Pharmexa-Epimmune, a subsidiary of Pharmexa A/S, and Ichor Medical Systems have entered into a collaborative agreement and have agreed to licensing terms for Pharmexa's HER-2 DNA AutoVacTM. This is the second time Pharmexa agrees to grant a non-exclusive license to the HER-2 DNA AutoVacTM vaccine.
HER-2 DNA AutoVac(TM) is aimed at breast cancer and has previously shown clinical effects in a Phase I/II study in 27 patients. In December 2002, Pharmexa published that active immunotherapy with up to five repeated doses of HER-2 DNA AutoVac(TM) was safe and well tolerated at all three dose levels examined, and was capable of inducing HER-2 specific cytotoxic T-cells and antibodies in patients with HER-2 positive metastatic breast cancer. According to the company, even in this small sample size trial, there were several indications that HER-2 DNA AutoVac(TM) had anti-tumor activity associated to the T-cell responses in these severely diseased metastatic breast cancer patients. Transient but significant tumor regression was observed in two patients, as measured by changes in metastatic lesions in the liver and in a lymph node, respectively. Stable disease was observed in another two patients, in whom the duration of the response was considered of significant duration in one of the cases, a patient with lytic bone metastasis at study entry.
With the aim to finance the further development, Ichor has submitted an SBIR Fast Track Application on Pharmexa's HER-2 DNA AutoVacTM vaccine delivered with Ichor's TriGridTM Delivery System (TDS) technology. If Ichor receives this SBIR grant, the companies will collaborate on the preclinical and Phase I testing of the vaccine, and Pharmexa will grant Ichor a non-exclusive license to develop the HER-2 DNA AutoVacTM delivered with Ichor's proprietary TDS electroporation technology. The agreement includes future milestone and royalty payments to Pharmexa.