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Protein Mapping Study Reveals Valuable Clues for COVID-19 Drug Development

NIH Director's Blog: Drug Development

That’s the strategy employed by remdesivir , the only antiviral drug currently authorized by the U.S. Food and Drug Administration to treat COVID-19. Another promising strategy is drugs that target the proteins within human cells that the virus needs to infect, multiply, and spread.

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Clover Biopharmaceuticals Announces Positive Phase 1 Data for its Adjuvanted S-Trimer COVID-19 Vaccine Candidates

The Pharma Data

Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. We and our collaborators are steadfast in our commitment to the development of safe, effective and accessible COVID-19 vaccines for the global population.”.

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Clover Biopharmaceuticals Announces Publication of Phase 1 Clinical Trial Data for its Adjuvanted COVID-19 Vaccine Candidates in The Lancet

The Pharma Data

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

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New insights into the role of viral capsids in gene therapy safety

Drug Target Review

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. Adeno-associated virus as a delivery vector for gene therapy of human diseases. Adeno-associated virus-based gene therapy for lifelong correction of genetic disease.

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Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36

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The Altascientist Issue 36: Navigating the Key Considerations of Your Nonclinical Cell and Gene Therapy Studies

Alta Sciences

However, there are significant challenges associated with the successful development of these complex, leading-edge therapies. The in vivo nonclinical study of cell and gene therapies includes a thorough understanding of on-and-off-target activity, immune responses, and other adverse events just to name a few.

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Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate

The Pharma Data

Clover’s S-Trimer antigen adjuvanted with CpG 1018 plus alum demonstrated low reactogenicity while providing high levels of neutralizing antibodies and a strong Th1-biased cell-mediated immune response. Food and Drug Administration (FDA).

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