A Phase 2, Randomized, Double Blind, Multicenter Study to Evaluate the Immunogenicity,Reactogenicity and Safety of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers. - BBV154 INTRANASAL PHASE 2 STUDY

Start Date13 Sep 2023

Sponsor / Collaborator

Bharat Biotech International Ltd.

NCT05567471 / CompletedPhase 3

Phase 3, Randomized, Multi-Centric, Open-labeled Study to Evaluate Immunogenicity and Safety of BBV154 Booster Dose in Participants Previously Vaccinated With EUA Vaccines

A total sample size of 875 healthy volunteers ages ≥18 years will be recruited in this study in the ratio of 2:1:2:1:1.
Group 1: (BBV154 in COVAXIN recipients): In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine in form of drops (0.5 mL) via intranasal route, in individuals previously vaccinated with COVAXIN.
Group 2: (BBV152(COVAXIN) in COVAXIN recipients): In this group, 125 participants will be recruited and administered with a booster dose of BBV152 vaccine, in individuals previously vaccinated with COVAXIN.
Group 3: (BBV154 in COVISHIELD recipients) In this group, 250 participants will be recruited and administered with a booster dose of BBV154 vaccine, in individuals previously vaccinated with COVISHIELD.
Group 4: (BBV152(COVAXIN) in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of BBV152 (COVAXIN) vaccine, in individuals previously vaccinated with COVISHIELD.
Group 5: (COVISHIELD in COVISHIELD recipients) In this group, 125 participants will be recruited and administered with a booster dose of Covishield vaccine, in individuals previously vaccinated with COVISHIELD.

Start Date26 Feb 2022

Sponsor / Collaborator

Bharat Biotech International Ltd.

CTRI/2022/02/040065 / CompletedPhase 3

A Phase III randomized open label multi-center study to compare immunogenicity and safety of BBV154 with COVAXINÂ®, and to assess Lot to Lot Consistency of BBV154 in Healthy Volunteers - BBV154-Phase III

Start Date15 Feb 2022

Sponsor / Collaborator

Bharat Biotech International Ltd.

100 Clinical Results associated with iNCOVACC

100 Translational Medicine associated with iNCOVACC

100 Patents (Medical) associated with iNCOVACC

Literatures (Medical) associated with iNCOVACC

04 May 2023·bioRxiv : the preprint server for biology

A bivalent ChAd nasal vaccine protects against SARS-CoV-2 BQ.1.1 and XBB.1.5 infection and disease in mice and hamsters.

Author: Harastani, Houda ; Soudani, Nadia ; Bricker, Traci ; Desai, Pritesh ; Kashentseva, Elena A ; Curiel, David T ; Schmidt, Aaron G ; Dmitriev, Igor P ; Liang, Chieh-Yu ; Diamond, Michael S ; Darling, Tamarand L ; Boon, Adrianus C M ; Ying, Baoling

We previously described a nasally delivered monovalent adenoviral-vectored SARS-CoV-2 vaccine (ChAd-SARS-CoV-2-S, targeting Wuhan-1 spike [S]; iNCOVACC^®) that is currently used in India as a primary or booster immunization. Here, we updated the mucosal vaccine for Omicron variants by creating ChAd-SARS-CoV-2-BA.5-S, which encodes for a pre-fusion and surface-stabilized S protein of the BA.5 strain, and then tested monovalent and bivalent vaccines for efficacy against circulating variants including BQ.1.1 and XBB.1.5. Whereas monovalent ChAd-vectored vaccines effectively induced systemic and mucosal antibody responses against matched strains, the bivalent ChAd-vectored vaccine elicited greater breadth. However, serum neutralizing antibody responses induced by both monovalent and bivalent vaccines were poor against the antigenically distant XBB.1.5 Omicron strain and did not protect in passive transfer experiments. Nonetheless, nasally delivered bivalent ChAd-vectored vaccines induced robust antibody and spike-specific memory T cell responses in the respiratory mucosa, and conferred protection against WA1/2020 D614G and Omicron variants BQ.1.1 and XBB.1.5 in the upper and lower respiratory tracts of both mice and hamsters. Our data suggest that a nasally delivered bivalent adenoviral-vectored vaccine induces protective mucosal and systemic immunity against historical and emerging SARS-CoV-2 strains without requiring high levels of serum neutralizing antibody.

