ZIOPHARM Oncology Inc. (NASDAQ:ZIOP) has announced its Q3 2020 earnings results and corporate update.
Advancing Sleeping Beauty TCR-T program
In the wake of the COVID-19 pandemic, the company’s employees have been working remotely. They have been advancing programs safely except for those in the laboratory. The company CEO, Laurence Cooper, said that despite the challenging environment, the company has been making progress in executing and making substantial advancements. For instance, the company is making massive progress with the Sleeping Beauty TCR-T program from the Houston campus in partnership with MD Anderson. The company expanded its infrastructure footprint in Houston by leasing MD Anderson facilities to enhance laboratory presence.
The company expanded its TCRs library, targeting neoantigen hotspots with more IP licenses from NCI. ZIOPHARM completed tech transfer for engineering runs to NCI and is currently validating NCI methodology in the GMP facility. Enrolment of patients with solid tumors at NCI decreased because of the pandemic. Still, NCI is now screening patients for neoantigens and TCRs for the expanded patient cohort for the TCR-T trial.
Cooper said that they have been gathering data to support regulatory documents for the combination of TCR with cytokine biology through next-generation technologies. ZIOPHARM has built a bioinformatics program supporting neoantigen identification, and the TCR-T manufacture will be a vital part of the program.
The company is on track to file an IND in Q1 2021, and it has prioritized the TCR-T hotspot study, which will commence in mid-2021. Cooper confirmed that the company is preparing to submit the IND application based on the FDA’s information through the pre-IND process.
ZIOPHARM received the rare pediatric designation for IL-12 in DIPG
During the third quarter, the company received a rare pediatric designation for controlled IL-12 in the experimental treatment of diffuse intrinsic pontine glioma (DIPG). At the early stage of the trial, the company will focus on patients’ safety because the treatment is for children with no alternative for survival since their DIPG invades the brainstem. ZIOPHARM is closely monitoring the tolerability and safety of initial patients, which the company will present at the Society for Neuro-Oncology conference.