Clinical trials

Moderna Announces First Participant Dosed in Phase 1 Study of Its IL-2 mRNA Therapeutic

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Monday, August 2, 2021
Research, Infectious diseases, Genetics, Clinical trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Nucleic acids, RNA, Medical research, COVID-19 vaccines, Clinical trials, Moderna, Messenger RNA, RNA vaccine, Uğur Şahin, mRNA-6231, Moderna, MRNA-6231, MODERNA

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participant has been dosed in the Phase 1 study of mRNA-6231, the Companys mRNA-encoded IL-2 modified for the expansion of regulatory T cells.

Key Points: 
  • Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participant has been dosed in the Phase 1 study of mRNA-6231, the Companys mRNA-encoded IL-2 modified for the expansion of regulatory T cells.
  • This is our first mRNA autoimmune candidate, and the first to be subcutaneously administered.
  • Today marks another important step in our mission to deliver on the promise of mRNA to help patients across diseases.
  • Moderna now has active clinic programs in five different therapeutic areas: infectious disease, oncology, cardiovascular, rare disease and autoimmune disease.

Arcturus Announces Approval of a Clinical Trial Application to Advance ARCT-154, a Next Generation STARR™ mRNA Vaccine Targeting the SARS-CoV-2 Delta Variant and Other Variants of Concern

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Monday, August 2, 2021
Infectious diseases, Health, Genetics, Pharmaceutical, Clinical trials, Coronaviridae, COVID-19 vaccines, Clinical trials, COVID-19, ARCT, Variants of SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2 Delta variant, Variant of concern

Titers were determined by calculating the dilution that resulted in 50% inhibition of cells expressing GFP encoded by the pseudovirus, a surrogate of virus infection.

Key Points: 
  • Titers were determined by calculating the dilution that resulted in 50% inhibition of cells expressing GFP encoded by the pseudovirus, a surrogate of virus infection.
  • We are very pleased to advance ARCT-154 into a significant, staged Phase 3 clinical development study with our partner to target SARS-CoV-2 variants of concern, including the Delta variant.
  • ARCT-154 utilizes Arcturus STARR mRNA technology, and our preclinical immunogenicity data demonstrates that our newly developed vaccine candidate elicits a strong neutralizing antibody immune response against the Delta variant and other variants of concern, said Joseph Payne, President and CEO of Arcturus.
  • Arcturus technologies are covered by its extensive patent portfolio (222 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries).

Sensyne grows medical research dataset to 60 million patients

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Monday, August 2, 2021
Data management, Biotechnology, Technology, Health, Pharmaceutical, Other Technology, Medical devices, Software, Internet, Mobile, Wireless, Clinical trials, Health sciences, Health, Clinical research, Pharmaceutical industry, Medical research, Clinical pharmacology, Clinical trial, Design of experiments, Sensyne Health, Phesi Inc., SENSYNE HEALTH, PHESI INC.

Between December 2020 and July 2021 Phesi grew its clinical research and clinical trial dataset from 13 million to 42 million patients through a concerted effort in acquiring and structuring data registries of de-identified data.

Key Points: 
  • Between December 2020 and July 2021 Phesi grew its clinical research and clinical trial dataset from 13 million to 42 million patients through a concerted effort in acquiring and structuring data registries of de-identified data.
  • At the same time, Sensyne, through its unique ethical Strategic Research Agreement (SRA) model that partners with healthcare systems, grew its real world patient dataset from 6 million to over 18 million patients.
  • Sixty million patients is an important milestone in our journey to create the worlds best data resource for medical research.
  • The 42 million Phesi clinical research and clinical trial dataset does not form part of this 100 million target.

Arcturus Therapeutics Collaborates with Vingroup to Establish Manufacturing Facility in Vietnam for Arcturus’ Investigational mRNA Vaccines for COVID-19

Retrieved on: 
Monday, August 2, 2021
Health, Infectious diseases, Manufacturing, Genetics, Other Manufacturing, Pharmaceutical, Nucleic acids, COVID-19 vaccines, Clinical trials, RNA vaccines, Moderna COVID-19 vaccine, COVID-19 vaccine, Vaccine, Messenger RNA, Arcturus Therapeutics, Arcturus COVID-19 vaccine

Arcturus will provide Vinbiocare with an exclusive license to manufacture the vaccines in Vietnam at the facility solely for distribution in Vietnam.

Key Points: 
  • Arcturus will provide Vinbiocare with an exclusive license to manufacture the vaccines in Vietnam at the facility solely for distribution in Vietnam.
  • The license and technology transfer applies toward drug product manufacturing but not toward mRNA drug substance manufacturing.
  • Vinbiocare will also pay for mRNA drug substance supplied by Arcturus and royalties on vaccines produced at the Facility.
  • Arcturus investigational COVID-19 vaccines utilize Arcturus self-transcribing and replicating (STARR) mRNA technology, and the STARR mRNA is delivered with Arcturuss lipid-mediated delivery system called LUNAR delivery system.

IASO Biotherapeutics’ World’s First Fully Human CD19/CD22 Dual-Targeted CAR-T Drug Receives Two IND Clearances, Enters Clinical Trials

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Monday, August 2, 2021
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical trials, Branches of biology, Medical specialties, Biology, Immunology, Immune system, Biotechnology, Cell biology, Chimeric antigen receptor T cell, Gene therapy, Immunogenicity, DNA sequencing, Antibody, CT120, Non-Hodgkin Lymphoma (NHL), Acute B-Lymphoblastic Leukemia (B-ALL), IASO Biotherapeutics, CT120, NON-HODGKIN LYMPHOMA (NHL), ACUTE B-LYMPHOBLASTIC LEUKEMIA (B-ALL), IASO BIOTHERAPEUTICS

Moreover, CT120 uses fully human antibody sequences, which can reduce the anti-drug antibody (ADA) effect and improve the in vivo persistence of CAR-T cells.