15 Dec 2022·The Journal of clinical investigation

Stabilized recombinant SARS-CoV-2 spike antigen enhances vaccine immunogenicity and protective capacity

Article

Author: Dulovic, Alex ; Rohde, Cornelius ; Tscherne, Alina ; Mayer, Leonie ; Beythien, Georg ; Volz, Asisa ; Becker, Stephan ; Fathi, Anahita ; Addo, Marylyn M ; Ciurkiewicz, Malgorzata ; Kupke, Alexandra ; Fendel, Rolf ; Dahlke, Christine ; Esen, Meral ; Klug, Martha ; Armando, Federico ; Baumgärtner, Wolfgang ; Schwarz, Jan H ; Limpinsel, Leonard ; Meyer Zu Natrup, Christian ; Jany, Sylvia ; Schünemann, Lisa-Marie ; Halwe, Sandro ; Freudenstein, Astrid ; Schneiderhan-Marra, Nicole ; Shin, Dai-Lun ; Clever, Sabrina ; Kalodimou, Georgia ; Sutter, Gerd ; Kremsner, Peter ; Weskamm, Marie L ; Brosinski, Katrin ; Tuchel, Tamara

The SARS-CoV-2 spike (S) glycoprotein is synthesized as a large precursor protein and must be activated by proteolytic cleavage into S1 and S2. A recombinant modified vaccinia virus Ankara (MVA) expressing native, full-length S protein (MVA-SARS-2-S) is currently under investigation as a candidate vaccine in phase I clinical studies. Initial results from immunogenicity monitoring revealed induction of S-specific antibodies binding to S2, but low-level antibody responses to the S1 domain. Follow-up investigations of native S antigen synthesis in MVA-SARS-2-S-infected cells revealed limited levels of S1 protein on the cell surface. In contrast, we found superior S1 cell surface presentation upon infection with a recombinant MVA expressing a stabilized version of SARS-CoV-2 S protein with an inactivated S1/S2 cleavage site and K986P and V987P mutations (MVA-SARS-2-ST). When comparing immunogenicity of MVA vector vaccines, mice vaccinated with MVA-SARS-2-ST mounted substantial levels of broadly reactive anti-S antibodies that effectively neutralized different SARS-CoV-2 variants. Importantly, intramuscular MVA-SARS-2-ST immunization of hamsters and mice resulted in potent immune responses upon challenge infection and protected from disease and severe lung pathology. Our results suggest that MVA-SARS-2-ST represents an improved clinical candidate vaccine and that the presence of plasma membrane-bound S1 is highly beneficial to induce protective antibody levels.

30 Jul 2022·Mikrobiyoloji bulteni

Humoral Immune Response in Inactivated SARS-CoV-2 Vaccine: When Should a Booster Dose be Administered?

Article

Author: Candevir, Aslihan ; Demirhindi, Hakan ; Kibar, Filiz ; Mete, Burak ; İnaltekin, Ayşe ; Kara, Ertan ; Tanır, Ferdi ; Çetiner, Salih

