Imugene Ltd (ASX:IMU, OTC:IUGNF) is trading higher on achieving the holy grail in cancer treatment of three complete responses in patients who had previously experienced a return of their cancer following autologous CAR T therapy.
A complete response means that the cancer has not returned.
Shares have been as much as 30.65% higher in ASX trading intra-day to A$0.081.
Non-Hodgkin’s lymphoma
Results come from the company’s ongoing Phase 1b clinical trial of azer-cel (azercabtagene zapreleucel), an allogeneic off-the-shelf CD19 CAR T-cell therapy, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin’s lymphoma (NHL).
This trial has treated 10 patients to date, all of whom had previously experienced a return of their cancer following autologous CAR T therapy, a challenging patient group with high unmet medical needs.
The trial involved two cohorts:
- Cohort A - six of the 10 patients were treated with azer-cel and lymphodepletion (chemotherapy); and
- Cohort B - four of the 10 patients were treated with azer-cel, lymphodepletion (chemotherapy) and interleukin 2 (IL-2).
Complete response for three patients
Three of the patients achieved a complete response, including two from Cohort B who have maintained their complete response for more than 120 and 90 days, respectively.
Cohort B, which included an additional treatment with interleukin 2 (IL-2), showed a higher overall response rate (ORR) of 67% compared to 33% in Cohort A.
Nine of the patients from the two cohorts are considered evaluable, meaning they qualified for at least a day-28 scan.
One patient from Cohort B has been treated and is awaiting their 28-day scan.
“We are delighted that the first two patients in the Cohort B in our azer-cel Phase 1b trial achieved a complete response and continue to maintain their complete responses, one for over 120 days and the other for over 90 days," said chief medical officer Paul Woodard MD.
“All four patients enrolled in Cohort B have failed four to five prior treatments, including autologous CAR T therapy.
“All four patients remain on the study and given the robust response rates and durability seen to date, we will continue to enrol patients in the azer-cel plus IL-2 cohort and will closely follow all patients for further responses and durability.”
The company plans to continue enrolling patients in this cohort and closely monitor their responses as it moves towards a potential Phase 2/3 registrational trial with the US Food and Drug Administration (FDA).
Staying in the body
Managing director and CEO Leslie Chong said: “I am proud of our clinical development team who assessed ways to enhance azer-cel's durability of response, as one of the biggest challenges in CAR T therapy is ensuring that the modified T-cells stay in the body long enough to kill cancer cells.”
“To maximise the response rates and durability further, we added a very low dose of IL-2 to the regimen in Cohort B.
“We are pleased with the results, which suggest improved outcomes in patients, and we look forward to amassing more data using this dosing regimen.
“We will continue to seek biomarker evidence from Cohort B patients that suggest our strategy is improving the performance of azer-cel.”
Imugene is also exploring the potential of azer-cel beyond blood cancers, with future plans to combine it with its onCARlytics program for solid tumour treatments, potentially expanding its market reach significantly.