Immunotherapeutic Strategy Results Presented at AACR 2013 Annual Meeting
NEW YORK, NY, USAI April 9, 2013 I ZIOPHARM Oncology, Inc. (ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today the presentation of results from a study in a breast cancer murine model demonstrating the anti-tumor effects and tolerability of Ad-RTS-mIL-12, a viral vector DNA-based therapeutic for the controlled, local expression of IL-12, an important protein for enhancing antitumor immunity. The data were presented at the American Association for Cancer Research 2013 Annual Meeting (AACR 2013) taking place April 6-10, 2013 in Washington, D.C. The study was conducted jointly by ZIOPHARM and Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function. ZIOPHARM is Intrexon’s exclusive channel partner for the development of in vivo therapeutics in oncology.
For the study, intratumoral administration of Ad-RTS-mIL-12 (Ad) was examined in a 4T1 BALB/c mouse breast carcinoma model. Production of murine IL-12 was controlled using Intrexon’s RheoSwitch Therapeutic System(R) (RTS(R)) platform and oral administration of the activator ligand INXN-1001 (AL). Oral administration of AL was found to elicit a dose-related increase in plasma AL levels, which correlated with increasing tumor levels of AL. The increase in tumor AL levels in combination with Ad in turn resulted in a dose-related increase in expression of mIL-12 in the tumor, with minimal increase in serum mIL-12. This increase in AL-regulated tumor IL-12 levels correlated with an increase in tumor-infiltrating CD4+ and CD8+ T cells in and adjacent to the tumor, concomitant with a decrease in tumor regulatory T cells. This resulted in a dose-related decrease in tumor growth rate. Moreover, the therapeutic strategy appears to be well tolerated, as no change in clinical signs or body weight was observed in the treated animals when compared with vehicle alone.
Samuel Broder, M.D., Chairman of Intrexon’s Therapeutic Opportunities Committee and former Director of the NCI (National Cancer Institute), stated, “Two major obstacles for the development of immunotherapeutics in the treatment of cancer are the ability of tumors to evade the anti-cancer capabilities of the immune system and the toxicity often associated with the systemic administration of immunomodulating agents. To overcome these challenges, we have developed Ad-RTS-IL-12, a DNA-based system for the regulated expression of IL-12, that allows for localized, controlled expression of immunomodulating cytokines and activation of their corresponding anti-tumor effects. This strategy is now being tested in the clinic, with the recent launch of a Phase 2 Study of Ad-RTS-IL-12 combined with palifosfamide in the treatment of advanced breast cancer.”
Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, commented, “These results support the hypothesis that localized delivery of IL-12 results in an increase in tumor infiltrating lymphocytes concomitant with a reduction in tumor growth. These findings suggest the applicability of this strategy in the treatment of breast cancer, especially in the context of recent literature addressing the positive correlation of survival with immune response measured in breast cancer tumors treated with non-immune therapies. This novel synthetic biology approach, which is being explored in several ongoing clinical studies, holds transformative potential for the treatment of cancer.”
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company’s clinical programs include:
Ad-RTS-IL-12 is currently being tested in two Phase 2 studies, the first for the treatment of advanced melanoma, and the second in combination with palifosfamide for the treatment of non-resectable recurrent or metastatic breast cancer. Ad-RTS-IL-12 uses synthetic biology to enable controlled delivery of therapeutic interleukin-12 (IL-12), a protein important for enhancing the development of an immune response to cancer. Being developed in partnership with Intrexon Corporation, ZIOPHARM’s DNA synthetic biology platform employs an inducible gene-delivery system that enables controlled delivery of genes that produce therapeutic proteins to treat cancer. This is achieved by placing IL-12 under the control of Intrexon’s proprietary biological “switch” (the RheoSwitch Therapeutic System(R) or RTS(R) platform) to turn on/off the therapeutic protein expression at the tumor site.
Palifosfamide (ZIO-201) is a potent, bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide.
Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer.
Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K.
ZIOPHARM’s operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com.
