Capsid

GeoVax Presents Data on GEO-CM04S1, a Next Generation Covid-19 Vaccine

Retrieved on: 
Thursday, April 4, 2024
Biotechnology, Georgia State University, Messenger, Death, Doctor of Philosophy, SARS-CoV-2, Capsid, ACE2, Combat, Infection, Cancer, Omicron, Vaccine, Antigen

ATLANTA, GA, April 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that its Chief Scientific Officer, Mark Newman, PhD, presented data on GEO-CM04S1, the Company’s next-generation Covid-19 vaccine candidate, during the 24th Annual World Vaccine Congress in Washington, DC.

Key Points: 
  • During his presentation, titled “Vaccine Induction of Broadly-Specific Antibody and T Cell Responses to Combat SARS-CoV-2 Variation”, Dr. Newman described GeoVax’s development program for GEO-CM04S1.
  • The data presented were generated in collaboration with scientists at Georgia State University using the human ACE2 transgenic mice, one of the “gold standard” small animal models used for studying Covid vaccines.
  • GEO-CM04S1 incorporates both the spike (S) and nucleocapsid (N) antigens of SARS-CoV-2 and is specifically designed to induce broadly specific antibody and T cell responses.
  • I anticipate similar findings will be observed in our Phase 2 clinical trials as the studies are unblinded later this year.”

Orphan designation: Adeno-associated viral vector containing modified U1 snRNA Treatment of Duchenne muscular dystrophy, 08/10/2009 Positive

Retrieved on: 
Tuesday, April 9, 2024
Community, Eurostat, Civil service commission, Diagnosis, U1 spliceosomal RNA, Capsid, Gene, B cell, Cell, Disease, Agonal respiration, Patient, Committee, Knowledge, Regulation, EMA, IRIS, Protein, Human, Duchenne muscular dystrophy, Dystrophin, European, COMP, Heart, European Commission, Safety, Muscle weakness, Blood, DMD, DSM-IV codes, Medicine, Pharmaceutical industry

Orphan designation: Adeno-associated viral vector containing modified U1 snRNA Treatment of Duchenne muscular dystrophy, 08/10/2009 Positive

Key Points: 


Orphan designation: Adeno-associated viral vector containing modified U1 snRNA Treatment of Duchenne muscular dystrophy, 08/10/2009 Positive

Sangamo Therapeutics Announces Data From Novel Proprietary Neurotropic AAV Capsid Demonstrating Industry-leading Blood-brain Barrier Penetration and Brain Transduction in NHPs

Retrieved on: 
Wednesday, March 13, 2024
Research, Neurology, Genetics, Clinical Trials, Health, Pharmaceutical, General Health, Other Science, Science, STAC, AAV, Sangamo Therapeutics, Gene, Brain, Capsid, Gene expression, ALS, BBB, Central nervous system, Novartis, CNS, CTA, DRG, Traffic barrier, Prion, NHP, Tropism, IND, Nav1.7, Neuron, Biogen, Tauopathy, Excipient, Therapy, DSM-IV codes, Spinal cord, Liver, Animal, Vaccine

Sangamo is exploring avenues to resume development of these programs internally, subject to receipt of adequate funding, or with new potential collaborators.

Key Points: 
  • Sangamo is exploring avenues to resume development of these programs internally, subject to receipt of adequate funding, or with new potential collaborators.
  • In NHP studies when administered intravenously at clinically relevant doses, STAC-BBB demonstrated its potential to be a leading neurotropic capsid.
  • Exhibited 700-fold higher transgene expression in neurons compared to the benchmark capsid AAV9 and outperformed all other known published neurotropic capsid variants evaluated in the study.
  • STAC-BBB was well tolerated in NHPs, with no notable treatment related pathological findings in brain, spinal cord or peripheral tissues.

Solid Biosciences Announces Licensing Agreement with Armatus Bio for the Use of AAV-SLB101, a Proprietary, Muscle-Targeted Capsid, in the Development of an RNAi Therapy to treat FSHD

Retrieved on: 
Thursday, March 7, 2024
Liver, Duchenne, Toxicity, Inflammation, DMD, Facioscapulohumeral muscular dystrophy, DUX4, Solid, FSHD, Capsid, MicroRNA, Oxidative stress, B cell, IND, RNA interference, AAV, Atrophy, Vaccine

The AAV-SLB101 capsid has been shown in preclinical studies to have enhanced biodistribution and improved expression in muscle cells.

