Centers for Disease Control & Prevention

RESEARCH TRIANGLE PARK, N.C., Sept. 30, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Department of Health and Human Services (HHS) has awarded BioCryst up to a $69 million contract for the procurement of up to 95,625 doses over a five-year period of RAPIVAB® (peramivir injection) for the treatment of influenza. The contract, awarded by the HHS Office of the Administration for Strategic Preparedness and Response (ASPR), will supply the Center for the Strategic National Stockpile (SNS), the nation’s largest supply of life-saving pharmaceuticals and medical supplies for use in a public health emergency. The contract is structured with a 12-month base ordering period and four optional 12-month ordering periods, which the government can exercise on an annual basis. ASPR has executed the first ordering period for $13.9 million and BioCryst plans to supply 19,125 doses to fulfill this option between now and September 29, 2025. “Since the 2009 H1N1 pandemic, RAPIVAB has been an important component of the U.S. government’s influenza preparedness efforts. As we continue to see emerging changes to circulating influenza viruses, we are pleased to fulfill this order to ensure RAPIVAB remains readily available as a therapeutic option in the event of a potential serious influenza outbreak,” said Dr. Helen Thackray, chief research and development officer of BioCryst. RAPIVAB was originally stockpiled by the U.S. government under an emergency use authorization in 2009 during the H1N1 influenza pandemic. In 2018, the Centers for Disease Control and Prevention awarded the company a $34.7 million contract for the procurement of up to 50,000 doses of RAPIVAB over a five-year period for the SNS, which was completed by BioCryst in 2022. About RAPIVAB® (peramivir injection)RAPIVAB® (peramivir injection) is approved in the United States for the treatment of acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days. It is administered via an intravenous infusion for a minimum of 15 minutes at recommended doses of 600 mg for adults and adolescents and 12 mg/kg for pediatric patients ages six months to 12 years. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit www.rapivab.com to learn more. About BioCryst Pharmaceuticals BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. BioCryst leverages its expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat diseases. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies. For more information, please visit www.biocryst.com or follow us on LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding BioCryst’s plans and expectations for RAPIVAB. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the HHS may purchase smaller quantities of RAPIVAB than currently anticipated, or none at all; BioCryst relies on third-party manufacturers to manufacture RAPIVAB in a timely manner and in accordance with applicable governmental regulations, and any failure of such third-party manufacturers to perform their obligations could impact BioCryst’s ability to supply RAPIVAB pursuant to the HHS procurement contract; and government contracts contain certain terms and conditions, including termination provisions, that subject BioCryst to additional risks. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst’s most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s forward-looking statements. BCRXW Contact:John Bluth+1 919 859 7910jbluth@biocryst.com

VANCOUVER, Canada I August 22, 2024 I BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF ) (“BioVaxys” or the “Company”) highlights the potential of its novel lipid-in-oil delivery platform, DPX™, across multiple infectious disease studies and announces its plans for partnering and further development. BioVaxys’ DPX™ technology (“DPX”) is a patented delivery platform that can incorporate a range of bioactive molecules to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease. Key findings demonstrated in completed infectious disease studies, which are discussed in more detail below include: BioVaxys President and Chief Operating Officer Kenneth Kovan says “With data so compelling and supportive of the value of DPX-based vaccines for infectious diseases, we are seeking various off-balance sheet avenues to support development.  The significant cargo capacity of DPX and the proven ability to package diverse antigens such as that shown with our DPX-SurMAGE multi-antigen cancer vaccine, could also greatly benefit potential partnerships for developing more effective viral vaccines, such as a multivalent mRNA DTP vaccine to address the recognized problem of immunity to the Bordetella pertussis waning over time, or for emerging global diseases such as MPox, where a DPX-mRNA formulation could have significant advantage. This fits well with our strategy of expanding development partnerships with DPX beyond oncology.” 100% of Subjects in a Phase 1 Study Treated with a DPX-based RSV Vaccine Developed Antibodies with Persistent Immune Response DPX™+RSV(A) “DPX-RSV” is BioVaxys’ vaccine candidate targeting the respiratory syncytial virus (RSV) based on a DPX formulation of the SHe peptide of group A RSV.  Results of a Phase 1 study showed that more than nine months after the last vaccination, 15 of 16 participants (93%) who received DPX-RSV demonstrated antigen-specific immune responses. This study evaluated the safety and immune response profile of two doses of DPX-RSV in 40 healthy older adult volunteers (aged 50-64 years) and was well tolerated amongst all study participants, with no SAEs reported.  