DOCSLIB.ORG

Vaxart's Oral Vaccine Is Room Temperature Stable

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Vaxart's Oral Vaccine Is Room Temperature Stable developing The Pill Against COVID-19 Forward-Looking Statement This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop (including enrolling a sufficient number of subjects and manufacturing sufficient quantities of its product candidates) and commercialize its COVID-19 vaccine candidate and preclinical or clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations regarding the timing and nature of future announcements including, those related to clinical trials and results of preclinical studies; Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for coronaviruses; the potential applicability of results seen in our preclinical trials to those that may be seen in human studies or clinical trials; the expected role of mucosal immunity in blocking transmission of COVID-19; and Vaxart’s expectations with respect to the effectiveness of its products or product candidates, including Vaxart’s potential role in mitigating the impact of COVID-19 globally. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials or preclinical studies, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial and preclinical study data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law. 2 Key Investment Highlights Disruptive, Clinically Validated, Oral Vaccine Platform Potential to transform the vaccine ecosystem Completed 12 clinical trials against different 6 viruses Oral, room-temperature stable COVID-19 program May offer the most practical global solution to pandemic Oral convenience, potential superior efficacy due to mucosal immunity, ease of distribution – room temp. stable Pipeline focused on several very large opportunities besides COVID-19 Norovirus, HPV, influenza & RSV Resources to aggressively continue clinical advancement and commercialization Cash: $133M (at end 3Q 2020) 3 Developing a Groundbreaking Solution: Oral Tablet COVID-19 Vaccine Vaccine as a pill + Convenient mode of administration, rapid and painless: no needles, self administration (no appointments, no lines, social distancing) Potentially more protective than injectable vaccines: activates mucosal immunity – the first line of defense, plus multiple immune system mechanisms Ease of distribution and storage, globally: room temperature stable tablet – no cold chain, no needles or devices, no waste Vaxart’s COVID-19 vaccine is the only oral vaccine from a platform with clinical data, and the only mucosal vaccine in the U.S.’s Operation Warp Speed NHP challenge study 4 • VAAST Oral Tablet Vaccine Platform • COVID-19 Oral Tablet Vaccine Program - Vaccine structure and immunogenicity in mice - Protection in hamster challenge study - Advantages in administration and distribution • Pipeline and Management team 5 Proprietary Oral Vaccine Platform : VAAST TM Intestinal Delivery + Targeted Immune Activation ANTIGEN COVID-19 (Disease- Norovirus Room-temperature (25⁰C) stable Specific) Influenza enteric-coated tablets Ad5 TLR3 DELIVERY ADJUVANT VEHICLE (“Vector-Based” (Immune Backbone) Stimulator) VAASTTM: Vector-Adjuvant-Antigen Standardized Technology Manufacturing Adjuvant & Antigen are Co-expressed: Patents with Broad Composition of Standardized Potential Safety, Efficacy Benefits Matter and Method Claims 6 Vaxart’s oral vaccine platform designed to activate the mucosal immune system: the 1st line of defense against airborne viruses such as COVID-19 and flu Protection against Airborne Viruses: Oral vaccine activates immunity in the right places Vaxart’s oral vaccine triggers a broad immune response, activating systemic and mucosal immunity: ✤ Nose ✤ Lungs ✤ Intestine ✤ Mouth Injectable vaccines only activate systemic immunity 7 Efficacy against airborne viruses: Vaxart’s oral flu vaccine protected against illness as well as the leading injectable flu vaccine Phase II clinical trial comparing Vaxart’s oral tablet flu vaccine and Sanofi’s Fluzone injectable flu vaccine Protection