Kymera Therapeutics ( NASDAQ: KYMR ) reported data from a patient group portion of its drug KT-474 (IRAK4) from a phase 1 trial, and updates on its three oncology programs: KT-413 (IRAKIMiD), KT-333 (STAT3) and KT-253 (MDM2).
KT-474 :
The company said Part C of its KT-474 phase 1 trial was designed to confirm that the Pharmacokinetics/Pharmacodynamics ((PK/PD)) and safety data previously shown in healthy people would translate into patients with hidradenitis suppurativa (HS) and atopic dermatitis (AD), also known as eczema.
HS is a condition which causes painful lumps to form under the skin, usually in areas where the skin rubs together, such as armpits and groin.
In the patients, KT-474 showed plasma PK in Part C which was comparable to healthy people in MAD3. Baseline IRAK4 level in skin lesions of patients with HS and AD was about two-fold higher compared to healthy volunteers., the company said.
Kymera added KT-474 showed IRAK4 knockdown in both blood and skin that was comparable to MAD3, with maximum degradation exceeding 90%. Target degradation was similar across patients with HS and AD in both blood and skin.
KT-474 was generally safe and well-tolerated, with no serious adverse events and there were no drug-related infections, according to the company.
In addition, Kymera said that Sanofi ( NASDAQ: SNY ), which is collaborating with Kymera on the development of KT-474 (SAR444656) outside the oncology and immune-oncology fields, has committed to advance KT-474 (SAR444656) into phase 2 trials, with initial such studies planned in HS and AD. The first study is expected to start in 2023.
Oncology Degraders: KT-333, KT-413, KT-253:
KT-333 : Kymera said KT-333 is being evaluated in a phase 1 trial in adult patients with relapsed and/or refractory lymphomas, leukemias and solid tumors.
Plasma PK and PD translated as expected in humans with mean maximum STAT3 degradation in PBMC after the first 2 doses averaging 66%, with maximum STAT3 knockdown of up to 86%, the company added.
KT-413 : Meanwhile, a phase 1 study is testing KT-413 administered as an IV infusion once every 3 weeks to adult patients with relapsed and/or refractory B-cell non-Hodgkin's lymphomas.
The company added that plasma PK and PD also translated as expected in humans with DL1 and DL2 showing dose-dependent degradation of IRAK4, Ikaros and Aiolos in PBMC, with up to 95/100% knockdown of Ikaros/Aiolos and 40% knockdown of IRAK4 in DL2.
KT-253 : Kymera noted that the FDA has cleared an application to start a trial of the drug and the company is planning a phase 1 trial of KT-253 in adult patients with liquid and solid tumors in 2023.
KYMR +32.69% to $34.30 premarket Dec. 14
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Kymera surges 30% as Sanofi plans to advance drug after promising data in skin disorders