Vaccination induces the development of long-lasting immunity necessary for a sustained and essential protective antibody response. Understanding how long the humoral immune response induced by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) inactivated vaccine lasts is important to create an effective immunization scheme. This study aimed to detect the first, third, sixth month concentrations and seroconversion rates of the antibodies induced by the inactivated vaccine. The study included 282 healthcare workers who were vaccinated at days 0 and 28 by the inactivated SARS-CoV-2 vaccine (3 μg/0.5ml). Anti-S-RBD-IgG (receptor binding domain) antibody concentrations and seroconversion rates were examined in vaccinated healthcare workers at the first, third and sixth months after the vaccination. MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA) (Snibe Diagnostics, Chinese) kit was used for the detection of antibodies. The mean age of the healthcare workers was 38.93 ± 10.59 (min= 21-max= 64). After the administration of the second vaccine dose, the participants were found to be reactive for anti-SRBD-IgG antibodies by 98.2% and 97.8% at the first and third months, respectively,. The decrease in the mean plasma concentrations of anti-S-RBD IgG was observed as 56.7% in the cohort with only two doses of the vaccine (first month: 42.4 AU/ml versus third month: 18.2 AU/ml). In the cohort with a history of coronavirus disease 2019 (COVID-19) prior to the vaccination, the decrease was observed as 25.1% (first month: 58.29 versus third month: 43.64 AU/ml) and at a mean of 57.4 (0-90) days prior to vaccination, the decrease rate was 43.1% (first month: 55.05 AU/ml versus third month: 31.28 AU/ml), keeping more stable in participants infected at a mean of 183.1 (91-330) days prior to vaccination(a decrease of 5.2%; with 62.34 AU/ml at first and 59.08 AU/ml at third months). At the end of the sixth month, antibodies could not be detected in 16.7% of people who (n= 42) received two doses of the inactivated vaccine, and the amount of anti-S-RDB IgG decreased by an average of 52.5% compared to the third month, and by 74.8% compared to the first month. Antibody concentrations at the first, third, and sixth months after the vaccination with two doses of the inactivated SARS-CoV-2 vaccine were found to be decreased and at the sixth month, the rate of non-reactive people was 16.7%. As participants who had COVID-19 at a mean of 181 (90-330) days before the vaccination presented with a more stable antibody level, it can be concluded that a booster at months 6-12, resulting in a schedule of 0-1-6 months, is recommended for the inactive SARS-CoV-2 vaccination for effective herd immunity.

News (Medical) associated with iNCOVACC

08 Nov 2022

·www.prnewswire.com

Extremely Robust COVID-19 Clinical Trial Pipeline With 420+ Key Companies Expected to Change the Pace of the COVID-19 Treatment

