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    Synthorx Initiates Patient Dosing in Australia and Announces Clearance of IND in the U.S. for THOR-707

    Jocelyn Aspa
    Jul. 24, 2019 09:45AM PST
    Biotech Investing

    Synthorx (NASDAQ:THOR) has announced it has begun its  Phase 1/2 clinical trial of THOR-707 in Australia as well as receiving clearance from the US Food and Drug Administration (FDA) for the company’s investigational new drug application of THOR-707. As quoted in the press release: The single agent and combination arms of the trial are evaluating …

    Synthorx (NASDAQ:THOR) has announced it has begun its  Phase 1/2 clinical trial of THOR-707 in Australia as well as receiving clearance from the US Food and Drug Administration (FDA) for the company’s investigational new drug application of THOR-707.

    As quoted in the press release:

    The single agent and combination arms of the trial are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of THOR-707 in patients with advanced or metastatic solid tumors.

    “Our preclinical studies of THOR-707 have shown expansion of NK and CD8+ T cells, and durable anti-tumor effects without vascular leak syndrome (VLS), the toxicity that has limited the use of high-dose IL-2”, said Laura Shawver, Ph.D., president and chief executive officer of Synthorx. “Taken together, the favorable pre-clinical attributes of THOR-707 suggest that this may provide a differentiated product with clinically meaningful anti-tumor activity, minimal regulatory T cell-driven immunosuppression and convenient dosing schedules for patients”. This is the first Synthorin to enter the clinic engineered using Synthorx’ Expanded Genetic Alphabet platform, which enables the site-specific incorporation of novel amino acids to enhance the pharmacological properties of protein therapies like IL-2.

    Click here to read the full press release.

    nasdaq:thoraustraliaus food and drug administration
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