BOSTON, Aug 08, 2019 (GLOBE NEWSWIRE via COMTEX) -- - FDA Cleared IND for Phase 1 Trial of Sleeping Beauty TCR-T cell therapy for
patients with solid tumors at the National Cancer Institute (NCI) -
- Exclusive license from NCI for library of T-cell receptors (TCRs) targeting neoantigens in the hotspots KRAS, p53 and EGFR -
- Balance sheet strengthened with $45 million in proceeds from early warrant exercise -
- NCI's Dr. Drew Deniger to direct TCR program; Sath Shukla named CFO -
- Company to host conference call and webcast today at 8:30 a.m. ET -
Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") /zigman2/quotes/200291745/composite ZIOP -0.38% , a clinical stage immuno-oncology company developing next generation cell and gene therapies, today announced its financial results for the second quarter ended June 30, 2019, and provided an update on the Company's recent activities.
"We have made significant advancements in our programs during the second quarter. The FDA cleared the IND for the first non-viral, neoantigen-specific TCR-T cell therapy at the NCI using our Sleeping Beauty system and we announced an exclusive license to an expansive library of TCRs against neoantigens in three of the most important hotspot families," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "In our Controlled IL-12 program, we completed enrollment of the third dosing cohort in our phase 1 combination trial with nivolumab and initiated a phase 2 combination trial with Regeneron's Libtayo. Finally, we refined our plans for the third-generation Sleeping Beauty CD19-specific CAR-T phase 1 trial at MD Anderson Cancer Center, which we continue to expect to commence later this year."
David Mauney, M.D., President of Ziopharm, added, "As our clinical programs continue to advance, we have strengthened our balance sheet and expanded the breadth and depth of our corporate leadership. We are proud to welcome Sath Shukla and Dr. Drew Deniger to our leadership team and Heidi Hagen to our Board of Directors. We are grateful that through the support of key shareholders who exercised their existing warrants several years prior to expiration, we added $45 million to our treasury to provide us with cash into the first half of 2021, which we expect will allow us to see data readouts in the three programs."
Since the beginning of the second quarter, Ziopharm has announced positive corporate developments regarding expansion of the management team and strengthening of the company's balance sheet.
Sleeping Beauty TCR-T Therapies
The Company is using its non-viral gene transfer technology to implement personalized T-cell therapy targeting solid tumors with TCRs. Under a Cooperative Research and Development Agreement (CRADA), the NCI is initiating a clinical trial to treat patients with metastatic/advanced solid tumors using the Company's Sleeping Beauty transposon/transposase platform to genetically modify patient-derived T cells with TCRs to target patient-specific neoantigens.
Sleeping Beauty CAR-T Therapies
Ziopharm is advancing the Sleeping Beauty platform for the rapid personalized manufacture (RPM) of CAR-T cells, co-expressing membrane-bound interleukin-15, or mbIL15, with a safety switch, enabling T cells to be infused within two days after genetic modification. This work on our third-generation Sleeping Beauty technology is undertaken in collaboration with MD Anderson Cancer Center in the United States and in Greater China through a joint venture, Eden BioCell.
Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, to control the production of human interleukin 12 (hIL-12) which activates the immune system to recruit and sustain cancer-fighting T cells within solid tumors. Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex for the treatment of recurrent glioblastoma multiforme (rGBM) as a monotherapy and in combination with immune checkpoint inhibitors.