COVID-19 clinical trial pipeline constitutes 420+ key companies continuously working towards developing 520+ COVID-19 vaccines and drugs, analyzes DelveInsight LAS VEGAS, Nov. 8, 2022 /PRNewswire/ -- DelveInsight's ' COVID-19 Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline COVID-19 vaccines in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the COVID-19 competitive domain. Key Takeaways from the COVID-19 Pipeline Report Over 420+ COVID-19 companies are evaluating 520+ COVID-19 pipeline therapies in various stages of development, and their anticipated acceptance in the COVID-19 market would significantly increase market revenue. Leading COVID-19 companies such as Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others are evaluating novel drugs for COVID-19 to improve the treatment landscape. Key COVID-19 pipeline therapies in various stages of development include XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. In October 2022, eFFECTOR Therapeutics announced the completion of enrollment for the second cohort of a three-cohort Phase Ib clinical trial of zotatifin in non-hospitalized adults with confirmed COVID-19 infection. In October 2022, Pfizer/BioNTech and Moderna's bivalent COVID-19 booster vaccines targeting the BA.4 and BA.5 subvariants of Omicron have been approved for use in children and adolescents in the United States. In October 2022, an intranasal formulation of AstraZeneca's widely used COVID-19 vaccine, Vaxzevria, failed at the first hurdle, with results from a phase I trial revealing that it was unable to stimulate a strong immune response to the virus. In September 2022, Bharat Biotech's Covid-19 vaccine candidate codenamed BBV154, which has now been rechristened iNCOVACC became the world's first intranasal Covid-19 vaccine to be granted emergency use authorization (EUA) after the Indian drug regulator approved it for a two-dose primary immunization of those aged 18 years and above. COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III In July 2022, Revive Therapeutics Ltd. is pleased to provide an update on the Company's U.S. Food & Drug Administration ("FDA") Phase III clinical trial (the "Study") (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The Company had unblinded the pre-dose selection data (the "Data") to potentially support the amended Study protocol with the new primary efficacy endpoints. The assigned unblinded statistician team is currently analyzing the Data, and the Company aims to submit the amended Study protocol to the FDA shortly thereafter. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcomes observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization In April 2022, Direct Biologics, FDA approved the company to proceed with its Phase III clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV Company to receive FDA Phase III approval for an Investigational New Drug (IND) indication to date In April 2022, Direct Biologics announced that the US Food and Drug Administration (FDA) had awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. In March 2022, Akston Biosciences Corp and Biolexis, a division of Stelis Biopharma Ltd., entered into a licensing, manufacturing, and commercialization agreement for Akston's AKS-452, a protein subunit COVID-19 vaccine. Biolexis gained the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa, largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence, and established relationships Request a sample and discover the recent advances in COVID-19 treatment @ COVID-19 Competitive Landscape Report COVID-19 Overview Coronavirus disease (COVID-19) is an infectious disease caused by the most recently discovered coronavirus, SARS coronavirus 2. (SARS-CoV-2). COVID-19 causes a respiratory illness similar to the flu. The COVID-19 symptoms include cough, fever, and difficulty breathing. The majority of people infected with the COVID-19 virus will experience mild to moderate respiratory illness and will recover without the need for special care. People over the age of 65 and those with underlying medical conditions such as cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illnesses. When an infected person coughs or sneezes, the COVID-19 virus is primarily transmitted through saliva or nasal discharge droplets. Discover more about COVID-19 testing @ New Treatment for COVID-19 COVID-19 Pipeline Analysis: Drug Profile Sargramostim: Nobelpharma Nobelpharma's drug Sargramostim is a synthetic version of a natural substance produced in the body. It is used to boost the body's production of white blood cells. Sargramostim is given to patients with decreased ability to produce white blood cells. It is also used in some medical procedures (for example, bone marrow/stem cell transplants). It is a supportive medication but does not aid cancer treatment. The product is currently in Phase II/III development for the treatment of COVID-19. Sotrovimab: Vir Biotechnology Vir Biotechnology's Sotrovimab is a monoclonal antibody that neutralizes SARS-CoV-2. