| Item 7.01 | Regulation FD Disclosure. |
On November 23, 2019, Ziopharm Oncology (the “Company”) issued a press release announcing the presentation of new interim analyses of clinical data at the 2019 Society for Neuro-Oncology (SNO) Annual Meeting.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report onForm 8-K. The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
In the press release described above, the Company provided an update from two ongoing studies of its ControlledIL-12 platform, orAd-RTS-hIL-12 plus veledimex, both as monotherapy and in combination with aPD-1 inhibitor, for the treatment of recurrent or progressive glioblastoma multiforme (“rGBM”) in adults.
Monotherapy Expansion Substudy Interim Results
In a phase 1 clinical trial of patients with rGBM (the “Main Study”), a subset of patients (n=6) with unifocal disease who receivedlow-dose steroids along with 20 mg of veledimex plusAd-RTS-hIL-12, achieved 17.8 months median overall survival, or mOS.Thirty-six additional patients with rGBM were recruited in a substudy (the “Expansion Substudy”) designed to encourage use oflow-dose steroids and 20 mg veledimex to further understand the potential of ControlledIL-12 as a monotherapy.
The Company has provided the following interim update for the Expansion Substudy:
| | • | | A decrease in tumor from baseline resulted in a patient’s lesion being too small to measure, assessed as a partial response (per iRANO), with follow up ongoing |
| | • | | MRI findings of pseudoprogression in subjects, consistent with immune-mediated anti-tumor effects |
| | • | | Subjects in the Expansion Substudy were comparable to the subjects in the Main Study except a higher percentage of subjects in the Expansion Substudy had multifocal disease (as compared with unifocal disease) and fewer recurrences |
| | • | | Subjects receiving 20 mg of veledimex in both the Main Study and Expansion Substudy (n=20) with unifocal disease at entry, receivinglow-dose steroids (defined as <20 mg cumulative dosing of dexamethasone) had a mOS of 16.2 months. The mOS for these subjects in the Expansion Substudy alone (n=14) has not been reached at a mean follow up of 9.7 months |
| | • | | Subjects with multifocal disease at entry that received 20mg of veledimex andlow-dose steroids (n=13) had a mOS of 10.1 months. Literature shows that multifocal glioblastoma is associated with worse prognosis compared to unifocal disease |
| | • | | Adverse reactions were consistent with prior studies of ControlledIL-12 and were predictable, dose-related, and promptly reversible upon discontinuation of veledimex |
Combination Study Interim Results
The Company is also studyingAd-RTS-hIL-12 plus veledimex in combination with nivolumab, an immune checkpoint inhibitor, in a phase 1 dose-escalation trial of patients with rGBM. The Company has provided the following interim update for this trial:
| | • | | Decrease by 64% in a patient’s tumor from baseline resulting in a partial response (per iRANO), with follow up ongoing |
| | • | | MRI findings of pseudoprogression in subjects, consistent with immune-mediated anti-tumor effects |
| | • | | Active dosing is ongoing and mOS has not been reached, with a mean follow up for subjects of 4.8 months |
| | • | | No dose limiting toxicities, no serious adverse events that were considered related to the combination with nivolumab and no clinically significant overlapping toxicities have been observed |
| | • | | Drug-related toxicities were comparable to the Main Study, being predictable, dose-related, and promptly reversible upon discontinuation of veledimex and there have been no drug-related deaths |
