Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients With Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) With Documented Viral Infections With PIV, hMPV or RSV

The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with documented viral infections due to PIV, hMPV, or RSV. PUL-042 or a placebo will be administered 3 times over a 6-day period. The total duration of the study will be approximately 30 days.

开始日期2025-06-27

申办/合作机构

Pulmotect, Inc.

[+1]

NCT03097796

/ Withdrawn临床1期

An Open-Label, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of PUL-042 Inhalation Solution in Subjects With Hematologic Malignancies and Recipients of Stem Cell Transplantation

Subjects with hematologic malignancies or recipients of a first allogenic or autologus hematopoietic stem cell transplant, without any evidence or respiratory infection, will receive 4 doses of PUL-042 Inhalation Solution over a 2 week period. Subjects will be evaluated for tolerability of the drug. If tolerated, dose escalation may occur with up to 4 dose levels tested

开始日期2024-12-01

申办/合作机构

Pulmotect, Inc.

[+2]

NCT04312997

/ Completed临床2期

A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

Adults who have tested positive for SARS-CoV-2 infection and who may require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome

开始日期2020-06-16

申办/合作机构

Pulmotect, Inc.

[+1]

100 项与 ODN/Pam2 相关的临床结果

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100 项与 ODN/Pam2 相关的转化医学

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100 项与 ODN/Pam2 相关的专利（医药）

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项与 ODN/Pam2 相关的文献（医药）

2025-05-14·mBio

Immunotherapy with nebulized pattern recognition receptor agonists restores severe immune paralysis and improves outcomes in mice with influenza-associated pulmonary aspergillosis

Article

作者: Burch-Eapen, Madeleine ; Wang, Yongxing ; Moghaddam, Seyed J. ; Bharadwaj, Uddalak ; Ntita, Mbaya ; Kulkarni, Vikram K. ; Foncerrada Lizaola, Jania ; Covarrubias López, Daniela ; Wurster, Sebastian ; Evans, Scott E. ; Matula, Lauren M. ; Bhoda, Keerthi ; Kontoyiannis, Dimitrios P. ; Larsen, Katherine E. ; Rodríguez Carstens, Paris ; Albert, Nathaniel D. ; Pantaleón García, Jezreel

ABSTRACT:

Influenza-associated pulmonary aspergillosis (IAPA) is a potentially deadly superinfection in patients with influenza pneumonia, especially those with severe disease, underlying immunosuppression, corticosteroid therapy, or requiring intensive care support. Given the high mortality of IAPA, adjunct immunomodulatory strategies remain a critical unmet need. Previously, the desensitization of pattern recognition pathways has been described as a hallmark of IAPA pathogenesis and a predictor of mortality in IAPA patients. Therefore, we studied the impact of nebulized Toll-like receptor 2/6/9 agonists Pam2 CSK4 (Pam2) and CpG oligodeoxynucleotides (ODNs) on infection outcomes and pulmonary immunopathology in a corticosteroid-immunosuppressed murine IAPA model. Mice with IAPA receiving mock therapy showed rapidly progressing disease and a paralyzed immune response to secondary Aspergillus fumigatus infection. Nebulized Pam2ODN was well tolerated and significantly prolonged event-free survival. Specifically, dual-dose Pam2ODN therapy before and after A. fumigatus infection led to 81% survival and full recovery of all survivors. Additionally, transcriptional analysis of lung tissue homogenates revealed induction of pattern recognition receptor signaling and several key effector cytokine pathways after Pam2ODN therapy. Moreover, transcriptional and flow cytometric analyses suggested increased frequencies of macrophages, natural killer cells, and T cells in the lungs of Pam2ODN-treated mice. Collectively, immunomodulatory treatment with nebulized Pam2ODN strongly improved morbidity and mortality outcomes and alleviated paralyzed antifungal immunity in an otherwise lethal IAPA model. These findings suggest that Pam2ODN might be a promising candidate for locally delivered immunomodulatory therapy to improve outcomes of virus-associated mold infections such as IAPA.