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make resistance development more difficult. Sotrovimab, which incorporates Xencor, Inc.'s XtendTM technology, has also been designed to achieve high concentrations in the lungs for optimal penetration into SARS-CoV-2-affected airway tissues and to have an extended half-life. Discover more about the list of FDA-approved drugs for COVID-19 @ Antiviral Drugs for COVID-19 Treatment A snapshot of the COVID-19 Pipeline Drugs mentioned in the report: Learn more about the emerging COVID-19 pipeline therapies @ COVID-19 Clinical Trials Scope of the COVID-19 Competitive Landscape Report Coverage: Global Key COVID-19 Companies: Westvac Biopharma, Xenothera, Windtree Therapeutics, Vir Biotechnology, ViiV Healthcare, Verastem, VBL Therapeutics, Vasomune Therapeutics, Inc., Valneva, Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories, UNION Therapeutics, Trustem, Toscana Life Sciences, Throne Biotechnologies, Thirty respiratory Limited, Theravance Biopharma, TC BioPharm, Syntax for Science, S.L, SyneuRx, Swedish Orphan Biovitrum, Swedish Herbal Institute AB, Stemedica Cell Technologies, Staidson (Beijing) Biopharmaceuticals Co., Ltd, Sound Pharmaceuticals, Sorrento Therapeutics, SolAeroMed, SK Bioscience, Sinovac Biotech Co., Ltd, Sinocelltech, Shenzhen Kangtai Biological Products Co., Ltd., Shaperon, Senhwa Biosciences, Inc., Selva Therapeutics, Archivel Farma, R-Pharm, Rohto Pharmaceutical, Revimmune, Resverlogix Corporation, Restorbio, Resolve Therapeutics, Renibus Therapeutics, ReiThera, Regeneron Pharmaceuticals, RedHill Biopharma, Red de Terapia Celular, Reata Pharmaceuticals, Inc., Qurient Co, Quercis Pharma, PureTech, Pulmotect, PTC Therapeutics, Pluristem Ltd., Pliant Therapeutics, Pharming Technologies B.V., Pharmenterprises, Pharmamel S.L., Pharma Holdings, Pharco Pharmaceuticals, Pfizer, Petrovax, Paion UK Ltd., Ashvattha Therapeutics, Inc. (Orpheris), OPKO Health, Oncotelic Inc., National Resilience, Inc. (Ology Bioservices), Olatec Therapeutics LLC, Novavax, Novartis Pharmaceuticals, Notitia Biotechnologies Company, Noorik Biopharmaceuticals, Nobelpharma, Moderna, Moderna, MetrioPharm, Merck Sharp & Dohme Corp., Merck KGaA, Medicago Inc., Mallinckrodt, Mabwell (Shanghai) Bioscience Co., Ltd., Lifefactors Zona Franca, Leading BioSciences, Kiniksa Pharmaceuticals, Ltd., 3M, 4D Pharma, AbbVie, Apotex, AgelessRx, AgenTus Therapeutics, AiCuris, AlloVir, Apeiron Biologics, Bausch Health Americas, BeiGene, Biotest, Bio-Thera Solutions, Cadila Healthcare Limited, Cellenkos, Cellularity Incorporated, Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, Frontier Biotechnologies, FSD Pharma, Genentech, Inc., Globavir Biosciences, Grand Medical, Grifols Therapeutics LLC, Inotrem, Ionis Pharmaceuticals, Jazz Pharmaceuticals, Kamada, Kiadis Pharma, Medicine Invention, MedRegen LLC, Miltenyi Biomedicine, Natureceuticals Sdn Bhd, NeoImmune Tech, Neutrolis, Ology Bioservices, Oncovir, OPKO Health, Organicell Regenerative Medicine, and others Key COVID-19 Pipeline Therapies: XAV-19, Sinapultide, VIR-7831, Maraviroc, Duvelisib, VB 201, AV-001, VLA2001, T3 solution for injection, UNIKINON, UNI911, Umbilical cord derived mesenchymal stem cells, MAD0004J08, Stem Cell Educator therapy, RESP301, TD-0903, TCB008, Bemiparin, Pentarlandir™ UPPTA, Emapalumab, Kan Jang capsules, hMSC, BDB-001, Ebselen, COVI-DROPS| Placebo, STI-5656, COVI-AMG, PSC-04, S-1226, GBP510, SARS-COV-2 inactivated vaccine, SCTA01, SARS-CoV-2 Vaccine (Vero Cells), Inactivated, NuSepin, Silmitasertib, SLV213, RUTI® vaccine, Olokizumab + RPH-104, Mesenchymal stem cell (ADR-001), CYT107, Apabetalone, RTB101, RSLV-132, RBT-9, GRAd-COV2, REGN-COV2 Antibody Cocktail, ABC 294640, Upamostat, Mesenchymal Stromal Cells, Bardoxolone methyl, Telacebec, IQC-950AN, LYT-100, PUL-042, PTC-299, PLX-PAD, PLN-74809, Conestat alfa, Treamid, Melatonin, LTX-109, Selenium, Ramipril, PF-06650833, Polyoxidonium, Remimazolam, OP-101, Rayaldee, OT-101, ADM03820, OLT 1177, NVXCoV 2373, DFV890, Crizanlizumab, MAS-825, NBT-NM108, Ambrisentan, Sargramostim, Gam-COVID-Vac, mRNA-1283, mRNA-1273, MP1032, Molnupiravir, M5049, Covifenz, INOmax, MW33, COVID-19 convalescent plasma, LB1148, Mavrilimumab, and others. Dive deep into rich insights for drugs for COVID-19 treatment; visit @ COVID-19 Vaccines Table of Contents For further information on the COVID-19 guidelines, reach out @ COVID-19 Treatment Guidelines Related Reports COVID-19 Pipeline COVID-19 Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COVID-19 companies, including Chiesi Farmaceutici S.p.A., Clene Nanomedicine, Codagenix, Debiopharm, Direct Biologics, Eiger BioPharmaceuticals, Emergent Biosolutions, Enlivex Therapeutics, Evergreen Therapeutics, Faron Pharmaceuticals, among others. Common Cold Market Common Cold Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Pipeline Common Cold Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key common cold companies, including Sanotize Research and Development, Orbis Biosciences, Exscientia, EURRUS Biotech, among others. Common Cold Epidemiology Common Cold Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted common cold epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key acute respiratory distress syndrome companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, among others. Chronic Obstructive Pulmonary Disease Market Chronic Obstructive Pulmonary Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic obstructive pulmonary disease companies, including United Therapeutics, Verona Pharma PLC, AstraZeneca, Chiesi Farmaceutici S.p.A., GlaxoSmithKline, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Global Kinase Inhibitor in Autoimmune Diseases Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | Chimeric Antigen Receptor (CAR) T-Cell Therapy Market | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Report | Crows Feet Market | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market | Insulin Glargine Biosimilar Insight Related Healthcare Blogs Increasing COPD Prevalence ARDS Market Outlook Emerging ARDS Therapies About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

