Noxopharm Ltd (ASX:NOX) is building momentum around a phase two trial for its experimental immunotherapy DARRT-2 cancer treatment candidate.
The company reports its first patient cohort has been fully enrolled and an Australian site has joined two clinical centres in the US as a DARRT-2 trial site.
Ultimately, the progress continues to advance NOX’s treatment candidate, which the company believes could one day address the challenges seen in other immunotherapy treatments.
Speaking to the headway, Noxopharm chief medical officer Dr Gisela Mautner said: “This phase two study builds on our phase one trial, where we saw promising signals that it may be possible to achieve cancer reduction through the abscopal response.
“A combination of Veyonda and low-dose radiation therapy would be a very important new treatment option for cancer patients worldwide as many of the current immunotherapy treatments have considerable limitations.”
About DARRT
Direct and Abscopal Response to Radiotherapy (DARRT) is an experimental immunotherapy cancer treatment based on the combination of Veyonda® and a well-tolerated low dose of external beam radiotherapy.
The aim of the DARRT treatment is to trigger an immune response in a single tumour, resulting in tumours in the rest of the body resolving despite not receiving any radiation.
This form of immune response is known as an abscopal response — the subject of considerable clinical interest worldwide because of its potential to offer significant benefits over other forms of immunotherapies.
Those potential benefits include a broader range of responding cancer types, fewer side effects, greater access to treatment, fewer logistical challenges, and greater cost-effectiveness.
The trial
A trial of DARRT-2 is being undertaken across multiple sites in North America, Europe and Australia involving roughly 100 patients with metastatic cancers — such as prostate, breast and lung — who are eligible for low-dose radiotherapy.
The DARRT-2 trial marks the first time that Veyonda has been made available to patients in the United States, with patients enrolled at both the prestigious Beverly Hills Cancer Center in Los Angeles and the renowned MD Anderson Cancer Center in Houston.
The latter is of the largest cancer treatment centres in the world and consistently rated one of the best cancer treatment centres in the US.
Now, DARRT-2’s first Australian site is also open for enrolment.
Noxopharm reported that interest in the trial is strong and growing, with the first dosage group quickly enrolled following study opening.
The fine print
DARRT-2 builds on the early promise seen in the phase one DARRT-1 study by increasing the intensity of Veyonda treatment.
The initial cohort of three patients are receiving 1200 milligrams of Veyonda daily — the same dose used in DARRT-1.
The clinical response of these patients will then be reviewed by the Safety Steering Committee after the first cycle.
From here, patients will be enrolled in the 1600-milligram dose, with 2400 milligrams marking the final dose in the trial.
Patients will be scanned on a regular basis to measure their response to treatment, and interim safety updates will be provided over the course of 2022.
More sites in Australia, the US and Europe will come online progressively over the next few months.