IMPORTANCE:

The COVID-19 pandemic has highlighted the significant healthcare burden, morbidity, and mortality caused by secondary fungal pneumonias. Given the heightened prevalence of severe viral pneumonias, such as influenza, and poor outcomes of secondary mold pneumonias, adjunct immunotherapies are needed to prevent and treat secondary infections. We herein demonstrate severely paralyzed immunity to secondary Aspergillus fumigatus infection in a corticosteroid-immunosuppressed mouse model of influenza-associated pulmonary aspergillosis (IAPA), partially due to dysregulated pathogen-sensing pathways. To overcome immune paralysis and IAPA progression, we used a dyad of nebulized immunomodulators (Toll-like receptor agonists). Nebulized immunotherapy significantly improved morbidity and mortality compared to mock therapy, increased frequencies of mature mononuclear phagocytes and natural killer cells in the lung, and stimulated antimicrobial signaling. Collectively, this proof-of-concept study demonstrates the feasibility and efficacy of locally delivered immunomodulatory therapy to alleviate virus-induced immune dysregulation in the lung and improve outcomes of post-viral mold pneumonias such as IAPA.

2023-06-01·American journal of respiratory cell and molecular biology

Redox-Dependent Activation of Lung Epithelial STAT3 Is Required for Inducible Protection against Bacterial Pneumonia

Article

作者: Evans, Scott E. ; Pantaleon Garcia, Jezreel ; Wang, Yongxing ; Kulkarni, Vikram V.

Abstract:

The lung epithelium is dynamic, capable of considerable structural and functional plasticity in response to pathogen challenges. Our laboratory has demonstrated that an inhaled combination of a Toll-like receptor (TLR) 2/6 agonist and a TLR9 agonist (Pam2ODN) results in robust protection against otherwise lethal pneumonias. We have previously shown that intact epithelial TLR signaling and generation of multisource epithelial reactive oxygen species (ROS) are required for inducible protection. Further investigating the mechanisms underlying this phenomenon of inducible resistance, reverse-phase protein array analysis demonstrated robust STAT3 (signal transducer and activator of transcription 3) phosphorylation following treatment of lung epithelial cells. We show here that Pam2ODN-induced STAT3 phosphorylation is IL-6–independent. We further found that therapeutic epithelial STAT3 activation is required for inducible protection against Pseudomonas aeruginosa pneumonia. Additional studies showed that inhibiting epithelial dual oxidases or scavenging ROS significantly reduced the Pam2ODN induction of STAT3 phosphorylation, suggesting a proximal role for ROS in inducible STAT3 activation. Dissecting these mechanisms, we analyzed the contributions of redox-sensitive kinases and found that Pam2ODN activated epithelial growth factor receptor in an ROS-dependent manner that is required for therapeutically inducible STAT3 activation. Taken together, we demonstrate that epithelial STAT3 is imperative for Pam2ODN’s function and describe a novel redox-based mechanism for its activation. These key mechanistic insights may facilitate strategies to leverage inducible epithelial resistance to protect susceptible patients during periods of peak vulnerability.

2020-12-01·American journal of respiratory cell and molecular biology

CD8+ T Cells: Exacting a Toll in Viral Pneumonia

Communications

作者: Ballinger, Megan N. ; Davis, Ian C.

Acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly spread across the globe, resulting in more than 170,000 deaths in the United States alone.Severely ill SARS-CoV-2-infected patients can develop a form of acute respiratory distress syndrome (ARDS) termed coronavirus disease (COVID-19).In the current study, Pam2-ODN pretreatment did not alter either the kinetics or the magnitude of the macrophage response to infection,indicating that their role may not be essential.Nevertheless, the link between early TLR stimulation and modulation of antiviral T-cell responses is an intriguing, and somewhat counterintuitive, finding, which will have implications for both our understanding of the pathogenesis of viral lung injury and its treatment.

项与 ODN/Pam2 相关的新闻（医药）

2025-07-08

·EINPresswire

Pulmotect Initiates Landmark Phase 2 Clinical Trial in Immunosuppressed Cancer Patients

