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In fiscal year 2008 and into fiscal year 2009, TJU has celebrated the commercial development successes of three faculty inventions out-licensed by OTT.
Brain Cancer Vaccine
In 2003, BioAdvance awarded its first round of seed investment grants to seven start-up companies. One of the recipients was Spliceomix, Inc., a fledgling company founded one year earlier by TJU faculty member/inventor, Dr. Albert Wong, to further develop a cancer therapeutic vaccine technology with strong, supporting animal model data. Spliceomix had licensed the technology from TJU. The company also received funding from Ben Franklin Technology Partners of Southeastern Pennsylvania in 2003.
Spliceomix was renamed Alteris Therapeutics, Inc., and, in May 2005, Celldex Therapeutics, Inc., a spin-out of Princeton-based biotech Medarex, Inc., entered into an agreement with Alteris to purchase substantially all of its assets.
In October 2007, Celldex and publicly-traded Avant Immunotherapeutics, Inc., of Needham, MA, announced a merger, which completed in March 2008, under which the combined company retained the Celldex name.
In April 2008, Pfizer sub-licensed the experimental cancer therapeutic vaccine from Avant, and TheStreet.com reported that Pfizer “will pay Avant $40 million in cash upfront and make a $10 million equity investment in the micro-cap biotech company in exchange for worldwide rights to CDX-110, a therapeutic vaccine that targets a defective protein thought to promote the growth of cancer cells… In addition to the combined $50 million upfront payment totaling $390 million tied to the successful investment, Avant is eligible to receive milestone development and approval of CDX-110. Pfizer is taking over all development costs for CDX-110 and will pay double-digit royalties to Avant on the sales of the drug, if the drug’s approved.”
In addition to an ongoing Phase II study, a multi-center Phase II/III clinical trial to test CDX-110 for treatment of Newly Diagnosed Glioblastoma Multiforme (GBM) with EGFRvIII Expression is currently enrolling patients.
TJU has received and expects to receive very significant financial compensation from the sub-license arrangement and achievement of further development milestones.
Rabies Therapeutic Antibody
Crucell N.V., a Netherlands-based biopharma with a proprietary cell line for large-scale manufacturing of recombinant proteins and antibodies, licensed TJU’s rabies antibody technology, developed by faculty members Drs Bernard Dietzschold and D. Craig Hooper, in April 2003. The company also sponsored research in Dr. Dietzschold’s laboratory to develop the technology. A two-antibody cocktail containing the licensed antibody was tested in multiple Phase I studies in late 2006 and the beginning of 2007, with promising results.
In January 2008, Crucell announced that it had signed an exclusive agreement with sanofi pasteur, the vaccines division of sanofi-aventis Group, for the rabies monoclonal antibodies for post-exposure prophylaxis. According to Crucell’s press release, “ under the terms of the agreement, Crucell will continue to perform the development activities. Crucell will be responsible for the manufacturing of the final product and will retain exclusive distribution rights in Europe, co-exclusive distribution rights in China, and the rights to sell to supranational organizations such as UNICEF. Crucell will receive a payment of € 10 million following the execution of the agreement and will be eligible for milestone payments of up to € 66.5 million.”
The company also announced that the rabies monoclonal antibody cocktail entered a Phase II clinical trial in the US in March 2008 and abroad in May 2008.
TJU has received and expects to receive sizeable sub-license revenue from this deal.
Targeted Oncolytic Virotherapy
In August 2007, Jennerex Biotherapeutics, Inc., licensed key recombinant vaccinia virus patent rights from TJU for its targeted oncolytic virotherapy platform. The licensed technology was developed by Jefferson faculty members Drs Michael Mastrangelo, Edmund Lattime, David Berd, and Laurence Eisenlohr. The inventors had published a number of articles on a successful Phase I clinical trial for the treatment of malignant melanoma using the technology.
In May 2008, the company announced in a press release the publication of promising results of a Phase I clinical trial on liver cancer. The company planned to begin Phase 2a clinical trials for liver cancer and squamous cell head and neck cancers in early 2008. It is also initiating lung cancer and melanoma clinical trials.
In August 2008, Jennerex announced a further milestone “closing of a financing transaction with gross proceeds of $8.3 million USD, exceeding the target of $8 million USD.”
TJU has received and anticipates the further receipt of substantial license-related income from the company’s continuing development of the technology.
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