Date: 2015-05-12
Type of information: Licensing agreement
Compound: CVac™ immuno?oncology program
Company: Prima Biomed (Australia) Sydys Corporation (USA - WA)
Therapeutic area: Cancer - Oncology
Type agreement: licensing
Action mechanism: immunotherapy product. CVac therapy is a personalized immunocellular therapeutic that has been investigated for the treatment of epithelial cancers. CVac stimulates the patient’s own immune system to target and destroy tumours. It has been investigated in multiple Phase I and Phase II studies with positiveresults.
Disease:
Details: * On May 12, 2016, Prima BioMed and Sydys Corporation announced an agreement through which Sydys will license Prima’s CVac™ immuno?oncology program and oversee its future development. Under the terms of the agreement, Sydys will license Prima’s CVac related assets, including manufacturing protocols, clinical data from Phase I and Phase II trials, patents and know-how. Prima will also sell certain assets including some equipment and inventory to Sydys. Dr Sharron Gargosky, the former Chief Technical Officer of Prima who has overseen the development of CVac since 2010, will also transition to Sydys as a consultant to continue the development of CVac. Marc Voigt, Prima's CEO, will join the Sydys board of directors soon after closing.
Development highlights for CVac include:
? Completion of a randomized Phase II trial that identified epithelial ovarian cancer patients in second remission as the target CVac patient population
? CR2 patients receiving CVac have experienced a clinically meaningful improvement in overall survival, as indicated by final data analysis. These data demonstrated medianOS of standard of care patients of 25.53 months, while the CVac arm had not reached a median at 42 months (HR=0.17)
? CR2 patients receiving CVac experienced a clinically significant improvement in progression free survival of greater than 12.91 months, compared with a PFS of 4.94 months (HR=0.32) for the standard?of?care CR2 for ovarian cancer is a high unmet medical need; CVac has obtained Orphan Designation for the treatment of ovarian cancer by both the FDA and EMA and Fast Track Designation with the FDA.
Financial terms: In this spin out transaction Prima will receive a 9.9% equity stake in Sydys at the time of closing as consideration for the assets being transferred. Given the significant capital requirements for conducting clinical trials, no upfront payment will be received however should CVac be successfully commercialized, Prima could receive over A$400 million (US$293 million) in development, regulatory and commercial milestone payments payable for achievement of set commercial sales targets, in addition to low single digit royalties on sales.
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