Ziopharm Oncology Completes Enrollment of Controlled IL-12 Monotherapy Expansion Substudy in Phase 1 Brain Cancer Trial
Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, as a drug to control the production of interleukin 12 (IL-12). In the setting for the treatment of rGBM, previously reported Phase 1 data demonstrated an increased survival benefit when using 20mg of veledimex, which is extended further when patients also received low-dose steroids versus higher doses. A majority of the newly enrolled patients in the substudy were treated with low-dose steroids.
“Glioblastoma is a difficult-to-treat brain cancer, with very few therapeutic options at recurrence and there is a significant need to develop new treatment options,” said Rimas Lukas, M.D., associate professor of Neurology at Feinberg
The Company is now evaluating data from 51 patients with rGBM treated with 20mg veledimex dose and assessing the impact of systemic dosing of steroids. The safety profile in the substudy is consistent with the main, Phase 1, dose-escalation study (Clinicaltrials.gov NCT02026271) in which patients received varied systemic dosing of steroids, with all adverse reactions being manageable and reversible. Ziopharm anticipates reporting on preliminary data from this substudy at medical meetings this year.
About Ad-RTS-hIL-12 plus veledimex
At the 2018 annual meeting of the
The Company has treated more than 100 patients, including more than 75 patients with rGBM, with Ad-RTS-hIL-12 plus veledimex and administered more than 1,300 doses of veledimex across three types of solid tumors, building a significant safety profile, mechanistic dataset and evidence of anti-tumor effect. Biopsy data demonstrated that Controlled IL-12 turns immunologically-cold tumors hot based on sustained infiltration of killer T cells which is likely responsible for the preliminary improved survival observed with use of Ad-RTS-hIL-12 plus veledimex as monotherapy in patients with rGBM. Biopsy data also revealed upregulation of immune checkpoints providing a compelling rationale for combining Controlled IL-12 with PD-1 inhibitors.
Learn more about Controlled IL-12 online at https://ziopharm.com/controlled-il-12/.
About Ad-RTS-hIL-12 plus veledimex in combination with PD-1 inhibitors
The Company also is advancing Controlled IL-12 as a combination therapy with PD-1 inhibitors. Enrollment in a substudy of the ongoing Phase 1 trial to evaluate Controlled IL-12 in combination with the PD1 inhibitor OPDIVO® (nivolumab) is on track to be completed in the second quarter of this year (Clinicaltrials.gov NCT03636477). The Company is expected to begin a Phase 2 trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Regeneron Pharmaceuticals’ PD-1 antibody Libtayo® (cemiplimab-rwlc) in the second quarter of 2019.
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Source: ZIOPHARM Oncology Inc