One of the two doses of DPX+RSV(A) was tested out to one year and 100% of older adults (7/7 immune responders) maintained antigen-specific immune responses one year after receiving a booster dose. After one year, their antibody levels measured were still at peak with no sign of decrease. RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the U.S. Centers for Disease Control and Prevention, each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older. Currently available RSV vaccines including GSK’s Arexvy, Moderna’s mResvia, and Pfizer’s Abrysvo target either the F or G proteins of the virus and provide protection by neutralizing the RSV virus. Clinical measures of efficacy focus on the amount of neutralizing antibodies in the bloodstream. DPX-RSV works differently; it targets the SH viral ectodomain of the RSV virus and, instead of neutralizing the virus, it enables the immune system to recognize and destroy infected cells. BioVaxys has exclusive worldwide licenses on applications that target the SH ectodomain antigen in RSV. The Company is exploring opportunities to out-license this product to potential partners. Animal challenge studies with DPX-Based Anthrax Vaccine Demonstrated 100% Immunity from Single Injection The promise and versatility of the DPX platform for infectious disease applications has been additionally supported by in vivo studies of a DPX formulation targeting anthrax, with a DPX Anthrax vaccine formulation exhibiting 100% immunity following a single injection. In a preclinical study led by the National Institutes of Health, a single intramuscular injection of recombinant B. anthracis -protective antigen (rPA) formulated in the Company’s DPX platform (“DPX-rPA”) was compared in animal models to rPA in alum, and to Biothrax® (anthrax vaccine adsorbed (AVA)), a US Food and Drug Administration approved vaccine that requires five administrations over 12 months with annual boosting to maintain pre-exposure prophylaxis.  Serological analysis of anti-rPA immunoglobulin G and toxin neutralization activity demonstrated higher responses induced by DPX-rPA when compared to rPA in alum.  In rabbit and non-human primate (“NHP”) studies, the DPX-rPA formulation generated an immune response in as little as 14 days after a single immunization, whereas AVA required two immunizations. In the rabbit study, a single injection of DPX-rPA or two injections of AVA conferred 100% protection from a lethal anthrax challenge. Furthermore, in the NHP study, single-dose DPX-rPA was 100% protective against challenge, whereas one primate in the two-dose AVA group and all saline-administered animals succumbed to infection. Anthrax, caused by exposure to aerosolized spores of Bacillus anthracis , remains a very serious biological threat, and is categorized by the Centers for Disease Control and Prevention (CDC) as a Category A biothreat agent, along with botulism, plague, smallpox, tularemia, and viral hemorrhagic fevers posing the greatest risk to national security.  At-risk populations for non-weaponized occupational exposure include those working with infected animals, contaminated animal products or environments such as farmers, veterinarians, livestock handlers, diagnostic laboratory workers, agriculture and wildlife workers, and workers who butcher animals or process meat, hides, hair and wool. The ideal anthrax vaccine would provide rapid protection with a single dose, generate a durable immune response, and have enhanced stability for stockpiling purposes. An anthrax vaccine formulated in DPX™ is expected to provide these characteristics. There are currently no approved anthrax vaccines that can provide single dose, rapid protection. Currently approved anthrax vaccines include Biothrax, which requires multiple doses over the span of a year, and more recently, Cyfendus, which is intended for people with suspected or confirmed inhalational exposure to anthrax and is given in two intramuscular doses over two weeks and must be given together with antibiotics. As the efficacy of Cyfendus for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax, BioVaxys is exploring potential advancement of DPX-rPA with its current preclinical data with the US Dept of Defense, Battelle and other organizations. DPX-rHA for Influenza Achieves Higher Antibody Levels than Alum rHA Vaccine and Protects Against Multiple Flu Strains Most recently, in preclinical influenza studies in a murine model, a single dose of DPX formulated with recombinant hemagglutinin (rHA) was shown to exhibit higher and more durable levels of HA antibodies than Alum+rHA. Alum is the market-standard adjuvant that can increase the immunogenicity of recombinant hemagglutinin (rHA) in influenza vaccines. When combined with rHA, alum can generate anti-HA titers that are 10 times higher than without the alum adjuvant. Additional in vivo studies compared two different strains (Puerto Rico H1N1 and Hong Kong H3N2) of heat inactivated whole influenza virus packaged in DPX (DPX+FLU) compared to Alum + heat inactivated whole influenza virus (Alum+FLU).  One month post vaccination the mice were challenged with both live influenza strains, with the animals that received DPX+FLU having an almost 100% survival 10 days post challenge to both the Puerto Rico H1N1 and Hong Kong H3N2 strains, compared to ~70% survival for mice challenged with Puerto Rico H1N1and receiving Alum+FLU, and <20% survival for mice challenged with Hong Kong H3N2 strain and receiving Alum+FLU. BioVaxys is planning further preclinical studies to evaluate a quadrivalent (four flu strains) DPX formulation. BioVaxys Technology Corp . ( www.biovaxys.com ), registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© “neoantigen” tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological diseases. Through a differentiated mechanism of action, the DPX™ platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. The Company’s clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX™ platform, and is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX™+SurMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX™-RSV for Respiratory Syncytial Virus, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© “neoantigen” tumor cell construct platform for refractive late-stage ovarian cancer. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF ). For more information, visit www.biovaxys.com and connect with us on X and LinkedIn. SOURCE: BioVaxys Technology

