Remove Clinical Development Remove Immune Response Remove RNA Remove Trials
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Merck and Moderna partner to develop and sell cancer vaccine

Pharmaceutical Technology

In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs. They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018. Under the latest deal terms, Merck will pay Moderna $250m to exercise its option for mRNA-4157/V940.

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Gene Therapy and Pharmacokinetics

Camargo

When developing a clinical development program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dosing with gene therapy drugs, to characterize exposure-response data and inform rational dosing.

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?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Worldwide Clinical Trials

To discuss your study and how to reduce the chances of receiving a clinical hold, talk with us. . The pandemic has had a lasting impact on the ability of sites to participate in trials, particularly in the US. It really is—there has been a 10x increase in cell and gene therapies in the clinical development pipeline since 2012.

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Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

The Pharma Data

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

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Race for COVID-19 vaccine hots up as EMA begins review of BioNTech/Pfizer jab

pharmaphorum

In the case of a rolling review, the EMA evaluates trial data as they become available before a complete filing is submitted. The vaccine is based on different technology from AZ’s rival: while AZ’s uses a weakened and genetically modified cold virus to prime the immune system, BNT162b2 is based on a string of RNA.

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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. The phase 1 clinical trial was a randomized, double-blind and placebo-controlled study in 150 adult and elderly participants.

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

The Pharma Data

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant.