RNA transfection

EQS-News: Mainz Biomed Announces IRB Approval and Initiation of US Pivotal FDA Clinical Study

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Sunday, December 18, 2022
Institutional review board, IRB, Integral, Colorectal cancer, American Cancer Society, CRC, Food, FDA, US Foods, Colon, AA, DNA, Korea Disease Control and Prevention Agency, Cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NPV, Gene expression, Trial of the century, CDC, Emirates, PPV, PCR, RNA transfection, Ageing, Biomarker, United Arab Emirates, Patient, Pharmaceutical industry, Medical imaging

Mainz Biomed will now initiate the study, which will form the basis of the data package to be submitted for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization.

Key Points: 
  • Mainz Biomed will now initiate the study, which will form the basis of the data package to be submitted for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization.
  • ReconAAsense is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States.
  • Based on the study’s outcome, Mainz Biomed will decide on the integration of the biomarkers evaluated in ColoFuture’s eAArly DETECT into the ReconAAsense study.
  • ColoAlert is currently marketed across Europe and the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 for US regulatory approval.

aTyr Pharma Announces LTBP1 as Target of DARS tRNA Synthetase Fragment

Retrieved on: 
Thursday, December 15, 2022
Scripps Research, Drug discovery, SAN, ATyr Pharma, Disease, Molecular medicine, DARS, Transforming growth factor beta, RNA transfection, Fibrosis, Research, Risk, Biology, COVID-19, Pharmaceutical industry, LTBP1

SAN DIEGO, Dec. 15, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced new findings from its tRNA synthetase platform. The target for a naturally occurring fragment of Aspartyl-tRNA Synthetase (DARS) was identified as latent transforming growth factor beta binding protein 1 (LTBP1).

Key Points: 
  • SAN DIEGO, Dec. 15, 2022 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced new findings from its tRNA synthetase platform.
  • The target for a naturally occurring fragment of Aspartyl-tRNA Synthetase (DARS) was identified as latent transforming growth factor beta binding protein 1 (LTBP1).
  • The company expects to present additional findings around the interaction between LTBP1 and this fragment of DARS at an upcoming scientific conference.
  • aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets.

Biosplice Announces Interim Data from Phase 3 Long-Term Extension Clinical Trial in Knee Osteoarthritis and the Initiation of a New Phase 3 Trial

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Thursday, December 15, 2022
Conference, Physician, Protein, Clinical trial, Rheumatology, LOR, SAN, Biosplice Therapeutics, WOMAC, KL2, Safety, Science, Alternative splicing, CLK, American Conference, RNA transfection, Osteoarthritis, Knee, Cancer, Therapy, Injection, Biology, Patient, Pharmaceutical industry, Dietary supplement, Tutoring, MD

“We believe these unique data highlight lorecivivint’s promise to potentially provide structural benefit to the millions of patients suffering from osteoarthritis,” commented Biosplice Chief Medical Officer, Yusuf Yazici, MD.

Key Points: 
  • “We believe these unique data highlight lorecivivint’s promise to potentially provide structural benefit to the millions of patients suffering from osteoarthritis,” commented Biosplice Chief Medical Officer, Yusuf Yazici, MD.
  • We recently initiated our phase 3 OA-21 clinical trial and are enrolling subjects.
  • The primary efficacy objective of OA-07 is to measure the disease-modifying potential of lorecivivint over multiple years and injections.
  • The OA-21 phase 3 clinical trial is designed as a 16-week study with a primary endpoint of Pain NRS at 12 weeks.

Providence Therapeutics Announces New mRNA Rabies Vaccine Program and Achievement of Preclinical Proof-of-Concept Milestone

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Thursday, December 15, 2022
Observation, Government of Canada, Diversified Specialty Institute Holdings, Inc., Partnership, Post-exposure prophylaxis, Government, Cancer, University, Mouse, Vaccine, RNA transfection, Rabies, Public expenditure, Infection, MBA, Public health, Disease, Therapy, Death, COVID-19, Patient, PTX-COVID19-B, Mount Everest

CALGARY, Alberta, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Providence Therapeutics Holdings Inc. ("Providence"), a clinical-stage biotechnology company pioneering mRNA vaccines for infectious diseases and oncology, today announced that its new mRNA vaccine program for rabies post-exposure prophylaxis has achieved a preclinical proof-of-concept milestone. The candidate was developed in partnership with Everest Medicines (“Everest”) utilizing Providence’s clinically validated mRNA technology platform.