VaccineGene TherapyAntibodyBiosimilarCell Therapy

16 Aug 2022

·www.biospace.com

COVID-19: Novavax Seeks EUA for Booster, TB Vaccine may Hold Promise and More

Courtesy of rafapress/Getty Images Entering the third year of the COVID-19 pandemic, it’s clear we’ll have to learn to live with the disease. That said, the biopharma industry is keeping its figurative foot on the pedal with R&D focused on helping us to manage it. Novavax Seeks EUA for COVID-19 Booster Novavax submitted an application to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for its COVID-19 vaccine to be used as a booster shot. The vaccine was granted an EUA in adults 18 and older in July. The submission is based on data from the Phase III PREVENT-19 trial in the United States and Mexico and from the U.K.-sponsored COV-BOOST Phase II study. “It’s important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations,” Stanley C. Erck, president and CEO of Novavax said in a statement. A 100-Year-Old TB Vaccine Might Protect Against COVID-19 Investigators at Harvard Medical School and Massachusetts General Hospital published research showing the potential of multiple doses of the bacillus Calmette-Guerin (BCG) tuberculosis vaccine against COVID-19 and potentially other infectious diseases. They conducted a study in type 1 diabetes patients before COVID-19-specific vaccines were available. 12.5% of people in the placebo cohort had confirmed COVID-19, compared with only 1% of the BCG-treated cohort — meaning vaccine effectiveness of about 92%. The BCG vaccine also offered protection against other infectious diseases and decreased symptoms. It was first introduced in 1921 as an avirulent TB strain of Mycobacterium bovis and is given to about 100 million children around the world every year. It also costs less than a dollar per dose in most parts of the world. Back to School - Without Masks As kids head back to school, most districts have abandoned masking requirements. And in many cases, other public health measures appear to have been left by the wayside. One example is Massachusetts, where the emphasis is on personal responsibility. Even asymptomatic students and staff are not required to quarantine, regardless of vaccination status, though the state does recommend masking for ten days after exposure. “With COVID-19 vaccines now readily available, treatments accessible to those at higher risk, for severe disease, and widespread availability of self-tests, DESE and DPH have continued to evolve our support for schools in collaboration with the medical community and in line with the most recent CDC guidance issued August 11, 2022,” DESE commissioner Jeffrey Riley and DPH commissioner Margret Cooke said. Public Health Officials Struggle with Fall Planning Public health officials in charge of vaccination programs recognize that this fall is going to be complicated. In addition to the usual fall influenza vaccine drives, the U.S. plans to roll out updated COVID-19 boosters. As noted, flu shots typically wane, so people don’t want to get it too early. Although it’s tough for epidemiologists to predict exactly when flu season will peak, they don’t want to recommend flu shots in September, for example, if the peak of flu season will be in February. They have a similar problem with COVID-19 boosters, as people will be considering their third, fourth and even fifth shots when the Omicron-specific bivalent vaccines become available. Yet with two winters of COVID-19, no one knows when another surge will occur, what variant it will be and even if it will happen, since Omicron subvariants have spread effectively through the summer. Claire Hannan, executive director of the Association of Immunization Managers, told STAT News, “I used to think that flu was really challenging. There was never a year that was the same as the previous year. And I think the challenges around supply and trying to plan and optimal planning, they’re very difficult...And throwing COVID boosters into the mix, it just makes it more complicated.” Pfizer’s Bourla Tests Positive for COVID-19 Pfizer’s CEO, Albert Bourla, tested positive for COVID-19 on Monday. He indicated he is experiencing “very mild symptoms.” In a statement, Bourla said, “I would like to inform the public that I have tested positive for COVID-19. I am thankful to have received four doses of the Pfizer-BioNTech vaccine, and I am feeling well while experiencing very mild symptoms. (I) have started a course of Paxlovid.” MediciNova Plans to Test Ibudilast in Long COVID Study MediciNova plans to participate in RECLAIM (Recovering from COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial). This is a grant-funded, multi-center trial. The company intends to evaluate MN-166 (ibudilast) and other drugs for Long COVID. It is collaborating with the University Health Network, an academic health sciences center in Toronto. The study is funded by the Canadian government. Ibudilast is a small molecule that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is being otherwise developed for amyotrophic lateral sclerosis (ALS), multiple sclerosis, degenerative cervical myelopathy, glioblastoma, chemotherapy-induced peripheral neuropathy and substance use disorder. It has also been evaluated in COVID-19 patients at risk for developing acute respiratory distress syndrome. Revive Therapeutics Amends Trial Protocol for COVID-19 Revive Therapeutics reported plans to amend its Phase III trial of Bucillamine in mild to moderate COVID-19. The drug is an oral therapy with anti-inflammatory and antiviral properties. After studying the supporting pre-dose selection data with the unblinded statistician team, it is proposing new primary efficacy endpoints, which it will submit to the FDA for further discussion. The new proposed endpoints may include the time to resolution from COVID-19 via PCR test and the rate of sustained clinical resolution of certain COVID-19 symptoms. Bharat Biotech Submits Intranasal COVID-19 Vaccine Candidate to Regulators India’s Bharat Biotech submitted data from Phase III trials of BBV154, its intranasal COVID-19 vaccine, to India’s drug regulatory body. It is requesting approval for a primary two-dose regiment and a booster dose that could be used with other vaccines. “Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract,” the company stated. “These may provide the potential to reduce infection and transmission. Further studies are being planned.”