Key Points: 
  • Moreover, CT120 uses fully human antibody sequences, which can reduce the anti-drug antibody (ADA) effect and improve the in vivo persistence of CAR-T cells.
  • The CD19 antibody sequence of CT120 is developed on IASO Bios fully human antibody platform IMARS and high throughput CAR-T drug selection platform.
  • The companys high-throughput CAR-T drug selection platform, which uses cutting-edge single-cell analysis and next-generation sequencing (NGS) technology, can implement cost effective, high efficiency functional CAR-T candidate screening.
  • Adopting a fully human design, CT120 has low immunogenicity, reduces the ADA effect, and improves CAR-T cells viability.

SaNOtize inks agreement with Indian biotech Glenmark to commercialize Nitric Oxide Nasal Spray for COVID-19 treatment in India and other Asian markets

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Monday, August 2, 2021
Other Manufacturing, Research, Clinical trials, Public policy, Government, Healthcare reform, Manufacturing, Biotechnology, Pharmaceutical, Health, Science, Epidemiology, Health sciences, Health, Articles, Infectious diseases, Global health, Pandemics, Virus, Zoonoses, Nitric oxide, Infection, Antimicrobial, SaNOtize, Glenmark Pharmaceuticals Ltd, SANOTIZE, GLENMARK PHARMACEUTICALS LTD

Available as a simple nasal spray, it is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs.

Key Points: 
  • Available as a simple nasal spray, it is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs.
  • The committee has recommended a Phase III clinical trial to be conducted in Indian patients in the weeks to follow.
  • SaNOtize developed and patented a Nitric Oxide Releasing Solution platform technology (NORS) to treat and prevent microbial infections in 2017.
  • SaNOtize Research & Development Corp. is a biotech company based in Vancouver, BC working to commercialize the multi-faceted antimicrobial properties of a liquid that produces nitric oxide.

IMV Inc. to Announce Second Quarter 2021 Results and Host a Conference Call and Webcast on August 11, 2021

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Monday, August 2, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Virotherapy, IMV, Digital Picture Exchange, Immunotherapy

ET to discuss the companys second quarter 2021 financial and operational results.

Key Points: 
  • ET to discuss the companys second quarter 2021 financial and operational results.
  • The webcast will be recorded and will then be available on the IMV website for 30 days following the call.
  • IMV is pioneering a novel class of cancer immunotherapies based on the Companys proprietary delivery platform (DPX).
  • IMV is also developing another DPX-based immunotherapy: DPX-SurMAGE, a dual targeted immunotherapy to be evaluated in subjects with bladder cancer.

Autobahn Therapeutics Announces Orphan Drug Designation Granted to ABX-002 for the Treatment of X-linked Adrenoleukodystrophy

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Monday, August 2, 2021
FDA, Health, Genetics, Clinical trials, Pharmaceutical, Biotechnology, Health, Life sciences, Pharmaceuticals policy, Adrenoleukodystrophy, Leukodystrophies, Orphan drug

Autobahn Therapeutics, a biotechnology company focused on restoring hope for people affected by CNS disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the companys investigational product candidate, ABX-002, for the treatment of patients with X-linked adrenoleukodystrophy (X-ALD).

Key Points: 
  • Autobahn Therapeutics, a biotechnology company focused on restoring hope for people affected by CNS disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the companys investigational product candidate, ABX-002, for the treatment of patients with X-linked adrenoleukodystrophy (X-ALD).
  • Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States.
  • Autobahn Therapeutics is focused on restoring hope for people affected by CNS disorders.
  • Autobahn is leveraging its brain-targeting chemistry platform to unlock new therapeutic opportunities through precision tuning of the central exposure of its molecules.

SAPHNELO (anifrolumab) Approved in the US for Moderate to Severe Systemic Lupus Erythematosus

Retrieved on: 
Monday, August 2, 2021
FDA, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Medical specialties, Autoimmune diseases, Clinical medicine, Medicine, Cutaneous lupus erythematosus, Connective tissue diseases, Lupus, William Osler, Syndromes, Anifrolumab, Sjögren syndrome, Rheumatology

AstraZenecas SAPHNELO (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

Key Points: 
  • AstraZenecas SAPHNELO (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
  • SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
  • Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.
  • The Companys growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential, in areas including rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic-driven diseases.

Radicle Science Launches Largest Longitudinal Real World Evidence Study to Determine Effectiveness of CBD Products

Retrieved on: 
Monday, August 2, 2021
Science, Research, Alternative medicine, Health, Tobacco, Specialty, Clinical trials, Retail, Plant anatomy, Plant morphology, Plant cognition, Radicle

Radicle Science , a transformative healthtech B-corp validating natural products for the first time, announces the launch of the Radicle ACES (Advancing CBD Education and Science) study.

Key Points: 
  • Radicle Science , a transformative healthtech B-corp validating natural products for the first time, announces the launch of the Radicle ACES (Advancing CBD Education and Science) study.
  • A rigorous scientific study of this magnitude has never before been conducted in the CBD market, said Pelin Thorogood, Co-founder and Executive Chair of Radicle Science.
  • Radicle ACES is Institutional Review Board (IRB) approved and will capture CBD effectiveness data directly from nearly 3,000 study participants.
  • About Radicle Science: Radicle Science is a transformative healthtech B-corp offering the first ever path to natural product validation at scale.