US-based biotechnology firm Arvinas has reported positive data from the ongoing Phase I clinical trials of its cancer drug candidates, ARV-110 and ARV-471.
Based on the company’s PROTAC platform, ARV-110 and ARV-471 are protein degrader products that target the androgen receptor (AR) and the oestrogen receptor (ER), respectively.
The open-label, dose-escalation Phase I trials of the drug candidates are designed to assess safety, tolerability and pharmacokinetics, along with anti-tumour activity and pharmacodynamics.
ARV-110’s study involves 28-36 metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed on a minimum of two previous systemic therapies.
The trial assessing ARV-471 will enrol 24-36 participants suffering from oestrogen receptor-positive (ER+) / human epidermal growth factor receptor-2 negative (HER2-) locally advanced or metastatic breast cancer.
ARV-471 will be tested in patients who had prior hormonal therapy and chemotherapy.
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Initial trial results indicated that both the drugs are well tolerated across the doses evaluated, without any dose-limiting toxicities (DLTs) or grade 2, 3, or 4 adverse events.
ARV-110 data is from the first three dose-escalation cohorts assessing 35mg, 70mg and 140mg doses. The company also reported dose-proportional exposures of the drug.
For ARV-471, the results are from three patients in the 30mg dose cohort.
Arvinas CEO John Houston said: “We are seeing a favourable overall safety profile for both clinical programs to date, and dose-proportional exposures of ARV-110.
“We are encouraged by these initial results as we work to create well-tolerated therapies to treat serious diseases.”
The company will increase the dose of ARV-110 to 280mg and that of ARV-471 to 60mg in the next cohorts. Additional data from the Phase I trials is expected to be available next year.