CancerVax licenses PII oncology products

Tarcanta and Tarcanta (Ireland), CancerVax's wholly owned subsidiaries have obtained the exclusive rights to complete the clinical development of three specific active immunotherapeutic (SAI) product candidates that target the epidermal growth factor receptor (EGFR) signaling pathway for the treatment of cancer.

Under the agreements, CancerVax rights include commercialisation of successful product candidates within the US, Western Europe, Canada, Japan, Australia, New Zealand and Mexico. Published data from early Phase I and II studies of the lead product candidate, SAI-EGF, suggest that SAI-EGF was well tolerated and may increase the survival of patients with advanced stage non-small-cell lung cancer¹

The EGFR signaling pathway is known to be an important factor in cancer cell growth in a number of solid tumours, such as lung, glioma, breast, bladder, colorectal, head and neck, ovarian, pancreatic and prostate cancers. In addition to the Phase II product candidate, SAI-EGF, which targets epidermal growth factor (EGF), the licensing agreements also include rights to SAI-TGF-alpha, which targets transforming growth factor-alpha (TGF-alpha) that binds to and activates EGFR, and SAI-EGFR-ECD, which targets the extracellular domain of EGFR, both of which are in preclinical development.

The execution of license agreements for the three product candidates followed the receipt of a license from the US Department of Treasury's Office of Foreign Assets Control, authorising CancerVax and its Tarcanta subsidiaries to enter into the transactions with CIMAB, a Cuban biotechnology company, and YM BioSciences, a Canadian company.

'We are very excited about the potential of these novel product candidates in the treatment of patients with solid tumours. We plan to advance the clinical development of the lead Phase II product candidate, SAI-EGF, in the treatment of non-small-cell lung cancer. The SAI-EGF product candidate, along with the SAI-TGF-alpha and SAI-EGFR-ECD product candidates that are currently in preclinical development, gives CancerVax a pipeline of novel approaches to this important pathway,' said David Hale, president and ceo of CancerVax.

Under the terms of the license agreements, CancerVax will provide upfront access fees, technology transfer fees, development and commercialisation milestones and royalties upon commercial sales, if any. With the execution of these agreements, CancerVax is obligated to make access and technology transfer payments of approximately $6m over the next three years.

If the three product candidates are approved for commercialisation in the US, Europe and Japan, CancerVax is also obligated to pay additional milestone payments, up to a maximum of approximately $35m, based upon meeting specified regulatory, clinical and commercialisation milestones, and royalties on future net sales of product, if any.

'CancerVax has built a portfolio of novel oncology therapies and platforms, including our product candidate, Canvaxin, which is in international Phase III clinical trials for the treatment of patients with Stage III or Stage IV, or advanced-stage, melanoma. We are nearing the completion of enrollment of patients with Stage III melanoma,' said Hale. 'Since each of our three new SAI product candidates is intended to interact with the EGFR signaling pathway in a separate and unique manner, they may potentially be complementary to each other, to other cancer treatments in our pipeline, and to other EGFR, chemotherapy or biological products, which are currently marketed or in clinical development.'