Against Illness • Trial Funded by the U.S. Reduction in Illness Rate Biomedical Advanced Research and Development Authority -27% (BARDA) -39% • Results published in January 2020 48% 35% 29% • Compared to those unvaccinated, illness rates were 39% lower in those taking Vaxart’s oral vaccine, and 27% lower in those vaccinated Vaxart Oral Fluzone Placebo with Fluzone Vaccine Liebowitz, et al, Lancet ID, 2020 8 Oral vaccines have the potential for sterilizing immunity against airborne pathogens such as COVID-19 and flu – preventing infection altogether By triggering a strong Protection Against Infection mucosal immunity, Reduction in Infection Rate Vaxart’s oral vaccine has the potential to prevent infection altogether -48% -38% 71% BARDA-funded phase II clinical 44% 37% trial comparing Vaxart’s oral tablet flu vaccine and Sanofi’s Fluzone injectable flu vaccine. P = 0.001 P = 0.009 Vaxart Oral Fluzone Placebo Vaccine Liebowitz, et al, Lancet ID, 2020 Defined by % of subjects shedding 36 hours post challenge to remove pass-through virus 9 Oral vaccine correlate of protection different than injectable Vaxart Fluzone BARDA’s Random Forest Analysis: • IgA ASC most important immunological feature for protection against shedding for the Oral Vaccine • HAI most important feature for protection against shedding for the QIV vaccine Liebowitz, et al, Lancet ID, 2020 10 Safety Profile and Tolerability Comparable to Placebo in Influenza Long-term safety & Flu challenge study tolerability: Any symptoms (solicited) Pain at injection site Tenderness at injection site Placebo 42% 2.8% 2.8% 462 subjects vaccinated (n=36) Oral tablet vaccine (n=72) 29% 2.9% 4.3%* 12 clinical trials Fluzone 36% 13.9% 26.4 (n=72) % 6 different viruses Pain: a key reason for which people don’t like needles * Placebo injection given to those receiving the oral vaccine Source: Liebowitz et al., Lancet Infectious Diseases, Jan 2020 LeadingWith injectable its COVID COVID--19 phase19 vaccine I trial, Vaxart’scandidates VAAST have oral adverse vaccine eventsplatform so severe, entered they arethe administered13th clinical trial along against with Advilthe 7th virus 11 VAAST Oral Vaccine Platform Highlights • Well tolerated clinical vaccine platform • Clinically shown to protect as well as leading
Load more

Recommended publications
  • 28Th WHO Regulatory Update on COVID-19
    28th WHO Regulatory Update on COVID-19 05 February 2021 Key Messages Vaccines are giving us a window of opportunity to bring the pandemic under control. The number of vaccinations globally has now overtaken the number of reported infections. But more than three quarters of those vaccinations are in just 10 countries while around 130 countries, with 2.5 billion people, are yet to start their first vaccination. WHO encourages COVID vaccine manufacturers to share their dossiers with WHO faster and more fully for assessment of emergency use listing. Highlights and main issues • WHO has been tracking virus variants since the beginning of the COVID-19 outbreak. With the emergence of new variants of concern, these efforts have been stepped-up to set up systems to quickly identify and study emerging variants. • WHO is working with relevant stakeholders on a common naming system for variants. The aim is to name variants that have potential impact on severity, on transmission and any that have any impact on diagnostics, therapeutics and vaccines. • On 3 February, COVAX has published an interim distribution forecast to provide information on early projected availability of doses of the Pfizer/BioNTech vaccine in Q1 2021 and the AstraZeneca/Oxford vaccine candidate in first half 2021 to COVAX Facility participants. • On 29 January 201, the EU granted a conditional marketing authorisation, based on a recommendation from the EMA, for the AstraZeneca COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. • The WHO Strategic Advisory Group of Experts (SAGE) on Immunization has issued interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19 in people aged 18 years and older.