VaccineAntibodySmall molecular drugEmergency Use Authorization

10 Sep 2021

·www.biospace.com

Bharat's Intranasal Vaccine Speeds into Phase II on Heels of Strong Data

Bharat Biotech's intranasal COVID-19 vaccine candidate is expected to enter the Phase II portion of a Phase II/III study within the next few weeks. This marks the second vaccine against the novel coronavirus developed by the India-based company. It’s a significant milestone for intranasal formulations. The nod from India’s Health Authority makes Bharat’s BBV154 candidate the first intranasal vaccine in development for COVID-19 in the country. Phase I data from the intranasal formulation, is promising. Not only was the vaccine candidate well-tolerated, but the medication also blocks viral entry into the body. Full details of the study will be presented at a later date. The company has suggested that an intranasal formulation of the vaccine provides a broad immune response at the site of infection, the mucus membranes of the nasal passages. There is a school of thought that this type of administration will provide a stronger immune response than intramuscular injections currently used in multiple vaccines, including Bharat’s Covaxin, a whole virion inactivated COVID-19 vaccine, which has already been authorized in India. This is essential for blocking infection within an individual and the ability to transmit the virus. The company and its U.S.-based partner Ocugen, are seeking authorization for Covaxin in the United States as well. However, earlier this summer, the Pennsylvania-based Ocugen ran into some trouble with its plans to bring Bharat’s vaccine to the U.S. As BioSpace previously reported, Ocugen was forced to change its application from potential emergency use to a full Biologics License Application. And that requires additional data. Bharat aims to use real world data from the millions of doses of Covaxin administered in India as part of a planned Phase IV study. The intranasal approach Bharat is taking with its second COVID-19 vaccine candidate is also one unsuccessfully attempted by Maryland-based Altimmune. In June, the company announced its intranasal vaccine candidate, dubbed AdCOVID, fell short in a Phase I study. The company acknowledged that the immunogenicity data generated in the study “exhibited very low immune responses in every parameter where it was tested.” As a result, Altimmune halted the development of that particular vaccine candidate. According to the U.S. Centers for Disease Control and Prevention, approximately 54% of the eligible population in the United States is fully vaccinated against COVID-19. About 75.3% of eligible adults have received at least one jab of the available vaccines.

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COVID-19 respiratory infection	Phase 3	IN	Bharat Biotech International Ltd.	26 Feb 2022

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