Key Points: 
  • CALGARY, Alberta, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Providence Therapeutics Holdings Inc. ("Providence"), a clinical-stage biotechnology company pioneering mRNA vaccines for infectious diseases and oncology, today announced that its new mRNA vaccine program for rabies post-exposure prophylaxis has achieved a preclinical proof-of-concept milestone.
  • “We look forward to continuing to advance our rabies mRNA vaccine program with Everest as a critical part of a growing pipeline of mRNA vaccine candidates for infectious diseases with unmet needs around the world.”
    In a head-to-head immunogenicity comparison study with a commercial inactivated rabies vaccine, mice dosed with Providence’s pre-clinical rabies vaccine candidate produced higher levels of serum neutralizing antibodies than those of mice dosed with the comparator vaccine.
  • Providence and Everest hold 50/50 global rights to develop and commercialize the rabies vaccine.
  • Achieving this preclinical proof-of-concept milestone triggers the execution of a 3,492,365-share transfer of Everest’s publicly traded shares to Providence.

Evaxion to present a full clinical readout on two personalized cancer immunotherapies in Q2 2023

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Thursday, December 15, 2022
DNA, Cancer, Degenerative disease, Genetically modified bacteria, RNA transfection, Immune system, Melanoma, AI, Patient, Pharmaceutical industry, Vaccine

COPENHAGEN, Denmark, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, today announced that they expect to present data from their two clinical trials of personalized cancer immunotherapies (cancer vaccines) EVX-01 and EVX-02 in the second quarter of 2023.

Key Points: 
  • COPENHAGEN, Denmark, Dec. 15, 2022 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, today announced that they expect to present data from their two clinical trials of personalized cancer immunotherapies (cancer vaccines) EVX-01 and EVX-02 in the second quarter of 2023.
  • By mid-2023, Evaxion will present the full clinical readout of EVX-01 in metastatic melanoma and of EVX-02 in patients with resected malignant melanoma.
  • Evaxion’s CEO Per Norlén comments:
    “We are thrilled about the progress of our personalized cancer neoantigen programs, with EVX-01 already in Phase 2b.
  • Evaxion has a broad pipeline of novel product candidates, including three personalized cancer immunotherapies.

Anima Biotech To Present And Participate In Panel Discussion At The 5th RNA Targeted Drug Discovery Summit

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Wednesday, December 14, 2022
Molecule, Sustainable Development Investment Partnership, Pharma, MOA, RNA, RNA-targeting small molecule drugs, Takeda Pharmaceutical Company, Moai, Anima, Doctor of Philosophy, Arbutus Biopharma, RNA transfection, Lightning, Small molecule, Alzheimer's disease, Interactive Futures, AI, Automation, Lilly, Tau, Vaccine, Pain, Neuroscience, Fibrosis

During the conference, Anima Biotech’s chief business officer, Kevin Pong, Ph.D. will join the Biopharma & Investment Partnerships panel – Exploring the Future of RNA Investment & Collaborations Space for Small Molecules.

Key Points: 
  • During the conference, Anima Biotech’s chief business officer, Kevin Pong, Ph.D. will join the Biopharma & Investment Partnerships panel – Exploring the Future of RNA Investment & Collaborations Space for Small Molecules.
  • The panel takes place Wednesday, December 14, 2022 at 11:50 a.m.
  • Anima is advancing mRNA Lightning, a novel platform for the discovery of small molecule mRNA drugs and their mechanisms of action.
  • With our deep expertise in mRNA biology, we were able to advance them at unprecedented speed and success rate.

Gritstone bio Granted Two New U.S. Patents for Self-amplifying mRNA (samRNA)

Retrieved on: 
Tuesday, December 13, 2022
RNA, EDGE, Nature Biotechnology, Annual report, Epitope, Membrane protein, Security (finance), Immunology, Degenerative disease, Patent, Genome, Vaccine, Infection, RNA transfection, IP, Immune system, 1836 U.S. Patent Office fire, Severe acute respiratory syndrome coronavirus 2, Antigen, CORAL, Therapy, Pharmaceutical industry, Gritstone

11,510,973 includes claims covering antigen-encoding samRNA vectors and has broad applicability across Gritstone’s candidates in oncology and infectious disease.