    [Show full text]
  • Update on Approved and Candidate COVID-19 Vaccines in the EU
    Update on approved and candidate COVID-19 vaccines in the EU Dr. Marco Cavaleri Head of Biological Health Threats and Vaccines Strategy, EMA An agency of the European Union Outline 1 EMA response to COVID-19 pandemic - milestones 2 COVID-19 vaccines approved in the EU 3 Benefits and risks of COVID-19 vaccines 4 Real world evidence on effectiveness 5 Studies in children 6 Vaccines under review by EMA 7 Adapting COVID-19 vaccines to variants 8 Additional information Classified as public by the European Medicines Agency EMA RESPONSE TO COVID-19 PANDEMIC Milestones in the fight against the pandemic Scientific & regulatory Rapid development & Transparency & mobilisation evaluation outreach Approval: Comirnaty, COVID-19 vaccine Moderna, COVID-19 vaccine AstraZeneca, COVID-19 vaccine Janssen Accelerated development & evaluation procedures WHO declares pandemic COVID-19 Experts’ Task Force Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2020 2021 1 Classified as public by the European Medicines Agency COVID-19 vaccines approved in the EU 4 vaccines authorised in the EU • Comirnaty and Moderna vaccines contain a molecule called messenger RNA (mRNA) with instructions for producing the spike protein from SARS-CoV-2, the virus that causes COVID-19 • The AstraZeneca and Janssen vaccine uses a non-replicating adenovirus as a carrier that has been modified to produce the spike protein from SARS-CoV-2. • The vaccines do not contain the SARS-CoV-2 virus causing COVID-19 itself and cannot cause the disease. Comirnaty COVID-19 Vaccine COVID-19 Vaccine COVID-19 Vaccine (BioNTech/Pfizer) Moderna AstraZeneca Janssen 21 Dec 6 Jan 29 Jan 11 Mar 2 Classified as public by the European Medicines Agency BENEFITS AND RISKS Efficacy of COVID-19 vaccines in trials All COVID-19 vaccines approved in the EU have a positive benefit-risk balance in prevention of COVID-19 disease.
    [Show full text]
  • Vaxart, Inc. Signs Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP
    6/25/2020 Print - Vaxart, Inc. Signs Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP Source: Vaxart, Inc. June 25, 2020 08:00 ET Vaxart, Inc. Signs Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP Enabling Production of A Billion or More COVID-19 Vaccine Doses Per Year Through Large Scale Lyophilization, Tableting and Coating SOUTH SAN FRANCISCO, Calif., June 25, 2020 (GLOBE NEWSWIRE) -- Vaxart, Inc. (“Vaxart” or the “Company”), a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, announced today that it signed a Memorandum of Understanding with Attwill Medical Solutions Sterilflow, LP (AMS) affirming the parties’ intent to establish AMS as a resource for lyophilization development and large scale manufacturing including tableting and enteric coating for Vaxart’s oral COVID-19 vaccine. AMS will be assigning dedicated resources and equipment for the scale up and commercial production of the vaccine upon entering a formal agreement. “We believe AMS’ experience coupled with its ability to manufacture a billion or more doses per year would be a beneficial addition to our group of CDMO partners and enable the large scale manufacturing and ultimate supply of our COVID-19 vaccine for the US, Europe and other countries in need,” said Andrei Floroiu, CEO of Vaxart Inc. “We believe our oral vaccines, generated on our proven platform, have the potential to offer superior protection against airborne viruses such as SARS-CoV-2 by triggering both mucosal and systemic immunity while being administered by a room temperature-stable tablet, an enormous logistical advantage in large vaccination campaigns.” About Vaxart Vaxart is a clinical-stage biotechnology company focused on developing oral tablet vaccines designed to generate mucosal and systemic immune responses that protect against a wide range of infectious diseases and has the potential to provide sterilizing immunity for diseases such as COVID-19.
    [Show full text]
  • Vaccine Formulations for Protection Against Covid-19 Infection
    VACCINE FORMULATIONS FOR PROTECTION AGAINST COVID-19 INFECTION KRISTY M. AINSLIE, Professor and Vice Chair, Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina January 18, 2021 PATH TO SARS-CoV-2 PANDEMIC 2003 2012 2019 Wuhan, China, severe Before 2003 only twelve Severe acute respiratory Middle East respiratory acute respiratory animal or human syndrome coronavirus syndrome coronavirus syndrome coronavirus 2 coronaviruses were (SARS-CoV) (MERS-CoV) (SARS-CoV-2) emerged identified 8096 cases and 774 2,442 cases and 842 >78M cases and >1.7M deaths deaths deaths SARS-CoV-2 likely crossed over from bats at a wet market in Wuhan, although Pangolin’s are also likely a host. Kristy Ainslie, PhD – UNC Eshelman School of Pharmacy – Jan 18, 2021 SARS-CoV-2 BINDS THROUGH SPIKE PROTEIN TO ACE2 RBD: Receptor Binding domain NTD: N-terminal domain CTD: C-terminal domain S protein: Spike protein ACE2: Angiotensin-converting enzyme 2 - Host receptor where spike protein binds Kristy Ainslie, PhD – UNC Eshelman School of Pharmacy – Jan 18, 2021 COVID-19 IMMUNOPATHOLOGY SARS-CoV-2 infection Can include hyper-immune responses is thought to act in • A cytokine storm that leads to immune cell infiltration of the lungs part through antibody- • Alveolar damage can lead to pulmonary failure dependent • Can result in acute respiratory distress syndrome (ARDS) enhancement (ADE). Non-neutralizing antibodies formed after infection or vaccination could lead to enhanced virus uptake in cells. ADE with SARS-CoV- 2 infection has not been characterized in humans. Kristy Ainslie, PhD – UNC Eshelman School of Pharmacy – Jan 18, 2021 Image: Ulrich et al.