SOURCE: ZIOPHARM
Post Views: 239
Immunotherapeutic Strategy Results Presented at AACR 2013 Annual Meeting
NEW YORK, NY, USAI April 9, 2013 I ZIOPHARM Oncology, Inc. (ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced today the presentation of results from a study in a breast cancer murine model demonstrating the anti-tumor effects and tolerability of Ad-RTS-mIL-12, a viral vector DNA-based therapeutic for the controlled, local expression of IL-12, an important protein for enhancing antitumor immunity. The data were presented at the American Association for Cancer Research 2013 Annual Meeting (AACR 2013) taking place April 6-10, 2013 in Washington, D.C. The study was conducted jointly by ZIOPHARM and Intrexon Corporation, a synthetic biology company that utilizes its proprietary technologies to provide control over cellular function. ZIOPHARM is Intrexon’s exclusive channel partner for the development of in vivo therapeutics in oncology.
For the study, intratumoral administration of Ad-RTS-mIL-12 (Ad) was examined in a 4T1 BALB/c mouse breast carcinoma model. Production of murine IL-12 was controlled using Intrexon’s RheoSwitch Therapeutic System(R) (RTS(R)) platform and oral administration of the activator ligand INXN-1001 (AL). Oral administration of AL was found to elicit a dose-related increase in plasma AL levels, which correlated with increasing tumor levels of AL. The increase in tumor AL levels in combination with Ad in turn resulted in a dose-related increase in expression of mIL-12 in the tumor, with minimal increase in serum mIL-12. This increase in AL-regulated tumor IL-12 levels correlated with an increase in tumor-infiltrating CD4+ and CD8+ T cells in and adjacent to the tumor, concomitant with a decrease in tumor regulatory T cells. This resulted in a dose-related decrease in tumor growth rate. Moreover, the therapeutic strategy appears to be well tolerated, as no change in clinical signs or body weight was observed in the treated animals when compared with vehicle alone.
Samuel Broder, M.D., Chairman of Intrexon’s Therapeutic Opportunities Committee and former Director of the NCI (National Cancer Institute), stated, “Two major obstacles for the development of immunotherapeutics in the treatment of cancer are the ability of tumors to evade the anti-cancer capabilities of the immune system and the toxicity often associated with the systemic administration of immunomodulating agents. To overcome these challenges, we have developed Ad-RTS-IL-12, a DNA-based system for the regulated expression of IL-12, that allows for localized, controlled expression of immunomodulating cytokines and activation of their corresponding anti-tumor effects. This strategy is now being tested in the clinic, with the recent launch of a Phase 2 Study of Ad-RTS-IL-12 combined with palifosfamide in the treatment of advanced breast cancer.”
Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, commented, “These results support the hypothesis that localized delivery of IL-12 results in an increase in tumor infiltrating lymphocytes concomitant with a reduction in tumor growth. These findings suggest the applicability of this strategy in the treatment of breast cancer, especially in the context of recent literature addressing the positive correlation of survival with immune response measured in breast cancer tumors treated with non-immune therapies. This novel synthetic biology approach, which is being explored in several ongoing clinical studies, holds transformative potential for the treatment of cancer.”
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company’s clinical programs include:
Ad-RTS-IL-12 is currently being tested in two Phase 2 studies, the first for the treatment of advanced melanoma, and the second in combination with palifosfamide for the treatment of non-resectable recurrent or metastatic breast cancer. Ad-RTS-IL-12 uses synthetic biology to enable controlled delivery of therapeutic interleukin-12 (IL-12), a protein important for enhancing the development of an immune response to cancer. Being developed in partnership with Intrexon Corporation, ZIOPHARM’s DNA synthetic biology platform employs an inducible gene-delivery system that enables controlled delivery of genes that produce therapeutic proteins to treat cancer. This is achieved by placing IL-12 under the control of Intrexon’s proprietary biological “switch” (the RheoSwitch Therapeutic System(R) or RTS(R) platform) to turn on/off the therapeutic protein expression at the tumor site.
Palifosfamide (ZIO-201) is a potent, bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide.
Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer.
Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K.
ZIOPHARM’s operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com.
SOURCE: ZIOPHARM
Post Views: 239
