ZIOPHARM Oncology, Inc., a small molecule late-stage oncology drug development company, and Intrexon Corporation, a next generation synthetic biology company, announced today a global exclusive channel partnership in oncology where ZIOPHARM will develop and commercialize DNA-based therapeutics using Intrexon's UltraVector® Technology. Under the partnership, ZIOPHARM will utilize Intrexon's advanced transgene engineering platform for the controlled and precise cellular production of anti-cancer effectors. ZIOPHARM will have rights to Intrexon's entire human in vivo effector platform within the field of oncology which includes two lead clinical-stage product candidates, one which is in an advanced Phase I study and another which will be the subject of an Investigational New Drug ("IND") filing during the first half of 2011. ZIOPHARM and Intrexon will host a conference call and audio webcast today, Thursday, January 6th at 5:00 p.m. ET to discuss the global exclusive channel partnership.
“RJ is a visionary and a winner with a long record of success and value creation in the life sciences. His addition to the ZIOPHARM Board of Directors will be invaluable, and we look forward to his many contributions in this role.”
Intrexon employs its modular genetic engineering platform in the areas of therapeutics, protein production, industrial, and agriculture products. The exclusive channel partnership between Intrexon and ZIOPHARM has been established specifically for the field of human oncologic therapeutics. Under the partnership, Intrexon remains responsible for technology discovery efforts and managing the patent estate as well as for certain aspects of manufacturing. ZIOPHARM will be responsible for conducting preclinical and clinical development of candidates, as well as for other aspects of manufacturing and the commercialization of the candidates.
Intrexon's core synthetic biology technology is designed to create Better DNA™ at industrial scale, enabling unprecedented control over the function and output of living cells by providing external control over in vivo activation and regulation of potent effectors. This platform, called UltraVector®, provides speed, flexibility, consistency and precision to the design, production and testing of rationally designed complex transgenes and their encoded genetic circuits. These qualities allow an iterative and rational approach to transgene design, which can be continually engineered until their performance is optimized. Through this process, Intrexon is able to overcome the challenges inherent in current therapeutic strategies, including recombinant protein therapies and constitutive gene therapies, thereby enhancing capabilities, improving safety and lowering cost for human therapeutics. The lead oncology product candidate developed using Intrexon's technologies is currently in Phase Ib clinical study for metastatic melanoma. ZIOPHARM expects to submit an Investigational New Drug (IND) application with U.S. Food and Drug Administration for a second oncology product candidate in the first half of this year.
"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 application," said Jonathan Lewis, M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of ZIOPHARM. "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 drug development capabilities and our ability to translate science to the patient using our world-class global team."
"We are very pleased to collaborate with ZIOPHARM, which, under the leadership of Jonathan Lewis, is building an industry leading oncology company with a strategic vision regarding cancer medicine. ZIOPHARM's oncology expertise, development capabilities, as well as its excellent reputation within the oncology community make ZIOPHARM an exceptional investment for Intrexon and ideal partner to rapidly achieve the full therapeutic benefit and commercial potential of Intrexon's disruptive technologies," stated RJ Kirk, Intrexon's Chairman and CEO. "This collaboration leverages the capabilities and strengths of each partner and has the potential to create significant value for shareholders."
Under terms of the agreement:
- Intrexon will purchase 2,422,542 shares of ZIOPHARM's common stock (representing 5% of ZIOPHARM's currently outstanding shares) in a private placement for a total purchase price of $11,628,202, or $4.80 per share, which is the trailing 10-day volume-weighted average price per share of ZIOPHARM's common stock;
- ZIOPHARM will simultaneously issue to Intrexon for no additional consideration an additional 3,631,391 shares of its common stock, representing 7.495% of ZIOPHARM's currently outstanding shares; ZIOPHARM has agreed to issue to Intrexon additional shares of its common stock for no additional consideration, representing an additional 7.495% under certain conditions upon dosing of the first patient in a ZIOPHARM-conducted U.S. Phase II clinical trial of a product candidate created, produced or developed by ZIOPHARM using Intrexon technology;
- Intrexon has agreed to purchase up to $50 million in conjunction with securities offerings that may be conducted by ZIOPHARM in the future, subject to certain conditions and limitations;
- Subject to certain expense allocations, ZIOPHARM will pay Intrexon 50% of the cumulative net quarterly profits derived from the sale of products developed from the channel partnership.
Pursuant to the agreement, Mr. Kirk has agreed to join the ZIOPHARM Board of Directors. In addition to his responsibilities at Intrexon, Mr. Kirk has served, since March 1999, as Senior Managing Director and Chief Executive Officer of Third Security, LLC, an investment management firm founded by Mr. Kirk. Additionally, Mr. Kirk founded and became Chairman of the Board of New River Pharmaceuticals Inc. in 1996, and was President and Chief Executive Officer between October 2001 and April 2007. New River was acquired by Shire plc in 2007. Mr. Kirk also currently serves as a member of the Board of Directors of Halozyme Therapeutics, Inc. (Nasdaq: HALO), and as Chairman of the Board for Clinical Data, Inc. (Nasdaq: CLDA). Previously, Mr. Kirk served as a member of the Board of Directors of Scios, Inc. (acquired by Johnson & Johnson) between February 2000 and May 2002. Mr. Kirk served on the Board of Visitors of Radford University from July 2003 to June 2009, was Rector of the Board from September 2006 to September 2008, and has served on the Board of Directors of the Radford University Foundation, Inc. since September 1998. He has served on the Board of Visitors of the University of Virginia and Affiliated Schools since July 2009, on the Virginia Advisory Council on Revenue Estimates since July 2006, on the Governor's Economic Development and Jobs Creation Commission since April 2010, and served as a member of the Board of Directors of the Virginia University Research Partnership from July 2007 to November 2010. Mr. Kirk received a B.A. in Business from Radford University and a J.D. from the University of Virginia.
Regarding Mr. Kirk's appointment, Dr. Lewis added: "RJ is a visionary and a winner with a long record of success and value creation in the life sciences. His addition to the ZIOPHARM Board of Directors will be invaluable, and we look forward to his many contributions in this role."
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