Key Points: 
  • The AAV-SLB101 capsid has been shown in preclinical studies to have enhanced biodistribution and improved expression in muscle cells.
  • Under the terms of the agreement, Solid granted Armatus a non-exclusive worldwide license to utilize AAV-SLB101 for treatment of FSHD and will provide Armatus AAV-SLB101 plasmid material, preclinical data characterizing AAV-SLB101, and manufacturing and regulatory know-how to enable development.
  • Armatus will be responsible for the development and commercialization of licensed products incorporating AAV-SLB101.
  • With this license in place, we are eager to advance our optimized ARM-201 construct as the lead candidate toward clinical evaluation.”

NanoMosaic launches AAV gene therapy bioprocessing and manufacturing QC assays for simultaneous capsid & transgene interrogation with high standardization

Retrieved on: 
Wednesday, March 6, 2024
Doctor of Philosophy, University of Massachusetts, Capsid, Microbiology, Transgene, Genetic, GEN, Dicarboxylic acid, Data analysis, Protein, Patient safety, Heart, Mary Ann Liebert, QC, AAV, Research, SBS, Workflow, Vaccine

The assays are seamlessly deployable across upstream and downstream stages of the gene therapy workflow, while harmonizing the data from bioprocessing to batch release QC.

Key Points: 
  • The assays are seamlessly deployable across upstream and downstream stages of the gene therapy workflow, while harmonizing the data from bioprocessing to batch release QC.
  • "The objectives pursued by NanoMosaic are positive steps forward for a space desperate for a fit-for-purpose tool that can be standardized throughout the entire gene therapy development and manufacturing processes.
  • "NanoMosaic is excited to offer a unique solution to a challenging and fast-growing gene therapy market," said Qimin Quan, PhD, co-founder and Chief Scientific Officer.
  • NanoMosaic will feature the platform and unique gene therapy applications in a live broadcast scientific webinar alongside industry leaders on March 26, 2024, hosted by Genetic Engineering News (GEN).

GeoVax Reports Positive Interim Data From Phase 2 Clinical Trial of GEO-CM04S1 as a Universal Covid-19 Vaccine Booster

Retrieved on: 
Tuesday, February 6, 2024
SARS-CoV-2, XBB 1.5, Antigen, Pfizer, Public, Immune system, Omicron, COVID-19, Patient, Safety, Biotechnology, MPH, GeoVax, Vaccine, MVA, Vaccination, Cancer, Labs, Infection, Capsid

ATLANTA, GA, Feb. 06, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced positive initial safety and immune response findings from its Phase 2 clinical trial at one month following administration of its Covid-19 vaccine, GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a heterologous booster in 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466), was fully enrolled at the end of Sept 2023.

Key Points: 
  • The trial remains blinded to dose of vaccine received, with study subjects being followed for a total of one year.
  • To date, there have been no serious adverse events, and adverse events were in line with other routine vaccinations.
  • The immunological responses measured throughout the study period include both neutralizing antibodies against SARS-CoV-2 variants and specific T-cell responses.
  • We look forward to providing further updates regarding the successful progress of the clinical development of GEO-CM04S1.”

Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2

Retrieved on: 
Wednesday, January 24, 2024
Capsid, Therapy, SAN, Biotechnology, Partnership, Exosome, Infection, COVID-19, NIH, Project, NIAID, Messenger, Immunity, Duchenne muscular dystrophy, Bangladesh Technical Education Board, SARS-CoV-2, Trial of the century

SAN DIEGO, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19. As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study.

Key Points: 
  • As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval.
  • We view the NIH SARS-CoV-2 project as the first clinical step towards development of a next generation vaccine platform that may be extended to other infectious diseases.
  • Our platform is designed to combine the speed of response of an mRNA vaccine with the potential efficacy of a protein vaccine.
  • Further, our StealthX™ vaccine is free of both adjuvant and lipid nanoparticles and in preclinical studies has generated a strong immune response at low doses.