    [Show full text]
  • Adenoviral Vector-Based Vaccine Platforms for Developing the Next Generation of Influenza Vaccines
    Review Adenoviral Vector-Based Vaccine Platforms for Developing the Next Generation of Influenza Vaccines Ekramy E. Sayedahmed 1 , Ahmed Elkashif 1, Marwa Alhashimi 1, Suryaprakash Sambhara 2,* and Suresh K. Mittal 1,* 1 Department of Comparative Pathobiology, Purdue Institute for Immunology, Inflammation and Infectious Disease, Purdue University Center for Cancer Research, College of Veterinary Medicine, Purdue University, West Lafayette, IN 47907, USA; [email protected] (E.E.S.); [email protected] (A.E.); [email protected] (M.A.) 2 Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA * Correspondence: [email protected] (S.S.); [email protected] (S.K.M.) Received: 2 August 2020; Accepted: 17 September 2020; Published: 1 October 2020 Abstract: Ever since the discovery of vaccines, many deadly diseases have been contained worldwide, ultimately culminating in the eradication of smallpox and polio, which represented significant medical achievements in human health. However, this does not account for the threat influenza poses on public health. The currently licensed seasonal influenza vaccines primarily confer excellent strain-specific protection. In addition to the seasonal influenza viruses, the emergence and spread of avian influenza pandemic viruses such as H5N1, H7N9, H7N7, and H9N2 to humans have highlighted the urgent need to adopt a new global preparedness for an influenza pandemic. It is vital to explore new strategies for the development of effective vaccines for pandemic and seasonal influenza viruses. The new vaccine approaches should provide durable and broad protection with the capability of large-scale vaccine production within a short time. The adenoviral (Ad) vector-based vaccine platform offers a robust egg-independent production system for manufacturing large numbers of influenza vaccines inexpensively in a short timeframe.
    [Show full text]
  • Edição Atualizada Em 30/11/2020
    30 | NOVEMBRO | 2020 Edição atualizada 30 | NOVEMBRO | 2020 Edição atualizada 2020 Ministério da Saúde. Todos os direitos reservados. É permitida a reprodução parcial ou total desta obra desde que citada a fonte e que não seja para venda ou qualquer fim comercial. Venda proibida. Distribuição gratuita. Versão eletrônica disponível em: https://coronavirus.saude.gov.br/ Elaboração, distribuição e informações: MINISTÉRIO DA SAÚDE Secretaria de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde Departamento de Ciência e Tecnologia Esplanada dos Ministérios, Bloco G, Ed. Sede, Sobreloja CEP: 70.058-900 – Brasília/DF Tels.: (61) 3315-7990/9227 Site: www.saude.gov.br/sctie E-mail: [email protected] Supervisão geral: Hélio Angotti Neto – Secretário de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde (SCTIE/MS) Camile Giaretta Sachetti – Diretora do Departamento de Ciência e Tecnologia (Decit/SCTIE/MS) Patrícia de Souza Boaventura - Coordenadora-Geral de Ações Estratégicas em Pesquisa Clínica (CGPCLIN/Decit/SCTIE/MS) Priscilla Azevedo Souza – Coordenadora-Geral de Ações Estratégicas em Pesquisa Clínica - Substituta (CGPCLIN/Decit/SCTIE/MS) Elaboração e organização: Evandro de Oliveira Lupatini – CGPCLIN/Decit/SCTIE/MS Felipe Fagundes Soares – CGPCLIN/Decit/SCTIE/MS Felipe Nunes Bonifácio – CGPCLIN/Decit/SCTIE/MS Glícia Pinheiro Bezerra – CGPCLIN/Decit/SCTIE/MS João Paulo Alves Oliveira – CGPCLIN/Decit/SCTIE/MS Junia Carolina Rebelo dos Santos Silva – CGPCLIN/Decit/SCTIE/MS Karla Andreia Mette Waldrich Tauil –
    [Show full text]
  • The Importance of T-Cell Responses for COVID-19 Vaccines By
