Arcus Biosciences has received approval from the US Food and Drug Administration (FDA) validating its two new product candidates, AB928 and AB122.
The approval is based on the investigational new drug (IND) applications submitted by Arcus and has enabled the company to conduct its proposed Phase l/lb trial of AB928 in combination with other agents, including AB122 and chemotherapy.
The trial aims to examine the safety, tolerability and preliminary efficacy of the AB928 combination for the treatment of patients with breast and gynaecologic malignancies.
It will include a dose-escalation phase to determine the optimal dose of AB928 to be combined with fixed doses of AB122 and with each of the three different immunogenic cell death (ICD) inducing chemotherapy regimens.
After selecting the recommended dose of AB928 for each combination, the trial will enrol expansion cohorts to investigate AB928 in combination with AB122 or chemotherapy to begin three tumour-specific trials for breast, gynaecologic and gastrointestinal malignancies, as well as lung cancer and renal cell carcinoma (RCC).
Each of the trials will allow Arcus to add new AB928 combination arms in the future.
In the dose-escalation portion of the trials, the company will evaluate the evidence of immune engagement to enable a mechanistic understanding of early clinical responses and others.
Results from the dose-escalation portion of the Phase l/lb trial are scheduled to be available in the first half of next year.
In addition, Arcus plans to submit two additional IND applications this month.
If approved, the company will start trials of AB928 combinations in gastrointestinal malignancies, non-small cell lung cancer (NSCLC) and RCC.
Arcus has also been completing the regulatory process to investigate the combination of AB928 and AB122 in patients in Australia and expects to dose its first patient with this combination soon.