Intrexon Corporation Appoints Peter Emtage as Vice President, Synthetic Immunology
Dec 4 14
Intrexon Corporation announced the appointment of Peter Emtage, Ph.D., as Vice President, Synthetic Immunology. Dr. Emtage will focus on further advancing the company's oncology and immunology platforms to bring the next generation of cellular-based solutions that overcome the limitations of current treatments and address the most challenging malignancies. Dr. Emtage brings to Intrexon over sixteen years of biologics development experience in the fields of oncology, autoimmunity, infectious diseases, and inflammation. Most recently, Dr. Emtage was Vice President of Immune Mediated Therapy in the Oncology Innovative Medicines group at Medimmune.
ZIOPHARM Oncology, Inc. and Intrexon Corporation Present Clinical and Preclinical Data from Immuno-Oncology Programs at AACR Tumor Immunology and Immunotherapy Meeting
Dec 3 14
ZIOPHARM Oncology, Inc. and Intrexon Corporation announced the presentation of clinical and preclinical studies from their immuno-oncology programs at the American Association for Cancer Research (AACR) 2014 Immunology and Immunotherapy Meeting taking place December 1-4, 2014 in Orlando, Florida. Presentations include: Clinical results from the Ad-RTS-hIL-12 + veledimex studies in patients with advanced breast cancer and melanoma demonstrating local and systemic IL-12-mediated anti-cancer activity, as well as safety through control of both immune- and IL-12-mediated toxicity with use of the RheoSwitch. Therapeutic System(R) (RTS(R)) gene switch (Abstract #B11); Preclinical data supporting the potential for cytolytic activity against solid tumor targets with allogeneic, genetically-modified stem cells enabled for controlled release of cell-linking moieties (CLMs) within the tumor micro-environment (Abstract #B25); and Preclinical data describing the development of a novel, high-throughput screening technology for rapidly identifying bi-specific antibodies capable of inducing targeted immunologic activity through the activation of T-cells or other immune cells against tumors (Abstract #B16). Interim clinical trial results continue to validate dose-dependent oral veledimex control of the Interleukin-12 (IL-12) gene program module and the rapid reversibility of cytokine expression and associated adverse events in patients upon withdrawal of the activator ligand. Together the Companies intend to integrate this RTS-hIL-12 veledimex-controlled cytokine module into a suite of next generation cellular products armed with tumor specific targeting and signaling through chimeric antigen receptor (CAR), T-Cell Receptor (TCR), and cell linking moiety (CLM) platforms. In two open-label Phase II clinical studies, twelve patients with metastatic advanced stage breast cancer and twenty-six patients with metastatic melanoma were administered Ad-RTS-hIL-12, a novel DNA-based therapeutic candidate for the controlled expression of IL-12, a potent cytokine for stimulating an anti-cancer T-cell immune response. Following intra-tumoral injection of Ad--RTS--hIL--12, expression of IL-12 within patients was controlled by the RheoSwitch Therapeutic System(R) (RTS(R)) gene switch using the oral activator ligand, veledimex, at doses ranging from 5mg to 160mg. All subjects had heavy tumor burden and disease progression at the time of enrollment, with mean number of prior therapies at 14 and 10 for breast cancer and melanoma patients, respectively. Treatment with Ad-RTS-hIL-12 + veledimex resulted in an increase in the immune cytokine IL-12 and downstream cytokines, IFNg, IP-10 and IL-10, resulting in a significant increase in the number of CD8+ T-cells. Among seven evaluable subjects in the Phase II clinical study of Ad-RTS-IL-12 + veledimex in patients with recurrent or metastatic breast cancer, three had stable disease, including one triple negative BC subject who crossed the primary endpoint of 16 week progression free survival, for a disease control rate (stable disease or better) of 43%. Target lesions and tumor burden were significantly reduced in approximately 40% of patients. In the Phase I/II study of Ad-RTS-hIL-12 + veledimex in subjects with unresectable stage III/IV melanoma, of eighteen evaluable subjects, one had a partial response and six had stable disease, for a disease control rate of 39%. In melanoma patients for whom a response was observed, there was evidence of local and systemic anti-cancer activity.
Intrexon Corporation Announces Unaudited Consolidated Financial Results for the Third Quarter and Nine Months Ended September 30, 2014
Nov 13 14
Intrexon Corporation announced unaudited consolidated financial results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported total revenues of $21.197 million against $6.042 million a year ago. Operating loss was $15.047 million against $12.037 million a year ago. Loss before tax was $53.862 million against income before tax of $14.991 million a year ago. Net loss attributable to the company was $52.725 million or $0.53 per diluted share against net income attributable to the company of $15.498 million or $0.15 per diluted share a year ago. Adjusted EBITDA was $1.594 million against adjusted LBITDA of $5.034 million a year ago.
For the nine months, the company reported total revenues of $40.838 million against $16.617 million a year ago. Operating loss was $51.001 million against $40.297 million a year ago. Loss before tax was $103.525 million against $27.890 million a year ago. Net loss attributable to the company was $100.653 million or $01.02 per diluted share against $26.776 million or $2.05 per diluted share a year ago. Adjusted EBITDA was $8.754 million against adjusted LBITDA of $16.576 million a year ago.