Patients with a newly diagnosed glioblastoma multiforme (GBM) brain tumor may now enroll in a Phase 1b/2a clinical trial testing a triple immunotherapy combination for the cancer.
INO-5401 is an immunotherapy that encodes the antigens for the WT1, hTERT, and PSMA proteins found at high levels in several cancer cell types, but minimally expressed in healthy tissues.
Due to their specificity, these proteins have been designated by the National Cancer Institute as high priorities for cancer immunotherapy development.
While INO-5401 encodes for cancer proteins, INO-9012 encodes for the interleukin-12 (IL-12) protein, which triggers the activation and expansion of immune T-cells, boosting the anti-cancer immune response.
Cemiplimab, formerly known as REGN2810, is an anti-PD-1 immune checkpoint inhibitor developed by Regeneron and Sanofi. It is also used to boost the immune activity against tumor cells.
The new trial was designed to evaluate the safety and tolerability of the triple combination in 50 glioblastoma patients.
Conducted at 30 clinical sites in the United States, the study will also evaluate the overall immune response, as well as patients’ progression-free survival and overall survival rates.
The rationale behind the study is that combining the specificity of INO-5401 with therapies that boost immune responses — INO-9012 and cemiplimab — may lead to better response and survival rates.
Inovio also partnered with Genentech to test a similar approach in bladder cancer patients. The Phase 1/2 trial is testing INO-5401 and INO-9012 in combination with the already approved immune checkpoint inhibitor Tecentriq (atezolizumab).
“I believe that INO-5401, a three antigen product targeting WT-1, PSMA and hTERT, offers great potential to address multiple cancers,” J. Joseph Kim, president and CEO of Inovio, said in a press release. “Our INO-5401 combination study in GBM, as well as its sister study in advanced bladder cancer, represents an important opportunity for Inovio and its collaborators to address significant unmet medical need.”
This Phase1b/2a open-label study will be conducted and funded by Inovio based on the pre-established agreement between Inovio and Regeneron. Analysis of the trial data, particularly immunological measures, will be performed by both companies.