Synthetic biology firm Intrexon is paying $11.63 million for a 5% stake in Ziopharm Oncology as part of a global collaboration through which Ziopharm gains rights to use its partner’s UltraVector® transgene engineering platform for the development of DNA-based anticancer drugs. The deal gives Ziopharm rights to Intrexon’s complete human in vivo effector platform in the field of oncology, including a Phase I-candidate for metastatic melanoma and another anticancer candidate at the IND submission stage.
Intrexon retains the responsibility for technology discovery research, managing the patent estate, and certain aspects of manufacturing. Ziopharm will shoulder preclinical and clinical development of candidates along with their commercialization and other manufacturing responsibilities.
The financial nuts and bolts of the share-based agreement will see Intrexon pay $4.8 per share for the first 2,422,542 shares of Ziopharm’s common stock. Ziopharm will then immediately issue to Intrexon another 3,641,391 shares in its common stock at no cost, representing an additional 7.495% stake. Intrexon could subsequently receive shares representing yet another 7.495% stake in Ziopharm once the latter starts a U.S. trial evaluating a product developed using Intrexon technology.
Intrexon has also agreed the potential future purchase of up to a $50 million worth of Ziopharm securities offered under certain conditions and limitations. Meanwhile, Ziopharm could pay Intrexon 50% of cumulative net quarterly profits derived from the sale of products developed through the partnership.
Intrexon is exploiting its synthetic biology-based UltraVector genetic engineering platform for applications in therapeutics, protein production, industrial biotechnology, and agricultural biotechnology. The firm claims the platform provides flexible, consistent and precision-based capabilities for designing, producing, and testing complex transgenes.
“Controllable, scalable synthetic biology, the tightly regulated delivery of therapeutic proteins from within the body, is an aspirational and disruptive technology, which Intrexon has brought from scientific theory to medical applications,” claims Jonathan Lewis, M.D., Ziopharm CEO and CMO. “As the sole channel partner for in vivo therapeutic candidates for human oncology, Ziopharm plans to leverage this technology for next-generation products targeting key pathways used by cancers to grow and metastasize. Intrexon has developed a technology that is uniquely flexible, scalable, and controllable, adding significantly to our small molecule development capabilities.”
Ziopharm is focused on the development of small molecule anticancer drugs. The firm’s existing three lead candidates, Zymafos (palifosfamide), Zybulin (indibulin), and Zinapar (darinaparsin), are all in clinical development. Zymafos is a bi-functional DNA alkylator and cross-linker comprising the functional active metabolite of ifosfamide, a standard-of-care for treating sarcoma, lymphoma, ovarian, testicular, and other cancers. It is currently undergoing a Phase III trial as front-line therapy for metastatic soft tissue sarcoma. A Phase I intravenous trial is also ongoing to evaluate a combination of palifosfamide with standard-of-care in small cell lung cancer. Ziopharm is in addition preparing to start clinical development of an oral formulation of palifosfamide against solid tumors.
Zybulin is a novel, oral tubulin binding agent that targets both mitosis and cancer cell migration. It is in development for the treatment of solid tumors and is currently being studied in a Phase I/II metastatic breast cancer trial.
Zinapar is a novel organic arsenic mitochondrial-targeting agent being developed for the treatment of various hematologic and solid cancers. The drug is being developed initially for the intravenous treatment of peripheral T cell lymphoma, and a pivotal clinical study is expected to start later this year. An oral formulation of the drug is being evaluated in an Phase I study in solid tumors.