Leading oncology centers in the United States engaged to conduct the Phase 2 Antiviral Trial and further advance the development of PUL-042 HOUSTON, TX, UNITED STATES, July 8, 2025 / EINPresswire.com / -- Pulmotect , Inc., a privately held clinical-stage biotechnology company, today announced that it has begun dosing in their 100 patient Phase 2, double-blind, placebo controlled, clinical trial in immunosuppressed patients with hematologic malignancies. The trial is funded in part by an $8.9 million Product Development Research grant awarded by the Cancer Prevention and Research Institute of Texas ( CPRIT , ID#DP230066). “This clinical trial is a key stepping stone in our development program with PUL-042. The three viruses that we are targeting have no effective treatments and are the most serious and potentially lethal viruses that cause pneumonia in this patient population. It is unheard of for an agent to be clinically effective against multiple different viruses however, PUL-042 activates lung surface immunity to fight off infection and is effective in multiple preclinical models against viruses, bacteria and fungi. The prospect of viral resistance to treatment is non-exsitent due to PUL-042 being a host directed therapy which makes this an exciting and potentially paradigm changing therapeutic. ” said Dr. Colin Broom, CEO of Pulmotect. “This trial is an example of bringing private and public resources together to address a significant problem facing cancer patients. With funding support from the state of Texas, Fannin Partners and other investors we are able to conduct this trial with the participation of leading cancer centers across the country and their patients.” said Leo Linbeck III, Chairman, Pulmotect Board of Directors and Chairman, Fannin Partners. The Phase 2 antiviral trial is entitled “A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients with Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) with Documented Viral Infections with Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV).” (NCT06665100). The design of the trial builds upon the experience and results from Pulmotect's previous Phase 2 trials that demonstrated activity of inhaled PUL-042 against SARS-CoV-2 when administered by nebulization following diagnosis of viral infection. About PUL-042 PUL-042, a first-in-class, synergistic combination of two toll-like receptor agonists, activates the lungs’ surface innate immune system to inhibit and kill a wide range of respiratory pathogens. As microbes land on the epithelial cells of the lung lining, they are destroyed on contact by antimicrobial peptides and reactive oxygen species (ROS) that are released by epithelial cells. Activation of the innate immune system also triggers a response from the adaptive immune system. PUL-042 has demonstrated protection against a broad range of viral, bacterial and fungal respiratory pathogens in pre-clinical models, including models with immunocompromised animals. Phase 1 and 2 trials to date have demonstrated favorable tolerability in more than 200 subjects that included healthy individuals, COPD patients and subjects infected with SARS-CoV-2 with evidence of antiviral activity. PUL-042 may provide potentially life saving therapy for immunocompromised patients and also offer a broad-spectrum therapy for multiple other populations such as patients with COPD, asthma, seasonal infections and potential utility in future pandemics. About Pulmotect Pulmotect has an immunomodulatory platform technology and is developing PUL-042, a clinical-stage, first-in-class, inhaled, immunomodulatory agent. This synergistic agonist amplifies the innate immune defenses of the lung epithelial mucosa to provide broad-spectrum, pathogen-agnostic protection against respiratory infections. Invented at UT MD Anderson Cancer Center/Texas A&M University, PUL-042 has patents issued in 28 countries, both as a stand-alone composition of matter product and in combination with antivirals. PUL-042 R&D has been supported by the Department of Defense (DoD), National Institutes of Health (NIAID, NIGMS), CPRIT, other funding agencies, and private investors including Houston based Fannin Partners, LLC , a life sciences product development company. For more information, visit www.pulmotect.com . Brenton Scott Pulmotect, Inc. +1 713-579-9226 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床2期免疫疗法临床结果临床1期

2022-11-08

·PRNewswire

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. 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疫苗基因疗法抗体生物类似药细胞疗法

2021-10-28

·BioSpace

Texas A&M Drug Shows Promise Against Multiple Respiratory Infections

Texas A&M University Science Center, MD Anderson Cancer Center, and Pulmotect report that the drug PUL-042 appears to work against COVID-19 and other respiratory infections. The drug stimulates the innate immune system in the lungs. They believe it might work against all existing and future variants of SARS-CoV-2, the virus that causes COVID-19, in addition to future pandemics. “We have not found a virus PUL-042 cannot work against in the lungs, in animal studies,” said Dr. Colin Broom, chief executive officer of Pulmotect. “As an easily administered inhaled therapy, PUL-042 could have value in reducing the impact of COVID-19 irrespective of the development of further variants. It also has potential utility for other patient populations which we plan to explore, including immunosuppressed cancer patients.” On September 21, Pulmotect announced positive topline data from the first of two Phase II trials of PUL-042 against COVID-19. The U.S. Department of Defense (DOD) supported the trial. The study demonstrated that patients receiving inhaled PUL-042 had a statistically significant decrease in the time to improvement of combined respiratory symptoms of cough and shortness of breath. Patients tolerated the drug well when given as a single dose on day 1, day 3, and day 6 of the trial with patient follow-up for 28 days. In total, three patients were hospitalized when their COVID-19 progressed, two in the placebo arm who both required intensive care for five days and nine days, and one patient in the PUL-042 cohort was hospitalized for four days after receiving a single dose of the drug. The patient, however, did not require intensive care. The drug is a first-in-class, synergistic combination of two toll-like receptor agonists that activate the lung’s surface innate immune system. In addition to COVID-19, in animal models, it has shown protection against the coronaviruses that cause MERS and SARS. “I am excited about the topline results with PUL-042 and the shortening of time to symptoms improvement for patients with early COVID-19, which could have significant health and economic benefits as the global pandemic continues to unfold,” Broom said. “As an easily administered inhaled therapy, PUL-042 could have value in reducing the impact of COVID-19 irrespective of the development of further variants and has potential utility for other patient populations which we plan to explore including immunosuppressed cancer patients.” The drug was discovered by Magnus Höök, Ph.D., Regents and Distinguished Professor at the Texas A&M Health Institute of Biosciences and Technology, and Burton Dickey, M.D., chair of the pulmonary department at MD Anderson Cancer Center and instructional professor in the Texas A&M Engineering Medicine program. “The lungs are the point of entry for many viruses and bacteria,” Höök said. “By activating the innate immune defense of the lungs, PUL-042 can provide effective protection against a wide range of deadly pathogens. We believe that if we had this therapy available in December of 2019, we could have prevented the COVID-19 pandemic and avoided the 6 million lives lost.” The protection the drug offers only seems to last three to five days but can be re-administered once every few days.