GSK CEO Emma Walmsley said she’s confident that, for its RSV vaccine, 2025 “will be a year of growth, and that peak-year sales is secure.” The whole respiratory syncytial virus (RSV) vaccine field took a beating when the Centers for Disease Control and Prevention’s (CDC's) immunization committee doled out a limited recommendation last month. And it’s showing in GSK’s forecast for 2024.GSK on Wednesday took its 2024 vaccine sales projection down by a notch. Rather than high single- to low double-digit percent growth, the British pharma now expects vaccine sales to increase by low- to mid-single-digit percent this year at constant exchange rates.The company’s flagship shingles vaccine Shingrix disappointed in the second quarter. After driving continued growth, Shingrix posted a surprise 5.5% decline year over year during the three months, with its 832 million pounds sterling ($1.07 billion) haul falling 17.9% behind analysts’ expectations.The U.S. market turned out to be the main drag with sales down by 36%. GSK attributed the poor performance to channel inventory reductions, changes in retail vaccine prioritization thanks to new ways pharmacies process reimbursements from payers, and challenges in reaching additional consumers given Shingrix’s already high 37% penetration within its recommended population in the U.S.Based on the second-quarter dip, GSK doesn’t expect Shingrix to grow in 2024. But GSK said Shingrix was not the force driving the lower guidance for vaccines—the “pharmacy structural element” was a one-time shift, and physicians’ enthusiasm remains strong, GSK’s chief commercial officer, Luke Miels, told investors Wednesday during the company’s second-quarter earnings call.Instead, the reduced projection reflects the CDC’s revised recommendations for RSV vaccinations. Back in June, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to limit its policy in the 60-to-74 age group to those with underlying medical conditions that could predispose them to more severe RSV disease, while delaying a decision on the 50-to-59 group despite the FDA’s approval for GSK’s Arexvy earlier, leaving the strongest backing only for people 75 and older.The restrictions shocked the industry as RSV vaccine developers saw their stock prices tumble at the news. Airfinity, a London-based health analytics company, has slashed the RSV market value for seniors in the U.S. from $4.7 billion to $1.7 billion in 2030. But GSK CEO Emma Walmsley, during a Wednesday press conference, said she’s confident that “[20]25 will be a year of growth, and that peak-year sales is secure.” GSK has put Arexvy’s peak annual sales at 3 billion pounds.The new policy comes as RSV vaccines are entering only their second season. GSK’s Arexvy has been competing with Pfizer’s Abrysvo, and Moderna is joining the race with newly FDA-approved mRESVIA.Walmsley pointed out that Arexvy’s 90%-plus efficacy in high-risk individuals is the strongest among existing shots, and that the latest ACIP recommendation has put GSK in a good position.Based on existing contracts, GSK foresees Arexvy will retain market leadership during the 2024-25 season, Miels said. But he declined to offer the exact number of Arexvy’s share. In the previous season, GSK won two-thirds of the market against Pfizer.During Pfizer’s second-quarter call Tuesday, U.S. commercial chief Aamir Malik said the New York pharma has “significantly strengthened” its contracting position for Abrysvo this coming season. He also pointed to the shot’s current needle-free reconstitution kit that doesn’t require to be frozen and thawed.“I will also remind you that there’s many healthcare providers and pharmacies that prefer simplifying their vaccine management by having one vaccine for both older adults and maternal, which only Abrysvo can offer,” Malik said. For GSK’s part, Miels noted that contracts for vaccines are typically constructed for pediatric and adult populations separately. What really counts, Miels said, “is the systems are willing to concentrate on single vaccines and separate them out more vigorously versus push them together.”While GSK has maintained its long-term projection, which Miels said assumes that a booster is required, predicting Arexvy’s third-quarter performance may be difficult, because the CDC has not clarified the criteria for “high-risk” for the 60-to-74 age group.“I think ACIP is going to be very conservative about broader coverage until they’ve got complete clarity in terms of benefit risk,” Miels said.The ACIP has demanded more data, including real-world evidence from surveillance databases, to support RSV vaccines’ benefit-risk profile. GSK has two studies that will assess Arexvy’s efficacy, immunogenicity and safety over three RSV seasons, the company’s R&D chief, Tony Wood, Ph.D., said on the investor call.“We want to see what this product looks like at three years because that is going to have a huge impact on pricing, durability, et cetera, which are all the things—and particularly in European contracts—that payers concentrate on,” Miels said.Beyond Europe and the U.S., GSK has also had “some initial discussions” in China with its newly signed Shingrix partner Chongqing Zhifei Biologics around Arexvy, and the British drugmaker “would very much like to expand the collaboration to include RSV,” Miels said.Despite weaker vaccines performance, GSK still dialed up its full-year guidance for the entire group as its long-acting HIV offerings, new launches in oncology and the COPD inhaler Trelegy continued to perform better than expected. The company now expects sales excluding COVID products to rise between 7% to 9% at unchanged exchange rates, compared with previously between 5% to 7%.