Viral

EQS-News: G.ST Antivirals reports start of Phase II trial and announces appointment of Ronald Bruce Turner as new Chief Medical Officer

Retrieved on: 
Wednesday, April 10, 2024
JAMA, Recreational vehicle, Metabolism, CHDR, Entrepreneurship, Dean (education), Viral, Reproduction, University, Head, Volunteering, MD, Urinary tract infection, Infection, Medical school, Clinical trial, Pharmacokinetics, Southern Illinois University, Division, Virus, CMO, University School, Glycolysis, Pharmaceutical industry

An expert in the clinical research of respiratory viruses, Dr. Turner will oversee the Company’s current clinical trial and drive further clinical development.

Key Points: 
  • An expert in the clinical research of respiratory viruses, Dr. Turner will oversee the Company’s current clinical trial and drive further clinical development.
  • This study aims to assess the effectiveness of 2-DG in preventing illness from rhinoviruses, reducing infection rates, and easing symptom severity.
  • A total of 128 volunteers will participate, receiving up to four daily intranasal doses of either 2-DG or a placebo.
  • 2-DG is a unique and intriguing therapeutic approach to treating viral infections by blocking the virus’ nutrient access,” commented Ronald Bruce Turner, MD, CMO of G.ST Antivirals.

Recce Pharmaceuticals Granted New Patent in Israel for RECCE® Anti-Infectives

Retrieved on: 
Thursday, April 4, 2024
Escherichia coli, Central Bureau, Statistics, Burn, PCT, Shingles, Biotechnology, Growth, Disease, HIV, Klebsiella pneumoniae, COVID-19, Inhalation, HCMV, ASX, RCE, Recce, Viral, Pseudomonas aeruginosa, Virus, EBV, SARS-CoV-2, Staphylococcus aureus, Gonorrhea, Cytomegalovirus, Ross River virus, Neisseria meningitidis, GDP, Urinary tract infection, Skin, Streptococcus pyogenes, Patent, Staphylococcus, Streptococcus pneumoniae, Simplex, Infection, USD, Administration, Biology, Ageing, Pharmaceutical industry

SYDNEY, Australia, April 04, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), the Company developing a new class of synthetic anti-infectives, today announced that the State of Israel Patent Office has formally granted Recce a new family four patent (patent number: 295116), “Process for Preparation of Biologically Active Copolymer Comprising an Acrolein Derivative and a Polyalkylene Glycol Oligomer,” with expiry in 2041.

Key Points: 
  • SYDNEY, Australia, April 04, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), the Company developing a new class of synthetic anti-infectives, today announced that the State of Israel Patent Office has formally granted Recce a new family four patent (patent number: 295116), “Process for Preparation of Biologically Active Copolymer Comprising an Acrolein Derivative and a Polyalkylene Glycol Oligomer,” with expiry in 2041.
  • “We are thrilled to have received this newly granted patent in Israel,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • Israel’s pharmaceuticals and biotechnology market has a reputation for high R&D spending and an impressive international reach, with world-class export numbers and a growing market value.
  • Other examples include influenza A, Ross River virus, and coronaviruses, including those responsible for severe acute respiratory syndrome and SARS-CoV-2 (COVID-19).

Assembly Biosciences Reports Fourth Quarter and Year End 2023 Financial Results and Recent Highlights

Retrieved on: 
Thursday, March 28, 2024
Research, HSV, Assembly, Biotechnology, Partnership, Viral, Doctor of Philosophy, Safety, BeiGene, Simplex, Therapy, CMO

Revenues from collaborative research were $7.2 million for the year ended December 31, 2023.

Key Points: 
  • Revenues from collaborative research were $7.2 million for the year ended December 31, 2023.
  • Research and development expenses were $48.9 million for the year ended December 31, 2023, compared to $70.0 million in 2022.
  • General and administrative expenses were $22.9 million for the year ended December 31, 2023, compared to $24.1 million in 2022.
  • The investigational products and investigational product candidates referenced here have not been approved anywhere globally, and their safety and efficacy have not been established.

Atea Pharmaceuticals Completes Patient Enrollment in Global Phase 3 SUNRISE-3 Trial Evaluating Oral Antiviral Bemnifosbuvir for COVID-19 in High-Risk Patients

Retrieved on: 
Wednesday, March 27, 2024
Infection, Risk, COVID-19, Patient, Fast Track, Viral, Data monitoring committee, Death, Doctor of Philosophy, Safety, DSMB, Immunodeficiency, Atea, Food, Hospital, Pharmaceutical industry

BOSTON, March 27, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that the company has completed enrollment of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, or placebo for the treatment of COVID-19. Over 2,200 patients were randomized into the supportive care monotherapy cohort and less than 80 patients were randomized into the combination cohort. The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients. Secondary endpoints include other measurements of patient outcomes through Day 60 post-treatment.

Key Points: 
  • Over 2,200 patients were randomized into the supportive care monotherapy cohort and less than 80 patients were randomized into the combination cohort.
  • The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients.
  • Secondary endpoints include other measurements of patient outcomes through Day 60 post-treatment.
  • “COVID-19 continues to be a threat, leaving the most vulnerable at risk for severe outcomes from infection.