First in Class

100 项与 ODN/Pam2 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
造血干细胞移植	临床2期	美国	Pulmotect, Inc.	2025-06-27
白血病	临床2期	美国	Pulmotect, Inc.	2025-06-27
下呼吸道感染	临床2期	美国	Pulmotect, Inc.	2025-06-27
新型冠状病毒感染	临床2期	美国	Pulmotect, Inc.	2020-06-09
慢性阻塞性肺疾病	临床2期	英国	Pulmotect, Inc.	2019-01-21
鼻病毒感染	临床2期	英国	Pulmotect, Inc.	2019-01-21
呼吸系统疾病	临床2期	-	Pulmotect, Inc.	-
病毒性肺炎	临床前	美国	UT MD Anderson Cancer Center	2025-05-16

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04313023 (CTgov)	临床2期	新型冠状病毒感染	217	PUL-042 Inhalation Solution (PUL-042 Inhalation Solution)	壓衊顧觸獵獵蓋糧壓窪(網鹹網簾餘醖鹽願鏇艱) = 選醖淵構醖範遞觸艱構製淵蓋觸鏇鏇鑰窪鏇鏇 (範範齋鹹構獵製製壓憲, 觸製壓築鬱遞襯膚襯廠 ~ 繭積蓋壓構獵觸鏇願廠) 更多	-	2023-05-17
				Placebo (Sterile Saline for Inhalation)	壓衊顧觸獵獵蓋糧壓窪(網鹹網簾餘醖鹽願鏇艱) = 夢糧壓膚遞廠鏇糧艱構製淵蓋觸鏇鏇鑰窪鏇鏇 (範範齋鹹構獵製製壓憲, 憲夢鏇淵範鹹艱憲鹹築 ~ 襯窪齋淵繭鹹憲齋鑰製) 更多
NCT04312997 (CTgov)	临床2期	新型冠状病毒感染	101	PUL-042 Inhalation Solution (PUL-042 Inhalation Solution)	艱簾艱製憲襯鏇繭選鏇 = 壓淵襯艱範艱鹽築醖鬱蓋壓憲淵蓋窪膚鬱鏇積 (製壓繭憲鏇憲衊艱糧糧, 醖艱願觸選夢鹽觸願獵 ~ 廠壓鏇鏇鹹網壓糧觸醖) 更多	-	2023-04-18
				Placebo (Sterile Saline for Inhalation)	艱簾艱製憲襯鏇繭選鏇 = 餘廠鏇製選範廠選遞衊蓋壓憲淵蓋窪膚鬱鏇積 (製壓繭憲鏇憲衊艱糧糧, 齋觸憲顧簾選網顧鹹製 ~ 願餘積簾淵鏇觸壓築願) 更多
NCT04313023 (BusinessWire) 人工标引	临床2期	新型冠状病毒感染	217	PUL-042	顧簾鏇夢簾糧選繭醖憲(顧製廠築蓋憲願鑰襯顧) = no statistically significant difference 構鏇築膚積築繭選網窪 (鏇願鑰鬱醖壓糧顧廠憲 )	不佳	2021-12-01
				Placebo
NCT04312997 (BusinessWire) 人工标引	临床2期	新型冠状病毒感染	101	PUL-042	獵醖廠蓋範憲獵鹹範鬱(築鑰築製齋齋鹽廠網醖) = PUL-042 was well tolerated with a low incidence of adverse effects with no drug related serious adverse events reported in the trial and no deaths in this patient population. 淵範餘簾製繭鑰獵繭襯 (鏇網獵積獵觸衊壓憲衊 ) 更多	积极	2021-09-24
				Placebo