Respiratory Syncytial Virus Infections

Sales of Pfizers new vaccine for respiratory syncytial virus were lower in the third quarter than during the same period last year, but the company pointed to signs of growing market share as reason for confidence in the shots market potential.Between July and September, Abrysvo brought Pfizer $356 million in sales globally, compared to last years total of $375 million, according to third quarter earnings Pfizer reported Tuesday. Revenue across the first nine months was higher, reaching $557 million versus the $375 million last year, because Abrysvo wasnt approved in the U.S. for older adults until the end of May last year.So far, Pfizer has trailed competitor GSK, which has been able to dominate the nascent RSV vaccine market with its shot Arexvy, despite it only winning approval weeks earlier.However, Pfizer said Abrysvos market share has increased, exceeding 50% of shipped volume for the third quarter. Abrysvos slice of vaccinations in the retail setting has also climbed for nine consecutive weeks through mid-October, currently reaching 43%, Pfizer CEO Albert Bourla said in prepared remarks.Both companies are working to expand the number of people eligible for vaccination. Last week, the Food and Drug Administration cleared Abrysvo for use in certain adults aged 18 years to 59 years old who are at higher risk of RSV-related disease. Previously it only had been available for adults 60 years or older, or for pregnant women.On a conference call Tuesday, Pfizers commercial chief Aamir Malik said the company is seeing really good momentum in maternal vaccination. Over the first four weeks of the season, Malik said, Pfizer shipped 56% more units of Abrysvo to obstetricians and gynecologists in health systems than during the same period last year.However, uptake among older adults has been disrupted somewhat by recommendations provided this summer by the Centers for Disease Control and Prevention. The agency narrowed its guidance to urge vaccination most heavily in adults over 75 years old and in those aged 60 to 74 years who are at higher risk.Company executives said the updated guidelines have affected uptake. [Abrysvo vaccinations] are at lower volumes, from a market perspective, than where they were last year,“ said Malik, on Tuesdays call. Malik cited the CDCs recommendation, as well as the timing of COVID vaccination this year.CDC advisers, who have since met again following that recommendation, also havent endorsed expanding their recommendations to adults younger than 60, or recommending previously vaccinated individuals to get another shot.Mikael Dolsten, Pfizers departing chief scientific officer, said Tuesday the company is accumulating evidence on revaccination and suggested that an additional dose might be appropriate after several years.Beyond RSV, Pfizer also talked up its next-generation pneumococcal vaccines that it eventually hopes will replace its top-selling Prevnar 20. One, which covers 25 serotypes of the bacteria that causes disease, is in Phase 2 testing. Another, covering more than 30 serotypes, is in preclinical development.Both shots would provide additional coverage against pneumococcal disease, but Pfizer has competitors. Merck & Co. recently won approval of a 21-valent shot called Capvaxive, while biotechnology company Vaxcyte impressed with early trial data on a rival product. In a note to clients, analysts at Jefferies said Pfizers 25-valent shot might have difficulty competing. '

-- Head-to-head clinical results indicate a potential best-in-class combined efficacy & safety profile of non-adjuvanted bivalent RSV vaccine candidate (SCB-1019) -- -- RSV neutralizing antibodies for Clover's non-adjuvanted SCB-1019 matched GSK's AS01E-adjuvanted AREXVY in older adults, while demonstrating significantly better tolerability compared to AREXVY -- -- Clover plans to initiate clinical trials in 2025 evaluating SCB-1019 in an RSV re-vaccination setting and as part of a respiratory combination vaccine -- SHANGHAI, Oct. 28, 2024 /PRNewswire/ -- Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, today announced positive additional immunogenicity and safety data in older adult & elderly subjects from its Phase Ⅰ trial evaluating SCB-1019 – the company's non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate based on Clover's Trimer-Tag vaccine technology platform – compared head-to-head with GSK's AS01E-adjuvanted RSV vaccine (AREXVY). "We are pleased to announce positive head-to-head clinical data for our non-adjuvanted SCB-1019 RSV vaccine candidate compared to AS01E-adjuvanted AREXVY, indicating our potential best-in-class combined efficacy & safety profile," said Joshua Liang, Chief Executive Officer & Board Director of Clover. "While currently approved protein-based RSV vaccines are safe & effective when given as an initial dose, the ability to re-vaccinate effectively when protection