Kymera Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for KT-333 to treat Relapsed/Refractory (R/R) Cutaneous T-Cell Lymphoma (CTCL) and Peripheral T-Cell Lymphoma (PTCL).
KT-333 is a highly selective degrader of STAT3, a transcriptional regulator that is linked to inflammatory and autoimmune diseases as well as various cancers.
The company is also developing KT-333 to treat several STAT3-dependent pathologies including haematological malignancies and solid tumours.
Last year, KT-333 received orphan drug designation from the FDA for the treatment of both CTCL and PTCL.
Kymera Therapeutics chief medical officer Jared Gollob said: “The KT-333 fast track designation highlights the promise of degrading STAT3, a protein that has historically been undruggable, for the treatment of patients with CTCL and PTCL.
“We look forward to providing an update on the KT-333 Phase I clinical trial later this year, including initial evaluation of its antitumour activity in the target patient populations, and to working with the lymphoma community to rapidly advance this first-in-class heterobifunctional degrader in CTCL and PTCL in addition to exploring its potential in other cancers.”
A Phase I study is evaluating the pharmacokinetics, pharmacodynamics, tolerability, and safety of KT-333 in adults with R/R leukemias, solid tumours and lymphomas.
Adult patients in this ongoing oncology trial will receive weekly doses of KT-333.
The fast track process will expedite new medicines access to patients more quickly.