    May 2021 KOL Event UNLOCKING THE FULL POTENTIAL OF ORAL VACCINES Forward-Looking Statement This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this presentation regarding Vaxart’s strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “believe,” “could,” “potential,” “expect,” “will” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop and commercialize its product candidates; expected clinical results and trial data (including plans with respect to the proposed COVID-19 vaccine program); Vaxart’s intention to continue its efforts to advance its oral tablet seasonal flu vaccine; Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for mucosal pathogens such as norovirus, flu and RSV, as well as coronaviruses such as SARS, MERS and COVID-19; and Vaxart’s expectations with regard to the vaccination market. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these
    [Show full text]
  • Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines
    Review Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines Carlotta Biagi 1, Arianna Dondi 1,* , Sara Scarpini 1 , Alessandro Rocca 1, Silvia Vandini 2, Giulia Poletti 1 and Marcello Lanari 1 1 Pediatric Emergency Unit, Department of Medical and Surgical Sciences (DIMEC), Sant’Orsola University Hospital, 40138 Bologna, Italy; [email protected] (C.B.); [email protected] (S.S.); [email protected] (A.R.); [email protected] (G.P.); [email protected] (M.L.) 2 Pediatric and Neonatology Unit, Imola Hospital, 40026 Imola (Bologna), Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-051-2144635; Fax: +39-051-2144440 Received: 14 October 2020; Accepted: 10 November 2020; Published: 11 November 2020 Abstract: Respiratory syncytial virus (RSV) is the main cause of acute respiratory tract infections in infants and it also induces significant disease in the elderly. The clinical course may be severe, especially in high-risk populations (infants and elderly), with a large number of deaths in developing countries and of intensive care hospitalizations worldwide. To date, prevention strategies against RSV infection is based on hygienic measures and passive immunization with humanized monoclonal antibodies, limited to selected high-risk children due to their high costs. The development of a safe and effective vaccine is a global health need and an important objective of research in this field. A growing number of RSV vaccine candidates in different formats (particle-based vaccines, vector-based vaccines, subunit vaccines and live-attenuated vaccines) are being developed and are now at different stages, many of them already being in the clinical stage.
    [Show full text]
  • INTERNATIONAL STUDENT COVID VACCINE LIST and COMMUNICATION Dear International Student
    INTERNATIONAL STUDENT COVID VACCINE LIST and COMMUNICATION Dear International Student We have provided a list of Selected Countries to help you find the COVID-19 vaccine you may have already received. Please see the “WHO” list below to find your COVID-19 vaccine, and if it has been APPROVED. And please upload your record following these directions: https://youtu.be/wvBGeRqIMHc If you see that your vaccine HAS NOT yet been approved by “WHO”, you may be required to receive an approved COVID-19 vaccine and upload those records to meet UC campus policy and requirements. Many US Airports are now providing COVID-19 vaccine on-site. Here is a list of several California Airports that you may arriving where you may receive a vaccine IMMEDIATELY upon your entry into the U.S. LAX – Los Angeles https://www.flylax.com/TravelSafely SNA – Orange County https://hoagurgentcare.com/airport/ SFO – San Francisco https://www.flysfo.com/travel-well/vaccination-site-sfo If you have any additional questions or concerns, please call (949)824-2300 for support. THANK YOU for helping to ensure UCI continues to be a SAFE and HEALTHY Campus! Dr Chang INDIA SOUTH KOREA TAIWAN INDONESIA VIETNAM JAPAN Vaccine Vaccine Vaccine Vaccine Vaccine Vaccine Oxford–AstraZeneca Oxford-AstraZeneca Sinovac Sputnik V Pfizer–BioNTech Covishield Pfizer–BioNTech Oxford–AstraZeneca Oxford–AstraZeneca Sinopharm Janssen Sinopharm Moderna Pfizer–BioNTech Moderna Pfizer–BioNTech Moderna Moderna Covaxin Novavax Moderna Johnson & Johnson Oxford–AstraZeneca Sputnik V Novavax Nanocovax Johnson & Johnson Sputnik V COVIVAC Sputnik V CanSino Vabiotech MVC-COV1901 ZyCoV-D Corbevax Covovax .