against RSV disease wanes and the prevention of respiratory disease caused by other viruses related to RSV both remain unaddressed & high unmet needs globally. We look forward to evaluating SCB-1019 in an RSV re-vaccination setting and as part of a respiratory combination vaccine in clinical trials in 2025." In the ongoing Phase Ⅰ trial, 70 older adult & elderly subjects were enrolled and received either Clover's SCB-1019, GSK's AREXVY or saline placebo. Preliminary results for immunogenicity and safety for SCB-1019 are summarized below: Immunogenicity Results RSV Neutralizing Antibodies (nAbs): Non-adjuvanted SCB-1019 induced geometric mean titers (GMTs) in RSV-A and RSV-B nAbs that were comparable to AS01E-adjuvanted AREXVY at Day 28, with no statistically significant differences observed. RSV-A nAbs: SCB-1019 induced GMTs in RSV-A nAbs of approximately 30,500 IU/mL, compared to approximately 26,700 IU/mL for AREXVY and approximately 3,300 IU/mL for placebo at Day 28. RSV-B nAbs: SCB-1019 induced GMTs in RSV-B nAbs of approximately 32,000 IU/mL, compared to approximately 37,700 IU/mL for AREXVY and approximately 2,900 IU/mL for placebo at Day 28. RSV-B Specific Antibodies: SCB-1019 (bivalent RSV-A/B) included an approximately 1.5-fold higher trend in antibodies (Geometric Mean Ratio [GMR]) against a potent RSV-B specific neutralization epitope in Site V compared to AREXVY (monovalent RSV-A), based on an exploratory competitive-ELISA assay, indicating the potential for greater and more sustained immunological breadth upon re-vaccination if confirmed in subsequent studies. Safety & Reactogenicity Results Significantly lower rates of local adverse events (AEs) were observed for non-adjuvanted SCB-1019 (16.7%) compared to AS01E-adjuvanted AREXVY (76.7%). SCB-1019 was generally well-tolerated. Local and systemic AEs were generally mild for SCB-1019 and were comparable to saline placebo. No vaccine related serious adverse events (SAEs), adverse events of special interest (AESIs), or AEs leading to discontinuation were observed. Based on these positive Phase Ⅰ trial results, Clover plans to initiate clinical trials in 2025 evaluating SCB-1019 (non-adjuvanted bivalent RSV-A/B vaccine candidate) utilized in an RSV re-vaccination setting and as part of a respiratory combination vaccine. About Clover Clover Biopharmaceuticals is a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. With integrated research and development, manufacturing and commercial capabilities as well as strong partnerships with organizations globally, Clover has a diverse pipeline of candidates that have the potential to meaningfully reduce the burden of vaccine-preventable diseases—and to make more diseases preventable.  Clover Forward-looking Statements This press release contains certain forward-looking statements and information relating to us and our subsidiaries that are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used, the words "aim," "anticipate," "believe," "could," "estimate," "expect," "going forward," "intend," "may," "might," "ought to," "plan," "potential," "predict," "project," "seek," "should," "will," "would" and the negative of these words and other similar expressions, as they relate to us or our management, are intended to identify forward-looking statements. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. We give no assurance that these expectations and assumptions will prove to have been correct. Because forward-looking statements relate to the future, they are participant to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. We caution you therefore against placing undue reliance on any of these forward-looking statements. Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time. Clover Biopharmaceuticals: Corporate Communication: Lola Cao [email protected] Investor Relations: Michael Tu [email protected] SOURCE Clover Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BRISBANE, Australia & CAMBRIDGE, MA, USA I October 28, 2024 I Vaxxas , a clinical-stage biotechnology company commercializing a novel high-density microarray patch (HD-MAP) vaccination platform , today announced that the United States National Institutes of Health (NIH) has granted the company a license to a next-generation vaccine antigen (DS2), designed for use in prophylactic vaccines against Respiratory Syncytial Virus (RSV). Vaxxas’ worldwide license from the NIH enables the company to create the first needle-free, room-temperature stable RSV vaccine to enter clinical studies. The next-generation DS2 RSV vaccine antigen licensed by Vaxxas was developed by scientists at the NIH’s Vaccine Research Center and the National Institute of Allergy and Infectious Diseases to prompt a more robust and durable immune response against RSV compared to the antigen used in currently approved vaccines (DS-Cav1). “ Published preclinical results show the potential immunogenic advantages of this next-generation antigen as the basis for an RSV vaccine that could offer more robust and durable protection against the virus, compared to vaccines already on the market,” David L. Hoey, President and CEO of Vaxxas, said. “These advantages, coupled with our needle-free technology’s potential to eliminate the need for refrigerated distribution and enable self-administration, could offer a vaccine that makes a significant impact on the way we protect populations against this serious respiratory infection in the future.” Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialization, with five successful Phase I clinical trials involving more than 500 participants completed, including a second-generation COVID-19 vaccine candidate, a HD-MAP delivered flu vaccine showing greater immunogenicity than the approved injectable vaccine comparator, and a measles and rubella vaccine. With funding from the United States Biomedical Advanced Research and Development Authority (BARDA), the company is currently conducting its first U.S. IND-enabled Phase I clinical study for a pre-pandemic influenza vaccine involving 258 participants. Vaxxas plans to progress its needle-free HD-MAP/RSV vaccine to a Phase I clinical study after completing preclinical development of the product. About Respiratory Syncytial Virus (RSV) RSV is a common contagious virus affecting the lungs and breathing passages. The global burden of RSV is substantial, causing an estimated 33 million acute lower respiratory infection episodes per year, resulting in an estimated 3.6 million RSV-related hospitalizations and over 101,400 RSV-related deaths annually. RSV contributes substantially to morbidity and mortality burden globally in children aged 0-60 months, especially during the first six (6) months of life. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure which can lead to severe outcomes, such as pneumonia, hospitalization, and death. The 2023 approval of the world’s first RSV vaccines in the US and Europe, GSK’s AREXVY and Pfizer’s ABRYSVO, was a significant milestone in addressing the grave unmet medical needs associated with RSV. About HD-MAP needle-free vaccines The Vaxxas HD-MAP is comprised of thousands of microscopic projections molded into a small patch. Each microprojection is coated with a small dose of vaccine in a dried formulation. When applied to the skin using a proprietary, easy to use applicator, the patch delivers the vaccine to the abundant immune cells that naturally reside immediately below the skin surface. HD-MAP vaccine delivery offers many potential benefits over more traditional ways of administering vaccines. For example, the dried form of the vaccine is more stable at higher temperatures than vaccines in liquid formulations, therefore potentially reducing the need for cold-chain storage and distribution. Vaxxas’ HD-MAPs have proven safe and tolerable in hundreds of trial participants to date , and have been shown to induce equal or greater immune responses to injected vaccines at lower doses. Compared with needle and syringe systems, HD-MAP vaccines are also much easier to administer and are likely to have greater acceptability by healthcare workers and patients/subjects. Ultimately, HD-MAPs could enable a future in which vaccine patches could be shipped directly to peoples’ homes, workplaces, and schools, avoiding the delay, inconvenience, and safety challenges associated with traditional needle-and-syringe vaccine scheduling and administration. About Vaxxas Vaxxas is a privately held biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary HD-MAP. Vaxxas is targeting initial applications in infectious diseases and oncology. With success in several completed human clinical trials involving more than 500 participants; additional ongoing Phase I clinical studies for seasonal influenza and COVID-19; and other vaccine studies targeting pandemic influenza, funded by the United States Biomedical Advanced Research and Development Authority (BARDA), Vaxxas’ HD-MAP vaccine delivery platform is advancing toward commercialization. Vaxxas’ core technology was initially developed at The University of Queensland (UQ), and the company was established as a start-up in 2011 by UQ’s commercialization group UniQuest. The company was founded with the completion of an initial equity financing led by OneVentures Innovation Fund I with co-investors Brandon Capital Partners and US-based HealthCare Ventures, followed by a further financing led by OneVentures with UQ joining the most recent financing. OneVentures Innovation Fund I and Brandon BioCatalyst are supported by the Australian Government’s Innovation Investment Fund (IIF) program. The IIF is an Australian Government venture capital initiative that provides investment capital and managerial expertise through licensed venture capital fund managers to investee companies. Learn more at OneVentures and Brandon Capital . SOURCE: Vaxxas