ZIOPHARM Oncology Inc. (NASDAQ:ZIOP) announced financial results for the third quarter ended September 30, 2015, and provided an update on the company’s recent activities.
“The third quarter saw an important expansion of our pipeline with the signing of a new Exclusive Channel Collaboration with our longtime partner Intrexon to include immunotherapies for the treatment of graft-versus-host-disease, or GvHD,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. “This adds to our research programs with Intrexon in virotherapies, T-cell therapies and natural killer cell therapies for the treatment of cancer, all of which are advancing in the lab and clinic. We look forward to presenting a variety of data at scientific meetings before the end of this year.”
Ad-RTS-hIL-12 is a gene therapy candidate for the controlled expression of interleukin 12 (IL-12), a critical protein for stimulating an anti-cancer T cell immune response, using the RheoSwitch Therapeutic System® (RTS®) gene switch. ZIOPHARM is currently enrolling patients in two studies of Ad-RTS-hIL-12: a Phase 1b/2 study for the treatment of patients with locally advanced or metastatic breast cancer following standard chemotherapy and a multi-center Phase 1 study in patients with recurrent or progressive glioblastoma multiforme, a form of brain cancer. The Company expects that early results from each study will be presented at scientific meetings prior to year’s end.
In September, ZIOPHARM announced the presentation of preclinical and clinical data from the Company’s Ad-RTS-IL-12 program in various malignancies at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference in New York City.
These included a presentation highlighting additional evidence of systemic immune activation with Ad-RTS-hIL-12 and veledimex in advanced melanoma and breast cancer patients. Among other findings, treatment with Ad-RTS-hIL-12 and veledimex in patients with melanoma was found to increase the immune cytokine IL-12 and downstream cytokines, interferon gamma (IFN-g), interferon gamma-inducible protein 10 (IP-10) and interleukin 10 (IL-10), resulting in a significant increase in tumor infiltrating lymphocytes both locally, in injected lesions, and systemically, in non-injected lesions. These data provide clinical evidence of an abscopal response, in which local treatment affects other tumor sites at a distance, and confirm that localized therapy can lead to beneficial systemic anti-tumor effects.
A second presentation demonstrated the anti-tumor effects and tolerability of Ad-RTS-mIL-12 in mouse models of glioblastoma (brain cancer), colon cancer and melanoma. These data showed dose-related increases in veledimex in both plasma and brain tissue, leading to a corresponding elevation in expression of IL-12 mRNA. Ad-RTS-mIL-12 and veledimex also demonstrated systemic memory upon rechallenge in multiple syngeneic mouse models, providing further evidence of systemic anti-tumor immunity elicited by Ad-RTS-mIL-12.
ZIOPHARM announced in July 2015 that the U.S. Food and Drug Administration granted Orphan Drug Designation for Ad-RTS-hIL-12 and veledimex in the treatment of patients with malignant glioma. The FDA’s Office of Orphan Products grants orphan drug status to support development of medicines for underserved patient populations or rare disorders affecting fewer than 200,000 people in the U.S. Orphan Drug Designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, an accelerated review process, accelerated approval where appropriate, grant funding, tax benefits and an exemption from user fees.
Adoptive Cell Therapies
ZIOPHARM is developing various immuno-oncology programs, including chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR) and natural killer (NK) adoptive cell based therapies. These programs are being advanced in collaboration with Intrexon, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, and the MD Anderson Cancer Center.
ZIOPHARM expects that early results from its adoptive cell therapy programs, including data highlighting the Sleeping Beauty non-viral gene transfer technology, will be presented to the medical and scientific community prior to year end.
ZIOPHARM announced in September the publication of a preclinical study in Cancer Research, a journal of the American Association for Cancer Research, demonstrating the preferential targeting of solid tumor cells over healthy cells using engineered chimeric antigen receptor (CAR) T cells. The publication described how tuning the binding affinity of CARs to activate T cells based on the density of EGFR expression allows for targeting of cancer cells with high levels of EGFR, while sparing normal cells with low levels of EGFR. The study demonstrates an approach for translating the effects of adoptive CAR T-cells from liquid to solid tumors.
In September, Intrexon Corporation announced that it has formed a new Exclusive Channel Collaboration with ZIOPHARM for the treatment and prevention of graft-versus-host disease (GvHD). GvHD is a major complication of allogeneic hematopoietic stem-cell transplantation which significantly impairs the quality of life and survival of many recipients, and is unaddressed by existing treatments, which have limited efficacy and increased toxicity. The collaboration will focus on addressing the underlying pathologies of GvHD through engineered cell platforms to express and control delivery of interleukin-2 (IL-2), a cytokine critical for modulation of the immune system. The companies plan to employ two treatment approaches: infusion of regulatory T cells (Tregs) conditionally expressing IL-2 utilizing Intrexon’s proprietary gene control approaches such as its RheoSwitch® platform; and deployment of orally-delivered microbe-based ActoBiotics® therapeutics expressing IL-2 to modulate immune function.
Under the terms of the agreement, Intrexon is to receive a technology access fee of $10 million in cash and reimbursement for all research and development costs. The agreement also provides for equal sharing of operating profits.
In September, ZIOPHARM announced the appointment of Scott Tarriff to the Company’s Board of Directors. Mr. Tarriff, who serves as President, Chief Executive Officer and a Director of Eagle Pharmaceuticals, brings more than 25 years of pharmaceutical industry experience to ZIOPHARM.
Third-Quarter 2015 Financial Results
- Net loss for the third quarter of 2015 was $18.2 million, or $(0.14) per share, compared to a net loss of $6.1 million, or $(0.06) per share, for the third quarter of 2014. Included in the loss for the third quarter of 2014 was non-cash income of $5.8 million, or $(0.06) per share for the change in fair value of warrants.
- Research and development expenses were $17.0 million for the third quarter of 2015 compared to $9.7 million for the third quarter of 2014. The increase in research and development is due to a $10.0 million charge for in-process research and development with Intrexon for GvHD, and of $4.3 million related to CAR-T programs. These increases were offset by $5.7 million in savings related to discovery and nonclinical activities, $625 thousand in clinical study costs related to small molecule programs and $775 thousand savings in payroll, employee related and other expenses.
- General and administrative expenses were $3.1 million for the third quarter of 2015 compared to $2.8 million for the third quarter of 2014. The increase of $0.3 million in general and administrative expenses is primarily attributable to non-cash equity compensation and other employee related expenses.
- The Company ended the quarter with cash and cash equivalents of approximately $163.8 million. Given current development plans, the Company anticipates that current cash resources will be sufficient to fund our planned operations into the first quarter of 2018. (Original Source)
- Shares of Ziopharm Oncology Inc opened today at $11.43 and are currently trading up at $12.26. ZIOP has a 1-year high of $14.40 and a 1-year low of $3.03. The stock’s 50-day moving average is $10.95 and its 200-day moving average is $10.72.
On the ratings front, Ziopharm has been the subject of a number of recent research reports. In a report issued on September 29, J.P. Morgan analyst Cory Kasimov reiterated a Hold rating on ZIOP. Separately, on September 17, Griffin Securities’ Keith Markey reiterated a Buy rating on the stock and has a price target of $21.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Cory Kasimov and Keith Markey have a total average return of 0.9% and -23.6% respectively. Kasimov has a success rate of 52.7% and is ranked #1763 out of 3808 analysts, while Markey has a success rate of 15.8% and is ranked #3724.
ZIOPHARM Oncology Inc is a biopharmaceutical company. The Company is engaged in the acquiring, developing and commercializing portfolio of cancer therapies that can address unmet medical needs through synthetic biology.