Key Points: 
  • 11,510,973 includes claims covering antigen-encoding samRNA vectors and has broad applicability across Gritstone’s candidates in oncology and infectious disease.
  • Gritstone currently has eight applications granted or allowed in the United States, and approximately 300 patent applications pending in the United States and other jurisdictions.
  • Like traditional mRNA vaccines, samRNA vaccines use the host cell’s transcription system to produce target antigens to stimulate adaptive immunity.
  • Once identified, Gritstone then delivers its novel vaccine candidates (self-amplifying mRNA) to these optimal targets to drive neutralizing antibody and T cell immune response.

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

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Friday, December 9, 2022
Pediatrics, Immunotherapy, BioNTech, Clinical trial, Marketing, Omicron, Emergency Use Authorization, Safety, Originality, Science, Cancer, Peer review, Regeneron Pharmaceuticals, Pierre Geneves, News, Vaccine, RNA transfection, Hoffmann-La Roche, Infection, Research, Risk, Form 6-K, Pfizer–BioNTech COVID-19 vaccine, COVID-19, Publication, Medical device, Genentech, Pfizer, BNT162

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Key Points: 
  • Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
  • For more than 170 years, we have worked to make a difference for all who rely on us.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
  • This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995.

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

Retrieved on: 
Thursday, December 8, 2022
Pediatrics, Immunotherapy, BioNTech, Clinical trial, FDA, Marketing, Omicron, Safety, Originality, Science, Cancer, Peer review, Regeneron Pharmaceuticals, DO, Pierre Geneves, News, Vaccine, Vaccination, EUA, RNA transfection, Hoffmann-La Roche, Infection, BNT162, Research, Risk, Pfizer–BioNTech COVID-19 vaccine, COVID-19, Publication, Form, Pharmaceutical industry, Medical device, EU, Genentech, Pfizer

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Key Points: 
  • Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
  • For more than 170 years, we have worked to make a difference for all who rely on us.
  • Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
  • This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995.

Design Therapeutics Reports Positive Data from Single-Ascending Dose Trial of DT-216 for the Treatment of Friedreich Ataxia and Portfolio Progress

Retrieved on: 
Wednesday, December 7, 2022
RNA, Degenerative disease, Friedreich's ataxia, Security (finance), MAD, Webcast, Cerebellar ataxia, Research, CTG, Cohort, Plasma, Liver function tests, Clinical trial, Safety, CUG, Treatment, Female, Neurology, SAD, Vital signs, Therapy, Myotonic dystrophy, Investigational New Drug, FXN, UCLA, RNA transfection, Disease, Mutation, Caregiver, Division, Patient, GAA, Friedreich's Ataxia Research Alliance, PD, Nature, AES, AE, Pharmacokinetics, EST, DM1, IND, PK, Risk, Lead, Pharmaceutical industry, Vaccine, Mineral wool, FA, Design, Fuchs

CARLSBAD, Calif., Dec. 07, 2022 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today reported progress across its portfolio of novel GeneTAC™ small molecules. Today’s updates include initial results on DT-216 from the company’s single-ascending dose (SAD) Phase 1 clinical trial in patients with Friedreich ataxia (FA). The results show that DT-216 was generally well-tolerated and able to overcome the frataxin (FXN) transcription impairment that causes FA, with a greater than two-fold increase in FXN mRNA in the cohort with the highest response. These data support the continued advancement of DT-216 in the ongoing multiple-ascending dose (MAD) Phase 1 trial and the anticipated Phase 2 clinical trial in FA patients, which is on track to begin in 2023.

Key Points: 
  • Today’s updates include initial results on DT-216 from the company’s single-ascending dose (SAD) Phase 1 clinical trial in patients with Friedreich ataxia (FA).
  • The primary and secondary study objectives were to evaluate safety and tolerability, and pharmacokinetics (PK) of DT-216 in FA patients.
  • Patients in Cohorts 1-4 were dosed with a single bolus dose of DT-216 at increasing levels from 25 mg to 200 mg.
  • Design plans to dose at least three cohorts and report data from the MAD trial in mid-2023.