnant during weeks 32 through 36 of their pregnancy from September to January, There is a new tool to help protect babies in their first RSV season -- an immunization directly with an antibody to protect from RSV. This is not a vaccine but human-made protein that mimics antibodies that the body naturally makes in response to vaccines. RSV can develop into other conditions like bronchiolitis and pneumonia. A pneumonia vaccination is recommended for adults age 65 or older, those age 5 to 64 who are at increased risk for pneumonia due to chronic heart or lung disease or weakened immune systems and children younger than 5. "Whenever we have more virus in the community, it's likely that we'll also see more bacterial and viral pneumonia, and it can cause severe illness in people of all ages," Conroy said. "Keeping your guard up about respiratory illnesses is important because they're going to be here every year. There are so many things you can do to mitigate the spread of viruses. Get your vaccination, stay home if you're sick, avoid those who are sick and wear a mask if you're going out and not feeling well. All of these things can help prevent you from getting sick or spreading it to others." Two years later, 29-year-old still recovering from COVID-19 Joe James, 29, of Mansfield, Ohio, wasn't concerned about respiratory illness season until he got COVID-19 two years ago. He hadn't gotten the vaccine because he was young and didn't have any pre-existing health problems. For the first few days, it felt like the flu but when he woke up on the seventh day short of breath, he knew something was terribly wrong. He drove himself to the hospital where it was discovered that his oxygen saturation level was in the mid 70s. A normal reading is between 95% and 100% and anything below that is hypoxemia, which can be fatal. "They said 'Who drove you here?' I said 'I drove myself.' I was perplexed by the question because I didn't know what mid 70s meant. I thought I was just a little short of breath. They said 'You shouldn't even be having this full on conversation right now,'" James said. James was admitted to the intensive care unit at a local hospital and life flighted weeks later to Ohio State as his condition continued to deteriorate. He was ventilated, had a thoracotomy (a surgery opening up the chest) and at one point his oxygen saturation level dropped into the teens. "Joe had just about the worst go of it with COVID and to come out on the other side and be alive is really amazing," Conroy said. "It came on really suddenly for him and, unfortunately, he had so many complications including his lungs failing from the COVID pneumonia and really bad bacterial pneumonia that led to an abscess of his lung and complications. His lung took a really, really long time to heal. He spent over 200 days in the hospital before he got home." Two years later, James is still recovering from his illness, using supplemental oxygen and wearing braces on his legs to help him walk after he developed peripheral neuropathy while on the ventilator. "At one point Joe was so weak that he could barely lift his toes or hands and it took a really intense amount of rehab to recover from. Thankfully Joe survived and made it through such a long and terrible journey after COVID," Conroy said. Study results and methodology This study was conducted on behalf of The Ohio State University Wexner Medical Center by SSRS on its Opinion Panel Omnibus platform. The SSRS Opinion Panel Omnibus is a national, twice-per-month, probability-based survey. Data collection was conducted from Oct. 20-23 among a sample of 1,007 respondents. The survey was conducted via web (n=977) and telephone (n=30) and administered in English. The margin of error for total respondents is +/-3.6 percentage points at the 95% confidence level. All SSRS Opinion Panel Omnibus data are weighted to represent the target population of U.S. adults ages 18 or older.

A Phase 1/2a clinical trial is underway in children ages six to 59 months of age ATHENS, Ga. & LOS GATOS, Calif.--(BUSINESS WIRE)-- Blue Lake Biotechnology, Inc., a clinical-stage intranasal vaccine company developing PIV5-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases, announced the publication of positive Phase 1 clinical trial results of its intranasal RSV vaccine candidate BLB201 in Science Advances. Data generated during the first-in-human study of BLB201 showed that BLB201 was well-tolerated and stimulated RSV-specific antibody and cell mediated immune responses in adults ages 33 to 75 years following a single intranasal dose. "In the ever-evolving landscape of vaccine development, our Phase 1 study of BLB201 showcases the potential of the PIV5 vector platform,” said Blue Lake’s chief executive officer, Biao He, Ph.D. “The positive results not only position BLB201 well in the race for an effective RSV vaccine but also pave the way for using the PIV5 platform in developing other novel vaccines. We are excited about the future possibilities and the impact this could have on global health." BLB201 was found to increase RSV-specific serum antibody levels as well as RSV-specific mucosal antibodies following a single dose in adults and elderly, all of whom had evidence of prior exposure to RSV. In addition, administration of BLB201 was associated with increases in RSV F antigen-specific CD8+ cytotoxic T cells as well as Th1 CD4+ T cells (helper T cells), highlighting its potential to provide longer-lasting immunity against RSV. Of all intranasal RSV vaccine candidates that have so far been evaluated in adults, BLB201 has generated the most robust immune responses. The vaccine was well-tolerated. Side effects were generally mild, short-lived and self-limited. "The findings from this phase 1 study of BLB201 represent a significant leap forward in the quest to provide children with a safe and easy to administer vaccine that can provide durable protection,” said Paul Spearman, MD, Professor of Infectious Diseases at Cincinnati Children’s Hospital Medical Center and principal investigator of the study. “We are especially excited to see strong T cell immune responses after intranasal administration, which are important for maintaining long-lasting immunity.” RSV causes significant mortality and morbidity in the elderly and in infants. It has been difficult to develop an RSV vaccine that can be used in both populations, one which can overcome reduced immune responsiveness in the elderly while avoiding safety issues in infants. The Phase 1 results show that BLB201 is a promising intranasal vaccine candidate for the elderly. In addition, since live vaccines are believed to be safer for infant RSV vaccine development (i.e., unlikely to trigger a phenomenon called “enhanced RSV disease”), BLB201 may also be a safe and effective RSV vaccine for infants. To explore this potential, Blue Lake is now actively enrolling a Phase 1/2a study in infants and children between the ages of six to 59 months in the U.S. About BLB201 BLB201 is an RSV vaccine candidate that is currently in Phase 1/2a clinical testing in children ages six to 59 months of age. It has received Fast Track designation from the US Food and Drug Administration for the prevention of RSV-associated acute respiratory disease in adults (>60 years) and pediatric populations (<2 years). BLB201 encodes the RSV F protein and uses a proprietary PIV5 vector, which is not known to cause human disease. PIV5 has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. Blue Lake Biotechnology is developing BLB201 as an intranasal vaccine to prevent acute and severe disease associated with RSV infection. Phase 1 clinical trial results demonstrate BLB201's safety and ability to induce antibody and cell-mediated immune responses, positioning it as a promising candidate in the fight against RSV. About RSV Respiratory syncytial virus (RSV) is a highly contagious and common respiratory virus and one of the leading causes of acute respiratory disease, infecting more than 64 million people worldwide per year. For most people, it causes symptoms similar to the common cold, but for infants, the immunocompromised, people with chronic heart or lung disease, and older adults, it can cause severe illness and be life-threatening. Repeat infections with RSV are believed to be common, so even people who contracted RSV when they were younger adults and healthy can be at risk from RSV infection later in life. According to the Centers for Disease Control, up to 80,000 children under 5 years old and up to 160,000 older adults are hospitalized per year because of RSV infection in the US, with up to 10,000 deaths each year. While there are costly antibody drugs approved for use in infants that provide temporary passive immunity against RSV, there is no approved vaccine for generating prophylactic immunity against RSV. Such a vaccine is needed to protect populations at the highest risk from severe RSV disease, including the elderly as well as infants, to reduce the substantial health and economic burdens of RSV infection in the US and worldwide. About CyanVac and Blue Lake Biotechnology CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and durability with few vaccine-related side effects. Learn more at Blue Lake Biotechnology