    [Show full text]
  • Vaxart Expands Intellectual Property Portfolio with U.S. Patent Allowance
    March 7, 2018 Vaxart Expands Intellectual Property Portfolio With U.S. Patent Allowance Issued Claims Cover High Yield Production Process of Phase 2 Antiviral SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vaxart, Inc. (NASDAQ: VXRT) a clinical stage biotechnology company developing oral recombinant vaccines administered by tablet rather than by injection, today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for claims related to the Company's novel manufacturing process for producing hydrazine, a key intermediate in the preparation of teslexivir (BTA074). The new patent, titled "Method for the Synthesis of a Hydrazine that can be Used in the Treatment of the Papilloma Virus," will provide broad protection around the method of synthesis of teslexivir, which allows for greater efficiency and yield in the manufacturing process. "This latest patent is an important addition to our current intellectual property portfolio and its issuance further solidifies the protection around the manufacturing process of our teslexivir program," said Wouter Latour, M.D., president and chief executive officer of Vaxart. "Following the successful completion of our merger with Aviragen, we look forward to continuing to establish Vaxart as a leader in antiviral development, and we are on track to report top-line data from the ongoing Phase 2 trial of teslexivir in the second quarter of 2018." Teslexivir is a topical antiviral agent that is a potent and selective inhibitor of the interaction between two essential viral proteins, E1 and E2, an interaction that is a necessary step for human papillomavirus (HPV) types 6 and 11 DNA replication and thus viral production.
    [Show full text]
  • NOVAVAX, INC. (Exact Name of Registrant As Specified in Its Charter)
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2014 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No. 0-26770 NOVAVAX, INC. (Exact name of Registrant as specified in its charter) 20 Firstfield Road Delaware Gaithersburg, Maryland 20878 22-2816046 (State of incorporation) (Address of principal executive offices) (I.R.S. Employer Identification No.) Registrant’s telephone number, including area code: (240) 268-2000 Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registered Common Stock, Par Value $0.01 per share The NASDAQ Global Select Market Securities registered pursuant to Section 12(g) of the Act: Not Applicable Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No ¨ Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ¨ No x Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
    [Show full text]
  • Partnerships Key to Combating Viral Epidemics
    Partnerships key to combating viral epidemics Global viral threats such as Ebola and Zika have accelerated vaccine developers’ forays into public health and catalyzed new partnership strategies. feature nopparit/iStock/Thinkstock Chris Morrison In 2014, the Ebola epidemic hit West Africa, leaving governments, conducted ten trials across Africa, the United States and Europe; health organizations and biopharma companies scrambling for solu- Janssen published promising phase 1 trial results in April1. tions. As the epidemic escalated, companies partnered to advance Merck’s work in this space also highlights the key role of part- the few available vaccine candidates, none of which had reached nerships. The company evaluated the field from every angle, said clinical trials. “When there’s a public health emergency, you’re looking Gupta, before signing a deal with NewLink Genetics in November for anything,” said Swati Gupta, executive director of public health 2014. Although NewLink is better known for its portfolio of immuno- and scientific affairs for Merck Vaccines. By the time the Ebola oncology candidates, it possessed an Ebola vaccine candidate, outbreak began to ebb in 2015, at least four vaccines had entered rVSV-ZEBOV that was backed by a wealth of data from non-human first-in-human trials (Table 1). primate studies. “There were doses of vaccine already available that No sooner had the Ebola epidemic started to subside, however, were in the freezer,” said Gupta. Merck paid NewLink $30 million up than another infectious disease risk emerged. Zika virus started front, and the biotech received a $20 million milestone payment spreading through South America in 2015, and it is now threaten- when clinical trials began in early 2015.
    [Show full text]