NAYA Biosciences To Acquire Clinical Stage Gene Therapy Program for Leber's Hereditary Optic Neuropathy (LHON)

Retrieved on: 
Tuesday, January 23, 2024
Patient, Regenerative medicine, Fertility, Paratriathlon, AAV, Intercept Pharmaceuticals, Kite Pharma, University, Mitochondrion, Term sheet, LHON, Shearson, Acquisition, Safety, Vice, Intellectual property, FDA, Capsid, Letter, Arsenic trioxide, Paramount, Pharmaceutical industry

“The NAYA leadership team brings an agile entrepreneurial platform, broad development and commercialization experience, and access to public capital, which will unlock the potential of our promising AAV gene therapy platform for mitochondrial genetic diseases.

Key Points: 
  • “The NAYA leadership team brings an agile entrepreneurial platform, broad development and commercialization experience, and access to public capital, which will unlock the potential of our promising AAV gene therapy platform for mitochondrial genetic diseases.
  • The program has received over $6 million in grant funding to date and qualifies for Regenerative Medicine Advanced Therapy (RMAT) designation and multiple priority FDA review vouchers.
  • The combination of multiple orphan indications, multiple routes of administration, and multiple AAV serotypes applicable supports a broad gene therapy platform for mitochondrial orphan diseases.
  • The Florida Biotechnologies Transaction is contingent on the closing of the INVO Merger and sufficient financing to further develop the gene therapy programs from Florida Biotechnologies.

SCIENTISTS AT THE WCBP CONFERENCE HIGHLIGHT ADVANCEMENTS IN PROTEIN BIOTHERAPEUTIC CHARGE HETEROGENEITY CHARACTERIZATION USING THE MauriceFlex™ SYSTEM

Retrieved on: 
Wednesday, January 24, 2024
Patient, Mass spectrometry, Capsid, AAV, Sodium dodecyl sulfate, Spacecraft, Acceleration, Enzyme, Therapy, IEX, Fine chemical

The focus of these presentations was on the transformative impact of Bio-Techne's MauriceFlex™ system on their biotherapeutic development processes.

Key Points: 
  • The focus of these presentations was on the transformative impact of Bio-Techne's MauriceFlex™ system on their biotherapeutic development processes.
  • MauriceFlex™, known for its automated capillary isoelectric focusing (icIEF), also enables protein charge fractionation, allowing charge variant characterization in downstream analytics like mass spectrometry.
  • Like the Maurice™ system, the MauriceFlex™ also allows protein size analysis with capillary electrophoresis sodium dodecyl sulfate (CE-SDS).
  • "The discussions at the conference, particularly regarding the MauriceFlex™ system, reflect significant progress in the advancements of analytical techniques used in biotherapeutic development," said Will Geist, President of Bio-Techne's Protein Sciences Segment.

Solid Biosciences Granted FDA Orphan Drug Designation for Duchenne Muscular Dystrophy Gene Therapy Candidate SGT-003

Retrieved on: 
Tuesday, January 16, 2024
Patient, Duchenne, Solid, Nitric oxide synthase, ODD, IRB, Food, Capsid, FDA, NOS1, Duchenne muscular dystrophy, Clinical trial, Pharmaceutical industry

CHARLESTOWN, Mass., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has been granted orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for SGT-003, the company’s next-generation Duchenne muscular dystrophy (Duchenne) gene therapy candidate.

Key Points: 
  • CHARLESTOWN, Mass., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has been granted orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for SGT-003, the company’s next-generation Duchenne muscular dystrophy (Duchenne) gene therapy candidate.
  • “Obtaining ODD status for SGT-003, along with Fast Track Designation granted last month, furthers our efforts to meet the ongoing challenge of treating this devastating disease as expeditiously as possible,” said Bo Cumbo, President and Chief Executive Officer at Solid Biosciences.
  • “SGT-003 therapy stands out among other Duchenne gene therapy candidates by leveraging a novel capsid and a muscle tropic vector delivering a microdystrophin that incorporates a neuronal Nitric Oxide Synthase (nNOS) binding domain.
  • “Obtaining ODD status is an exciting development that we believe will aid our efforts to bring advanced treatment options to those patients affected by Duchenne.”