COVID-19 Virus Can Persist in the Body More Than a Year after Infection

Retrieved on: 
Tuesday, April 9, 2024
Research, Infection, Harvard Medical School, HIV/AIDS, Conditional sentence, COVID, UCSF, Biomedical Research, Coronavirus, UC, Nature, University, SARS-CoV-2, MD, Volunteering, Life, Protein, Consortium, Lymph, Division, Viral, Government, Vaccine

MEDFORD, Mass., April 8, 2024 /PRNewswire/ -- Research published today in Lancet Infectious Diseases and supported by PolyBio Research Foundation provides the strongest evidence yet that the COVID virus can persist for months or years after infection. The findings, published by a UC San Francisco/Harvard Medical School team, found that proteins created by the virus were still present for up to 14 months in a quarter of people tested. This demonstrates SARS-CoV-2 viral persistence as an urgent area of research underlying a breadth of chronic disease after COVID. 

Key Points: 
  • "The fact that every new SARS-CoV-2 infection has the potential to become chronic is perhaps the single most concerning aspect of this virus," says Dr. Amy Proal, President of PolyBio.
  • "We have compelling data that viral persistence is much more common than recognized which could have major health implications."
  • The researchers analyzed blood samples from 171 people who had been infected with the virus.
  • These findings greatly bolster evidence that the coronavirus can linger in tissue and organs, even after recovery from acute infection.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Saturday, April 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

Orphan designation: Mavorixafor Treatment of WHIM syndrome, 25/07/2019 Positive

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, WHIM, WHIM syndrome, Myelokathexis, Pneumonia, Bone marrow, CXCR4, Risk, Patient, Committee, Knowledge, Hypogammaglobulinemia, Antibody, Regulation, Viral, EMA, IRIS, Wart, Otitis, Protein, Lymphocyte, European, Infection, COMP, Immune system, European Commission, Neutrophil, Blood, Safety, Consultant, Marketing, Movement, Pharmaceutical industry

Orphan designation: Mavorixafor Treatment of WHIM syndrome, 25/07/2019 Positive

Key Points: 


Orphan designation: Mavorixafor Treatment of WHIM syndrome, 25/07/2019 Positive

Indaptus Therapeutics Previews Positive Mechanism of Action Data to be Presented at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Monday, March 25, 2024
Toxicity, B cell, CD8, Research, Cancer research, AACR, Chemokine, Therapy, Cytokine, Immune system, Poster, Viral, Decoy, Bacteria, Vaccine

NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announces that Dr. Michael Newman, Founder and Chief Scientific Officer of Indaptus, will present a poster at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego on Wednesday morning, April 10th. An abstract of the data to be presented has been published online in the AACR Journal, Cancer Research. The data confirm and significantly extend the proposed mechanism of action of the Company’s proprietary platform technology of attenuated and killed, non-pathogenic bacteria containing multiple immune receptor agonists for pulsed anti-tumor immunotherapy.

Key Points: 
  • An abstract of the data to be presented has been published online in the AACR Journal, Cancer Research.
  • The data confirm and significantly extend the proposed mechanism of action of the Company’s proprietary platform technology of attenuated and killed, non-pathogenic bacteria containing multiple immune receptor agonists for pulsed anti-tumor immunotherapy.
  • The activity was associated with induction of human tumor cell killing by Decoy bacteria in the presence of immune cells.
  • Potentially unacceptable toxicity from this breadth of immune activation is avoided by using systemically administered killed bacteria as a delivery vehicle.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in AlloVir, Inc. of Class Action Lawsuit and Upcoming Deadlines – ALVR

Retrieved on: 
Saturday, March 23, 2024
Clinical research associate, District court, Patient, Research, Ext, LLP, Viral, News, Virus, Complaint, Pomerantz, Action Replay, Court, Person

NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against AlloVir, Inc. (“AlloVir” or the “Company”) (NASDAQ: ALVR).

Key Points: 
  • NEW YORK, March 23, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against AlloVir, Inc. (“AlloVir” or the “Company”) (NASDAQ: ALVR).
  • To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

Orchard Therapeutics Outlines U.S. Launch Plans for Lenmeldy™ (atidarsagene autotemcel), the Only Approved Therapy for Children with Early-onset Metachromatic Leukodystrophy

Retrieved on: 
Wednesday, March 20, 2024
Encephalitis, ICER, Bone marrow, Patient, DSM-IV codes, Urinary tract infection, Travel, Child, Health technology assessment, Therapy, Children's Hospital of Philadelphia, Central nervous system, Risk, MLD, Qualification, Health, WAC, NBS, Nerve, Mutation, UCSF, Disease, Federation, Research, Acquisition, Genome, Rash, Stem cell, HSC, Hospital, Family, Swelling, FDA, Diagnosis, HTA, Caregiver, Traffic barrier, Viral, Fever, Kyowa Kirin, PSLI, Liver, Government, San Raffaele Hospital, ARSA, Pharmaceutical industry

TOKYO, LONDON and BOSTON, March 20, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the details of its U.S. commercial launch of Lenmeldy™ (atidarsagene autotemcel), formerly known as OTL-200, the first FDA-approved therapy for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile, (PSEJ), or early symptomatic early juvenile (ESEJ)—collectively referred to as early-onset—metachromatic leukodystrophy (MLD).

Key Points: 
  • Prior to Lenmeldy, there were no treatment options in the U.S. for early-onset MLD beyond supportive and end-of-life care.
  • This approach has the potential to restore enzymatic function to stop or slow disease progression with a single treatment.
  • Utilizing results from such studies, a multi-stakeholder working group is finalizing a nomination to add MLD to the U.S.
  • Based on current timelines and assumptions, Orchard Therapeutics expects the nomination will be submitted in mid-year 2024.