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news.The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation for AffyImmune’s CAR T-cell therapy, AIC100, to treat recurrent anaplastic thyroid cancer (ATC).
The interim results from a Phase I study of AIC100 have shown promising outcomes in the treatment of advanced thyroid cancer. Credit: Colin Behrens from Pixabay.
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The designation comes after the FDA reviewed the available initial clinical data showing AIC100’s potential to treat recurrent ATC.
RMAT designation is aimed at expediting the development and review of regenerative medicine therapies that show potential to fill unmet medical needs.
To qualify for RMAT designation, a regenerative medicine therapy must be intended to treat, modify, reverse, or cure a serious condition, and there must be preliminary clinical evidence indicating that the therapy could address unmet medical needs for the disease.
AffyImmune’s interim results from their Phase I study of AIC100 have shown promising outcomes in the treatment of advanced thyroid cancer.
The RMAT designation allows companies such as AffyImmune to benefit from increased interactions with the FDA.
These interactions are designed to expedite the drug development and review process.
The interim data from the Phase I clinical trial that assessed the safety and efficacy of AIC100 have been encouraging, with one patient achieving a metabolic complete response.
AIC100 works by specifically targeting ICAM-1 and is an affinity-tuned LFA-1 binder CAR T-cell therapy.
AffyImmune CEO Daniel Janse said: “We believe this important recognition from the FDA further supports the therapeutic potential of AIC100 to change the current treatment paradigm in advanced thyroid cancer and potentially other forms of aggressive solid tumours.
“RMAT designation was granted following the FDA’s review of safety and efficacy data from the first ten patients dosed with AIC100 in our Phase I study. We believe the RMAT designation reinforces the potential ability of AIC100 to meet the high unmet medical need in recurrent ATC, an aggressive disease where a standard of care is currently not available.”
